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The term “mRNA” only entered the average household in the past few months, as Moderna and Pfizer-BioNTech released their order viagra from canada erectile dysfunction treatments. But a handful of scientists have spent decades studying this novel approach to immunization. By the start of the viagra the technology was already so advanced that, when Chinese researchers published the genetic sequence for the erectile dysfunction in mid-January, Moderna order viagra from canada was able to concoct a treatment within 48 hours. Clinical trials began a matter of weeks after that. In nine months, the world was well on its way to viral security.It was a stunning debut for mRNA — shorthand for messenger ribonucleic acid, DNA’s sidekick — which had long ranked as a promising but unproven treatment.

After this encouraging success, order viagra from canada its proponents predict an equally impressive future. They have always believed in mRNA’s ability to protect against not only the likes of erectile dysfunction, but also a host of deadly diseases that resist traditional treatments, from malaria to HIV to cancer. In 2018, long before the past year’s confidence-boosting display, a group of researchers announced order viagra from canada “a new era in vaccinology.”It remains to be seen whether mRNA will live up to the hype. With concrete results attesting to its potential, though, interest is growing among investors and researchers alike. It helps that regulatory agencies and the public are familiar with it now, too, says Yale immunologist Rick Bucala.

€œThat has order viagra from canada really changed the landscape.”Andrew Geall, co-founder of one company testing RNA treatments and chief scientific officer of another, notes that mRNA has only just entered its infancy after a long gestation. Such is the nature of scientific progress. €œWe’ve had the technology bubbling for 20 years, and the major breakthrough is this clinical proof of two treatments,” he says. €œNow we’re set for 10 years of excitement.”Next Steps for mRNAThe goal of any treatment is to train the immune system to order viagra from canada recognize and defend against a viagra. Traditional treatments do so by exposing the body to the viagra itself, weakened or dead, or to a part of the viagra, called an antigen.

The new shots, as their name suggests, introduce only mRNA — the genetic material that, as you may remember from high school biology, order viagra from canada carries instructions for making proteins. Once the mRNA enters the cells, particles called ribosomes read its instructions and use them to build the encoded proteins. In the case of the erectile dysfunction treatments, those proteins are the crown-shaped “spike” antigens from which the erectile dysfunction derives its name (“corona” means crown in Latin). By themselves they are harmless, but the immune order viagra from canada system attacks them as foreign invaders, and in doing so learns how to ward off the real viagra. If it ever rears its spiky head thereafter, the body will remember and swiftly destroy it.But besides liberating the world from the worst viagra in generations, mRNA could help to vanquish many an intractable illness.

If all order viagra from canada the dreams of its advocates are realized, the erectile dysfunction treatments may, in hindsight, be only a proof of concept. In February, for example, Bucala and his colleagues patented a treatment against malaria, which has likely killed more humans than any other single cause and has mostly withstood immunization.Justin Richner, an immunologist with the University of Illinois, Chicago, is developing an mRNA treatment for dengue, another highly resistant viagra. Because mRNA is simply a genetic sequence, scientists can easily tweak it as necessary to find the most effective combination. €œOne of the advantages of the mRNA platform is how it can be so easily modified and manipulated to test novel order viagra from canada hypotheses,” Richner says.Read more. Dengue Fever Is on the Rise — a Ticking Time Bomb in Many Places Around the WorldGeall says the obvious candidates for mRNA treatments include what he calls the “Big 6,” all of which remain crafty foes.

Malaria, cancer, tuberculosis HIV, cytomegaloviagra, and respiratory syncytial viagra. His own company, Replicate Bioscience, order viagra from canada is working on the cancer front, as are several others, including BioNTech. Through genetic analysis of individual tumors, patients could one day receive personalized treatments, designed to target the specific mutations afflicting them.Currently, it’s difficult to tell whether an mRNA treatment will work on any particular pathogen. Many have shown promise in animal trials, only to falter in our order viagra from canada species. As Geall put it, “mice are not humans.” Some appear to be better bets than others — cytomegaloviagra and RSV respiratory syncytial viagra in particular — but for now, it’s too early to say where mRNA will next bear fruit.

€œDespite all we know about immunology, a lot of it is really empiric,” Bucala says. €œYou just have to try things and see if they work.” The viagra TamerBased on its recent achievements, mRNA’s next act may well order viagra from canada involve the next viagra. Perhaps its biggest strength is that it can be manufactured at speeds unheard of in the realm of traditional treatments, making it well-suited to addressing sudden surges of viagraes. €œOne of the great things about the mRNA field is how quickly you can go from a concept into a therapy that is ready for clinical trials,” Richner says. €œWe can make multiple different treatments and test them in a really rapid process.”Read order viagra from canada more.

erectile dysfunction treatment. A Basic Guide to Different treatment Types and order viagra from canada How They WorkSince 2018, Pfizer and BioNTech have been working on an mRNA treatment for seasonal flu. Under the status quo, experts must predict which variation of the viagra will pose the greatest threat each year and produce treatments to match it. But because mRNA is so easy to edit, it can be modified more efficiently to keep pace with the ever-mutating strains. €œI do think order viagra from canada the influenza treatment field will be transformed in the not too distant future,” Richner says.

A similar kind of gene-based treatment, made with self-amplifying RNA (saRNA), is even more nimble. Whereas basic mRNA treatments — like Moderna’s and Pfizer-BioNTech’s — inject all the genetic material at once, the self-amplifying version replicates order viagra from canada itself inside the cell. Just a small dose of this potent product can trigger the same immune response as a syringe-full of the current shots. Bucala’s malaria treatment and Geall’s cancer treatments both use this technology. €œThe big problem is order viagra from canada that treatments don’t prevent s,” Bucala says.

€œVaccinations prevent s.” With saRNA, manufacturers can ensure a lot more of them. After mRNA’s brilliant battle against erectile dysfunction treatment, it’s tempting to think of it as a panacea. But, Bucala says, “Is there something intrinsically order viagra from canada revolutionary about mRNA?. We don’t know yet.”It does come with some logistical challenges. For example, mRNA breaks down easily, so it must be refrigerated throughout the distribution order viagra from canada process.

Hurdles aside, though, the possibilities are vast, and investment may rise to meet the industry’s ambitions. treatment development isn’t typically a lucrative business, but erectile dysfunction treatment has made more than a few billionaires, “and others are watching,” Bucala says. €œI think it should become economically viable in our [current] model to get into treatment work again.”Geall agrees order viagra from canada. Even if some mRNA endeavors fizzle out, at least a few are bound to make the world proud. €œThere’s a lot of money out there that is going to be invested into these new approaches,” he says.

€œWe’re going to see failures, order viagra from canada but we’re going to see successes for sure.”When the U.S. Cracked down on drugs in the 1970s, the effort dried up most funding and research into psychedelic substances — which only in the past few years have regained momentum in the field of psychotherapy. In the ’70s, order viagra from canada rather than shut down all his work, one psychedelic researcher at Johns Hopkins University, Stan Grof, turned his attention to another potential avenue for attaining non-ordinary states of consciousness. Breathing.Grof, alongside his wife at the time, Christina Grof, developed the term Holotropic Breathwork for this technique, which loosely translates as “moving toward wholeness.” The practice in experiential psychotherapy emerged in the 1980s as a tool for self-exploration and inner healing, and has certified teaches who now facilitate it around the world. The framework integrates music with modern consciousness research, psychology and Eastern spiritual practices, according to the Grof Transpersonal Training program.Many people today teach this intense breathing practice, and other similar techniques that preceded it, such as kundalini yoga or pranayama.

But questions remain about the science behind what exactly is happening in the mind and body while practitioners lie on the floor and breathe order viagra from canada persistently in rapid patterns. And some clinicians have raised concerns about the safety, and risks, in a field with limited peer-reviewed studies.Meditation on a Freight TrainStacia Butterfield has been a certified Holotropic Breathwork teacher with Grof Transpersonal Training for roughly 15 years. She committed to the work order viagra from canada after having her own life-changing experience at a workshop, and has since worked closely with Grof himself and guided thousands of people in the practice. €œIt’s deceptively simple. It seems like just turning on music, laying down and taking some breaths, and away you go,” Butterfield says.

€œWhat we’re actually relying on is the spontaneous mobilization of the psyche.”First and order viagra from canada foremost, a guided Holotropic Breathwork session requires creating a safe container, Butterfield says, where people can let go of inhibitions or mental blocks. Facilitators are trained to guide people through that process in a group setting.One session lasts between two and three hours — often as part of a weekend or week-long retreat. People pair off and alternate in the roles of “sitter” (assisting the other) and “breather” (the person doing the heavy breathing). To begin, rhythmic order viagra from canada drumming sets the mood. The breather lays down and starts breathing rapidly, in a continuous way with no real break between inhales and exhales.The music typically has an emotional arc, almost like a movie soundtrack.

It might start off evocative and stimulating, then turn “increasingly dramatic and dynamic, and finally it order viagra from canada reaches a breakthrough quality,” according to a guide written by Stan and Christina Grof. This guide notes that when the breathing leads to non-ordinary states of consciousness in a practitioner, “there is a potential for unusually intense projections, including regressed longings for nurturing, sexual contact, or spiritual connection.” Facilitators are advised to assist clients with these feelings as they arise, while following their agreement to conduct the practice in an ethical manner.Butterfield says one core principle, like somatic therapy, is for participants to become aware of the messages and wisdom in their own body. €œSo many people are so busy, just cruising around [and] keeping the lid on everything else that is going on internally,” she says. €œ[In a session] they can just close their order viagra from canada eyes and go inward, and see what’s there.” She says visions, strong bodily sensations and emotions often arise. And she has watched people who had tried years of talk therapy make substantial progress in processing grief and loss, past trauma, life changes or even mental illnesses.One practitioner aptly described this practice as “meditation on a freight train,” Butterfield adds.

The reported dramatic experiences spark questions about what might actually be happening within the body and brain.Mysticism or Hyperventilation?. Pulmonologist Michael order viagra from canada Stephen, author of the book Breath Taking, says the practice of Holotropic Breathwork raises red flags for him because of its use of over-breathing, or hyperventilation. Biologically, when someone breathes heavily for an extended period, they can lose too much carbon dioxide, which makes the blood overly alkaline. The phenomenon often triggers an immediately physiological order viagra from canada response. €œWe start to get tingly in our fingers and dizzy when we hyperventilate, as our pH is rising too much,” says Stephen.Prolonged, excessive pH levels in the blood can also cause seizures, he adds.

€œJust before seizures happen, you can get lightheaded, a sort of high.” He attributes this to the non-ordinary states of consciousness that people might feel during Holotropic Breathwork. But he says few proper studies have order viagra from canada been done on the practice because of the dangers and ethics involved.Casualties of Heavy BreathingAnother breath specialist and integrative psychiatrist, Patricia Gerbarg, says that Holotropic Breathwork, and other forceful respiratory practices such as breath of fire, do have the potential to alter the mind. They can also bring about a lasting impact on people, but it’s not always beneficial or predictable.“It’s a stress on the system. You’re going through rapid changes in oxygen levels and the balance of various substances in order viagra from canada the body and the brain,” she says. And similar to drugs, “people can use them to attain different mental states,” she adds.Read More.

Can Breathing Like Wim Hof Make Us Super Human?. Healthy people tend to have a broader tolerance to endure these order viagra from canada shifts and unpredictable outcomes. But the same behavior can be harmful to someone who is less healthy, or dealing with a psychological disorder, says Gerbarg, who teaches psychiatry at New York Medical College.“Those kinds of intense, rapid shifts in your brain chemistry can cause adverse effects,” she says, adding that she is familiar with cases where people feel they “never recovered” from what these states did to them. Some literature uses the term kundalini psychosis, or physio kundalini syndrome, to describe people who cognitively lose touch with reality in pursuit of "spiritual awakening."One of Gerbarg’s concerns about the rise in popularity of these advanced, Eastern breathing practices is how they are inserted into the Western world and modern mindset. (Two other intense and forceful breathing practices include Tummo breathing, with a Tibetan buddhist lineage, and the Wim Hof Method.) The breathwork is often tied closely to a lifestyle and belief system, and many traditional practitioners dedicate hours a day for many years to master the techniques in a healthy way order viagra from canada.

Alternatively, people in modern Western cultures often struggle to commit to a new practice for 20 minute a day. €œ[Intense breathwork] is order viagra from canada becoming increasingly popular and people are doing it online,” Gerbarg says. €œThey aren’t often aware that there are risks,” or they might not know the pre-existing conditions their students have. The big responsibility ultimately falls on the teachers and facilitators to ensure everyone is safe. A Gentler TouchGerbarg and her husband Richard Brown, a professor of psychiatry at Columbia College of Physicians and Surgeons, have published several books on the healing potential of breath order viagra from canada.

And they offer evidence-based workshops and teaching resources through their Breath-Body-Mind Foundation.One of their most popular techniques, called coherent breathing, teaches gentle, slower and relaxed respiration. Once practitioners learn it, they can use it any point throughout the day when stress or anxiety is likely to rise up — even in mundane circumstances like being stuck in a long line — and trigger a string of reactions in the body.The goal is to inhale and exhale slowly through the nose at a rate of about five breaths per minute, or one breath cycle every 12 seconds. Gerbarg says this process can promptly activate the order viagra from canada rest-and-restore parasympathetic nervous system throughout the body, with millions of reactions and signals firing every second.Read More. How Slow, Deep Breathing Taps Into a Natural Rhythm in Our Bodies“It tells the brain, ‘the conditions are safe,’ ” she says. €œThe less effort, the more you get out order viagra from canada of this one.”The results of this technique may not feel like the freight-train experience of altered consciousness.

But it carries less risk and broader appeal to anyone interested in channeling their own breath for health and wellness.In a year marked by a viagra, economic downturn, racial unrest, and an election that culminated with a mob storming the U.S. Capitol, we’ve come face to face with stressors we could never have imagined prior to 2020. The causes order viagra from canada and health impacts of stress have been widely discussed as have a host of tools for tackling the mounting anxiety we feel in our daily lives. But cortisol, among the body’s most important steroid hormones, at the helm of our stress response, remains largely a mystery. Is our fight-or-flight response really tied to order viagra from canada our prehistoric ancestors?.

Has our modern world evolved beyond the antiquated workings of our endocrine system?. Here’s what we know. A Caveman order viagra from canada Instinct?. Cortisol, along with epinephrine and norepinephrine, activate the body’s sympathetic nervous system, triggering a lineup of physiological responses that speed up respiration, constrict blood vessels, dilate pupils, and slow down the digestive system. It’s called a fight-or-flight response, and it allows muscles to react more powerfully and move faster, priming us to, well, fight or flee.

Alan Goodman, a biological anthropologist at order viagra from canada Hampshire College in Amherst, MA, studies stress in prehistoric humans. He agrees that cortisol and the entire acute stress response system is an evolutionary design. “It’s an ancient mammalian system adapted to protect hunter order viagra from canada gathers,” says Goodman. Still, getting a window into the daily stress levels of prehistoric humans is difficult because we can’t look at their blood, he says, and cortisol doesn’t preserve well. Research published in the International Journal of Paleopathology, looked at cortisol accumulation in the hair of 2,000-year-old Peruvian mummies and found “repeated exposure to stress.” Another small pilot study of the same population found that hair samples suggest social, physiological, and environmental circumstances “strongly impacted stress levels.” But the research, says Goodman, has its shortcomings.

The study authors can’t rule out chemical changes to the samples over time and we’re not sure how accumulation in the hair corresponds to that of the blood order viagra from canada. Goodman prefers to look at skeletal indicators of prehistoric stress because cortisol production can also impact bone and teeth metabolism. He studies ancient populations in the Illinois River Valley from around 1200 AD, during the transition from hunting and gathering to order viagra from canada farming. “Enamel on the teeth grows like an onion and you can tell from teeth’s layers the years when the body was stressed,” says Goodman. His research shows a stress response likely brought on by the move from hunting and gathering to the building of civilizations and establishment of society.

€œLife becomes more complicated because societal structures have order viagra from canada a hierarchy,” he says. With the haves and have-nots, the winners and losers, stress becomes more convoluted, no longer confined to immediate threats. Goodman notices this in the teeth as humans build societies under chieftains. Although the enamel order viagra from canada stops growing once permanent teeth develop, a growth stunt, known as enamel dysplasia, is frozen in time. Like the rings of a tree, you can see the years when life was stressful.

This too, says order viagra from canada Goodman, is an imperfect model because and malnutrition can also impact enamel production. But after spending his career studying these populations, Goodman suspects it’s likely a combination of all three. He says that it’s clear stress has been around since the dawn of time but today our response has become more prolonged and in some cases, maladaptive. Chronic Disease and Cortisol Production In ancient populations high cortisol levels meant good health, basically indicating that a human order viagra from canada could still compete for survival, but in modern populations it can spell disaster. Sudha Seshadri, a professor of neurology and founder of the Glenn Biggs Institute for Alzheimer's &.

Neurodegenerative Diseases at the University of Texas Health Science Center in San Antonio, studies the link between neurodegenerative diseases and high cortisol levels. Cortisol levels, she says, should vary throughout the day, highest in the morning order viagra from canada when we’re the most active and lowest late at night when we should be sleeping. If levels don’t vary or are overly elevated in the morning, cortisol production can start to impact other parts of the body. €œChronic activation of fight or order viagra from canada flight can cause problems in certain regions of the brain,” says Seshadri. Her research published in the journal Neurology, has shown that those with higher morning cortisol levels are more likely to have problems with parts of the brain responsible for memory retention like the hypothalamus, which can be an early indicator of dementia and Alzheimer’s disease.

Chronic high cortisol levels are also linked to high blood pressure, heart disease, anxiety, and depression. Reducing Cortisol Levels People respond to stress with different degrees of cortisol activation, says Seshadri, order viagra from canada partially based on genetics and partially based on life experiences. €œHyper-activation” of fight or flight especially during early childhood, is linked to exaggerated responses to stress later in life. €œIt’s a vicious cycle, the more you’re exposed to stress, the more likely you order viagra from canada are to have an exaggerated response to it,” says Seshadri. For parents, monitoring responses to stress can have lifelong implications for children.

Studies also suggest that meditation seems to reduce cortisol levels, as does biofeedback, a technique that monitors heart rate, respiration, brain waves, muscle contractions, and perspiration and allows patients to respond to indicators in the moment, building awareness around and slowing their stress response. Additionally, exercise order viagra from canada generates its own positive chemicals for counteracting cortisol like dopamine, norepinephrine, and serotonin. Both Goodman and Seshadri agree that fight or flight is found in both modern and prehistoric populations. But it’s meant to help humans rapidly react to a physical threat and then laugh off their brush with death later, not stew all night over a perceived danger that never happens. “The problem with humans is that we’re symbolic beings, constantly finding meaning in situations where order viagra from canada there wasn’t any,” Goodman says.

Experts contend that cortisol still plays an important role in keeping us safe in our modern world. But the key is dampening your response once the threat has lifted, instead of constantly fearing the imagined sabertooth tiger lunging from around the corner.I was called to see Albert, a 35-year-old man, while he was an inpatient order viagra from canada at our hospital. Albert had experienced a bout of hematemesis (vomiting blood) and had been admitted to determine the cause. Although dramatic in nature, hematemesis is a common complaint that we gastroenterologists are trained to evaluate and treat. Most patients have garden-variety problems, such as stomach ulcers or esophagitis (inflammation in order viagra from canada the esophagus from acid reflux), that can lead to hematemesis.

These troubles are generally easily managed. But not this time.Albert told me that he had been feeling poorly for several months, with symptoms that seemed to come and go. He often experienced severe left-sided back pain that order viagra from canada would come on out of the blue, leave him in agony for a few days, and then suddenly disappear. Sometimes, he would get abdominal pains that would leave him doubled over, only to have them vanish for weeks at a time. This time, he had order viagra from canada been at home, feeling fine, when suddenly he was overcome by abdominal cramps and nausea.

He ran to the bathroom and retched severely, eventually bringing up the blood. Naturally, the episode terrified him. He called 911 and here he was.At the time of order viagra from canada our first visit, Albert seemed fine. He had been in the hospital for just under a day and was feeling like his old self. He wasn’t order viagra from canada taking any of the medications known to promote the formation of stomach ulcers — over-the-counter anti-inflammatories such as aspirin or ibuprofen are among the most common — and he denied ever having reflux symptoms.

His physical exam and blood tests were essentially normal. I suggested that we schedule an upper endoscopic exam for the next day, which would involve inserting a flexible camera into his mouth to evaluate his esophagus, stomach and the beginning of his small bowel, in order to look for a source of blood loss.Off to the ICU Upon arriving at the endoscopy lab the next day, I couldn’t help but notice that Albert’s name had been removed from the schedule of patients. I asked our receptionist what had happened order viagra from canada and was told that Albert had been moved to the intensive care unit. He was too unstable to undergo his endoscopic procedure. Assuming that he had vomited blood again — recurrent episodes of hematemesis are also common — I went to the ICU to see him, only to be told some startling news by the physician in charge.

Albert had experienced severe hemoptysis order viagra from canada (coughing up blood from his lungs), which had prompted his transfer to intensive care. He was currently on a ventilator as he was struggling to get enough oxygen on his own.This was a striking development. Hematemesis and hemoptysis are very different clinical entities, and usually the diseases that lead to one do order viagra from canada not lead to the other. Could Albert have two separate disease processes occurring simultaneously?. It was possible, but seemed unlikely.

I still wanted to get order viagra from canada a look at Albert’s esophagus, stomach and small bowel. The ICU doctors also wanted to get a good look at his lungs via a different type of endoscopy, known as a bronchoscopy. We agreed that we would both perform our respective examinations the following day, in the ICU, where he could be monitored closely. I also suggested we get a CT scan of Albert’s chest, abdomen and order viagra from canada pelvis.That evening, I got a call from the radiologist on call regarding the CT scan results — never a good sign. Albert appeared to have a mass in his left kidney as well as similar smaller lesions in his lungs and in the lining of his stomach.

The radiologist told me that this appeared to be kidney cancer that had already spread to many other sites in the body.This order viagra from canada was obviously very disturbing and ominous news. Still, it seemed to explain Albert’s symptoms and provide a unifying diagnosis. Cancerous lesions in the stomach and lungs can and do bleed. I logged on to my computer from home to look at the CT scan myself, and it order viagra from canada certainly looked to me just as the radiologist had described. But … I also noticed that the radiologist also reported that Albert had undergone prior surgical removal of his spleen, a fact that Albert had not mentioned to me when I asked him about his prior medical history.By the time I arrived in the ICU the next day, Albert had been removed from the ventilator and was breathing on his own.

He had already been told the results of his CT order viagra from canada scan and was understandably dejected. As we were setting up to do his endoscopy and bronchoscopy, I asked him what had happened to his spleen. €œOh, yeah,” he said, clearly recalling something he had not thought of in some time, “I was in a car accident in high school and my spleen ruptured and had to be removed. I forgot all about it.”After Albert was sedated, I inserted the endoscope order viagra from canada through his mouth. His esophagus was normal.

I did see several raised red lesions in the lining of his stomach. I have performed many order viagra from canada thousands of endoscopic procedures and seen more than my share of cancer. But these lesions did not look like cancer at all!. I was cautiously order viagra from canada optimistic. Still, the lesions were abnormal, so I dutifully biopsied several of the worrisome spots.

The rest of his exam was normal. When the order viagra from canada pulmonologists looked in Albert’s lungs with their bronchoscope, they saw similar spots. I suggested that they biopsy them as well, and began to wonder about Albert’s missing spleen. Perhaps we were wrong about his diagnosis.Venting His SpleenThe next day, the pathologist assigned to the case phoned me regarding Albert’s biopsies. He wanted to be sure we had biopsied the right areas order viagra from canada.

What he saw under his microscope didn’t look like stomach or lung. They appeared to be biopsies from order viagra from canada the spleen. Now we were getting somewhere.Albert didn’t have cancer, I concluded. He had splenosis. This is order viagra from canada a rare condition where tissue from a patient’s own spleen migrates to other parts of their body.

Trauma to the spleen — in the case of a car accident, for example — can result in splenic tissue being released into the abdomen and/or the bloodstream. From there, the tissue can take up residence almost order viagra from canada anywhere in the body. How tissue from the spleen is able to transplant itself is not well understood. Splenic lesions can be solitary or multiple, and we were not the first doctors to think a patient with splenosis had cancer. Sometimes the lesions in splenosis are totally asymptomatic, but they can cause bleeding or pain, compress other organs, and even lead to seizures if they find a foothold in the brain.The treatment for splenosis is to remove or ablate order viagra from canada symptomatic lesions.

The pulmonologist and I repeated our respective procedures and, using devices capable of cauterizing tissue, burned off as much of the errant splenic tissue as possible. We also removed the mass in Albert’s kidney. It too was splenic order viagra from canada tissue.All of this was a consequence of a car accident that had happened almost two decades ago. The splenic tissue had been alive in Albert all this time. Why the lung and order viagra from canada stomach lesions decided to bleed at nearly the same time remains a mystery.

Albert still has splenic implants in his body that can be treated if need be in the future, but he was overjoyed with his final diagnosis. It was certainly better than metastatic cancer. Douglas order viagra from canada G. Adler is a professor of medicine at the University of Utah School of Medicine in Salt Lake City. The cases described in Vital Signs are real, but names and certain details have been changed..

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When I started writing about science decades ago, artificial viagra patent intelligence seemed ascendant buy viagra. IEEE Spectrum, the technology magazine for which I worked, produced a special issue on how AI would transform the world. I edited an article in which computer scientist Frederick Hayes-Roth predicted that AI would soon replace experts in law, medicine, finance and other professions viagra patent.

That was in 1984. Not long afterward, the exuberance gave way to viagra patent a slump known as an “AI winter,” when disillusionment set in and funding declined. Years later, doing research for my book The Undiscovered Mind, I tracked Hayes-Roth down to ask how he thought his predictions had held up.

He laughed and replied, “You’ve got a mean streak.” AI had not lived up to expectations, he acknowledged. Our minds are hard to replicate, because we are “very, very complicated systems that are both evolved and viagra patent adapted through learning to deal well and differentially with dozens of variables at one time.” Algorithms that can perform a specialized task, like playing chess, cannot be easily adapted for other purposes. €œIt is an example of what is called nonrecurrent engineering,” Hayes-Roth explained.

That was viagra patent 1998. Today, according to some measures, AI is booming once again. Programs such as voice and face recognition are embedded in cell phones, televisions, cars and countless other consumer products.

Clever algorithms help viagra patent me choose a Christmas present for my girlfriend, find my daughter’s building in Brooklyn and gather information for columns like this one. Venture-capital investments in AI doubled between 2017 and 2018 to $40 billion, according to WIRED. A Price Waterhouse study estimates that by 2030 AI will boost global economic output by more than $15 trillion, “more than the current output of China and India combined.” In fact, some observers fear viagra patent that AI is moving too fast.

New York Times columnist Farhad Manjoo calls an AI-based reading and writing program, GPT-3, “amazing, spooky, humbling and more than a little terrifying.” Someday, he frets, he might be “put out to pasture by a machine.” Neuroscientist Christof Koch has suggested that we might need computer chips implanted in our brains to help us keep up with intelligent machines. Elon Musk made headlines in 2018 when he warned that “superintelligent” AI, much smarter than we are, represents “the single biggest existential crisis that we face.” (Really?. Worse than climate viagra patent change?.

Nuclear weapons?. Psychopathic politicians? viagra patent. I suspect that Musk, who has invested in AI, is trying to promote the technology with his over-the-top fearmongering.) Experts are pushing back against the hype, pointing out that many alleged advances in AI are based on flimsy evidence.

Last January, for example, viagra patent a team from Google Health claimed in Nature that their AI program had outperformed humans in diagnosing breast cancer. In October, a group led by Benjamin Haibe-Kains, a computational genomics researcher, criticized the Google health paper, arguing that the “lack of details of the methods and algorithm code undermines its scientific value.” Haibe-Kains complained to Technology Review that the Google Health report is “more an advertisement for cool technology” than a legitimate, reproducible scientific study. The same is true of other reported advances, he said.

Indeed, artificial intelligence, like viagra patent biomedicine and other fields, has become mired in a replication crisis. Researchers make dramatic claims that cannot be tested, because researchers—especially those in industry—do not disclose their algorithms. One recent review found that only 15 percent of AI studies viagra patent shared their code.

There are also signs that investments in AI are not paying off. Technology analyst Jeffrey Funk recently examined 40 start-up companies developing AI for health care, manufacturing, energy, finance, cybersecurity, transportation and other industries. Many of them were not “nearly as valuable to society viagra patent as all the hype would suggest,” Funk reports in IEEE Spectrum.

Advances in AI “are unlikely to be nearly as disruptive—for companies, for workers, or for the economy as a whole—as many observers have been arguing.” Science reports that “core progress in AI has stalled in some fields,” such as information retrieval and product recommendation. A study of algorithms viagra patent used to improve the performance of neural networks found “no clear evidence of performance improvements over a 10-year period.” The longstanding goal of “general” artificial intelligence, possessing the broad knowledge and learning capacity to solve a variety of real-world problems, as humans do, remains elusive. €œWe have machines that learn in a very narrow way,” Yoshua Bengio, a pioneer in the AI approach called deep learning, recently complained in WIRED.

€œThey need much more data to learn a task than human examples of intelligence, and they still make stupid mistakes.” Writing in The Gradient, an online magazine devoted to tech, AI entrepreneur and writer Gary Marcus accuses AI leaders as well as the media of exaggerating the field’s progress. AI-based autonomous cars, fake news detectors, diagnostic programs viagra patent and chatbots have all been oversold, Marcus contends. He warns that “if and when the public, governments, and investment community recognize that they have been sold an unrealistic picture of AI’s strengths and weaknesses that doesn't match reality, a new AI winter may commence.” Another AI veteran and writer, Erik Larson, questions the “myth” that one day AI will inevitably equal or surpass human intelligence.

In The Myth of Artificial viagra patent Intelligence. Why Computers Can’t Think the Way We Do, scheduled to be released by Harvard University Press in April, Larson argues that “success with narrow applications gets us not one step closer to general intelligence.” Larson says “the actual science of AI (as opposed to the pseudoscience of Hollywood and science fiction novelists) has uncovered a very large mystery at the heart of intelligence, which no one currently has a clue how to solve. Put bluntly.

All evidence suggests viagra patent that human and machine intelligence are radically different. And yet the myth of inevitability persists.” When I first started writing about science, I believed the myth of AI. One day, viagra patent surely, researchers would achieve the goal of a flexible, supersmart, all-purpose artificial intelligence, like HAL.

Given rapid advances in computer hardware and software, it was only a matter of time. And who was I to doubt authorities like Marvin Minsky? viagra patent. Gradually, I became an AI doubter, as I realized that our minds—in spite of enormous advances in neuroscience, genetics, cognitive science and, yes, artificial intelligence—remain as mysterious as ever.

Here’s the paradox. Machines are becoming undeniably smarter—and humans, it seems lately, more stupid, and yet machines will viagra patent never equal, let alone surpass, our intelligence. They will always remain mere machines.

That’s my guess, and my viagra patent hope. Further Reading. How Would AI Cover an AI Conference?.

Do We Need Brain Implants to Keep Up with Robots? viagra patent. The Many Minds of Marvin Minsky (R.I.P.) The Singularity and the Neural Code Who Wants to Be a Cyborg?. Mind-Body ProblemsThe items below are highlights from the free newsletter, “Smart, useful, science viagra patent stuff about erectile dysfunction treatment.” To receive newsletter issues daily in your inbox, sign up here.

Canada has pre-ordered more doses per person of treatments against erectile dysfunction than have any other countries and purchasing groups, reports freelance science journalist Asher Mullard for Nature (11/30/20). The U.S. And UK come in 2nd viagra patent and 3rd.

The story includes 2 graphics that illustrate the pre-ordering landscape. €œMany people in viagra patent low-income countries might have to wait until 2023 or 2024 for vaccination, according to estimates from the Duke Global Health Innovation Center,” Mullard writes. The makers of three treatments that look like they will be distributed widely in 2021 (AstraZeneca, Moderna, and Pfizer/BioNTech) forecast making an estimated total of 5.3 billion doses next year.

That would cover between 2.6 billion and 3.1 billion people, the story states. Most of those doses are already spoken for by individual, largely affluent or middle-income countries, the story states, leaving little for viagra patent low- and middle-income nations, “most of which seem to be relying on contributions from” a joint venture called COVAX. The purchasing and distribution group was formed to ensure equitable global access to treatments against erectile dysfunction.

Virologist and viagra patent treatment researcher Shane Crotty at the La Jolla Institute for Immunology tweeted a thread on 11/27/20 discussing the safety of RNA treatments (like those being tested by Moderna and Pfizer/BioNTech on large numbers of people and expected to receive emergency-use approval soon by the U.S. Food and Drug Administration). Crotty writes that RNA is analogous in some ways to viagra patent expiring messages on social media platforms, and that RNA treatments are “temporary messages instructing cells to make one viral protein temporarily.” He adds, “It takes 25 different erectile dysfunction proteins [complex molecules] to make a erectile dysfunction, so there is no worry about the RNA making a viagra.” Below is an estimated timeline for erectile dysfunction treatment distribution in the U.S., based on a thread tweeted by Dr.

Ashish Jha, dean of the Brown University School of Public Health, on 11/22/20. Jha drew the details in part from a televised interview between CNN’s Jake Tapper and Dr. Moncef Slaoui, chief scientific viagra patent advisor to Operation Warp Speed (the U.S.’s federally funded treatment development effort).

Https://threadreaderapp.com/thread/1330519144178085899.html First public immunizations (health care workers and long-term care facility residents, if U.S. Centers for Disease Control’s 12/2/20 recommendations are followed) would viagra patent start Dec. 11 or 12;perhaps 20 million people in U.S.

Vaccinated by end of December. About 30 viagra patent million more people in U.S. Vaccinated by end of January 2021, and combined with total people who have recovered from s, “that’ll slow spread,” Jha writes;about 40 percent immunity in the U.S.

Population by viagra patent February, bringing “meaningfully slower” spread of erectile dysfunction. treatments widely available in U.S. By April/May 2021 Moderna says it will soon start testing its messenger-RNA treatment against erectile dysfunction in 3,000 teenagers, reports Denise Grady at The New York Times (12/2/20).

AstraZeneca and Pfizer/BioNTech already made similar announcements for testing their treatments in children, the story states viagra patent. All three treatment groups each recently announced that their treatments are effective in large-scale experiments with adults, but “no treatment can be widely given to children until it has been tested in them,” Grady writes. €œtreatments meant for both adults and children viagra patent are generally tested first in adults to help make sure they are safe for pediatric trials [experiments].” treatments that work well in adults tend to also work well in children, with some dosing adjustments, according to Dr.

Paul Offit, a treatment researcher at Children’s Hospital of Philadelphia, Grady writes. Https://www.nytimes.com/2020/12/02/health/erectile dysfunction treatment-Moderna-treatment-children.html. Two recent studies suggest that wearing even an N95 mask during vigorous exercise did not result in workouts that felt harder or actually were viagra patent more physiologically draining, writes Gretchen Reynolds at The New York Times (11/18/20).

One of the studies found more carbon dioxide in the breath of N95-masked exercisers, but none of the subjects complained of headaches or breathing issues, the story states. The results came viagra patent as a surprise to the study subjects, Reynolds writes. The studies were conducted on healthy, active adults, so it is not clear if the findings would be the same in people who are less healthy or less active or who have breathing problems, the story states.

€œThe findings suggest that anyone who hesitates to wear a mask during exercise should try one — although not an N95 mask,” the story describes one of the study authors, an internal medicine physician at Rambam Health viagra patent Care Campus, as saying. Those masks slightly increase exercisers’ carbon dioxide levels and should be reserved for health care workers anyway, states the story, which also was published in Spanish. As anticipated, the U.S.

Centers for Disease Control (CDC) released recommendations (on 12/2/20) that include shortening the quarantine period from 14 days to as few as 7 days, at least for people who think they’ve could’ve been exposed to erectile dysfunction but then test negative, reports Colin Dwyer viagra patent at NPR. €œPeople should still watch closely for symptoms — such as a fever, a cough or a loss of taste or smell — for a full 14 days after possible exposure,” according to the CDC’s incident manager for its erectile dysfunction treatment response, Dwyer writes. The change is meant to increase the odds that people will comply with viagra patent the agency’s quarantine recommendations, the story states.

It also “allows health officials to focus their efforts on the period of time that people are most likely to become contagious,” the story quotes epidemiologist Jennifer Nuzzo of the Johns Hopkins Center for Health Security as saying (12/2/20). And if you’re confused about the meaning of quarantine versus isolation, or about the distinction between asymptomatic and presymptomatic, and the like, check out this helpful piece, “Clarifying erectile dysfunction treatment terminology,” by Lindsay Smith Rogers for Johns Hopkins Bloomberg School of Public Health (11/23/20). An 11/16/20 Q&A at Scientific American with Andrew Huberman, a Stanford University neuroscientist who studies viagra patent the visual system, details how our vision and our breathing can “offer us easy and accessible releases from stress,” particularly in the context of the viagra challenges and overall intensity of 2020.

For instance, emerging research suggests that altering our breathing can alter brain regions responsible for arousal and panic, writes freelance science journalist Jessica Wapner in the introduction to the Q&A. And when viagra patent we see stressful or exciting news, it increases our heart rate and breathing, Huberman says. You don’t want to miss this section.

Our eyes are “not connected to the brain. They are the viagra patent brain,” Huberman says. €œDuring development, the eyes are part of the embryonic forebrain.

Your eyes get extruded from the skull during the first trimester, and then they reconnect to the rest of the viagra patent brain.” One of the tips Huberman mentions. One can turn off their brain's stress response by changing the way we are viewing our environment, specifically by taking on a panoramic view that allows you to see “far into the periphery.” Also, “every time you exhale, you’re slowing down the heart rate,” he says. Check out Betsy Ladyzhets's weekly “erectile dysfunction treatment Data Dispatch, a newsletter written to help people make sense of myriad unstandardized (and often untrustworthy) viagra data sources.

The publication provides news on public health agencies, resources for understanding and communicating about the viagra, viagra patent context on how erectile dysfunction treatment data experts are thinking about major issues, and occasional interviews or original analysis. Ladyzhets is a data journalist and science writer who’s been managing her publication’s viagra coverage and volunteering at the erectile dysfunction treatment Tracking Project since the spring. All data sources featured in the newsletter since its July inception are compiled in a public Google spreadsheet, and Ladyzhets is working on other supplemental resources that may be useful for journalists, community leaders, and viagra patent data nerds alike.

You might enjoy, “Ten reasons why my New York bodega is better than your 7-Eleven,” by Caroline Ulwick for McSweeney’s. .Governments around the world are gearing up to use viagra patent an old regulatory tool for a new purpose. Protecting the economy from climate change.

Financial regulators for years have used “stress tests” to gauge whether major banks are prepared to stay afloat amid extreme, unanticipated—yet entirely plausible—economic shocks. They were widely implemented in the United States viagra patent and abroad following the 2007-08 global financial crisis to help prevent systemwide catastrophes down the line. Economists, environmentalists and advisers to President-elect Joe Biden warn that global warming could spur that next catastrophe.

The climate viagra patent finance proponents among them argue that major lenders should be required to undergo climate-related stress testing before it’s too late. Standing in the way are a slew of challenges—including insufficient corporate climate disclosures, still-developing climate projections and the banking sector itself, which has already signaled opposition to the idea. There’s a chance that banks could use their lobbying might to delay or water down future climate finance regulations, advocates say.

But global momentum around the issue—and the incoming Biden administration—could mean that viagra patent mandated climate stress testing in the United States isn’t far off. €œIt’s pretty tough to imagine that regulators wouldn’t do this, because I don’t see how they can act in an informed way if they don’t know what the problem is. And the only way you know the viagra patent problem is by looking under the hood of [banks’] balance sheets,” said Justin Guay, director of global climate strategy at the Sunrise Project.

€œThere is a very clear consensus agreement among regulators globally that climate change is a systemic risk,” Guay added. €œSo that ship has sailed.” According to Monsur Hussain, who heads financial institution research at Fitch Ratings Inc., the main point of stress testing is to help regulators assess how a financial system or firm would cope under immense pressure—climate-related or otherwise. They do so by modeling the impacts that an economic shock would have on a bank’s profitability and balance viagra patent sheet over a two- or three-year period.

The United States currently requires financial firms to conduct stress tests with a “pass-or-fail threshold,” Hussain said. If a bank does not have enough viagra patent capital on hand to stay in business during the simulated crisis, it fails. The Federal Reserve then requires firms that fail the tests to set aside extra capital to prevent the hypothetical situation from taking place in real life.

Climate finance proponents say regulators in the United States need to take a similar approach to climate change. They would do so by way of viagra patent climate scenarios that consider how physical risks—like extreme weather events—and the transition to a low-carbon economy could affect banks’ loans to vulnerable businesses and sectors. Between 2016 and 2019, for instance, companies in the fossil fuel industry received more than $2.7 trillion in financing from 35 major banks, according to a report compiled by a group of environmental organizations.

€œIf we have two hurricanes, viagra patent a wildfire and droughts in the farming country, will our banking system be able to withstand that?. We don’t really know,” said Sarah Dougherty, a former researcher at the Federal Reserve Bank of Atlanta who is now with the Natural Resources Defense Council. €˜A fundamental shift’ In June, a coalition of central banks—dubbed the Network for Greening the Financial System—published stress testing guidance for regulators around the viagra patent world.

The document included several high-level climate stress testing scenarios. Among them was an “orderly transition” scenario, which would help regulators gauge how much money banks would lose if governments set a price on carbon this year—and achieved net-zero emissions by 2050. But the NGFS also included a “hot house world” scenario, in viagra patent which no additional emissions policies are adopted and the world blows past the warming goals enshrined in the Paris Agreement—leading to severe climate impacts.

Central banks in countries including the United Kingdom, France and Japan have already unveiled their plans to roll out stress tests to gauge financial firms’ exposure to global warming. The U.S viagra patent. Central bank is much further behind its global peers on the issue and hasn’t yet indicated that it intends to do the same.

But there are signs of progress. The Federal Reserve in November acknowledged for the first time in its Financial Stability Report that global warming “is likely to increase financial shocks and financial system vulnerabilities” (Greenwire, Nov viagra patent. 10).

Also notable is the incoming Biden administration’s commitment to taking an all-of-government approach to viagra patent climate change, including by tapping a number of climate hawks to fill high-level economic positions (Climatewire, Nov. 25). €œFor the first time, potentially ever, finance policy is being used as climate policy, which is a fundamental shift—it never has been in the past,” Guay said.

The incoming administration and the Fed’s change in tone do not eliminate the challenges inherent to measuring how much climate change could cost banks in the long viagra patent term. Dougherty, Hussain and the Bank Policy Institute, a lobbying group, are among those who have emphasized that climate stress tests remain in their infancy—in part due to the reality that measuring banks’ exposure to global warming is far more complicated than assessing other hypothetical shocks. That’s for a few viagra patent reasons.

Climate stress tests would need to measure banks’ risk over a longer period. That’s because some climate impacts—such as sea-level rise and the transition to a low-carbon economy—will take place over several decades rather than several years. Beyond that, developing climate-related scenarios would require banks to make a variety of difficult assumptions—including predicting how climate change would affect each portfolio company, how viagra patent different sectors will adapt to rising temperatures, and what climate policies will be passed in the United States and elsewhere.

€˜Bridge too far’ There’s widespread agreement that those factors make climate stress testing complex. But there’s less consensus regarding what should be done with stress tests’ results—and whether they should be required at all viagra patent. Greg Baer, the chief executive of BPI—whose members include Bank of America Corp., Citibank and Goldman Sachs Group Inc.—said in a recent op-ed that “banks have an important role to play in managing a transition away from carbon.” But in an interview with E&E News, Baer said BPI’s stance is that climate stress tests are a “bridge too far.” “Trying to capture climate change effects decades in advance—without considering the extraordinary adaptability of the financial system and economy—and incorporating those results into the regulatory capital framework is no easier than predicting how viagras or machine learning will affect banks by 2050,” BPI argued in a recent research note.

For those reasons and more, the trade association concluded that it’s premature to incorporate climate change scenarios into existing macroeconomic stress tests—“and even more so to viagra patent link climate stress test[s] to capital requirements.” JPMorgan Chase &. Co., Bank of America and the Financial Services Forum—another banking trade group—did not respond to questions about their organizations’ stance on climate stress testing. A Wells Fargo &.

Co. Spokesperson declined to comment. A spokesperson for the American Bankers Association, another trade group, said in an email that quantifying climate impacts on financial firms “is in its early stages” and that “any potential changes to the regulatory framework, no matter how well-intended, must be thoroughly understood to avoid any unintended consequences.” Climate finance experts and advocates disagree with BPI’s position—or at least parts of it.

A global meltdown?. Financial regulatory expert Gregg Gelzinis, of the left-leaning Center for American Progress, acknowledged that measuring climate risk is riddled with challenges and that climate stress tests shouldn’t necessarily be used to adjust banks’ capital requirements right off the bat. €œYes, we are projecting out significantly into the future, and yes, a bank’s balance sheet as it stands in 2020 is going to be different than a bank’s balance sheet as it stands in 2030, or 2040, or 2050,” Gelzinis said.

But he disagreed that those challenges are insurmountable—or that they would render the tests’ results useless. €œIf climate stress tests show that 15 years from now, you’re expected to have ... Severe losses on your carbon-sensitive assets—things like fossil fuel bonds and fossil fuel loans—and it encourages you to today shift away from those assets, that’s a positive outcome,” Gelzinis added.

He also warned against regulators implementing stress tests that lack any consequences at all, amounting to what he called “completely toothless exercises.” In his view, banks think about climate stress tests as “maybe an interesting informational exercise. But they don’t want it in any way to impact how much capital they have to fund themselves with, which is one of the most powerful financial regulatory tools in regulators’ arsenal to bolster the resiliency of these banks.” Even if not immediately, he said, climate stress tests should lay the groundwork for more aggressive regulatory measures that would actively safeguard the financial system to avoid an economic meltdown in the future. Dougherty, the former Fed researcher, agreed.

€œOf course they don’t want to do something that might make them do more work and hold more capital in reserve,” she said. €œBut we also don’t want them to fail and take the entire financial system down with them.” Reprinted from Climatewire with permission from E&E News. E&E provides daily coverage of essential energy and environmental news at www.eenews.net..

When I started writing about science decades ago, order viagra from canada artificial http://www.mbstoday.org/mbs-partners-with-fca-in-nicaragua/ intelligence seemed ascendant. IEEE Spectrum, the technology magazine for which I worked, produced a special issue on how AI would transform the world. I edited an article in which computer scientist Frederick Hayes-Roth predicted order viagra from canada that AI would soon replace experts in law, medicine, finance and other professions. That was in 1984. Not long afterward, the exuberance gave way to a slump known as order viagra from canada an “AI winter,” when disillusionment set in and funding declined.

Years later, doing research for my book The Undiscovered Mind, I tracked Hayes-Roth down to ask how he thought his predictions had held up. He laughed and replied, “You’ve got a mean streak.” AI had not lived up to expectations, he acknowledged. Our minds are hard to replicate, because we are “very, very complicated systems that are both evolved and adapted order viagra from canada through learning to deal well and differentially with dozens of variables at one time.” Algorithms that can perform a specialized task, like playing chess, cannot be easily adapted for other purposes. €œIt is an example of what is called nonrecurrent engineering,” Hayes-Roth explained. That was order viagra from canada 1998.

Today, according to some measures, AI is booming once again. Programs such as voice and face recognition are embedded in cell phones, televisions, cars and countless other consumer products. Clever algorithms help me choose a Christmas present for my girlfriend, find my daughter’s building in Brooklyn and gather information order viagra from canada for columns like this one. Venture-capital investments in AI doubled between 2017 and 2018 to $40 billion, according to WIRED. A Price Waterhouse study estimates that by 2030 AI order viagra from canada will boost global economic output by more than $15 trillion, “more than the current output of China and India combined.” In fact, some observers fear that AI is moving too fast.

New York Times columnist Farhad Manjoo calls an AI-based reading and writing program, GPT-3, “amazing, spooky, humbling and more than a little terrifying.” Someday, he frets, he might be “put out to pasture by a machine.” Neuroscientist Christof Koch has suggested that we might need computer chips implanted in our brains to help us keep up with intelligent machines. Elon Musk made headlines in 2018 when he warned that “superintelligent” AI, much smarter than we are, represents “the single biggest existential crisis that we face.” (Really?. Worse than climate order viagra from canada change?. Nuclear weapons?. Psychopathic politicians? order viagra from canada.

I suspect that Musk, who has invested in AI, is trying to promote the technology with his over-the-top fearmongering.) Experts are pushing back against the hype, pointing out that many alleged advances in AI are based on flimsy evidence. Last January, for order viagra from canada example, a team from Google Health claimed in Nature that their AI program had outperformed humans in diagnosing breast cancer. In October, a group led by Benjamin Haibe-Kains, a computational genomics researcher, criticized the Google health paper, arguing that the “lack of details of the methods and algorithm code undermines its scientific value.” Haibe-Kains complained to Technology Review that the Google Health report is “more an advertisement for cool technology” than a legitimate, reproducible scientific study. The same is true of other reported advances, he said. Indeed, artificial intelligence, like order viagra from canada biomedicine and other fields, has become mired in a replication crisis.

Researchers make dramatic claims that cannot be tested, because researchers—especially those in industry—do not disclose their algorithms. One recent review found that only 15 percent of AI order viagra from canada studies shared their code. There are also signs that investments in AI are not paying off. Technology analyst Jeffrey Funk recently examined 40 start-up companies developing AI for health care, manufacturing, energy, finance, cybersecurity, transportation and other industries. Many of them were not “nearly as valuable to order viagra from canada society as all the hype would suggest,” Funk reports in IEEE Spectrum.

Advances in AI “are unlikely to be nearly as disruptive—for companies, for workers, or for the economy as a whole—as many observers have been arguing.” Science reports that “core progress in AI has stalled in some fields,” such as information retrieval and product recommendation. A study order viagra from canada of algorithms used to improve the performance of neural networks found “no clear evidence of performance improvements over a 10-year period.” The longstanding goal of “general” artificial intelligence, possessing the broad knowledge and learning capacity to solve a variety of real-world problems, as humans do, remains elusive. €œWe have machines that learn in a very narrow way,” Yoshua Bengio, a pioneer in the AI approach called deep learning, recently complained in WIRED. €œThey need much more data to learn a task than human examples of intelligence, and they still make stupid mistakes.” Writing in The Gradient, an online magazine devoted to tech, AI entrepreneur and writer Gary Marcus accuses AI leaders as well as the media of exaggerating the field’s progress. AI-based autonomous cars, fake news detectors, diagnostic programs and order viagra from canada chatbots have all been oversold, Marcus contends.

He warns that “if and when the public, governments, and investment community recognize that they have been sold an unrealistic picture of AI’s strengths and weaknesses that doesn't match reality, a new AI winter may commence.” Another AI veteran and writer, Erik Larson, questions the “myth” that one day AI will inevitably equal or surpass human intelligence. In The order viagra from canada Myth of Artificial Intelligence. Why Computers Can’t Think the Way We Do, scheduled to be released by Harvard University Press in April, Larson argues that “success with narrow applications gets us not one step closer to general intelligence.” Larson says “the actual science of AI (as opposed to the pseudoscience of Hollywood and science fiction novelists) has uncovered a very large mystery at the heart of intelligence, which no one currently has a clue how to solve. Put bluntly. All evidence suggests order viagra from canada that human and machine intelligence are radically different.

And yet the myth of inevitability persists.” When I first started writing about science, I believed the myth of AI. One day, order viagra from canada surely, researchers would achieve the goal of a flexible, supersmart, all-purpose artificial intelligence, like HAL. Given rapid advances in computer hardware and software, it was only a matter of time. And who was I to doubt authorities like Marvin order viagra from canada Minsky?. Gradually, I became an AI doubter, as I realized that our minds—in spite of enormous advances in neuroscience, genetics, cognitive science and, yes, artificial intelligence—remain as mysterious as ever.

Here’s the paradox. Machines are becoming order viagra from canada undeniably smarter—and humans, it seems lately, more stupid, and yet machines will never equal, let alone surpass, our intelligence. They will always remain mere machines. That’s my guess, and order viagra from canada my hope. Further Reading.

How Would AI Cover an AI Conference?. Do We Need order viagra from canada Brain Implants to Keep Up with Robots?. The Many Minds of Marvin Minsky (R.I.P.) The Singularity and the Neural Code Who Wants to Be a Cyborg?. Mind-Body ProblemsThe items order viagra from canada below are highlights from the free newsletter, “Smart, useful, science stuff about erectile dysfunction treatment.” To receive newsletter issues daily in your inbox, sign up here. Canada has pre-ordered more doses per person of treatments against erectile dysfunction than have any other countries and purchasing groups, reports freelance science journalist Asher Mullard for Nature (11/30/20).

The U.S. And UK order viagra from canada come in 2nd and 3rd. The story includes 2 graphics that illustrate the pre-ordering landscape. €œMany people in low-income countries might have to wait until 2023 or 2024 for vaccination, according to estimates from order viagra from canada the Duke Global Health Innovation Center,” Mullard writes. The makers of three treatments that look like they will be distributed widely in 2021 (AstraZeneca, Moderna, and Pfizer/BioNTech) forecast making an estimated total of 5.3 billion doses next year.

That would cover between 2.6 billion and 3.1 billion people, the story states. Most of those doses are already spoken for by individual, largely affluent or middle-income countries, the story states, leaving little for low- and middle-income nations, order viagra from canada “most of which seem to be relying on contributions from” a joint venture called COVAX. The purchasing and distribution group was formed to ensure equitable global access to treatments against erectile dysfunction. Virologist and treatment researcher Shane Crotty at the La Jolla Institute for Immunology tweeted a thread on 11/27/20 discussing the safety of RNA treatments (like those being tested by order viagra from canada Moderna and Pfizer/BioNTech on large numbers of people and expected to receive emergency-use approval soon by the U.S. Food and Drug Administration).

Crotty writes that RNA is analogous in some ways to expiring messages on social media order viagra from canada platforms, and that RNA treatments are “temporary messages instructing cells to make one viral protein temporarily.” He adds, “It takes 25 different erectile dysfunction proteins [complex molecules] to make a erectile dysfunction, so there is no worry about the RNA making a viagra.” Below is an estimated timeline for erectile dysfunction treatment distribution in the U.S., based on a thread tweeted by Dr. Ashish Jha, dean of the Brown University School of Public Health, on 11/22/20. Jha drew the details in part from a televised interview between CNN’s Jake Tapper and Dr. Moncef Slaoui, chief scientific advisor to Operation order viagra from canada Warp Speed (the U.S.’s federally funded treatment development effort). Https://threadreaderapp.com/thread/1330519144178085899.html First public immunizations (health care workers and long-term care facility residents, if U.S.

Centers for Disease Control’s 12/2/20 order viagra from canada recommendations are followed) would start Dec. 11 or 12;perhaps 20 million people in U.S. Vaccinated by end of December. About 30 million more people in order viagra from canada U.S. Vaccinated by end of January 2021, and combined with total people who have recovered from s, “that’ll slow spread,” Jha writes;about 40 percent immunity in the U.S.

Population by February, bringing “meaningfully slower” order viagra from canada spread of erectile dysfunction. treatments widely available in U.S. By April/May 2021 Moderna says it will soon start testing its messenger-RNA treatment against erectile dysfunction in 3,000 teenagers, reports Denise Grady at The New York Times (12/2/20). AstraZeneca and order viagra from canada Pfizer/BioNTech already made similar announcements for testing their treatments in children, the story states. All three treatment groups each recently announced that their treatments are effective in large-scale experiments with adults, but “no treatment can be widely given to children until it has been tested in them,” Grady writes.

€œtreatments meant for both adults and children are generally tested first in adults to help make sure they are safe for pediatric trials [experiments].” treatments that work well in adults tend to also work well in children, with some dosing adjustments, according to order viagra from canada Dr. Paul Offit, a treatment researcher at Children’s Hospital of Philadelphia, Grady writes. Https://www.nytimes.com/2020/12/02/health/erectile dysfunction treatment-Moderna-treatment-children.html. Two recent studies suggest that wearing even an N95 mask during vigorous exercise order viagra from canada did not result in workouts that felt harder or actually were more physiologically draining, writes Gretchen Reynolds at The New York Times (11/18/20). One of the studies found more carbon dioxide in the breath of N95-masked exercisers, but none of the subjects complained of headaches or breathing issues, the story states.

The results order viagra from canada came as a surprise to the study subjects, Reynolds writes. The studies were conducted on healthy, active adults, so it is not clear if the findings would be the same in people who are less healthy or less active or who have breathing problems, the story states. €œThe findings suggest that anyone who hesitates to wear a mask during exercise should try one — order viagra from canada although not an N95 mask,” the story describes one of the study authors, an internal medicine physician at Rambam Health Care Campus, as saying. Those masks slightly increase exercisers’ carbon dioxide levels and should be reserved for health care workers anyway, states the story, which also was published in Spanish. As anticipated, the U.S.

Centers for Disease Control (CDC) released recommendations (on 12/2/20) that include shortening the quarantine order viagra from canada period from 14 days to as few as 7 days, at least for people who think they’ve could’ve been exposed to erectile dysfunction but then test negative, reports Colin Dwyer at NPR. €œPeople should still watch closely for symptoms — such as a fever, a cough or a loss of taste or smell — for a full 14 days after possible exposure,” according to the CDC’s incident manager for its erectile dysfunction treatment response, Dwyer writes. The change is meant to order viagra from canada increase the odds that people will comply with the agency’s quarantine recommendations, the story states. It also “allows health officials to focus their efforts on the period of time that people are most likely to become contagious,” the story quotes epidemiologist Jennifer Nuzzo of the Johns Hopkins Center for Health Security as saying (12/2/20). And if you’re confused about the meaning of quarantine versus isolation, or about the distinction between asymptomatic and presymptomatic, and the like, check out this helpful piece, “Clarifying erectile dysfunction treatment terminology,” by Lindsay Smith Rogers for Johns Hopkins Bloomberg School of Public Health (11/23/20).

An 11/16/20 Q&A at Scientific American with Andrew Huberman, a Stanford University neuroscientist who studies the visual system, details how our vision and our breathing order viagra from canada can “offer us easy and accessible releases from stress,” particularly in the context of the viagra challenges and overall intensity of 2020. For instance, emerging research suggests that altering our breathing can alter brain regions responsible for arousal and panic, writes freelance science journalist Jessica Wapner in the introduction to the Q&A. And when we see stressful or exciting news, order viagra from canada it increases our heart rate and breathing, Huberman says. You don’t want to miss this section. Our eyes are “not connected to the brain.

They are the order viagra from canada brain,” Huberman says. €œDuring development, the eyes are part of the embryonic forebrain. Your eyes get extruded from the order viagra from canada skull during the first trimester, and then they reconnect to the rest of the brain.” One of the tips Huberman mentions. One can turn off their brain's stress response by changing the way we are viewing our environment, specifically by taking on a panoramic view that allows you to see “far into the periphery.” Also, “every time you exhale, you’re slowing down the heart rate,” he says. Check out Betsy Ladyzhets's weekly “erectile dysfunction treatment Data Dispatch, a newsletter written to help people make sense of myriad unstandardized (and often untrustworthy) viagra data sources.

The publication provides news on public health agencies, resources for understanding and communicating about the viagra, context on how erectile dysfunction treatment data experts are thinking about major issues, and occasional order viagra from canada interviews or original analysis. Ladyzhets is a data journalist and science writer who’s been managing her publication’s viagra coverage and volunteering at the erectile dysfunction treatment Tracking Project since the spring. All data sources featured in the newsletter since its July inception are compiled in a public Google spreadsheet, order viagra from canada and Ladyzhets is working on other supplemental resources that may be useful for journalists, community leaders, and data nerds alike. You might enjoy, “Ten reasons why my New York bodega is better than your 7-Eleven,” by Caroline Ulwick for McSweeney’s. .Governments around the world are gearing up to use an old regulatory tool order viagra from canada for a new purpose.

Protecting the economy from climate change. Financial regulators for years have used “stress tests” to gauge whether major banks are prepared to stay afloat amid extreme, unanticipated—yet entirely plausible—economic shocks. They were order viagra from canada widely implemented in the United States and abroad following the 2007-08 global financial crisis to help prevent systemwide catastrophes down the line. Economists, environmentalists and advisers to President-elect Joe Biden warn that global warming could spur that next catastrophe. The climate finance proponents among them argue that major lenders should be required to undergo climate-related stress order viagra from canada testing before it’s too late.

Standing in the way are a slew of challenges—including insufficient corporate climate disclosures, still-developing climate projections and the banking sector itself, which has already signaled opposition to the idea. There’s a chance that banks could use their lobbying might to delay or water down future climate finance regulations, advocates say. But global momentum around the issue—and the incoming Biden administration—could mean that mandated climate stress testing in the United order viagra from canada States isn’t far off. €œIt’s pretty tough to imagine that regulators wouldn’t do this, because I don’t see how they can act in an informed way if they don’t know what the problem is. And the only way you know the problem is by looking under the hood of [banks’] balance sheets,” said Justin Guay, director of global climate strategy at order viagra from canada the Sunrise Project.

€œThere is a very clear consensus agreement among regulators globally that climate change is a systemic risk,” Guay added. €œSo that ship has sailed.” According to Monsur Hussain, who heads financial institution research at Fitch Ratings Inc., the main point of stress testing is to help regulators assess how a financial system or firm would cope under immense pressure—climate-related or otherwise. They do so by modeling the impacts that an economic shock would have on a bank’s profitability and balance sheet over a order viagra from canada two- or three-year period. The United States currently requires financial firms to conduct stress tests with a “pass-or-fail threshold,” Hussain said. If a bank does not have enough order viagra from canada capital on hand to stay in business during the simulated crisis, it fails.

The Federal Reserve then requires firms that fail the tests to set aside extra capital to prevent the hypothetical situation from taking place in real life. Climate finance proponents say regulators in the United States need to take a similar approach to climate change. They would do so by way of order viagra from canada climate scenarios that consider how physical risks—like extreme weather events—and the transition to a low-carbon economy could affect banks’ loans to vulnerable businesses and sectors. Between 2016 and 2019, for instance, companies in the fossil fuel industry received more than $2.7 trillion in financing from 35 major banks, according to a report compiled by a group of environmental organizations. €œIf we have two hurricanes, a wildfire and droughts in the farming country, will our banking system be able to withstand that? order viagra from canada.

We don’t really know,” said Sarah Dougherty, a former researcher at the Federal Reserve Bank of Atlanta who is now with the Natural Resources Defense Council. €˜A fundamental shift’ In June, a coalition of central order viagra from canada banks—dubbed the Network for Greening the Financial System—published stress testing guidance for regulators around the world. The document included several high-level climate stress testing scenarios. Among them was an “orderly transition” scenario, which would help regulators gauge how much money banks would lose if governments set a price on carbon this year—and achieved net-zero emissions by 2050. But the NGFS also included a “hot house world” scenario, in which no additional emissions policies are adopted and the world blows past the warming goals enshrined in the Paris Agreement—leading order viagra from canada to severe climate impacts.

Central banks in countries including the United Kingdom, France and Japan have already unveiled their plans to roll out stress tests to gauge financial firms’ exposure to global warming. The U.S order viagra from canada. Central bank is much further behind its global peers on the issue and hasn’t yet indicated that it intends to do the same. But there are signs of progress. The Federal Reserve in November acknowledged for the first time in its Financial Stability Report that global warming “is likely to increase financial shocks and financial system vulnerabilities” (Greenwire, order viagra from canada Nov.

10). Also notable is order viagra from canada the incoming Biden administration’s commitment to taking an all-of-government approach to climate change, including by tapping a number of climate hawks to fill high-level economic positions (Climatewire, Nov. 25). €œFor the first time, potentially ever, finance policy is being used as climate policy, which is a fundamental shift—it never has been in the past,” Guay said. The incoming administration and the Fed’s change in tone do not eliminate the challenges inherent to measuring how much climate change could cost banks in the long term order viagra from canada.

Dougherty, Hussain and the Bank Policy Institute, a lobbying group, are among those who have emphasized that climate stress tests remain in their infancy—in part due to the reality that measuring banks’ exposure to global warming is far more complicated than assessing other hypothetical shocks. That’s for order viagra from canada a few reasons. Climate stress tests would need to measure banks’ risk over a longer period. That’s because some climate impacts—such as sea-level rise and the transition to a low-carbon economy—will take place over several decades rather than several years. Beyond that, developing climate-related scenarios would require banks to make a variety of difficult assumptions—including predicting how climate change would affect each portfolio company, how different sectors will adapt to rising temperatures, and what climate policies order viagra from canada will be passed in the United States and elsewhere.

€˜Bridge too far’ There’s widespread agreement that those factors make climate stress testing complex. But there’s less consensus regarding what should be done with stress tests’ order viagra from canada results—and whether they should be required at all. Greg Baer, the chief executive of BPI—whose members include Bank of America Corp., Citibank and Goldman Sachs Group Inc.—said in a recent op-ed that “banks have an important role to play in managing a transition away from carbon.” But in an interview with E&E News, Baer said BPI’s stance is that climate stress tests are a “bridge too far.” “Trying to capture climate change effects decades in advance—without considering the extraordinary adaptability of the financial system and economy—and incorporating those results into the regulatory capital framework is no easier than predicting how viagras or machine learning will affect banks by 2050,” BPI argued in a recent research note. For those reasons and more, the trade association concluded that it’s premature to order viagra from canada incorporate climate change scenarios into existing macroeconomic stress tests—“and even more so to link climate stress test[s] to capital requirements.” JPMorgan Chase &. Co., Bank of America and the Financial Services Forum—another banking trade group—did not respond to questions about their organizations’ stance on climate stress testing.

A Wells Fargo &. Co. Spokesperson declined to comment. A spokesperson for the American Bankers Association, another trade group, said in an email that quantifying climate impacts on financial firms “is in its early stages” and that “any potential changes to the regulatory framework, no matter how well-intended, must be thoroughly understood to avoid any unintended consequences.” Climate finance experts and advocates disagree with BPI’s position—or at least parts of it. A global meltdown?.

Financial regulatory expert Gregg Gelzinis, of the left-leaning Center for American Progress, acknowledged that measuring climate risk is riddled with challenges and that climate stress tests shouldn’t necessarily be used to adjust banks’ capital requirements right off the bat. €œYes, we are projecting out significantly into the future, and yes, a bank’s balance sheet as it stands in 2020 is going to be different than a bank’s balance sheet as it stands in 2030, or 2040, or 2050,” Gelzinis said. But he disagreed that those challenges are insurmountable—or that they would render the tests’ results useless. €œIf climate stress tests show that 15 years from now, you’re expected to have ... Severe losses on your carbon-sensitive assets—things like fossil fuel bonds and fossil fuel loans—and it encourages you to today shift away from those assets, that’s a positive outcome,” Gelzinis added.

He also warned against regulators implementing stress tests that lack any consequences at all, amounting to what he called “completely toothless exercises.” In his view, banks think about climate stress tests as “maybe an interesting informational exercise. But they don’t want it in any way to impact how much capital they have to fund themselves with, which is one of the most powerful financial regulatory tools in regulators’ arsenal to bolster the resiliency of these banks.” Even if not immediately, he said, climate stress tests should lay the groundwork for more aggressive regulatory measures that would actively safeguard the financial system to avoid an economic meltdown in the future. Dougherty, the former Fed researcher, agreed. €œOf course they don’t want to do something that might make them do more work and hold more capital in reserve,” she said. €œBut we also don’t want them to fail and take the entire financial system down with them.” Reprinted from Climatewire with permission from E&E News.

E&E provides daily coverage of essential energy and environmental news at www.eenews.net..

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If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Call your health care provider right away if you have any change in vision. Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking Viagra, you should refrain from further activity and call your doctor or health care professional as soon as possible. Using Viagra does not protect you or your partner against HIV (the viagra that causes AIDS) or other sexually transmitted diseases.

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IntroductionWhile the Buy amoxil online canada role and importance of solidarity has been the focus of long-running and extensive debate surrounding public health ethics and practice,1 the erectile dysfunction treatment viagra has cast this debate into even starker relief.2 In doing so, can i buy viagra over the counter at walgreens it has emphasised the particular importance of solidarity for the delivery of effective public health programmes by highlighting the potentially disastrous consequences of its absence. In this paper I can i buy viagra over the counter at walgreens examine these consequence with reference to the response of the current British government to erectile dysfunction treatment which failed to deliver an effective public health response to the crisis. I argue that this response represents mismanagement of a public health crisis, and a rejection of important democratic norms and values.Defining solidaritySolidarity has a wide range of definitions in academic discourse, with its precise features being the subject of heated debate.3 4 Historically, solidarity has been seen as emerging most readily, and most often between persons sharing relatively stable, deeply ingrained qualities, such as shared membership of a state or religious group,5 or commitment to shared political ideals and objectives.6 7 More recently, it has been suggested that more transient, or less deeply ingrained features of persons may serve as the basis for acts of solidarity, and at least short-term solidarity relationships.4 On a larger scale, it has also been suggested that recognition of shared vulnerability in the face of global threats to health, such as climate change and antimicrobial resistance, may serve as a catalyst for solidarity between nations and peoples.8 As I explain below, this perspective is particularly relevant to the current viagra context.2In this paper I rely mainly on the definition of solidarity offered by Prainsack and Buyx, who define solidarity as ‘enacted commitments to accept costs to assist others with whom a person or persons recognise similarity in a relevant respect’.4 Therefore, solidarity describes what it is that we do when we assist, benefit or support other people because we recognise some form of relevant similarity or connection with/to them. Thus solidarity is active, in can i buy viagra over the counter at walgreens that it is something we do, not merely a feeling or attitude.

It is also egalitarian, with motivation for action being grounded in recognition of what is shared between parties, not in what distinguishes them.3 Finally, acting in solidarity also involves incurring of costs of some kind, though these may be extremely minimal, or be counterbalanced by the benefits of a given solidarity action.Prainsack and Buyx argue that there are three main ‘tiers’ of solidaristic action. Interpersonal, group and institutional solidarity.4 The can i buy viagra over the counter at walgreens first of these tiers describes what happens between individual persons. For example, Prainsack and Buyx suggest that giving up one’s seat on a crowded bus for a can i buy viagra over the counter at walgreens pregnant fellow passenger is an act of solidarity when based on recognition of shared experience of discomfort while standing during pregnancy.4 The second tier ‘comprises manifestations of a shared commitment to carry costs to assist others with whom people consider themselves bound together through at least one similarity in a relevant respect’. These group solidarities occur when many individuals share a similar specific context, and engage in actions to benefit others with whom the context is shared.

Such solidarity is informal, though it may also be heavily normalised within a given community, such that it forms an expectation of behaviour.Tier 3 solidarity comprises formalised, can i buy viagra over the counter at walgreens or legally mandated expectations of behaviour. Here, solidarity is fully institutionalised, ‘in the form of legally enforceable norms’,4 such as progressive tax systems and welfare state arrangements. For example, the British National Health Service (NHS) exemplifies institutionalised solidarity, because it is funded through taxation and provides healthcare can i buy viagra over the counter at walgreens to citizens and legal residents of the UK, regardless of their ability to pay. According to Prainsack and Buyx, these three tiers of solidarity are closely connected, with tier 3 solidarity typically emerging from solidarity at tiers 1 and 2.

Correlatively, Sangiovanni discusses the participation in collaborative institutions as solidaristic practice when he argues that solidarity is grounded in ‘our joint action as authors of political and social institutions’.7 Thus, for Sangiovanni solidarity is something which can i buy viagra over the counter at walgreens emerges from shared participation in the construction and enactment of civic society. Solidarity can therefore be interpreted in a range of ways—as the act of carrying costs for relevantly similar others, ‘standing up for’, can i buy viagra over the counter at walgreens ‘standing up with’ and ‘standing up as’’ those persons with whom solidarity is identified,3 or the act of working together for a shared goal.7 Regardless of the precise definition adopted, at least basic solidarity, as active engagements in interpersonal and/or institutional egalitarian relationality, by all or most members of a group is fundamentally necessary for the existence and functioning of any community—as I explain below, it is particularly important in democracies.Solidarity and public healthIn normal circumstances, private individuals can engage in interpersonal and group solidarity in the context of public health provision, by avoiding social interaction when sick and helping others to do the same, by purchasing groceries for an ill neighbour, for example. Individuals can engage in tier 3 solidarity by participating in institutions which promote and protect public and individual health. For example, participation in fair taxation schemes can help fund health and welfare programmes, such can i buy viagra over the counter at walgreens as the British NHS, ensuring the accessibility of these services to all members of a given community, thereby contributing to public health and individual well-being.Correlatively, while elected and appointed governmental officials, such as cabinet ministers, can also engage in solidarity in the same way as their constituents, they also have additional responsibilities in virtue of their public role and status as elected representatives of their communities.

These responsibilities include things like enacting legislation which establishes and maintains institutions and programmes which promote and protect health. Such actions protect can i buy viagra over the counter at walgreens the health of their constituents, and they enable those constituents to more effectively engage in solidarity with their peers, by providing the systems necessary to do so most effectively, and guidance as to the reasons for so doing. It is therefore particularly important that elected officials engage in solidarity with their constituents in this manner because individual citizens lack the capacity to establish and govern public health institutions, and more importantly, have deferred authority to do these things to those in government through the democratic process.The delivery and maintenance of effective public health programmes relies on most members of a community engaging in solidarity in a range of ways. To illustrate, vaccination programmes cannot deliver herd immunity without mass can i buy viagra over the counter at walgreens participation from community members, but individuals cannot contribute to herd immunity if treatments are prohibitively expensive, or only available at an inaccessible venue.

They are can i buy viagra over the counter at walgreens also unlikely to contribute if they have been misled into believing that treatments are dangerous or unnecessary. Here, engagement in solidarity is required from both private individuals, who must participate in the programme, and elected officials, who must ensure it is accessible to all members of a community, and provide an epistemic context in which the importance and safety of the programme is widely understood, in order for it to be effective.Solidarity and erectile dysfunction treatmentIn his opening remarks to a press briefing on 18 March 2020, Tedros Adhanom Ghebreyesus, Director-General of WHO stated that “(the) spirit of solidarity must be at the centre of our efforts to defeat erectile dysfunction treatment”.2 Similar statements have also been made by a number of other agencies, each of which have emphasised solidarity’s role as an essential part of an effective public health response.9 Correlatively, many governments have instituted lockdowns, and are enforcing social distancing measures (to greater or lesser extent) in order to limit the spread of . We have all thereby been asked, even instructed, to avoid public gatherings, minimise our contact with can i buy viagra over the counter at walgreens others and help to protect our neighbours. In so doing, we engage in solidarity with our compatriots.For private individuals, engaging in solidarity with their peers in response to erectile dysfunction treatment is thus very similar to such engagement for public health under normal circumstances—participation in public health programmes, social distancing, community cooperation, and contributing through taxation to the cost of public health efforts and medical research.

Elected officials can do these can i buy viagra over the counter at walgreens things as individuals, but can also respond in their role as public officials in at least two additional ways. First, by collaborating with other governments to share information, and coordinate regional and global public health responses.10 Second, by ensuring that NHS exist and are adequately funded, staffed and equipped to be able to respond to the viagra, and by providing clear information and support to citizens so that they may engage in solidarity with one another.There has been great variation in the extent to which different regions have achieved engagement in solidarity across these vectors. New Zealand and South Korea both implemented thorough testing and tracing programmes which allowed them to counteract the spread of (and in South Korea, also reduced influenza s), while New Zealand also imposed strict lockdown protocols, going as far as closing its borders.11 12 can i buy viagra over the counter at walgreens Equally importantly, officials in both locations acted quickly, and communicated clearly with their communities, ensuring that residents knew how to minimise the risk of transmission, and why doing so was important. Individual members of these communities were thus able to engage in interpersonal solidarity, by following lockdown rules, maintaining social distancing, and participating in track and trace programmes, because their governments had proactively established the material can i buy viagra over the counter at walgreens and epistemological conditions where such engagement was enabled, empowered and encouraged.

By doing so, the New Zealand and South Korean governments thus engaged in solidarity with their constituents.In contrast, the current British government’s response to erectile dysfunction treatment lacked the transparency, clarity and urgency which characterised the actions of these more successful nations. First, while the UK and New Zealand each initiated lockdowns in the same week in late March, New Zealand at that stage had only 102 cases of erectile dysfunction treatment, can i buy viagra over the counter at walgreens with no deaths, compared with the UK’s total of 5687 cases and 281 deaths.12 13 Correlatively, while South Korea did not enforce a strict lockdown, it had enacted social distancing policies even earlier, at the end of February.11 The risk of ongoing transmission was therefore significantly higher in the UK than in either nation at this time.Second, communication from the current British government was often unclear, and the prime minister and other officials frequently downplayed the severity of the viagra—at one point the prime minister (who was later hospitalised with erectile dysfunction treatment) stated that he would not refrain from shaking hands, and that he had recently shaken hands with everyone in a erectile dysfunction treatment ward.14 In this way, the risks of erectile dysfunction treatment were initially minimised in official communications, creating uncertainty about how to act, and which guidance to follow. Exacerbating this issue, where advice was given, it was initially often discretionary, and little material support was made available to enable people to follow it. For example, on 16 March 2020, people were advised to work from home if possible and avoid social venues, such as pubs and theatres.15 However, this was not mandatory, and social venues were not required to close until 20 March, so some employees were required to work onsite, despite known risks.16Correlatively, no support was initially can i buy viagra over the counter at walgreens made available to those who could not work remotely, meaning that choices had to be made between employment and ‘fighting the viagra’.

Financial support can i buy viagra over the counter at walgreens was later made available, in the form of the government’s job retention scheme, which allowed employers to furlough non-essential workers, the wages of whom would be subsidised by government.17 However, this only covered 80% of employee wages, meaning that many of those furloughed would have to live on a reduced income. Likewise, while support has been offered to home owners in the form of mortgage holidays, at the time of writing, renters have not received similar assistance.18Third, the government also initially moved to adopt a strategy that deviated from the recommendations of the WHO, which focused on minimising rates through conventional public health measures, such as active testing, social distancing and increased emphasis on personal hygiene (hand washing, etc).19 In contrast, the government initially endorsed a ‘herd immunity’ strategy, which appeared to focus on allowing approximately 60% of the British population to become infected with the viagra, which would have led to an even higher level of excess mortality.20 Despite the eventual rejection of this strategy in favour of closer adherence to WHO guidelines, at the time of writing the UK has the world’s second highest erectile dysfunction treatment mortality rate.21 Further, the consequences of these policy choices were compounded because of the historical policy context in which they occur. In the last decade the NHS has seen a significant reduction in funding as a result of austerity policies.22 Consequently, many NHS trusts have can i buy viagra over the counter at walgreens found it extremely difficult to respond safely and effectively to the crisis, because of lack of resources (in terms of people, money and equipment)—the absence of sufficient personal protective equipment for those treating patients with erectile dysfunction treatment being particularly notable.23The current British government’s response to erectile dysfunction treatment therefore deviated significantly from those of nations with more successful responses, and from WHO guidance. In doing so, it established an epistemological and financial context where it was difficult for individuals to afford to follow public health guidelines, or to even know exactly what those guidelines required.

As I argued above, the successful delivery and maintenance of public can i buy viagra over the counter at walgreens health programmes requires engagement in solidarity from both private individuals, and government officials. Engagement in solidarity by the latter entails legislating for the delivery and management of effective public health programmes, and providing clear guidance for their constituents to follow.Unlike their counterparts in New Zealand and South Korea, the current British government has failed to achieve either of these objectives, though it should be noted, that there have also been high profile instances of individual agents in the UK failing to engage in solidarity with their communities.24 However, these solidarity failures must be considered in context. Arguably some failures of individuals to engage in solidarity may at least in can i buy viagra over the counter at walgreens part be attributed to governmental failures to deliver an effective public health response to erectile dysfunction treatment, or communicate its importance and requirements. It has been noted, for example, that panic buying and stockpiling can be sensible strategies in times of potential social chaos and market disruption—especially when told by the government that a total social lockdown may imminently limit access to necessities.25 can i buy viagra over the counter at walgreens In each of these cases, the individuals concerned do have duties of solidarity (as well as professional duties, in the case of healthcare workers) to their compatriots and communities, and failure to fulfil them may cause harm.

However, the costs and challenges of fulfilling those duties have been amplified (and in the case of the professional duties of healthcare workers dangerously so) by the government’s failure to fulfil its own responsibilities of solidarity.ConclusionEffective public health programmes cannot rely solely on private individuals always engaging in interpersonal solidarity in an optimal fashion. Private citizens all operate under epistemological constraints—we may not know of can i buy viagra over the counter at walgreens the needs of others with whom we would engage in solidarity if we had more complete information, or we may be honestly mistaken about the best way to engage in solidarity with people we do know about. Alternatively, we may know of the needs of others, but face material constraints which make providing significant assistance to them impossible. Governments must therefore engage in solidarity with their constituents by providing the epistemological, institutional, material and financial resources, which compensate for these constraints and thus can i buy viagra over the counter at walgreens make interpersonal solidarity possible.

By failing to do so, the current British government has failed to adequately protect the residents of the UK in a time of crisis. It has thus failed to engage in solidarity with its can i buy viagra over the counter at walgreens constituents, and effectively devolved responsibility for action to agents with far less power to deliver an effective response to erectile dysfunction treatment. Further and importantly, those thus tasked with responding to the viagra are disempowered in part because of the failures of the government.Had the government’s failures in response to erectile dysfunction treatment occurred despite the early adoption of recommended strategies proven to work elsewhere, they would not count as failures of solidarity, but of policy—as unfortunate consequences of mistakes made under challenging circumstances, despite a good faith effort to achieve the can i buy viagra over the counter at walgreens best possible outcome. The government’s actions became failures of solidarity when it ignored compelling and accessible information about how best to respond to the crisis, and did not take actions that they could and should have taken.

Further, by failing to provide either definitive rules, or sufficient material and financial support, the government devolved responsibility for responding to the crisis to their constituents and expected them to can i buy viagra over the counter at walgreens each individually act in the correct manner to prevent the spread of —an unrealistic expectation. As discussed above, private individuals operate under significantly stricter financial, social and epistemological constraints than their elected representatives, constraints which in this instance were exacerbated by the actions of those in power. Even under ideal conditions (that is, in the absence of material and epistemological constraints), reliance on mass individual choices delivering an appropriate response to erectile dysfunction treatment would not be can i buy viagra over the counter at walgreens an effective strategy. To rely on such a strategy where such constraints are present is mistaken, and arguably avoidably so.

It is also a dereliction of the government’s responsibilities to its constituents.Importantly therefore, the government’s can i buy viagra over the counter at walgreens actions represent more than mere failure to adequately protect its constituents. By devolving responsibility for action to those without sufficient power can i buy viagra over the counter at walgreens to act, the government’s actions should be recognised both as a failure of solidarity, and as a dereliction of it. Indeed, where engagement in solidarity by the government has occurred, it has frequently been delayed, insufficient or reluctantly provided, contributing to the significant excess mortality and morbidity experienced by the UK.21A government which fails to engage in solidarity with its constituents, makes an implicit statement about the nature of the relationship between itself and the rest of society. In doing so, and in abdicating their responsibilities to their constituents while simultaneously expecting them to collectively deliver an effective response to erectile dysfunction treatment, they redefine that relationship, from being one of elected representatives and can i buy viagra over the counter at walgreens constituents, to one of rulers and ruled.There are two ways to interpret the phrase ‘solidarity is for other people’.

First, it can be read as a statement of closeness and relationality—an expression of the understanding that solidarity is something we engage in to assist or benefit other people with whom we identify. Second, it can be understood as an assertion that the speaker holds themselves apart from other people—a claim that solidarity can i buy viagra over the counter at walgreens is something that other people should or may do, but that is not something with which the speaker is concerned. Sadly, recent events suggest that we must give serious consideration to the idea that it is this second interpretation which more accurately reflects the attitudes of the British government at this time.AcknowledgmentsThe author thanks Dr Agomoni Ganguli-Mitra for her very helpful comments on an earlier version of this paper..

IntroductionWhile the role and importance of solidarity has been the focus of long-running and extensive debate surrounding public health ethics and practice,1 the erectile dysfunction treatment viagra has cast this debate into Buy amoxil online canada even starker relief.2 In doing order viagra from canada so, it has emphasised the particular importance of solidarity for the delivery of effective public health programmes by highlighting the potentially disastrous consequences of its absence. In this paper I examine these consequence with reference to the response of the order viagra from canada current British government to erectile dysfunction treatment which failed to deliver an effective public health response to the crisis. I argue that this response represents mismanagement of a public health crisis, and a rejection of important democratic norms and values.Defining solidaritySolidarity has a wide range of definitions in academic discourse, with its precise features being the subject of heated debate.3 4 Historically, solidarity has been seen as emerging most readily, and most often between persons sharing relatively stable, deeply ingrained qualities, such as shared membership of a state or religious group,5 or commitment to shared political ideals and objectives.6 7 More recently, it has been suggested that more transient, or less deeply ingrained features of persons may serve as the basis for acts of solidarity, and at least short-term solidarity relationships.4 On a larger scale, it has also been suggested that recognition of shared vulnerability in the face of global threats to health, such as climate change and antimicrobial resistance, may serve as a catalyst for solidarity between nations and peoples.8 As I explain below, this perspective is particularly relevant to the current viagra context.2In this paper I rely mainly on the definition of solidarity offered by Prainsack and Buyx, who define solidarity as ‘enacted commitments to accept costs to assist others with whom a person or persons recognise similarity in a relevant respect’.4 Therefore, solidarity describes what it is that we do when we assist, benefit or support other people because we recognise some form of relevant similarity or connection with/to them. Thus solidarity is active, in that it is something we do, not merely a feeling or order viagra from canada attitude. It is also egalitarian, with motivation for action being grounded in recognition of what is shared between parties, not in what distinguishes them.3 Finally, acting in solidarity also involves incurring of costs of some kind, though these may be extremely minimal, or be counterbalanced by the benefits of a given solidarity action.Prainsack and Buyx argue that there are three main ‘tiers’ of solidaristic action.

Interpersonal, group and institutional solidarity.4 The first of these tiers describes what happens order viagra from canada between individual persons. For example, Prainsack and Buyx suggest that giving up one’s seat on a crowded bus for a pregnant fellow passenger is an act of solidarity when based on recognition of shared experience of discomfort while standing during pregnancy.4 The second tier ‘comprises manifestations of a order viagra from canada shared commitment to carry costs to assist others with whom people consider themselves bound together through at least one similarity in a relevant respect’. These group solidarities occur when many individuals share a similar specific context, and engage in actions to benefit others with whom the context is shared. Such solidarity is informal, though it may also be heavily order viagra from canada normalised within a given community, such that it forms an expectation of behaviour.Tier 3 solidarity comprises formalised, or legally mandated expectations of behaviour. Here, solidarity is fully institutionalised, ‘in the form of legally enforceable norms’,4 such as progressive tax systems and welfare state arrangements.

For example, the British National Health Service (NHS) exemplifies institutionalised solidarity, because it is funded through taxation and provides healthcare to citizens and legal residents of the UK, regardless of order viagra from canada their ability to pay. According to Prainsack and Buyx, these three tiers of solidarity are closely connected, with tier 3 solidarity typically emerging from solidarity at tiers 1 and 2. Correlatively, Sangiovanni discusses the participation in collaborative institutions as solidaristic practice when he argues that solidarity is grounded order viagra from canada in ‘our joint action as authors of political and social institutions’.7 Thus, for Sangiovanni solidarity is something which emerges from shared participation in the construction and enactment of civic society. Solidarity can therefore be interpreted in a range of ways—as the act of carrying costs for relevantly similar others, ‘standing up for’, ‘standing up with’ and ‘standing up as’’ those persons with whom solidarity is identified,3 or the act of working together for a shared goal.7 Regardless of the precise definition adopted, at least basic solidarity, order viagra from canada as active engagements in interpersonal and/or institutional egalitarian relationality, by all or most members of a group is fundamentally necessary for the existence and functioning of any community—as I explain below, it is particularly important in democracies.Solidarity and public healthIn normal circumstances, private individuals can engage in interpersonal and group solidarity in the context of public health provision, by avoiding social interaction when sick and helping others to do the same, by purchasing groceries for an ill neighbour, for example. Individuals can engage in tier 3 solidarity by participating in institutions which promote and protect public and individual health.

For example, participation in fair taxation schemes can help fund health and welfare programmes, such as the British NHS, ensuring the accessibility of these services to all members of a given community, thereby contributing order viagra from canada to public health and individual well-being.Correlatively, while elected and appointed governmental officials, such as cabinet ministers, can also engage in solidarity in the same way as their constituents, they also have additional responsibilities in virtue of their public role and status as elected representatives of their communities. These responsibilities include things like enacting legislation which establishes and maintains institutions and programmes which promote and protect health. Such actions order viagra from canada protect the health of their constituents, and they enable those constituents to more effectively engage in solidarity with their peers, by providing the systems necessary to do so most effectively, and guidance as to the reasons for so doing. It is therefore particularly important that elected officials engage in solidarity with their constituents in this manner because individual citizens lack the capacity to establish and govern public health institutions, and more importantly, have deferred authority to do these things to those in government through the democratic process.The delivery and maintenance of effective public health programmes relies on most members of a community engaging in solidarity in a range of ways. To illustrate, vaccination programmes cannot deliver herd immunity without mass participation from community members, but individuals cannot order viagra from canada contribute to herd immunity if treatments are prohibitively expensive, or only available at an inaccessible venue.

They are also unlikely to contribute if they have been order viagra from canada misled into believing that treatments are dangerous or unnecessary. Here, engagement in solidarity is required from both private individuals, who must participate in the programme, and elected officials, who must ensure it is accessible to all members of a community, and provide an epistemic context in which the importance and safety of the programme is widely understood, in order for it to be effective.Solidarity and erectile dysfunction treatmentIn his opening remarks to a press briefing on 18 March 2020, Tedros Adhanom Ghebreyesus, Director-General of WHO stated that “(the) spirit of solidarity must be at the centre of our efforts to defeat erectile dysfunction treatment”.2 Similar statements have also been made by a number of other agencies, each of which have emphasised solidarity’s role as an essential part of an effective public health response.9 Correlatively, many governments have instituted lockdowns, and are enforcing social distancing measures (to greater or lesser extent) in order to limit the spread of . We have all thereby been asked, even instructed, to avoid public gatherings, minimise our contact with others and help to order viagra from canada protect our neighbours. In so doing, we engage in solidarity with our compatriots.For private individuals, engaging in solidarity with their peers in response to erectile dysfunction treatment is thus very similar to such engagement for public health under normal circumstances—participation in public health programmes, social distancing, community cooperation, and contributing through taxation to the cost of public health efforts and medical research. Elected officials order viagra from canada can do these things as individuals, but can also respond in their role as public officials in at least two additional ways.

First, by collaborating with other governments to share information, and coordinate regional and global public health responses.10 Second, by ensuring that NHS exist and are adequately funded, staffed and equipped to be able to respond to the viagra, and by providing clear information and support to citizens so that they may engage in solidarity with one another.There has been great variation in the extent to which different regions have achieved engagement in solidarity across these vectors. New Zealand and South Korea both implemented thorough testing and tracing programmes which allowed them to counteract the spread of (and in South Korea, also reduced influenza s), while New Zealand also imposed strict lockdown protocols, going as far as closing its borders.11 12 Equally importantly, officials in both locations acted quickly, and communicated clearly with their communities, ensuring that residents knew how to minimise the risk of transmission, and why doing so order viagra from canada was important. Individual members of these communities were thus able to engage in interpersonal solidarity, by following order viagra from canada lockdown rules, maintaining social distancing, and participating in track and trace programmes, because their governments had proactively established the material and epistemological conditions where such engagement was enabled, empowered and encouraged. By doing so, the New Zealand and South Korean governments thus engaged in solidarity with their constituents.In contrast, the current British government’s response to erectile dysfunction treatment lacked the transparency, clarity and urgency which characterised the actions of these more successful nations. First, while the UK and New Zealand each initiated lockdowns in the same week in late March, New Zealand at that stage had only 102 cases of erectile dysfunction treatment, with no deaths, compared with the UK’s total of 5687 cases and 281 deaths.12 13 order viagra from canada Correlatively, while South Korea did not enforce a strict lockdown, it had enacted social distancing policies even earlier, at the end of February.11 The risk of ongoing transmission was therefore significantly higher in the UK than in either nation at this time.Second, communication from the current British government was often unclear, and the prime minister and other officials frequently downplayed the severity of the viagra—at one point the prime minister (who was later hospitalised with erectile dysfunction treatment) stated that he would not refrain from shaking hands, and that he had recently shaken hands with everyone in a erectile dysfunction treatment ward.14 In this way, the risks of erectile dysfunction treatment were initially minimised in official communications, creating uncertainty about how to act, and which guidance to follow.

Exacerbating this issue, where advice was given, it was initially often discretionary, and little material support was made available to enable people to follow it. For example, on 16 March 2020, people were advised to work from home if possible and avoid social venues, such as pubs and theatres.15 However, this was not mandatory, and social venues were not required to close until 20 March, so some employees were required to work onsite, despite known risks.16Correlatively, no support was initially made order viagra from canada available to those who could not work remotely, meaning that choices had to be made between employment and ‘fighting the viagra’. Financial support was later made available, in the form of the government’s job retention scheme, which allowed employers to furlough non-essential workers, the wages of whom would be subsidised by government.17 However, this only covered 80% of employee wages, meaning that many of those furloughed would have to live on a reduced order viagra from canada income. Likewise, while support has been offered to home owners in the form of mortgage holidays, at the time of writing, renters have not received similar assistance.18Third, the government also initially moved to adopt a strategy that deviated from the recommendations of the WHO, which focused on minimising rates through conventional public health measures, such as active testing, social distancing and increased emphasis on personal hygiene (hand washing, etc).19 In contrast, the government initially endorsed a ‘herd immunity’ strategy, which appeared to focus on allowing approximately 60% of the British population to become infected with the viagra, which would have led to an even higher level of excess mortality.20 Despite the eventual rejection of this strategy in favour of closer adherence to WHO guidelines, at the time of writing the UK has the world’s second highest erectile dysfunction treatment mortality rate.21 Further, the consequences of these policy choices were compounded because of the historical policy context in which they occur. In the last decade the NHS has seen a significant reduction in funding as a result of austerity policies.22 Consequently, many NHS trusts have found it extremely difficult to respond safely and effectively to the crisis, because of lack of resources (in terms of people, money and equipment)—the absence of sufficient personal protective equipment for those treating patients with erectile dysfunction treatment being order viagra from canada particularly notable.23The current British government’s response to erectile dysfunction treatment therefore deviated significantly from those of nations with more successful responses, and from WHO guidance.

In doing so, it established an epistemological and financial context where it was difficult for individuals to afford to follow public health guidelines, or to even know exactly what those guidelines required. As I argued above, the successful delivery and maintenance of public health programmes requires engagement in order viagra from canada solidarity from both private individuals, and government officials. Engagement in solidarity by the latter entails legislating for the delivery and management of effective public health programmes, and providing clear guidance for their constituents to follow.Unlike their counterparts in New Zealand and South Korea, the current British government has failed to achieve either of these objectives, though it should be noted, that there have also been high profile instances of individual agents in the UK failing to engage in solidarity with their communities.24 However, these solidarity failures must be considered in context. Arguably some failures of individuals to engage in solidarity may order viagra from canada at least in part be attributed to governmental failures to deliver an effective public health response to erectile dysfunction treatment, or communicate its importance and requirements. It has been noted, for example, that panic buying and stockpiling can be sensible strategies in times of potential social chaos and market disruption—especially when told by the government that a total social lockdown may imminently limit access to necessities.25 In each of these cases, order viagra from canada the individuals concerned do have duties of solidarity (as well as professional duties, in the case of healthcare workers) to their compatriots and communities, and failure to fulfil them may cause harm.

However, the costs and challenges of fulfilling those duties have been amplified (and in the case of the professional duties of healthcare workers dangerously so) by the government’s failure to fulfil its own responsibilities of solidarity.ConclusionEffective public health programmes cannot rely solely on private individuals always engaging in interpersonal solidarity in an optimal fashion. Private citizens all operate under epistemological constraints—we may not order viagra from canada know of the needs of others with whom we would engage in solidarity if we had more complete information, or we may be honestly mistaken about the best way to engage in solidarity with people we do know about. Alternatively, we may know of the needs of others, but face material constraints which make providing significant assistance to them impossible. Governments must therefore engage in solidarity with their constituents by providing the epistemological, institutional, material and financial resources, which compensate for these constraints and order viagra from canada thus make interpersonal solidarity possible. By failing to do so, the current British government has failed to adequately protect the residents of the UK in a time of crisis.

It has thus failed to engage in solidarity with its constituents, and effectively devolved responsibility for action to agents with far less power to deliver an effective response to order viagra from canada erectile dysfunction treatment. Further and importantly, those thus tasked with responding to the viagra are disempowered in part because of the failures of the government.Had the government’s failures in response to erectile dysfunction treatment occurred despite the early adoption of recommended strategies proven to work elsewhere, they would not count as failures of order viagra from canada solidarity, but of policy—as unfortunate consequences of mistakes made under challenging circumstances, despite a good faith effort to achieve the best possible outcome. The government’s actions became failures of solidarity when it ignored compelling and accessible information about how best to respond to the crisis, and did not take actions that they could and should have taken. Further, by failing to order viagra from canada provide either definitive rules, or sufficient material and financial support, the government devolved responsibility for responding to the crisis to their constituents and expected them to each individually act in the correct manner to prevent the spread of —an unrealistic expectation. As discussed above, private individuals operate under significantly stricter financial, social and epistemological constraints than their elected representatives, constraints which in this instance were exacerbated by the actions of those in power.

Even under ideal conditions (that is, in the absence of material and order viagra from canada epistemological constraints), reliance on mass individual choices delivering an appropriate response to erectile dysfunction treatment would not be an effective strategy. To rely on such a strategy where such constraints are present is mistaken, and arguably avoidably so. It is order viagra from canada also a dereliction of the government’s responsibilities to its constituents.Importantly therefore, the government’s actions represent more than mere failure to adequately protect its constituents. By devolving responsibility for action to those without sufficient power to act, the government’s actions order viagra from canada should be recognised both as a failure of solidarity, and as a dereliction of it. Indeed, where engagement in solidarity by the government has occurred, it has frequently been delayed, insufficient or reluctantly provided, contributing to the significant excess mortality and morbidity experienced by the UK.21A government which fails to engage in solidarity with its constituents, makes an implicit statement about the nature of the relationship between itself and the rest of society.

In doing so, and in abdicating their responsibilities to their constituents while simultaneously expecting them to collectively deliver an effective response to erectile dysfunction treatment, they redefine that relationship, from being one of elected representatives and constituents, order viagra from canada to one of rulers and ruled.There are two ways to interpret the phrase ‘solidarity is for other people’. First, it can be read as a statement of closeness and relationality—an expression of the understanding that solidarity is something we engage in to assist or benefit other people with whom we identify. Second, it can be order viagra from canada understood as an assertion that the speaker holds themselves apart from other people—a claim that solidarity is something that other people should or may do, but that is not something with which the speaker is concerned. Sadly, recent events suggest that we must give serious consideration to the idea that it is this second interpretation which more accurately reflects the attitudes of the British government at this time.AcknowledgmentsThe author thanks Dr Agomoni Ganguli-Mitra for her very helpful comments on an earlier version of this paper..

Viagra lowers blood pressure

Ofrin, WHO representative to http://www.wordsandbones.uni-tuebingen.de/symposium2016/?p=1 India viagra lowers blood pressure. It is important to remember that, by early February of this year, the economy and social activities reopened. We also saw that people were not behaving in a way that was appropriate to slowing erectile dysfunction treatment, and I think that's why we are where we are.

There are many reasons, but basically, viagra lowers blood pressure we gave the viagra a chance to keep transmitting.Dr. Yasmin Ali Haque, UNICEF representative to India. In 2020 we were working closely with the Indian Government on spreading health messaging and preventing s.

Life began getting back to normal this year, and this is when the second viagra lowers blood pressure wave hit. © UNICEF/Amarjeet Singherectile dysfunction treatment vials are stored in a government-run facility in New Delhi, India.An overwhelming waveDr. Ofrin.

The way the viagra lowers blood pressure viagra has spread is similar to what we’ve seen in Europe or the US, but the scale is very different. The density of the population is probably also a factor, and we’ve seen that the spikes are acute in metropolitan areas. In the weeks when the cases were rising, the system was able to absorb patients, and extra beds were also being made available last year.

So, it’s viagra lowers blood pressure a scale issue. The scale of the surge and the scale of the response.This viagra is adapting so fast, that no model has been able to predict how it will spread. We have to be ahead of the game.

It’s a viagra lowers blood pressure cycle of preparedness, readiness, response and recovery. You can’t stop. However, we do know how to deal with it.

Consistent testing, contact viagra lowers blood pressure tracing, active case finding, early treatment, and proper treatment. People need to observe erectile dysfunction treatment-appropriate behaviours, like the 3W's – Wear a mask, Wash your hands, Watch your distance – and vaccinate. This is the full arsenal of ammunition to fight the viagra.

It is viagra lowers blood pressure now a matter of using these tools consistently, and at scale. Listen below to our full audio interview with Dr. Ofrin.

All hands on deckDr viagra lowers blood pressure. Ali Haque. Right now, we’re focusing on getting essential oxygen equipment.

We’re also working on procuring testing machines, and getting erectile dysfunction treatments delivered viagra lowers blood pressure to people. We have a lot of experience vaccinating children, and we’re adapting that experience to anticipate what kind of bottlenecks we’re likely to face, as well as issues of treatment hesitancy or treatment eagerness. We have administered close to 160 million doses in about 110 days which is probably the fastest in the world.The challenge, of course is the numbers, the size of India, the distances and the terrain that sometimes needs to be covered.

It's not an easy job, but I believe that, if it’s possible anywhere, it is viagra lowers blood pressure going to be possible here. © UNICEF/Amarjeet Singherectile dysfunction treatment patients receive oxygen at a place of worship in Ghaziabad, India.Dr. Ofrin can u buy viagra over the counter.

India is one of the countries that does mass immunisation very, very well. If you look viagra lowers blood pressure at how things started in the US, they were not used to mass vaccination campaigns. India has a strong tradition and history of vaccinations, and that's why the launch on January 16 went well.

However, to achieve herd immunity, we do need to get everyone vaccinated but people also need to behave in ways that are appropriate.We have been tapping our network of 2600 public health specialists in India, and our experts in the field have been supporting our response. It's all viagra lowers blood pressure hands on deck for us. Many of our priority areas will continue to surround the maintenance of essential health services.

Of course, prevention and control is important, but the first priority is filling critical gaps.Listen below to our full interview with Dr. Ali Haque viagra lowers blood pressure. Consequences will last yearsDr.

Ali Haque. The consequences of this viagra will be viagra lowers blood pressure with us for years. We are already seeing the secondary effects, especially on children and the poorest and most marginalised groups.

In the best-case scenario, we estimate that about 50 per cent of children have access to remote learning. That means that around 150 million children of school-going age do not viagra lowers blood pressure have access. We are already hearing of stories of an increase in child labour, the early marriage of girls especially and even child trafficking.We need to address the psychosocial trauma the children are facing now, and to be prepared for the longer term effects.

With so many people dying, children are being left without parental care or without caregivers, so there needs to be an investment in fostering and alternative care arrangements for these children. But I think the way we have seen communities come together, and the extent to which the public has been donating, has been unprecedented viagra lowers blood pressure. This is going to be crucial if we are to see the investment in critical services that allow children to remain healthy, to thrive, and to recover from the trauma created by this viagra.

© UNICEF/Biju BoroA woman is vaccinated against erectile dysfunction treatment at a state dispensary in Guwahati, India.The UN agency has approved the Sinopharm treatment for emergency use, which is a prerequisite for inclusion in the global treatment solidarity initiative, COVAX. The treatment is easy to store, making it suitable for locations with limited resources, and proved 79 per cent effective in clinical viagra lowers blood pressure trials. €œThe addition of this treatment has the potential to rapidly accelerate erectile dysfunction treatment access for countries seeking to protect health workers and populations at risk”, said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products.

“We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable treatment distribution.” A treatment first The Sinopharm treatment is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG). It is the viagra lowers blood pressure first treatment to carry a treatment vial monitor. The vials have a small sticker that changes colour as the treatment is exposed to heat, so health workers know whether it can be safely used.

The treatment is recommended for adults 18 and older, with a two-dose schedule spaced over a period of three to four weeks. Although few people over 60 participated in the clinical trials, WHO did viagra lowers blood pressure not recommend an upper age limit for use as data suggests the treatment is likely to have a protective effect in older persons. Safely expediting treatments WHO emergency use listing (EUL) allows countries to expedite their own regulatory approval to import and administer erectile dysfunction treatments.

The EUL process assesses the suitability of new medicines, treatments and diagnostics during public health emergencies. The goal is to viagra lowers blood pressure make them available as rapidly as possible, while maintaining strict criteria of safety, efficacy and quality. The Sinopharm treatment is the sixth to receive the EUL approval.

The others are by Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Janssen (Johnson &. Johnson) and Moderna..

'We gave order viagra from canada navigate to this website the viagra a chance'Dr. Roderico H. Ofrin, WHO representative to India. It is important to remember that, by early order viagra from canada February of this year, the economy and social activities reopened.

We also saw that people were not behaving in a way that was appropriate to slowing erectile dysfunction treatment, and I think that's why we are where we are. There are many reasons, but basically, we gave the viagra a chance to keep transmitting.Dr. Yasmin Ali Haque, UNICEF representative to order viagra from canada India. In 2020 we were working closely with the Indian Government on spreading health messaging and preventing s.

Life began getting back to normal this year, and this is when the second wave hit. © UNICEF/Amarjeet Singherectile dysfunction treatment vials are stored in a government-run facility in New order viagra from canada Delhi, India.An overwhelming waveDr. Ofrin. The way the viagra has spread is similar to what we’ve seen in Europe or the US, but the scale is very different.

The density of the population is probably also a order viagra from canada factor, and we’ve seen that the spikes are acute in metropolitan areas. In the weeks when the cases were rising, the system was able to absorb patients, and extra beds were also being made available last year. So, it’s a scale issue. The scale of the surge and the scale of the response.This viagra is adapting so fast, that no model has been able to predict how order viagra from canada it will spread.

We have to be ahead of the game. It’s a cycle of preparedness, readiness, response and recovery. You can’t order viagra from canada stop. However, we do know how to deal with it.

Consistent testing, contact tracing, active case finding, early treatment, and proper treatment. People need order viagra from canada to observe erectile dysfunction treatment-appropriate behaviours, like the 3W's – Wear a mask, Wash your hands, Watch your distance – and vaccinate. This is the full arsenal of ammunition to fight the viagra. It is now a matter of using these tools consistently, and at scale.

Listen below to our order viagra from canada full audio interview with Dr. Ofrin. All hands on deckDr. Ali Haque order viagra from canada.

Right now, we’re focusing on getting essential oxygen equipment. We’re also working on procuring testing machines, and getting erectile dysfunction treatments delivered to people. We have a lot of experience vaccinating children, and we’re adapting that experience to anticipate what kind of bottlenecks we’re likely order viagra from canada to face, as well as issues of treatment hesitancy or treatment eagerness. We have administered close to 160 million doses in about 110 days which is probably the fastest in the world.The challenge, of course is the numbers, the size of India, the distances and the terrain that sometimes needs to be covered.

It's not an easy job, this article but I believe that, if it’s possible anywhere, it is going to be possible here. © UNICEF/Amarjeet Singherectile dysfunction treatment patients receive oxygen at a place of worship in Ghaziabad, India.Dr. Ofrin. India is one of the countries that does mass immunisation very, very well.

If you look at how things started in the US, they were not used to mass vaccination campaigns. India has a strong tradition and history of vaccinations, and that's why the launch on January 16 went well. However, to achieve herd immunity, we do need to get everyone vaccinated but people also need to behave in ways that are appropriate.We have been tapping our network of 2600 public health specialists in India, and our experts in the field have been supporting our response. It's all hands on deck for us.

Many of our priority areas will continue to surround the maintenance of essential health services. Of course, prevention and control is important, but the first priority is filling critical gaps.Listen below to our full interview with Dr. Ali Haque. Consequences will last yearsDr.

Ali Haque. The consequences of this viagra will be with us for years. We are already seeing the secondary effects, especially on children and the poorest and most marginalised groups. In the best-case scenario, we estimate that about 50 per cent of children have access to remote learning.

That means that around 150 million children of school-going age do not have access. We are already hearing of stories of an increase in child labour, the early marriage of girls especially and even child trafficking.We need to address the psychosocial trauma the children are facing now, and to be prepared for the longer term effects. With so many people dying, children are being left without parental care or without caregivers, so there needs to be an investment in fostering and alternative care arrangements for these children. But I think the way we have seen communities come together, and the extent to which the public has been donating, has been unprecedented.

This is going to be crucial if we are to see the investment in critical services that allow children to remain healthy, to thrive, and to recover from the trauma created by this viagra. © UNICEF/Biju BoroA woman is vaccinated against erectile dysfunction treatment at a state dispensary in Guwahati, India.The UN agency has approved the Sinopharm treatment for emergency use, which is a prerequisite for inclusion in the global treatment solidarity initiative, COVAX. The treatment is easy to store, making it suitable for locations with limited resources, and proved 79 per cent effective in clinical trials. €œThe addition of this treatment has the potential to rapidly accelerate erectile dysfunction treatment access for countries seeking to protect health workers and populations at risk”, said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products.

“We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable treatment distribution.” A treatment first The Sinopharm treatment is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG). It is the first treatment to carry a treatment vial monitor. The vials have a small sticker that changes colour as the treatment is exposed to heat, so health workers know whether it can be safely used. The treatment is recommended for adults 18 and older, with a two-dose schedule spaced over a period of three to four weeks.

Although few people over 60 participated in the clinical trials, WHO did not recommend an upper age limit for use as data suggests the treatment is likely to have a protective effect in older persons. Safely expediting treatments WHO emergency use listing (EUL) allows countries to expedite their own regulatory approval to import and administer erectile dysfunction treatments. The EUL process assesses the suitability of new medicines, treatments and diagnostics during public health emergencies. The goal is to make them available as rapidly as possible, while maintaining strict criteria of safety, efficacy and quality.

The Sinopharm treatment is the sixth to receive the EUL approval.

Viagra sublingual

Credit...Nathalie LeesPublished May 11, 2021Updated May 13, 2021Leer en españolIf there was ever a perfect viagra sublingual time to make a life change, this is it.Behavioral scientists have long known that times of disruption and transition also create new opportunities for growth and change. Disruption can come in many forms, and it happens when life knocks us out of our normal routines. It can be moving to a new city, starting a new job, getting married or divorced or having a child. And for many of us, there’s never been a bigger life disruption than the viagra, which changed how we work, eat, sleep and exercise, and even how we connect with friends and family.“I think this fresh start is really a big opportunity,” said viagra sublingual Katy Milkman, a professor at the Wharton School and author of the new book “How to Change.

The Science of Getting From Where You Are to Where You Want to Be. €œI don’t know when we’ll have another one like it. We have this blank slate to viagra sublingual work on. Everything is on the table to start fresh.”Much of Dr.

Milkman’s research has focused on the science of new beginnings, which she calls “the fresh start effect.” Dr. Milkman and her colleagues have found that we’re most viagra sublingual inclined to make meaningful changes around “temporal landmarks” — those points in time that we naturally associate with a new beginning. New Year’s Day is the most obvious temporal landmark in our lives, but birthdays, the start of spring, the start of a new school year, even the beginning of the week or the first of the month are all temporal landmarks that create psychological opportunities for change.In one study, Dr. Milkman found that students were most likely to visit the gym around the start of the week, the first of the month, following birthdays or after school breaks.

Another study viagra sublingual found that “fresh start language” helped people kick-start their goals. In that study, people were far more likely to start a new goal on a day labeled “the first day of spring” compared to an unremarkable day labeled “the third Thursday in March.” (It was the exact same day, just labeled differently.)Another study found that when people were advised to start saving money in a few months, they were less likely to do so than a group of people told to start saving around their birthday that was also a few months away. The birthday group saved 20 to 30 percent more money.Although the viagra is far from over, for many people, the lifting of restrictions and getting vaccinated means planning vacations and returning to more-normal work and school routines. It’s exactly the kind of psychological new beginning viagra sublingual that could prompt the fresh start effect, said Dr.

Milkman.“We have this opportunity with this blank slate to change our health habits and be very conscientious about our day,” said Dr. Milkman. €œWhat is our lunch routine going to look like? viagra sublingual. What is our exercise routine?.

There’s an opportunity to rethink. What do we want viagra sublingual a work day to look like?. € Join us for Well’s Fresh Start Challenge!. Starting Monday May 17 we’ll text you daily tips for mindful living.

To sign up, just text viagra sublingual “Hi” (or any word) to 917-809-4995 for a link to join. (Message and data rates may apply.). .outer-wrapper { display. Flex.

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#808080;}It’s Not Too Late to Reset.As the viagra recedes, some people are worried that the past year of lockdowns, restrictions and time at home was a missed opportunity. Leslie Scott, a nonprofit event organizer in Eugene, Ore., said she feels that she just muddled through a stressful year, rather than using the time to make meaningful life changes.“I sometimes wonder if I squandered this gift of time,” said Ms. Scott, who is an organizer of the Oregon Truffle Festival. €œI have all this anxiety that we’re just going to go back to what people think of as normal.

As we come out of our cocoons, am I emerging from something and moving toward something new?. Or am I just stuck?. €While some people did develop healthy new habits during viagra lockdowns, it’s not too late if you spent your viagra days just getting by. The good news is that the end of the viagra is probably a more opportune time for meaningful change than when you were experiencing the heightened anxiety of lockdowns.“erectile dysfunction treatment was an awful time for many of us,” said Laurie Santos, a psychology professor at Yale who teaches a popular online course called “The Science of Well-Being.” “There’s lots of evidence for what’s called post-traumatic growth — that we can come out stronger and with a bit more meaning in our lives after going through negative events.

I think we can all harness this awful viagra time as a time to get some post-traumatic growth in our own lives.”So What’s Your Next Chapter?. One of the biggest obstacles to change has always been the fact that we tend to have established routines that are hard to break. But the viagra shattered many people’s routines, setting us up for a reset, Dr. Santos said.“We’ve all just changed our routines so much,” she said.

€œI think many of us have realized during the viagra that some of the things we were doing before erectile dysfunction treatment weren’t the kind of things that were leading to flourishing in our lives. I think many of us were realizing that aspects of our work and family life and even our relationships probably need to change if we want to be happier.”One reason fresh starts can be so effective is that humans tend to think about the passage of time in chapters or episodes, rather than on a continuum, Dr. Milkman said. As a result, we tend to think of the past in terms of unique periods, such as our high school years, the college years, the years we lived in a particular town or worked at a certain job.

Going forward, we’re likely to look back on the viagra year as a similarly unique chapter of our lives.“We have chapter breaks, as if life is a novel — that is the way we mark time,” said Dr. Milkman. €œThat has implications for the psychology of fresh starts, because these moments that open a new chapter give us a sense of a new beginning. It’s easier to attribute any failings to ‘the old me.’ You feel like you can achieve more now, because we’re in a new chapter.”Take the Fresh Start Challenge!.

While the start of a new chapter is a great time for change, the pages will turn quickly. Now that we’re emerging from the restrictions of viagra life, social scientists say it’s an ideal time to start thinking about what you’ve learned in the past year. What are the new habits you want to keep, and what parts of your previagra life do you want to change?. €œIt’s time to rethink your priorities,” said Dr.

Milkman, who outlines more detailed steps for change in her new book. €œWe have to ask ourselves, ‘How am I going to schedule my time?. €™ We have a limited window to be deliberate about it, because pretty quickly, we’ll have a new pattern established, and we probably won’t rethink it again for a while.”A good first step is to take our 10-Day Fresh Start Challenge. Sign up, and starting Monday, May 17, we’ll send one or two messages a day to prompt moments of mindful reflection, build stronger connections and take small steps toward building healthy new habits.

You can text us, too!. The challenge will include 10 daily challenges, with a break over the weekend.To sign up, just text “Hi” or any word to 917-809-4995 for a link to join. (If you’re on your phone now, tap here to send the text. Message and data rates may apply.) If you prefer not to text or live outside the United States, you can follow along on the website or app.

Just bookmark this page and join us on May 17 for the first challenge.“I think a lot of us have realized how fragile some of the things were that gave us joy before, from going to the grocery store, to going out to a restaurant with friends, going to a movie, giving your mom a hug whenever you’d like,” said Dr. Santos. €œMy hope is that we’ll emerge from this viagra with a bit more appreciation for the little things in life.”AdvertisementContinue reading the main story#masthead-section-label, #masthead-bar-one { display. None }The erectile dysfunction OutbreakLatest UpdatesMaps and CasesState Reopening Trackertreatment RolloutNew Mask Guidancetreatments and ChildrenAdvertisementContinue reading the main storySupported byContinue reading the main storyThey’re Not Anti-treatment, but These Parents Are Hesitant About the erectile dysfunction treatment ShotMany of them are vaccinated, but when it comes to their kids, the unknowns give them pause.Published May 12, 2021Updated May 13, 2021Alejandra Gerardo, 9, looked up at her mother as she received her first shot of the Pfizer treatment during a clinical trial for children at Duke Health in Durham, N.C.Credit...Associated PressOn May 4, Dr.

Hina Talib, who goes by the handle @teenhealthdoc on Instagram, asked the parents among her 33,000 followers if they were hesitant to get the erectile dysfunction treatment for their 12- to 15-year-olds, and if so, why. Dr. Talib, who is a physician in the adolescent medicine division at Children’s Hospital at Montefiore in New York, was surprised to get 600 messages filled with questions and concerns.More often than not, Dr. Talib said, the parents had already had the erectile dysfunction treatment themselves, and would preface their message with.

€œI’m not an anti-vaxxer or an anti-masker. I’m just worried.” According to recently released polls, parents across the country share those concerns, with only about 30 percent saying they would get their children vaccinated right away. Parents of infants and preschoolers expressed more anxiety about the treatment than parents of teenagers did.In trials, there have been no serious safety concerns for children thus far, and Dr. Lee Savio Beers, the president of the American Academy of Pediatrics, heralded the recent emergency use approval of the Pfizer-BioNTech treatment for children 12 to 15 as “a critically important step in bringing life-saving treatments to children and adolescents.”Despite evidence of the treatment’s safety, several parents I spoke to over the past week were similarly hesitant about getting their children the shot.

They were not skeptical about all treatments. Their children tended to be up-to-date with recommended well-child treatments. Their overall fear was related to the newness of the treatment, and unknown future outcomes.As Kimberly Johnson, 38, the mom of elementary-school-age twins in Pound Ridge, N.Y., put it to me in a Facebook message. €œI’m not anti-vax but this all seems just too fast for me.

I don’t want my children to be responding to those lawyer ads you see on TV 25 years from now. You know the ones, ‘If you were under the age of 16 in the years 2021-2022 and received the erectile dysfunction treatment vaccination you could be entitled to compensation …’” #erectile dysfunction treatment-signup-module { margin-left. 20px. Margin-right.

600px. } @media (min-width. 600px) { #erectile dysfunction treatment-signup-module { margin-left. Auto.

} }For Teens, Concerns About Puberty and FertilityParents of adolescents I spoke to tended to be concerned about the treatment affecting puberty and future fertility for their children. Saadia Faruqi, 45, a children’s book author in Houston whose kids are 11 and 14, said that though she and her husband got the treatment, she worries about how it might affect her kids’ hormones, fertility and their growing bodies.Ms. Faruqi feels that if she makes the wrong decision for her children, “I’m going to be a bad mom,” she said. €œI don’t want either of my kids to turn around when they’re in adulthood and ask, ‘Why did you do this?.

€™â€Dr. Talib has also heard these concerns from parents of teens, and she said that while she understands the worry, there’s no biological mechanism that would make the erectile dysfunction treatment worse for teenagers.“Hormones related to puberty should not change the immune response, or the side effect profile of this treatment,” Dr. Talib said. In trials, the Pfizer-BioNTech erectile dysfunction treatment was extremely effective for children 12-15 — there were zero breakthrough s among the kids who received the inoculation.Akiko Iwasaki, a professor of immunobiology at Yale School of Medicine, who wrote an article for The Times debunking disinformation about the erectile dysfunction treatment and fertility, said.

€œEven during the treatment trials some of the women inadvertently got pregnant. There’s nothing even to empirically support” a link between infertility and the erectile dysfunction treatment. €œI have two daughters myself, who are in the 12-14 year age group, I totally understand the fear,” she said. €œBut there’s really no basis for it.”The erectile dysfunction Outbreak ›Latest UpdatesUpdated May 14, 2021, 5:49 p.m.

ETHere’s how the United States beat the variants, for now.Pfizer and Moderna treatments are powerfully effective against erectile dysfunction treatment, a C.D.C. Analysis confirmed.An abrupt U.S. Change on mask guidance has set off a confusing scramble for states and cities.For Younger Children, Worries About Allergies and Side EffectsMolly Herman, 35, who has a 2-year-old and is 32 weeks pregnant with her second child, said she’s anxious about giving her daughter the treatment, even though she chose to get the shot during her pregnancy. Her daughter has never had antibiotics and she’s barely been sick, so “I don’t know what she’s allergic to,” said Ms.

Herman, who lives in Medfield, Mass., and works in higher education.Nicole Frehsee Mazur, 39, who lives in Birmingham, Mich., was also concerned about her children, who are 4 and 6, having an allergic reaction to the treatment, because she had an averse response to the Moderna shot and the kids have allergies. €œI’m not opposed to vaccinating them, I would just like to wait until more kids are vaccinated,” she said.treatments may be available for children over 2 by September at the earliest, so these concerns are theoretical at the moment. Dr. Nia Heard-Garris, a pediatrician and a researcher at Feinberg School of Medicine at Northwestern University, said that she understands parents’ hesitations.

€œThat kind of conversation has been present before we had a feasible treatment, especially from groups that have been marginalized and experimented on. It’s not a fear that’s far-fetched,” she said.But Dr. Heard-Garris said she trusts the science and the data, and that the abstract fears of the treatment’s long-term effects should be weighed against the real-life impacts of the viagra. As the A.A.P.

AdvertisementContinue reading the order viagra from canada Continue Reading main storySupported byContinue reading the main storyNeed a Reset?. Take the 10-Day Fresh Start ChallengeStudies show that moments of disruption offer a unique opportunity to set and achieve new goals. Credit...Nathalie LeesPublished May 11, 2021Updated May 13, 2021Leer en españolIf there was ever a perfect time to make a life change, this is it.Behavioral scientists have long known that times of disruption and transition also create new opportunities for growth and change. Disruption can order viagra from canada come in many forms, and it happens when life knocks us out of our normal routines.

It can be moving to a new city, starting a new job, getting married or divorced or having a child. And for many of us, there’s never been a bigger life disruption than the viagra, which changed how we work, eat, sleep and exercise, and even how we connect with friends and family.“I think this fresh start is really a big opportunity,” said Katy Milkman, a professor at the Wharton School and author of the new book “How to Change. The Science of Getting From Where You Are to order viagra from canada Where You Want to Be. €œI don’t know when we’ll have another one like it.

We have this blank slate to work on. Everything is on the table to start fresh.”Much of order viagra from canada Dr. Milkman’s research has focused on the science of new beginnings, which she calls “the fresh start effect.” Dr. Milkman and her colleagues have found that we’re most inclined to make meaningful changes around “temporal landmarks” — those points in time that we naturally associate with a new beginning.

New Year’s Day is the most obvious temporal landmark in our lives, but birthdays, the start of spring, the start of a new school year, even the beginning of the week or the first of the month are all temporal landmarks that create psychological opportunities for change.In one study, Dr order viagra from canada. Milkman found that students were most likely to visit the gym around the start of the week, the first of the month, following birthdays or after school breaks. Another study found that “fresh start language” helped people kick-start their goals. In that study, people were far more likely to start a new goal on a day labeled “the first day of spring” compared to an unremarkable day labeled “the third Thursday in March.” (It was the exact same day, order viagra from canada just labeled differently.)Another study found that when people were advised to start saving money in a few months, they were less likely to do so than a group of people told to start saving around their birthday that was also a few months away.

The birthday group saved 20 to 30 percent more money.Although the viagra is far from over, for many people, the lifting of restrictions and getting vaccinated means planning vacations and returning to more-normal work and school routines. It’s exactly the kind of psychological new beginning that could prompt the fresh start effect, said Dr. Milkman.“We have this opportunity with this blank slate to change order viagra from canada our health habits and be very conscientious about our day,” said Dr. Milkman.

€œWhat is our lunch routine going to look like?. What order viagra from canada is our exercise routine?. There’s an opportunity to rethink. What do we want a work day to look like?.

€ Join order viagra from canada us for Well’s Fresh Start Challenge!. Starting Monday May 17 we’ll text you daily tips for mindful living. To sign up, just text “Hi” (or any word) to 917-809-4995 for a link to join. (Message and data order viagra from canada rates may apply.).

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} a:hover { color. #f04e23;} a:visited { color. #808080;}It’s Not Too Late to Reset.As the viagra recedes, some people are worried that the past year of lockdowns, restrictions and time at home was a missed opportunity. Leslie Scott, a nonprofit event organizer in Eugene, Ore., said she feels that she just muddled through a stressful year, rather than using the time to make meaningful life changes.“I sometimes wonder if I squandered this gift of time,” said Ms.

Scott, who is an organizer of the Oregon Truffle Festival. €œI have all this anxiety that we’re just going to go back to what people think of as normal. As we come out of our cocoons, am I emerging from something and moving toward something new?. Or am I just stuck?.

€While some people did develop healthy new habits during viagra lockdowns, it’s not too late if you spent your viagra days just getting by. The good news is that the end of the viagra is probably a more opportune time for meaningful change than when you were experiencing the heightened anxiety of lockdowns.“erectile dysfunction treatment was an awful time for many of us,” said Laurie Santos, a psychology professor at Yale who teaches a popular online course called “The Science of Well-Being.” “There’s lots of evidence for what’s called post-traumatic growth — that we can come out stronger and with a bit more meaning in our lives after going through negative events. I think we can all harness this awful viagra time as a time to get some post-traumatic growth in our own lives.”So What’s Your Next Chapter?. One of the biggest obstacles to change has always been the fact that we tend to have established routines that are hard to break.

But the viagra shattered many people’s routines, setting us up for a reset, Dr. Santos said.“We’ve all just changed our routines so much,” she said. €œI think many of us have realized during the viagra that some of the things we were doing before erectile dysfunction treatment weren’t the kind of things that were leading to flourishing in our lives. I think many of us were realizing that aspects of our work and family life and even our relationships probably need to change if we want to be happier.”One reason fresh starts can be so effective is that humans tend to think about the passage of time in chapters or episodes, rather than on a continuum, Dr.

Milkman said. As a result, we tend to think of the past in terms of unique periods, such as our high school years, the college years, the years we lived in a particular town or worked at a certain job. Going forward, we’re likely to look back on the viagra year as a similarly unique chapter of our lives.“We have chapter breaks, as if life is a novel — that is the way we mark time,” said Dr. Milkman.

€œThat has implications for the psychology of fresh starts, because these moments that open a new chapter give us a sense of a new beginning. It’s easier to attribute any failings to ‘the old me.’ You feel like you can achieve more now, because we’re in a new chapter.”Take the Fresh Start Challenge!. While the start of a new chapter is a great time for change, the pages will turn quickly. Now that we’re emerging from the restrictions of viagra life, social scientists say it’s an ideal time to start thinking about what you’ve learned in the past year.

What are the new habits you want to keep, and what parts of your previagra life do you want to change?. €œIt’s time to rethink your priorities,” said Dr. Milkman, who outlines more detailed steps for change in her new book. €œWe have to ask ourselves, ‘How am I going to schedule my time?.

€™ We have a limited window to be deliberate about it, because pretty quickly, we’ll have a new pattern established, and we probably won’t rethink it again for a while.”A good first step is to take our 10-Day Fresh Start Challenge. Sign up, and starting Monday, May 17, we’ll send one or two messages a day to prompt moments of mindful reflection, build stronger connections and take small steps toward building healthy new habits. You can text us, too!. The challenge will include 10 daily challenges, with a break over the weekend.To sign up, just text “Hi” or any word to 917-809-4995 for a link to join.

(If you’re on your phone now, tap here to send the text. Message and data rates may apply.) If you prefer not to text or live outside the United States, you can follow along on the website or app. Just bookmark this page and join us on May 17 for the first challenge.“I think a lot of us have realized how fragile some of the things were that gave us joy before, from going to the grocery store, to going out to a restaurant with friends, going to a movie, giving your mom a hug whenever you’d like,” said Dr. Santos.

€œMy hope is that we’ll emerge from this viagra with a bit more appreciation for the little things in life.”AdvertisementContinue reading the main story#masthead-section-label, #masthead-bar-one { display. None }The erectile dysfunction OutbreakLatest UpdatesMaps and CasesState Reopening Trackertreatment RolloutNew Mask Guidancetreatments and ChildrenAdvertisementContinue reading the main storySupported byContinue reading the main storyThey’re Not Anti-treatment, but These Parents Are Hesitant About the erectile dysfunction treatment ShotMany of them are vaccinated, but when it comes to their kids, the unknowns give them pause.Published May 12, 2021Updated May 13, 2021Alejandra Gerardo, 9, looked up at her mother as she received her first shot of the Pfizer treatment during a clinical trial for children at Duke Health in Durham, N.C.Credit...Associated PressOn May 4, Dr. Hina Talib, who goes by the handle @teenhealthdoc on Instagram, asked the parents among her 33,000 followers if they were hesitant to get the erectile dysfunction treatment for their 12- to 15-year-olds, and if so, why. Dr.

Talib, who is a physician in the adolescent medicine division at Children’s Hospital at Montefiore in New York, was surprised to get 600 messages filled with questions and concerns.More often than not, Dr. Talib said, the parents had already had the erectile dysfunction treatment themselves, and would preface their message with. €œI’m not an anti-vaxxer or an anti-masker. I’m just worried.” According to recently released polls, parents across the country share those concerns, with only about 30 percent saying they would get their children vaccinated right away.

Parents of infants and preschoolers expressed more anxiety about the treatment than parents of teenagers did.In trials, there have been no serious safety concerns for children thus far, and Dr. Lee Savio Beers, the president of the American Academy of Pediatrics, heralded the recent emergency use approval of the Pfizer-BioNTech treatment for children 12 to 15 as “a critically important step in bringing life-saving treatments to children and adolescents.”Despite evidence of the treatment’s safety, several parents I spoke to over the past week were similarly hesitant about getting their children the shot. They were not skeptical about all treatments. Their children tended to be up-to-date with recommended well-child treatments.

Their overall fear was related to the newness of the treatment, and unknown future outcomes.As Kimberly Johnson, 38, the mom of elementary-school-age twins in Pound Ridge, N.Y., put it to me in a Facebook message. €œI’m not anti-vax but this all seems just too fast for me. I don’t want my children to be responding to those lawyer ads you see on TV 25 years from now. You know the ones, ‘If you were under the age of 16 in the years 2021-2022 and received the erectile dysfunction treatment vaccination you could be entitled to compensation …’” #erectile dysfunction treatment-signup-module { margin-left.

Calc(100% - 40px). Max-width. 600px. } @media (min-width.

600px) { #erectile dysfunction treatment-signup-module { margin-left. Auto. Margin-right. Auto.

Width. 100%. } }For Teens, Concerns About Puberty and FertilityParents of adolescents I spoke to tended to be concerned about the treatment affecting puberty and future fertility for their children. Saadia Faruqi, 45, a children’s book author in Houston whose kids are 11 and 14, said that though she and her husband got the treatment, she worries about how it might affect her kids’ hormones, fertility and their growing bodies.Ms.

Faruqi feels that if she makes the wrong decision for her children, “I’m going to be a bad mom,” she said. €œI don’t want either of my kids to turn around when they’re in adulthood and ask, ‘Why did you do this?. €™â€Dr. Talib has also heard these concerns from parents of teens, and she said that while she understands the worry, there’s no biological mechanism that would make the erectile dysfunction treatment worse for teenagers.“Hormones related to puberty should not change the immune response, or the side effect profile of this treatment,” Dr.

Talib said. In trials, the Pfizer-BioNTech erectile dysfunction treatment was extremely effective for children 12-15 — there were zero breakthrough s among the kids who received the inoculation.Akiko Iwasaki, a professor of immunobiology at Yale School of Medicine, who wrote an article for The Times debunking disinformation about the erectile dysfunction treatment and fertility, said. €œEven during the treatment trials some of the women inadvertently got pregnant. There’s nothing even to empirically support” a link between infertility and the erectile dysfunction treatment.

€œI have two daughters myself, who are in the 12-14 year age group, I totally understand the fear,” she said. €œBut there’s really no basis for it.”The erectile dysfunction Outbreak ›Latest UpdatesUpdated May 14, 2021, 5:49 p.m. ETHere’s how the United States beat the variants, for now.Pfizer and Moderna treatments are powerfully effective against erectile dysfunction treatment, a C.D.C. Analysis confirmed.An abrupt U.S.

Change on mask guidance has set off a confusing scramble for states and cities.For Younger Children, Worries About Allergies and Side EffectsMolly Herman, 35, who has a 2-year-old and is 32 weeks pregnant with her second child, said she’s anxious about giving her daughter the treatment, even though she chose to get the shot during her pregnancy. Her daughter has never had antibiotics and she’s barely been sick, so “I don’t know what she’s allergic to,” said Ms. Herman, who lives in Medfield, Mass., and works in higher education.Nicole Frehsee Mazur, 39, who lives in Birmingham, Mich., was also concerned about her children, who are 4 and 6, having an allergic reaction to the treatment, because she had an averse response to the Moderna shot and the kids have allergies. €œI’m not opposed to vaccinating them, I would just like to wait until more kids are vaccinated,” she said.treatments may be available for children over 2 by September at the earliest, so these concerns are theoretical at the moment.

Dr. Nia Heard-Garris, a pediatrician and a researcher at Feinberg School of Medicine at Northwestern University, said that she understands parents’ hesitations. €œThat kind of conversation has been present before we had a feasible treatment, especially from groups that have been marginalized and experimented on. It’s not a fear that’s far-fetched,” she said.But Dr.

Heard-Garris said she trusts the science and the data, and that the abstract fears of the treatment’s long-term effects should be weighed against the real-life impacts of the viagra. As the A.A.P.

Over the counter female viagra walmart

(PDF Version - over the counter female viagra walmart 406 KB) Date http://tristangough.com/levitra-discount-code Adopted. 2000/02/14 Revised Date. 2021/04/08 Effective over the counter female viagra walmart Date. 2021/05/11 Foreword Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance over the counter female viagra walmart to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach.

Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a over the counter female viagra walmart therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.Document change logDate. 2018/04/05Change. Updated in accordance with the September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations.Location (section, paragraph).

All Nature of and/or reason for change. The updates to the Guidance Document are being made following the amendments to the Patented Medicines (Notice of Compliance) Regulations, which came into force on September 21, 2017. The updates also reflect current administrative practices (e.g. Update of terminology from “patent hold” to “Intellectual Property Hold”). Date.

2021/04/08 Change. Updated in accordance with the new Health Products and Food Branch organizational structure. Location (section, paragraph). All Nature of and/or reason for change. Change in Health Products and Food Branch organizational structure.Table of Contents 1.

Introduction1.1 Policy objectivesIn accordance with the Regulatory Impact Analysis Statement (RIAS) published in the Canada Gazette, Part II on October 18, 2006, Footnote 1 Canada's pharmaceutical patent policy objective is to "balance the effective patent enforcement over new and innovative drugs with the timely entry of their lower priced generic competitors". The Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) were introduced originally by Industry Canada (now known as Innovation, Science and Economic Development Canada) under the Patent Act. The PM(NOC) Regulations intersect with drug approval under the Food and Drugs Act and Division 8 of the Food and Drug Regulations. 1.2 Policy statementsThe early working exception of subsection 55.2(1) of the Patent Act allows a subsequent manufacturer to use a patented invention for the purpose of seeking regulatory approval of that product. The provision, therefore, provides an exception from infringement.

The PM(NOC) Regulations provide the balance, through a patent enforcement mechanism, to ensure that the early working exception is not abused by linking the regulatory approval of a generic drug to the patent status of the innovative product. 1.3 Scope and applicationThis guidance document provides information regarding the administration of the PM(NOC) Regulations by the Office of Patented Medicines and Liaison (OPML) within the Office of Submissions and Intellectual Property (OSIP), Resource Management and Operations Directorate (RMOD), Health Canada. It is applicable to drugs that receive a notice of compliance (NOC), including pharmaceutical, biological, radiopharmaceutical and veterinary drugs.1.4 BackgroundThe PM(NOC) Regulations were originally enacted in 1993, and have undergone various amendments. The most recent amendment came into force on September 21, 2017. Under the pre-2017 version of the PM(NOC) Regulations, innovative drug companies could commence legal proceedings for an order prohibiting the Minister of Health from granting an NOC for a generic version of a patented medicine.

The September 21, 2017 amendments to the PM(NOC) Regulations replaced these prohibition application proceedings with full actions resulting in final determinations of patent infringement and validity. The pre-2017 version of the PM(NOC) Regulations will continue to apply in respect of any matter that relates to a notice of allegation (NOA) served on a first person before September 21, 2017.2. Definitions Filing date of a submission Refers to the date that the submission is deemed administratively complete by Health Canada (i.e. Once all elements and forms required for processing are completed and submitted to Health Canada). This date may differ from the date of original receipt should the submission be considered administratively incomplete at the time of receipt.

The filing date established for a submission is not affected by subsequent screening or review activities. In the Drug Submission Tracking System - Industry Access, the filing date of a submission is indicated in the CR Date field. Filing date of a patent Refers to the Canadian filing date of a Canadian patent application as established by the Canadian Intellectual Property Office (CIPO). Patent Refers to a granted Canadian patent (not a patent application). Biosimilar biologic drug Refers to a biologic drug that obtains market authorization subsequent to a version previously authorized in Canada, and with demonstrated similarity to a reference biologic drug.

A biosimilar relies in part on prior information regarding safety, efficacy and effectiveness that is deemed relevant due to the demonstration of similarity to the reference biologic drug and which influences the amount and type of original data required. Biosimilar biologic drugs were previously referred to as Subsequent Entry Biologics.3. General information3.1 GeneralThe OPML within OSIP, RMOD administers the PM(NOC) Regulations. All drug submissions seeking an NOC, including those submitted to the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Natural and Non-Prescription Health Products Directorate (NNHPD) and Veterinary Drugs Directorate (VDD), are assessed to determine if they fall within the scope of the PM(NOC) Regulations. The directorates mentioned above are a part of Health Canada's Health Products and Food Branch (HPFB).

3.2 Patent RegisterPursuant to subsection 3(2) of the PM(NOC) Regulations, the RMOD is required to maintain a register of patents that have been submitted for addition to the register and certificates of supplementary protection (CSPs) in which any of those patents are set out. The Patent Register is available online and is refreshed nightly. Any questions, comments or problems with the Patent Register should be directed to the OPML (hc.opml-bmbl.sc@canada.ca).3.3 Drug Identification Number (DIN) cancellation - deletion of Patent Lists from the Patent RegisterSubsection 3(3) of the PM(NOC) Regulations applies to drugs for which the drug identification number (DIN) has been cancelled under the Food and Drug Regulations. As provided for in subsection 3(3), patents added to the Patent Register in respect of a drug for which the DIN was cancelled shall be deleted from the Patent Register by the RMOD 90 days after the DIN was cancelled. An exception to this rule exists for cancellations effected as a result of a change in manufacturer.

Form IV. Patent Lists (Form IVs) deleted as a result of a DIN cancellation will be re-added to the Patent Register upon re-activation of the DIN, i.e. Receipt of a DIN Notification Form, as required by section C.01.014.3 of the Food and Drug Regulations. A first person who submits such a DIN Notification Form should also notify the OPML.3.4 How to provide information to the RMOD3.4.1 How to provide litigation informationAs the Minister of Health will not be a party to actions for patent infringement under the PM(NOC) Regulations, litigation documents in such actions will no longer be served on the Minister. However, the RMOD must have access to relevant information to determine whether there are any barriers under the PM(NOC) Regulations that would prohibit issuance of an NOC for a second person’s submission.

As such, under section 6.13 of the PM(NOC) Regulations, a person who brings an action for infringement is to provide the RMOD with certain documents as soon as feasible. The RMOD may also request any information or document required to assess whether NOC issuance is prohibited under section 7 of the PM(NOC) Regulations. Requests for verification of any portion of a submission served with an NOA or produced in the course of a court action can be made under section 6.05 of the PM(NOC) Regulations. All information related to litigation, including requests for verifications, must be submitted to the RMOD electronically and no duplicate copy should be sent in paper format. Please provide the information by email to.

Hc.opml-bmbl.sc@canada.ca, or on an acceptable media format, using the requirements outlined below. As with other drug submission information submitted electronically, any information received after 5:00 pm Eastern Standard Time, on a weekend, or on a Statutory Holiday will be considered received on the next business day.By emailLitigation information should be provided via email unless it exceeds the size limit, in which case it should be provided on media. The sender assumes the risk of transmitting confidential or sensitive information through email. The maximum email size accepted by the corporate mail server is 20 megabytes. Anything larger should be sent on media.

Documents contained in the email should not be password protected. Please indicate PM(NOC) Regulations, the court file number and the stakeholder name in the subject line of the email.On mediaElectronic media may be sent by courier / mail. The media formats acceptable when providing information are. Compact Disc-Recordable (CD-R) conforming to the Joliet specification Digital Versatile Disc-Random Access Memory (DVD-RAM) Universal Disc Format (UDF) standard Single and dual layer Recordable Digital Versatile Discs Universal Serial Bus (USB) 2.0 or 3.0 drive Media and files should not be password protected Files stored on the media should not be zipped All information should be provided on a single disc/drive Media should be scanned using current viagra-scanning software and should be certified viagra-free All media should be labelled. The label on the disc/drive should contain the following information.

PM(NOC) Regulations Stakeholder name Court file number "This media has been viagra-scanned and we certify that it is viagra free" Subsequent to burning the CD/DVD or transferring data to a drive, stakeholders should ensure that all files can be opened and no files are corrupt Information provided on approved media formats should be sent to the below address, to the attention of the OPML:Office of Submissions and Intellectual PropertyResource Management and Operations Directorate Health Products and Food Branch Health Canada Finance Building 101 Tunney's Pasture Driveway Address Locator. 0201A1 Ottawa, Ontario K1A 0K9 3.4.2 How to provide other informationAs is currently required, other information related to the PM(NOC) Regulations should be submitted in either the electronic Common Technical Document (eCTD) format or the non-eCTD electronic-only format in module 1.2.4.1 - Patent Information. In accordance with Health Canada's Guidance Document. Preparation of Drug Regulatory Activities in the Electronic Common Technical Document Format, regulatory transactions accepted in the eCTD format include. Written correspondence related to the PM(NOC) Regulations NOA packages (e.g.

Proof of service of the NOA on the first person and a copy of the NOA) under the PM(NOC) Regulations Form IVs, including updates, filed in accordance with the PM(NOC) Regulations Form V. Declaration re. Patent Lists (Form Vs), including updates, filed in accordance with the PM(NOC) Regulations, and Consent letters (under the PM(NOC) Regulations)For eCTD submissions, the regulatory transactions listed above should be submitted via the Common Electronic Submissions Gateway, as indicated in the Frequently Asked Questions - Common Electronic Submissions Gateway and the CESG Health Canada Reference Guide. For non-eCTD submissions, the above-noted information should be sent on an acceptable media format as indicated in the Guidance Document. Preparation of Drug Regulatory Activities in the 'Non-eCTD Electronic-Only' Format.As with other drug submission information submitted electronically, any information received after 5:00 pm Eastern Standard Time, on a weekend, or on a Statutory Holiday will be considered received on the next business day.4.

Section 4 of the PM(NOC) Regulations4.1 GeneralThe requirements that must be met before a patent can be added to the Patent Register are provided by section 4 of the PM(NOC) Regulations. Section 4 describes. The timing requirements for filing patent lists. The required content of patent lists. The drug submissions for which patent lists may be filed.

And eligibility requirements relating to the claims of the patent.The following sections provide more detailed guidance regarding these requirements. A patent list must be submitted using the Form IV. Patent List template, available on the Health Canada website. Refer to Appendix A for instructions on how to complete the form. First persons are requested to complete one form per patent, per submission, per DIN.

4.2 Timing requirementsA first person wishing to file a patent list for a particular drug must meet the timing requirements set out in subsections 4(5) and 4(6) of the PM(NOC) Regulations. The timing requirements continue to apply during the reconsideration process set out in Health Canada's Guidance Document Reconsideration of Decisions Issued for Human Drug Submissions. 4.2.1 Patent Lists at time of filing a submissionPursuant to subsection 4(5) of the PM(NOC) Regulations, a first person wishing to submit a patent list must do so at the time it files the new drug submission (NDS) or supplement to a new drug submission (SNDS) to which the patent list relates. Only patent lists that accompany the drug submission will be accepted and patent lists submitted separately will be refused as not meeting the timing requirements.4.2.2 Patent Lists after time of filing a submissionPursuant to subsection 4(6) of the PM(NOC) Regulations, a first person may also submit a patent list in respect of a previously filed drug submission provided that the following conditions are met. the Canadian filing date of the patent precedes the drug submission filing date, and the patent list is submitted to the RMOD within thirty days after the issuance of the patent.In these circumstances, a first person must, in addition to submitting all of the information required under subsection 4(4), identify the submission number to which the newly granted patent relates.

4.3 Content requirements and prioritisationAll patent lists received by the RMOD will be evaluated for completeness against the list of required information set out in subsection 4(4) of the PM(NOC) Regulations. It should be noted, however, that the RMOD does not have a duty to make corrections or suggestions or inform first persons of any deficiencies in the content of patent lists. In the case of a newly-issued patent, it is recommended that patent lists be submitted to the RMOD as soon as possible. Where deficiencies are identified, first persons may have an opportunity to correct a patent list or submit additional patent lists before the end of the 30-day period. For more information on how to complete a Form IV, please consult Appendix A.

In order to expedite the evaluation by the RMOD, first persons are encouraged to include (i.e. As part of the cover letter) with their patent lists a list of eligible patent claims and a description of how such claims correspond to the drug submission in respect of which the patent list is filed, as well as page references to relevant portions of the drug submission, where applicable. The RMOD will prioritise evaluations for submissions for which an NOC has already issued.4.4 Drug submissions eligible for filing a Patent List In accordance with subsection 4(1) of the PM(NOC) Regulations, a patent list may be filed in relation to an NDS or an SNDS. Both “new drug submission” and “supplement to a new drug submission” are defined in subsection 3(1) of the PM(NOC) Regulations. Pursuant to these definitions and to subsections 4(2) and 4(3), only the following clearly defined submission types provide an opportunity to add a patent to the Patent Register.

An NDS, except an NDS based solely on the change of name of the manufacturer (see definition of “new drug submission” in subsection 3(1)) An SNDS for a change in formulation An SNDS for a change in dosage form An SNDS for a change in use of the medicinal ingredient4.5 Product specificity requirementsIn addition to the timing, content and submission requirements outlined in the previous sections, section 4 of the PM(NOC) Regulations sets out additional product-specificity requirements which are to be considered in determining the eligibility of a patent to be added to the Patent Register. As discussed in the RIAS accompanying the October 5, 2006 amendments, in order for a patent to qualify for protection under the PM(NOC) Regulations, it must be relevant to the drug product the first person is approved to sell. The amendments entrench the concept of drug product specificity as the key consideration required of the Minister in applying the eligibility requirements under the PM(NOC) Regulations. In turn, the amended language more precisely reflects the intended link between the subject matter of a patent on a patent list and the content of the underlying submission for the NOC in relation to which it is submitted. 4.5.1.

Patent List in relation to a New Drug SubmissionIn order to be eligible to be added to the Patent Register, the patent must contain a claim for the medicinal ingredient, a claim for the formulation containing the medicinal ingredient, a claim for the dosage form, or a claim for the use of the medicinal ingredient, which has been approved through the issuance of an NOC in respect of the submission. The RMOD considers the following three questions when applying the requirements of section 4 of the PM(NOC) Regulations. What does the patent claim?. What is approved in the submission?. Does the patent claim what is approved in the submission?.

In general, the RMOD will not consider the following types of patents as being eligible to be added to the Patent Register. a purely process patent a patent for a medical device a patent for an intermediate used in the manufacture of the medicinal ingredient a patent for a metabolite of the medicinal ingredient, and a patent for an impurity present in the final drug productClaim for the medicinal ingredientAs specified in the definition of “claim for the medicinal ingredient”, product-by-process patents and patents claiming biological drugs are eligible to be added to the Patent Register provided that all other requirements set out in the PM(NOC) Regulations are met. This definition also clarifies that patents claiming different polymorphs of the medicinal ingredient are eligible for listing. As specified in the RIAS accompanying the October 5, 2006 amendments to the PM(NOC) Regulations, the term “polymorph” is meant to include different crystalline, amorphous, hydrated and solvated forms of the approved medicinal ingredient.A patent claiming an enantiomer is not eligible to be added to the Patent Register in respect of a medicinal ingredient that is a racemate. In addition, a patent that claims varying ratios of enantiomers is not eligible to be added to the Patent Register with respect to a racemate of the medicinal ingredient.

Similarly, a patent directed specifically to a racemic mixture or a mixture of two enantiomers in varying ratios will not be eligible to be added to the Patent Register in relation to a drug containing only one of the enantiomers. In accordance with subsection 4(2.1), a patent that claims a medicinal ingredient is eligible to be added to the Patent Register in respect of a drug that contains that medicinal ingredient in combination with other medicinal ingredients. However, patents claiming a combination of medicinal ingredients contained in a single formulation or dosage form are not eligible to be added to the Patent Register in respect of a drug that contains only one of the claimed medicinal ingredients. Claim for the formulation that contains the medicinal ingredient The formulation claimed in the patent must correspond to the formulation approved in the relevant drug submission. A claim for the formulation may or may not specify non-medicinal ingredients.

Under paragraph 4(2.1)(b), a patent that contains a claim for the formulation is eligible to be added to the Patent Register if the drug contains the non-medicinal ingredients in the claim, even if the drug contains additional non-medicinal ingredients. For example, a patent claiming a formulation that contains non-medicinal ingredient X would not be eligible to be added to the Patent Register in respect of a drug that does not contain non-medicinal ingredient X. Conversely, the same patent would be eligible to be added to the Patent Register in respect of a drug that contains non-medicinal ingredients X and Y. Claim for the dosage formThe dosage form claimed in the patent must correspond to the dosage form approved in the relevant drug submission as noted on the NOC. This would include novel dosage forms, for example, patents that claim.

a patch an extended-release tablet or capsule, and an implantHowever, patents directed solely towards a dispenser, a container or packaging (e.g. An inhaler, an intravenous stand, or a syringe) would not be considered to contain a claim for the dosage form. Claim for the use of the medicinal ingredientThe RMOD will refer to the indication section of the Product Monograph (PM) of the drug to determine whether or not the patent claims an approved use of the medicinal ingredient. However, it is not expected that the language in the patent will be reproduced exactly in the PM. As PMs do not exist for veterinary products, generally the labelling information and package insert will be used.

A patent containing a claim for the use of a medicinal ingredient is eligible to be added to the Patent Register in respect of a drug that contains that medicinal ingredient in combination with other medicinal ingredients, if the drug is approved for the use claimed in the patent. Patents claiming the use of a combination of medicinal ingredients will generally not be eligible to be added to the Patent Register against a drug containing only one of the medicinal ingredients in the combination. However, patents claiming the use of a medicinal ingredient in combination with one or more other medicinal ingredient(s) are eligible to be added to the Patent Register, if said combination use is found in the indication section of the drug's approved PM. However, in order to be eligible, the patent claims must not be limited to the use of the combination in a single formulation or dosage form. For example, a patent claiming the sequential use of medicinal ingredient A in combination with medicinal ingredient B for the treatment of X could be added to the Patent Register in respect of a drug solely containing medicinal ingredient A, if the claimed use of the combination is found in the drug's approved PM.

4.5.2 Patent List in relation to a Supplement to a New Drug SubmissionA new patent may only be added to the Patent Register in respect of the following three specific types of SNDSs. an SNDS for a change in formulation (this includes a change in strength) an SNDS for a change in dosage form, and an SNDS for a change in use of the medicinal ingredientIn addition to this requirement and in keeping with the product-specificity requirements, the patent will only be eligible to be added to the Patent Register if it contains a claim for the very change approved in the supplement. Therefore, if the supplement is for a new formulation, dosage form or use, the patent must contain a claim for the new formulation, dosage form or use in order to be eligible to be added to the Patent Register. Subsection 4(3) of the PM(NOC) Regulations does not allow the addition of patents containing claims solely for the medicinal ingredient (including polymorphic forms). The RMOD considers the following three questions when applying the requirements of subsection 4(3) of the PM(NOC) Regulations.

What does the patent claim?. What is the change approved in the submission?. Does the patent claim the very change approved in the submission?. 4.5.3 Carry-forward provisionSubsection 4.1(2) of the PM(NOC) Regulations is a "carry-forward" provision. Under subsection 4.1(2), a first person who submits a patent list in relation to an NDS referred to in subsection 4(2) may, if the list is added to the Patent Register, resubmit the same list in relation to an SNDS, but may not submit a new patent list in relation to a supplement except in accordance with subsection 4(3).

Similarly, a patent on a patent list that has been added to the Patent Register in respect of a supplement under subsection 4(3) may be "carried forward" in respect of a subsequently approved supplement. The RMOD is required to give effect to the product-specificity requirements in applying the "carry-forward" provision under subsection 4.1(2). As such, patents which are already included on the Patent Register will be "carried forward" to a new DIN, provided the product-specificity requirements continue to be met (e.g. A patent that contains a claim for the medicinal ingredient will be carried forward in respect of a supplement for a new strength or dosage form).In all cases, the RMOD will apply the same timing requirements to patent lists submitted under the "carry-forward" provision as are applied to patent lists submitted under section 4 of the PM(NOC) Regulations. When submitting a patent list with a supplement and the patent is already included on the Patent Register, the RMOD recommends that the first person submit such a patent list under the "carry forward" provision, unless the patent contains a specific claim for the changed formulation, the changed dosage form or the changed use, for which the supplement was submitted.4.5.4 ConsultationAs permitted by subsection 3(8) of the PM(NOC) Regulations, the RMOD may consult with officers or employees of the Patent Office in the CIPO regarding the claims construction of the patent.

The CIPO may be consulted to verify if a patent has lapsed. The RMOD may also consult with the relevant review area within the HPFB, where necessary, regarding the information in the drug submission (e.g. Regarding the approved use of the medicinal ingredient).4.6 ProcessFor patent lists submitted at the time of filing of a drug submission and for newly-issued patents submitted for drug submissions under review, the RMOD will conduct a preliminary evaluation to ensure that the patents meet all eligibility requirements. If a patent is preliminarily found to be eligible, the RMOD will inform the first person in writing, indicating that the eligibility determination is subject to a final review at the time of issuance of the NOC. The RMOD will conduct a final check of the eligibility of the patent prior to addition to the Patent Register, as what is approved may be different from what was initially submitted.

This final check is to ensure that no significant changes were made to the drug submission during the review process that would affect the patent eligibility, for example, changes to the indication, dosage form, route of administration or strength of the drug. The final patent check will also ensure that there have been no changes to the jurisprudence which would affect the eligibility of the patent for addition to the Patent Register. This check does not delay the issuance of the NOC. If the RMOD preliminarily determines a patent to be ineligible, the RMOD will notify the first person, in writing, that the patent has been found ineligible to be added to the Patent Register. The first person will then be provided with an opportunity to submit written representations as to the patent's eligibility to be added to the Patent Register.

If representations are provided, they will be taken into consideration by the RMOD and a final decision regarding the patent eligibility will subsequently be communicated to the first person.4.7 Certificates of Supplementary Protection A CSP provides an additional period of protection, of up to 2 years, for drugs containing a new medicinal ingredient, or a combination thereof, protected by an eligible patent. For more information on CSPs, please consult the Health Canada Guidance Document Certificate of Supplementary Protection Regulations. In accordance with subsection 4(3.1) of the PM(NOC) Regulations, a CSP is eligible to be added to the Patent Register in respect of an NDS or SNDS if two requirements are met. The first requirement is that the patent set out in the CSP must be included on the Patent Register in respect of that submission or supplement. The second requirement is that the submission or supplement relates to a drug with respect to which the CSP grants rights, privileges and liberties referred to in section 115 of the Patent Act.Section 115 of the Patent Act provides that the scope of the CSP is the same as that of the patent, but only with respect to the making, constructing, using or selling of any drug that contains the medicinal ingredient or combination of medicinal ingredients set out in the certificate, by itself or in addition to any other medicinal ingredient.

The following scenarios are provided as examples. Example 1a. CSP No. 1 is issued in relation to medicinal ingredient X and the NDS for Drug A. The patent set out in CSP No.

1 is included on the Patent Register in respect of Drug A. The scope of the CSP includes Drug A because Drug A contains medicinal ingredient X. As both requirements of subsection 4(3.1) are met, CSP No. 1 is eligible to be added to the Patent Register in respect of Drug A.Example 1b. The patent set out in CSP No.

1 is included on the Patent Register in respect of Drug B. Drug B contains medicinal ingredient X in combination with medicinal ingredient Y. The scope of CSP No. 1 includes Drug B because Drug B contains medicinal ingredient X. As both requirements of subsection 4(3.1) are met, CSP No.

1 is eligible to be added to the Patent Register in respect of Drug B. Example 2. CSP No. 2 is issued in relation to medicinal ingredient W and the NDS for Drug C. However, the patent set out in CSP No.

2 is not included on the Patent Register in respect of Drug C. Therefore, the requirement of paragraph 4(3.1)(a) is not met and CSP No. 2 is not eligible to be added to the Patent Register.Example 3. CSP No. 3 is issued in relation to the NDS for Drug D, containing medicinal ingredient Y.The patent set out in CSP No.

3 is included on the Patent Register in respect of Drug D, containing medicinal ingredient Y. Drug D is within the scope of CSP No. 3 because it contains the medicinal ingredient set out in the CSP. Therefore, CSP No. 3 is eligible to be added to the Patent Register in respect of Drug D.

The patent set out in CSP No. 3 is also included on the Patent Register in respect of another drug, Drug E, containing medicinal ingredient Z. CSP No. 3 does not grant rights, privileges and liberties in respect of Drug E in accordance with section 115 of the Patent Act, as Drug E does not contain the medicinal ingredient Y or the "same" medicinal ingredient, per the Certificate of Supplementary Protection Regulations and section 105 of the Patent Act. Therefore, CSP No.

3 is not eligible to be added to the Patent Register in respect of Drug E because the requirement of paragraph 4(3.1)(b) of the PM(NOC) Regulations is not met. 4.7.1 ProcessOnce issued, all CSPs will be assessed by the RMOD in accordance with subsection 4(3.1) of the PM(NOC) Regulations for eligibility to be added to the Patent Register without requiring a separate form or request from the first person. To assess the eligibility of a CSP, the RMOD will first determine if the patent set out in the CSP is included on the Patent Register. If the patent is included on the Patent Register, the RMOD will assess whether the drug on the Patent Register is a drug with respect to which the CSP grants rights, privileges and liberties referred to in section 115 of the Patent Act. If the patent is not on the Patent Register, the CSP is not eligible to be added to the Patent Register, and the RMOD will not provide an assessment in writing.

For CSPs found eligible for addition to the Patent Register, the RMOD will insert the CSP number and expiry date in the office use section of the corresponding patent list(s) and will update the Patent Register. The first person will also be notified in writing. The expiry date of the CSP will be reflected in a separate field on the Patent Register from the expiry date of the patent. If the patent set out in the CSP is included on the Patent Register, but the RMOD determines that the CSP is not eligible to be added to the Patent Register, the first person will be notified in writing. The first person will have the opportunity to provide representations.

The RMOD will consider any representations before a final decision is made. It is possible that a CSP will be added to the Patent Register before publication of the CSP issuance on the Register of Certificates of Supplementary Protection and Applications. When completing a Form IV for a patent that is set out in a CSP, first persons should provide the information relating to the patent only. For example, enter the patent number and the expiry date of the patent in Part 3 of the form, and not the CSP number or expiry date. The RMOD will insert the information in relation to the CSP in the office use section of the form.

In accordance with subsection 4(1.1) of the PM(NOC) Regulations, a patent list may include a patent that has expired if it is set out in a CSP that has taken effect. As such, if a patent has expired and the term of a CSP is in effect when submitting a Form IV with a submission, the first person should continue to enter the patent information on the form, as described above.4.8 Addition of patent(s) and CSP(s) to the Patent RegisterAs provided for in subsection 3(7) of the PM(NOC) Regulations, no patent on a patent list or CSP shall be added to the Patent Register until the drug submission in respect of which the patent list was submitted receives an NOC. In addition to this requirement, the RMOD will not add any patent or CSP until it has completed a final evaluation and is satisfied that the patent or CSP meets the eligibility requirements set out in section 4, described above. The RMOD will prioritise evaluations for submissions for which an NOC has already issued. It is recognised that certain terminology proposed by the company at the time of filing a drug submission does not become final until review and approval through the issuance of an NOC.

Therefore, at the time of NOC issuance, it is possible that the information on Part 2 of the Form IV does not match the NOC, e.g. The medicinal ingredient, brand name, strength, route of administration and dosage form. If this information does not match the NOC, the first person is expected to request updates to the patent list, in accordance with the obligations set out in subsection 4(7). The RMOD will not update a patent list without written permission from the first person. Replacement Form IVs should not be provided by first persons.

Upon receipt of the written permission, the RMOD will make the requested changes to the Form IV to align the terminology on the Form IV with that approved on the NOC. Where permission is not received in a timely manner, there may be delays in adding the patent lists to the Patent Register.4.9 Accuracy of Patent List informationPursuant to subsection 4(7), first persons are required to keep the information on their patent lists up to date. The update of information, however, does not provide an opportunity to add a new patent. A first person should notify the RMOD in writing of any updates to the information included on the patent lists. Examples of an update include a change to the company name or address, the name and address for service of an NOA, patent lapse, or the dedication of the patent to the public interest.

The onus is on the first person to ensure that the information on the patent list and the Patent Register is accurate and current. Please note that due to the complexities of corporate mergers and acquisitions, information is not automatically updated when an NOC is issued for a company name change or merger. To ensure receipt of an NOA from a second person, the company name and address for service must be current. First persons wishing to update a patent list should forward to the RMOD a letter outlining the requested changes. First persons are requested not to provide the RMOD with new forms.

The RMOD will not assume any responsibility for errors arising from the failure of the first person to provide up-to-date information. First persons are encouraged to view the Form IVs on the Patent Register, available online, to ensure the accuracy of the information.4.10 Re-issued patentsIf a patent that is included on the Patent Register is re-issued by the CIPO, the RMOD recommends that the first person submit a new Form IV within 30 days of the date of re-issuance. The granted date entered on the patent list should be the date the patent was re-issued. The RMOD will conduct a review to determine whether the patent remains eligible to be included on the Patent Register. If the RMOD is of the view that the patent is no longer eligible, the RMOD will notify the first person, in writing, that the patent has been found ineligible for inclusion on the Patent Register.

The first person will then be provided with an opportunity to submit written representations as to the patent's eligibility for inclusion on the Patent Register. If representations are provided, they will be taken into consideration by the RMOD and a final decision regarding the patent eligibility will subsequently be communicated to the first person.5. Section 5 of the PM(NOC) Regulations5.1 Scope and application of Section 5In accordance with subsection 5(1), when a second person files a submission seeking an NOC for a drug and the submission directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada by a first person and in respect of which there are patents and/or CSPs included on the Patent Register, the second person must include in the submission the required statements or allegations set out in subsection 5(2.1) of the PM(NOC) Regulations. Subsection 5(2) applies when a second person files a supplement for a change in formulation, a change in dosage form, or a change in use of the medicinal ingredient and the supplement directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada by a first person and in respect of which there are patents and/or CSPs included on the Patent Register. While the terminology in section 5 is intended to capture abbreviated new drug submissions (ANDSs) and supplements to abbreviated new drug submissions (SANDSs), the language of section 5 of the PM(NOC) Regulations is not exclusive to ANDSs and SANDSs.

It is also intended to capture NDSs and SNDSs that directly or indirectly compare the drug with, or make reference to, another drug marketed in Canada, including biosimilar drug submissions and submissions relying on third-party data.A biosimilar must be subsequent to a biologic drug that is approved in Canada and to which a reference is made. Sponsors may use a non-Canadian sourced version as a proxy for the Canadian drug in the comparative studies. If the Canadian drug is marketed in Canada and has patents or CSPs included on the Patent Register, NDSs and SNDSs submitted in accordance with Health Canada's Guidance Document. Information and Submission Requirements for Biosimilar Biologic Drugs are considered to make a comparison or reference within the meaning of section 5. Sponsors of such submissions will be required to comply with the requirements for second persons under the PM(NOC) Regulations.NDSs which seek approval based on independent clinical trials and not on a comparison or reference to a drug which has patents and/or CSPs included on the Patent Register are not captured by section 5.

In addition, submissions that do not result in a subsequent entry version of the drug which has patents and/or CSPs included on the Patent Register are not captured by this section. For example, a submission for a drug indicated for use in combination with a drug on the Patent Register will not be required to comply with section 5 of the PM(NOC) Regulations. 5.1.1 Administrative drug submissionsWhen a manufacturer files a drug submission in accordance with Health Canada's Guidance Document Administrative Processing of Submissions and Applications. Human or Disinfectant Drugs, the administrative drug submission does not trigger application of section 5 of the PM(NOC) Regulations. Rather, only the originating submission which directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada under an NOC issued to a first person, will trigger the application of section 5 of the PM(NOC) Regulations.

Subsequently filed administrative drug submissions that cross-reference the originating drug submission will not re-trigger section 5 of the PM(NOC) Regulations and should not include a Form V. An NOC will be issuable in respect of an administrative drug submission after the requirements of the Food and Drug Regulations have been met and only after the originating drug submission receives its NOC. In the case where the originating drug submission is placed on Intellectual Property (IP) Hold, the administrative drug submission will also be placed on IP Hold. If consent is received from the patent owner under subsection 7(2) of the PM(NOC) Regulations, or subsection 7(3) of the pre-September 21, 2017 version of the PM(NOC) Regulations, and the NOC issues for the originating drug submission, the NOC for the administrative drug submission will also issue, as the requirements of the PM(NOC) Regulations have been met for the originating drug submission. In accordance with subsection 5(4) of the PM(NOC) Regulations, the date of filing on which the Patent Register is frozen is specific to the originating drug submission.

As such, any patent added to the Patent Register in respect of the first person's drug on or after the date of filing of the originating drug submission need not be addressed in respect of the administrative submission. The Patent Register is, in effect, "frozen" as of the date of filing of the originating drug submission.Example 1. Generic A files an ANDS for its drug X on January 2, 2018 and addresses the patents included on the Patent Register in respect of the first person's drug prior to January 2, 2018 as required by section 5 of the PM(NOC) Regulations. Subsequently, Generic A receives an NOC for its drug X. Generic B then enters into a licensing agreement with Generic A and files an administrative ANDS for its identical drug XX, cross-referencing Generic A's ANDS.

Generic A continues marketing its drug X while Generic B is assigned a distinct DIN for its drug XX after the requirements of the Food and Drug Regulations have been met. Subsection 5(1) of the PM(NOC) Regulations is not re-triggered in respect of Generic B's administrative ANDS for its drug XX. Therefore, Generic B does not need to address the patents included on the Patent Register in respect of the first person's drug prior to receiving an NOC for its drug XX. Example 2. Generic C files an ANDS for its drug Y on January 2, 2018 and elects to await expiry of the patents included on the Patent Register in respect of the first person's drug prior to January 2, 2018.

Subsequently, upon meeting the requirements under the Food and Drug Regulations, Generic C's ANDS for its drug Y is placed on IP Hold. Generic D then enters into a licensing agreement with Generic C and files an administrative ANDS for its identical drug YY, cross-referencing Generic C's ANDS. An NOC is issuable in respect of Generic D's administrative ANDS for its drug YY after the requirements of the Food and Drug Regulations have been met and only after Generic C receives an NOC for its ANDS for its drug Y. Therefore, Generic D's administrative ANDS will be placed on IP Hold until the NOC issues for Generic C's drug.5.2 Submission of a Form V. Declaration re.

Patent ListUnder subsections 5(1) and 5(2) of the PM(NOC) Regulations, a second person must include in the submission or supplement the required statements or allegations set out in subsection 5(2.1) for each patent and CSP included on the Patent Register in respect of the first person's drug. The required statements and allegations are set out in the Form V. One Form V must be submitted for each patent included on the Patent Register, and for each strength of the second person's drug. Refer to Appendix B for instructions on how to complete the Form V. Every required Form V must be a part of a drug submission.

Filing of a Form V prior to the filing of a drug submission or supplement is not permitted. However, revised Form Vs are accepted by the RMOD. A submission or supplement requiring a Form V will be considered administratively incomplete without one. It will be placed on Patent-Form V Hold and will not be transmitted to the relevant reviewing bureau/centre until the required Form V has been received by the RMOD. The filing date of the submission is as defined above in section 2 of this document.A second person will be required to address all patents that are added to the Patent Register before the date of filing of its submission or supplement.

If a second person cancels its submission or supplement and subsequently re-files, or the relevant directorate issues a rejection letter (e.g. A screening rejection letter, a notice of non-compliance-withdrawal or a notice of deficiency-withdrawal), the original date of filing is lost and the new date of filing becomes the date on which the submission or supplement is re-filed and considered administratively complete. 5.3 Freezing the Patent Register. Addressing additions to the Patent Register on or after the date of filing of a second person's submission or supplementUnder subsection 5(4) of the PM(NOC) Regulations, a second person is not required to address a patent, or associated CSP setting out that patent, added to the Patent Register in respect of the first person's drug on or after the date of filing of the second person's submission. The Patent Register is, in effect, "frozen" in respect of the patents included on the Patent Register as of the date of filing of the second person's submission.The date of filing on which the Patent Register is frozen is specific to a second person's submission or supplement.

Each second person benefits from the same freezing mechanism as of the date of filing of their respective submissions or supplements with the HPFB. The PM(NOC) Regulations address the possible situation where a CSP is added to the Patent Register after the second person has filed its submission or supplement, but where the patent set out in the CSP was added to the Patent Register before the second person filed its submission or supplement. If this occurs, the PM(NOC) Regulations prohibit the issuance of an NOC to the second person until the expiry of the CSP, if certain conditions are met. The CSP must set out a patent in respect of which the second person was required to make a statement or allegation but did not make an allegation, or a patent in respect of which the Court has made a declaration of infringement. In addition, the CSP must be included on the Patent Register in respect of the same submission or supplement as the patent.

5.4 Certification of date of filingWhen a second person's submission or supplement is considered administratively complete, the RMOD will issue to the second person an acknowledgement and certification letter to certify the date of filing of the submission. This letter will be identified by the title "Acknowledgement and Certification of Information Received". Under subparagraph 5(3)(c)(i) of the PM(NOC) Regulations, this certification must be served with an NOA on the first person. Please note that the acknowledgement and certification is not the same as a regular acknowledgement letter, which does not have the title "Acknowledgement and Certification of Information Received". The acknowledgement letter does not certify the date of filing of the submission.5.5 Deemed date of filing under Canada's Access to Medicines RegimeIn cases where a second person has filed a submission or supplement under Canada's Access to Medicines Regime (CAMR), also known as An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), subsection 5(5) of the PM(NOC) Regulations provides for a deemed date of filing in order to comply with the data protection provisions under section C.08.004.1 of the Food and Drug Regulations.

CAMR provides a framework within which eligible countries can import less expensive generic versions of patented drugs and medical devices. Notwithstanding that a second person may receive authorization to export a given drug under a compulsory license granted by the Commissioner of Patents, the HPFB will not grant an NOC providing Canadian market authorization unless the requirements for both data protection under section C.08.004.1 of the Food and Drug Regulations, and the PM(NOC) Regulations have been met. Subsection C.08.004.1 of the Food and Drug Regulations provides an eight-year period of market exclusivity for innovative drugs. In addition, a subsequent-entry manufacturer is prevented from filing a submission for a copy of that innovative drug for the first six years of the eight-year period. The eight-year period may be extended by six months through a pediatric extension.

The introduction of the six-year no filing period requires an exception to allow for the filing of drug submissions within the framework of CAMR. The addition of subsection 5(5) to the PM(NOC) Regulations provides this exception. For the purpose of subsection 5(3), which governs the service of an NOA, and subsection 5(4), which governs the freezing of the Patent Register, there is a deemed date of filing for submissions and supplements filed under CAMR, and referred to in paragraph C.07.003(b) of the Food and Drug Regulations. That date of filing is deemed to be six years after the date of issuance of the first person’s NOC provided that. The drug to which the second person makes a comparison or reference is an innovative drug within the meaning of subsection C.08.004.1(1) of the Food and Drug Regulations, and the date that the submission or supplement is received by the HPFB is less than six years from the day on which the first NOC was issued in respect of the innovative drug.The result is that, under subsection 5(3) of the PM(NOC) Regulations, a second person may not serve an NOA before the deemed filing date of its submission or supplement, which is six years after the date of issuance of the first person's NOC.

In addition, under subsection 5(4), the Patent Register will be frozen six years after the date of issuance of the first person's NOC. During that time, a first person may continue to add patents to the Patent Register in accordance with the PM(NOC) Regulations. 5.6 Notice of Allegation and information to be served on a First Person5.6.1 Timing of serviceUnder paragraph 5(3)(a) of the PM(NOC) Regulations, a second person who makes an allegation under paragraph 5(2.1)(c) must serve on the first person an NOA relating to the submission or supplement that forms the basis of the allegation, but may not do so before the filing date of the submission or supplement.The address for service of the first person is located on the patent list. Service by registered mail (as defined by Canada Post) is deemed to be effected on the addressee five days after mailing. 5.6.2 Contents of Notice of Allegation and documents served with a Notice of AllegationUnder subparagraph 5(3)(b)(i) of the PM(NOC) Regulations, an NOA must include a description of the medicinal ingredient, dosage form, strength, route of administration and use of the drug in respect of which the submission or supplement has been filed.

The RMOD will verify that this information corresponds with that of the submission or supplement on file with the HPFB. The RMOD will also verify that the manufacturer in the submission is the same as the second person who has served the NOA. If any piece of information is missing from the NOA, or does not correspond with the information in the submission or supplement, the RMOD will notify the second person of the deficiencies identified in the NOA. As a transparency measure, the RMOD will also copy the first person on this correspondence. The second person will be required to serve an NOA reflecting all of the correct information outlined in subparagraph 5(3)(b)(i) of the PM(NOC) Regulations.

A certification of the date of filing of the submission or supplement is required to be served with the NOA. As discussed above, the certification of the date of filing of the submission or supplement is provided by the RMOD in the form of the "Acknowledgement and Certification of Information Received" letter.5.6.3 Information to provide to the RMODIn accordance with paragraph 5(3)(e) of the PM(NOC) Regulations, the second person must provide to the RMOD proof of service of the NOA, along with a copy of the NOA. A copy of the documents required to be served with the NOA under paragraphs 5(3)(c) and 5(3)(d) do not need to be provided to the RMOD. It is recommended that second persons provide the proof of service and a copy of the NOA to the RMOD as soon as possible following service on the first person to allow the RMOD a period of time to review the NOA. Allowing for a period to review the NOA to ensure the information required by subparagraph 5(3)(b)(i) is included in the NOA and corresponds with the submission or supplement may provide an opportunity for second persons to address any deficiencies before an action is brought by the first person or patent owner.5.6.4 Retraction of a Notice of AllegationUnder subsection 5(6), a second person who has served an NOA on a first person must retract that NOA and serve a notice of retraction on the first person within 90 days after either.

the date on which the Minister notifies the second person under paragraph C.08.004(3)(b) or C.08.004.01(3)(b) of the Food and Drug Regulations that the submission or supplement does not comply with the requirements of section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, or the date of the cancellation by the second person of the submission or supplement to which the allegation relates.The types of notices requiring a retraction of an NOA include, for example, a screening rejection letter, a notice of non-compliance-withdrawal or a notice of deficiency-withdrawal. A copy of the retraction or withdrawal of the NOA should be provided to the RMOD. The RMOD will acknowledge the retraction or withdrawal in writing, and will copy the first and second person.5.7 Second Person company name changes prior to NOC issuanceA second person's submission may be transferred to another manufacturer prior to NOC issuance, if there is a company merger or licensing agreement. If an NOA has been served on the first person, the new second person should notify the first person of its new name in order to ensure transparency. 6.

Sections 6 and 7 of the PM(NOC) Regulations6.1 ActionsWhen a first person is served with an NOA, the first person or patent owner may bring an action against the second person in the Federal Court for a declaration that the making, constructing, using or selling of the second person's drug would infringe any patent or CSP that is the subject of an allegation. The first person or patent owner has a period of 45 days after the date of service of the NOA to bring the action. If an action is brought, the Minister is prohibited from issuing the NOC to the second person for up to 24 months (the statutory stay).6.2 Intellectual property holdOnce the examination of a second person's submission has been completed, the submission will be placed on IP Hold if the requirements of the PM(NOC) Regulations have not been met. The manufacturer will be notified in writing of the date on which the examination was completed and that the submission has been placed on IP Hold. An invoice for the review of the submission will also be issued, where applicable.

Once the requirements of the PM(NOC) Regulations have been met, the submission may remain on IP Hold until the expiration of any data protection period for the first person’s drug under section C.08.004.1 of the Food and Drug Regulations. Where there is a notifiable change submission, it will be placed on IP Hold while the related submission is on IP Hold. The manufacturer will not be notified in writing when a notifiable change submission has been placed on IP Hold. Second persons are encouraged to view the status of their submissions in the Drug Submission Tracking System – Industry Access. The status of the notifiable change submission will be updated to IP Hold when the review of the submission is complete.

In accordance with subsection 8(2) of the PM(NOC) Regulations and paragraph 8(1)(a) of the pre-September 21, 2017 version of the PM(NOC) Regulations, the Minister may be requested to certify the date on which a NOC would have been issued to a second person in the absence of the PM(NOC) Regulations.6.3 NOC issuance to a Second Person in the absence of an action for patent infringementA first person or patent owner has a period of 45 days following service of an NOA to bring an action in the Federal Court. If no action is brought, the NOC may be issuable to the second person on the 46th day after the NOA was served, if the requirements of the Food and Drug Regulations have been met. As such, the RMOD will verify on day 46 whether a copy of a statement of claim has been received. The Minister of Health is not a party to actions for patent infringement, therefore a copy of the statement of claim should not be served on the Minister. However, in accordance with section 6.13 of the PM(NOC) Regulations, a copy of the statement of claim must be provided to the RMOD as soon as feasible.

Please refer to section 3.4.1 of this document for information on how to provide the statement of claim to the RMOD. The RMOD will rely on the absence of a statement of claim to establish that no action was brought in the Federal Court. It is recommended that first persons and patent owners provide a copy of the statement of claim to the RMOD within the 45-day period to avoid any unwanted issuance of an NOC to the second person.6.4 Verification of portions of a submission or supplementPre-September 21, 2017 version of the PM(NOC) Regulations Under paragraph 6(7)(a) of the pre-September 21, 2017 PM(NOC) Regulations, a second person may be ordered by the court to produce any portion of the submission or supplement filed for an NOC that is relevant to the disposition of the issues in the prohibition proceeding. In addition, the court may order the production of any changes, as they are made, to the portion during that proceeding. Under paragraph 6(7)(b), the RMOD may be ordered to verify that any portions of the submission or supplement produced by the second person correspond fully to the information in the submission or supplement, usually within 30 days of receipt of the productions.

In such cases, the second person should produce the relevant documents directly to the first person. The first person will then direct the documents to the attention of the RMOD through counsel for the RMOD.September 21, 2017 version of the PM(NOC) Regulations Section 6.05 of the PM(NOC) Regulations provides that, on the request of any party to an action under the regulations, the RMOD must verify that any portion of a submission or supplement that is required to be served with an NOA, or that is produced as a result of an order, corresponds to the information in the submission or supplement. The documents to be verified shall be provided directly to the RMOD as outlined in section 3.4.1 of this guidance document. To ensure a transparent process, the RMOD recommends that the documents to be verified be provided by the first person or patent owner. Where the documents are provided by the second person, the RMOD will not produce a copy to the first person or patent owner.6.4.1 Verification processThe RMOD is required only to verify whether the portions produced by the second person correspond with the relevant submission or supplement on file at the HPFB.

The RMOD is not required to produce additional documentation, or make any statements or characterizations regarding the nature of the portions produced by the second person. In keeping with the pre-September 21, 2017 practice, the RMOD will endeavour to complete verification requests within 30 days. To facilitate the verification process, parties are encouraged to continue to provide good quality copies of documents that are indexed using the format found in the example below, with respect to their location within the original submission or supplement. If the productions are not formatted in a format acceptable to the RMOD, they may be rejected for verification. To this effect, productions to be verified under either version of the PM(NOC) Regulations should be formatted as follows:Index:The documents should be indexed and tabbed.

The index should denote the location of the documents from within the production. It is important to note that providing detailed descriptions and information in the index will assist the RMOD in locating the documents and verifying the production efficiently.Description of Item:If multiple versions of a document were filed in respect of the relevant submission, for example a PM, add the "date of preparation" to the description (see Tab 2 of the example in Appendix C). If multiple documents have similar titles, use a distinguishing name and/or highlight the difference(s) between the documents (see Tab 6 of the example in Appendix C).Location:If a document is located in a Master File, provide the Master File number and note whether the document can be found in the Unrestricted/Open or Restricted/Closed portion of the file (see Tabs 4 and 5 of the example in Appendix C). Pages within a tab:When only certain pages are provided for verification from a larger document, note the page numbers to be verified in the index and the complete number of pages of the document (see Tab 3 of the example in Appendix C). Tabs:Use a naming convention similar to “Tab –3 - [name of document ]” when formatting the electronic production.

If there are multiple documents contained in one tab, use one New Folder per tab (see Tab 7 of the example in Appendix C).6.5 ConsentUnder subsection 7(2) of the PM(NOC) Regulations, or subsection 7(3) of the pre-September 21, 2017 version of the PM(NOC) Regulations, the owner of the patent may provide consent to the making, constructing, using or selling of the drug in Canada by the second person. The consent letter must be signed by the owner of the patent or by a person authorized to act on the owner’s behalf. If the letter is signed by a person authorized to act on behalf of the patent owner, this must be stated in the letter. The letter should indicate the following. The patent and/or CSP numbers for which consent is being provided the second person's submission number the medicinal ingredient the second person's name, and a statement that for the purposes of subsection 7(2) or 7(3) of the PM(NOC) Regulations, as the case may be, the owner of the patent consents to the making, constructing, using or selling of the drug in Canada by the second person.6.6 Renouncing the 24-month stayParagraph 7(1)(d) of the PM(NOC) Regulations prohibits the Minister from issuing an NOC to a second person for a 24-month period from the day on which an action is brought under subsection 6(1).

However, a party who brings an action may renounce application of this 24-month period under paragraph 7(5)(b). To do so, each of the parties who bring an action must provide to the RMOD a notice that they renounce the application of the 24-month stay, at the time the action is brought.The notice should indicate the following. the second person's submission number the patent and/or CSP numbers the court file number, and a statement that the application of paragraph 7(1)(d) of the PM(NOC) Regulations is being renounced in accordance with paragraph 7(5)(b) of the PM(NOC) Regulations.7. Maintenance of the Patent RegisterThe RMOD is responsible for maintaining the Patent Register in accordance with subsection 3(2) of the PM(NOC) Regulations. The RMOD is required to add any patent on a patent list or CSP that meets the requirements for addition to the Patent Register and to refuse to add any patent or CSP that does not meet the requirements for addition to the Patent Register.

The RMOD must also delete any patents or CSPs from the Patent Register as outlined in the PM(NOC) Regulations, as follows. If the patent or CSP was added to the Patent Register due to an administrative error if the patent or CSP has been declared invalid or void under subsection 60(1) or 125(1) of the Patent Act if the patent or CSP has been declared under subsection 6.07(1) to be ineligible for inclusion on the Patent Register if the first person requests that the patent or CSP be deleted from the Patent Register if the patent has expired, unless a CSP in which that patent is set out is included on the Patent Register in respect of the same submission, or if the CSP has expired.A patent or CSP declared ineligible for inclusion on the Patent Register will not be deleted until the period for appealing the decision to the Federal Court of Appeal ends, or until the conclusion of any appeal to the Federal Court of Appeal. This same delay does not apply to patents or CSPs declared invalid or void, which will be deleted after an initial finding. If a patent or CSP was deleted because of a finding of invalidity or ineligibility, it will be added back to the Patent Register, with a new date added, if the decision is subsequently reversed or set aside on appeal. Second persons who file submissions in the interim when the patent is not on the Patent Register will not need to address the patent.

The first person will be notified in writing once a patent or CSP has been deleted from the Patent Register in accordance with paragraph 3(2)(c). Subsection 3(2.3) provides the RMOD with discretion to review the eligibility of all the patents on the Patent Register. This may occur when, for instance, the eligibility requirements are called into question by new jurisprudence. If it is necessary to undertake a review of the Patent Register under subsection 3(2.3) of the PM(NOC) Regulations, the RMOD will notify first persons in writing if a patent or CSP has been found not to meet the requirements for inclusion on the Patent Register. If, during the course of such a review, an inquiry is received from an interested party regarding the inclusion of the patent on the Patent Register, a copy of the inquiry will be provided to the first person.

As such, inquiries should not be marked confidential. The first person will then be provided with an opportunity to submit written representations as to the patent or CSP’s eligibility for inclusion on the Patent Register. If representations are provided, they will be taken into consideration by the RMOD and a final decision regarding the patent eligibility will subsequently be communicated to the first person and the inquirer. Note, however, that the mere receipt of an inquiry will not be considered as a sufficient basis to trigger a review of the entire Patent Register.AppendicesAppendix A - How to complete a Form IV. Patent List Please submit one Form IV per patent, per submission, per DIN.

Part 1Select whether the patent list is being filed with the submission, or whether it is a newly issued patent for listing against a previously filed submission. The PM(NOC) Regulations require that all patents submitted for listing must be linked with a submission for an NOC. Therefore, in the case of a newly issued patent, the first person must provide the submission number. However, if the Form IV is being filed with the submission, the RMOD will insert the submission number on the form.Select "NDS" if the Form IV is to be added to the Patent Register in accordance with subsection 4(2) of the PM(NOC) Regulations. Select "SNDS" if the Form IV is to be added to the Patent Register in accordance with subsection 4(3) of the PM(NOC) Regulations, and then select the appropriate option(s).

Change in formulation, change in dosage form or change in use. Select "Carry forward, in accordance with section 4.1(2)" if the patent is already included on the Patent Register and the patent is being resubmitted in relation to the submission or supplement. Note. When submitting a patent list with an SNDS for a change in formulation, change in dosage form or change in use of the medicinal ingredient, and the patent is already listed on the Patent Register for the same product, the RMOD recommends that the first person submit such a patent under the "carry forward" provision, unless the patent contains a specific claim for the changed formulation, dosage form or use for which the supplement was submitted.Part 2Enter the information about the drug as it appears, or as it is expected to appear, on the NOC. Medicinal ingredient(s).

Enter the medicinal ingredient(s) contained in the drug as it appears, or as it is expected to appear, on the NOC.Brand Name. Enter the brand name under which the drug is (or will be) marketed. If the brand name has not yet been determined, it may be left blank and will be entered by the RMOD when the NOC is issued.Human or Veterinary. Indicate human or veterinary. Strength per unit.

Provide the strength of the medicinal ingredient(s) (e.g. 10 mg, 100 mg, 0.5 mg/10 ml). Please note that one Form IV should be submitted per DIN. If there is more than one medicinal ingredient, list the strengths in the order that the medicinal ingredients appear in the medicinal ingredient field. Therefore, the names of the medicinal ingredients do not need to be repeated in the strength field.

Dosage Form. Provide the physical form of the drug (e.g. Tablet, capsule, solution, powder) as it appears, or as it is expected to appear, on the NOC. Route(s) of Administration. Provide the route of administration of the drug (e.g.

Oral, nasal, subcutaneous) as it appears, or as it is expected to appear, on the NOC. DIN. In the case of the first submission for an NOC for a drug, the DIN will not be known by the first person. Therefore, this field should be left blank and the RMOD will insert the DIN once the NOC issues. In all other cases, the DIN for the drug should be provided.

Please note that one Form IV per DIN should be submitted.Use(s) of the Medicinal Ingredient(s). Enter the specific use(s) of the drug for which approval is being sought, or which has been approved, in the submission or supplement to which the patent list relates. Part 3Enter the information about the patent. Patent Number. Enter the Canadian patent number being submitted for addition to the Patent Register.

If a CSP has issued in respect of the patent, enter the patent number only in this section. The RMOD will insert the CSP number and expiry date in the office use section, where applicable. Code. Indicate whether the first person is the owner of the patent, has an exclusive licence or has obtained consent from the owner of the patent to have it included on the patent list. A.

Applicant is the owner of the patent B. Applicant has an exclusive license C. Applicant has obtained the consent of the owner of the patent for the inclusion of the patent on the above patent list Filing Date of Patent Application. Indicate the Canadian patent application filing date. Date Granted.

Enter the date on which the Canadian patent was granted by the CIPO. Expiration Date. Enter the date on which the patent term will expire. The term of a patent is 20 years from date of filing for patent applications filed on or after October 1, 1989. For patent applications filed before October 1, 1989, the expiry date is the later of 17 years from date of grant of the patent or 20 years from the date of filing.

If a CSP has issued in respect of the patent, enter the expiration date of the patent in this section. The RMOD will insert the CSP number and expiry date in the office use section, where applicable. Part 4Enter the address in Canada for service, on the first person, of an NOA referred to in paragraph 5(3)(a) or the name and address for service in Canada of another person on whom service may be made with the same effect as if service were made on the first person. A post office box (P.O.) box is not an acceptable address, as it cannot accept registered mail. The RMOD recommends using contact person titles (e.g.

Director, Regulatory Affairs) rather than a name in this section to reduce the number of changes required to the form due to corporate staffing changes.The onus is on the first person to keep this information up-to-date, in accordance with subsection 4(7) of the PM(NOC) Regulations. Part 5Enter the manufacturer and contact information and provide a certification that the information included on the patent list is accurate and that the patent on the list meets the eligibility requirements of subsection 4(2) or 4(3) of the PM(NOC) Regulations. The RMOD will use the contact information provided in this section to correspond with the first person regarding the patent list.Part 6 This section is for office use only. Appendix B - How to complete a Form V. Declaration re Patent List Please submit one Form V per patent, per submission, per DIN.

Part 1Select whether the form is an amendment to a previously filed Form V, or if the Form V is being filed with the submission. Part 2 Enter the information about the second person's drug. Medicinal ingredient(s). Enter the medicinal ingredient(s) contained in the second person's drug as it appears, or as it is expected to appear, on the NOC. Brand Name.

Enter the brand name of the second person's drug as it appears, or as it is expected to appear, on the NOC. Drug Use. Indicate human or veterinary. Strength per unit. Provide the strength of the medicinal ingredient (e.g.

10 mg, 100 mg, 0.5 mg/10 ml). Please note that one Form V should be submitted per DIN. If there is more than one medicinal ingredient, list the strengths in the order that the medicinal ingredients appear in the medicinal ingredient field. Therefore, the names of the medicinal ingredients do not need to be repeated in the strength field. Dosage Form.

Provide the physical form of the drug (e.g. Tablet, capsule, solution, powder) as it appears, or as it is expected to appear, on the NOC. Route(s) of Administration. Provide the route of administration of the drug (e.g. Oral, nasal, subcutaneous) as it appears, or as it is expected to appear, on the NOC.

Use(s) of medicinal ingredient(s). Enter the specific uses of the drug for which approval is being sought in the second person's submission. Part 3Enter the information about the first person's drug. Part 3.1Provide the Canadian patent number and expiry date of each patent included on the Patent Register for the first person's drug. Please note that one Form V should be submitted per patent, per DIN.

If there is a CSP number included on the Patent Register, enter the number and expiry date.Part 3.2In this section, the second person must select one of the statements or at least one of the allegations required by subsection 5(2.1) of the PM(NOC) Regulations. Part 4Provide the name and address of the manufacturer of the drug (the name of the company that is seeking the NOC) and contact information, which will be used by the RMOD to correspond with the second person regarding the form. Any NOA served should be from the company seeking the NOC.Part 5This section is for office use only. Appendix C - Sample productions for verification Sample Index Example Tab Sequence Section Description of Item Location 1 0002 3.2.S.1.2 Quality - Body of Data - Drug Substance - Stability - Stability Data - Supplier Commitment [Submission no.] 2 0005 1.3.1 Non-Annotated Product Monograph [date of preparation] [Submission no.] 3 0004 3.2.S.3 Characterization, pp. 416-423 of 739 [Submission no.] 4 0000 1.0.4 Master File [Master File No.] - Administrative Information and Prescribing Information - Quality Overall Summary Master File [Master File No.] - Open Portion or Closed Portion 5 The portions of [drug manufacturer name]'s Master File [Master File No.] that comprise the Productions are the following.

0001 3.2.S.1 General Information, pp. 6-7 of 739 Unrestricted Part or Restricted Part 6 0009 5.3.1.2 Comparative Bioavailability and Bioequivalence Study Reports. Comparative, Randomized 2-way Crossover Bioavailability Study of Tablets Under Fed Conditions, Drug Concentration by Formulation [Submission no.] Comparative Bioavailability and Bioequivalence Study Reports. Comparative, Randomized 2-way Crossover Bioavailability Study of Tablets Under Fasting Conditions, Drug Concentration by Formulation 7 0003 3.2.1.5 Drug Product - Specification(s) [drug name] - 10-mg-release-specifications [Submission no.] Drug Product - Specification(s) [drug name] - 15-mg-release-specifications [Submission no.] Drug Product - Specification(s) [drug name] - 20-mg-release-specifications [Submission no.].

(PDF Version order viagra from canada - 406 KB) Date Adopted. 2000/02/14 Revised Date. 2021/04/08 Effective order viagra from canada Date. 2021/05/11 Foreword Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide order viagra from canada assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach.

Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory order viagra from canada requirements have not been met.As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.Document change logDate. 2018/04/05Change. Updated in accordance with the September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations.Location (section, paragraph).

All Nature of and/or reason for change. The updates to the Guidance Document are being made following the amendments to the Patented Medicines (Notice of Compliance) Regulations, which came into force on September 21, 2017. The updates also reflect current administrative practices (e.g. Update of terminology from “patent hold” to “Intellectual Property Hold”). Date.

2021/04/08 Change. Updated in accordance with the new Health Products and Food Branch organizational structure. Location (section, paragraph). All Nature of and/or reason for change. Change in Health Products and Food Branch organizational structure.Table of Contents 1.

Introduction1.1 Policy objectivesIn accordance with the Regulatory Impact Analysis Statement (RIAS) published in the Canada Gazette, Part II on October 18, 2006, Footnote 1 Canada's pharmaceutical patent policy objective is to "balance the effective patent enforcement over new and innovative drugs with the timely entry of their lower priced generic competitors". The Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) were introduced originally by Industry Canada (now known as Innovation, Science and Economic Development Canada) under the Patent Act. The PM(NOC) Regulations intersect with drug approval under the Food and Drugs Act and Division 8 of the Food and Drug Regulations. 1.2 Policy statementsThe early working exception of subsection 55.2(1) of the Patent Act allows a subsequent manufacturer to use a patented invention for the purpose of seeking regulatory approval of that product. The provision, therefore, provides an exception from infringement.

The PM(NOC) Regulations provide the balance, through a patent enforcement mechanism, to ensure that the early working exception is not abused by linking the regulatory approval of a generic drug to the patent status of the innovative product. 1.3 Scope and applicationThis guidance document provides information regarding the administration of the PM(NOC) Regulations by the Office of Patented Medicines and Liaison (OPML) within the Office of Submissions and Intellectual Property (OSIP), Resource Management and Operations Directorate (RMOD), Health Canada. It is applicable to drugs that receive a notice of compliance (NOC), including pharmaceutical, biological, radiopharmaceutical and veterinary drugs.1.4 BackgroundThe PM(NOC) Regulations were originally enacted in 1993, and have undergone various amendments. The most recent amendment came into force on September 21, 2017. Under the pre-2017 version of the PM(NOC) Regulations, innovative drug companies could commence legal proceedings for an order prohibiting the Minister of Health from granting an NOC for a generic version of a patented medicine.

The September 21, 2017 amendments to the PM(NOC) Regulations replaced these prohibition application proceedings with full actions resulting in final determinations of patent infringement and validity. The pre-2017 version of the PM(NOC) Regulations will continue to apply in respect of any matter that relates to a notice of allegation (NOA) served on a first person before September 21, 2017.2. Definitions Filing date of a submission Refers to the date that the submission is deemed administratively complete by Health Canada (i.e. Once all elements and forms required for processing are completed and submitted to Health Canada). This date may differ from the date of original receipt should the submission be considered administratively incomplete at the time of receipt.

The filing date established for a submission is not affected by subsequent screening or review activities. In the Drug Submission Tracking System - Industry Access, the filing date of a submission is indicated in the CR Date field. Filing date of a patent Refers to the Canadian filing date of a Canadian patent application as established by the Canadian Intellectual Property Office (CIPO). Patent Refers to a granted Canadian patent (not a patent application). Biosimilar biologic drug Refers to a biologic drug that obtains market authorization subsequent to a version previously authorized in Canada, and with demonstrated similarity to a reference biologic drug.

A biosimilar relies in part on prior information regarding safety, efficacy and effectiveness that is deemed relevant due to the demonstration of similarity to the reference biologic drug and which influences the amount and type of original data required. Biosimilar biologic drugs were previously referred to as Subsequent Entry Biologics.3. General information3.1 GeneralThe OPML within OSIP, RMOD administers the PM(NOC) Regulations. All drug submissions seeking an NOC, including those submitted to the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Natural and Non-Prescription Health Products Directorate (NNHPD) and Veterinary Drugs Directorate (VDD), are assessed to determine if they fall within the scope of the PM(NOC) Regulations. The directorates mentioned above are a part of Health Canada's Health Products and Food Branch (HPFB).

3.2 Patent RegisterPursuant to subsection 3(2) of the PM(NOC) Regulations, the RMOD is required to maintain a register of patents that have been submitted for addition to the register and certificates of supplementary protection (CSPs) in which any of those patents are set out. The Patent Register is available online and is refreshed nightly. Any questions, comments or problems with the Patent Register should be directed to the OPML (hc.opml-bmbl.sc@canada.ca).3.3 Drug Identification Number (DIN) cancellation - deletion of Patent Lists from the Patent RegisterSubsection 3(3) of the PM(NOC) Regulations applies to drugs for which the drug identification number (DIN) has been cancelled under the Food and Drug Regulations. As provided for in subsection 3(3), patents added to the Patent Register in respect of a drug for which the DIN was cancelled shall be deleted from the Patent Register by the RMOD 90 days after the DIN was cancelled. An exception to this rule exists for cancellations effected as a result of a change in manufacturer.

Form IV. Patent Lists (Form IVs) deleted as a result of a DIN cancellation will be re-added to the Patent Register upon re-activation of the DIN, i.e. Receipt of a DIN Notification Form, as required by section C.01.014.3 of the Food and Drug Regulations. A first person who submits such a DIN Notification Form should also notify the OPML.3.4 How to provide information to the RMOD3.4.1 How to provide litigation informationAs the Minister of Health will not be a party to actions for patent infringement under the PM(NOC) Regulations, litigation documents in such actions will no longer be served on the Minister. However, the RMOD must have access to relevant information to determine whether there are any barriers under the PM(NOC) Regulations that would prohibit issuance of an NOC for a second person’s submission.

As such, under section 6.13 of the PM(NOC) Regulations, a person who brings an action for infringement is to provide the RMOD with certain documents as soon as feasible. The RMOD may also request any information or document required to assess whether NOC issuance is prohibited under section 7 of the PM(NOC) Regulations. Requests for verification of any portion of a submission served with an NOA or produced in the course of a court action can be made under section 6.05 of the PM(NOC) Regulations. All information related to litigation, including requests for verifications, must be submitted to the RMOD electronically and no duplicate copy should be sent in paper format. Please provide the information by email to.

Hc.opml-bmbl.sc@canada.ca, or on an acceptable media format, using the requirements outlined below. As with other drug submission information submitted electronically, any information received after 5:00 pm Eastern Standard Time, on a weekend, or on a Statutory Holiday will be considered received on the next business day.By emailLitigation information should be provided via email unless it exceeds the size limit, in which case it should be provided on media. The sender assumes the risk of transmitting confidential or sensitive information through email. The maximum email size accepted by the corporate mail server is 20 megabytes. Anything larger should be sent on media.

Documents contained in the email should not be password protected. Please indicate PM(NOC) Regulations, the court file number and the stakeholder name in the subject line of the email.On mediaElectronic media may be sent by courier / mail. The media formats acceptable when providing information are. Compact Disc-Recordable (CD-R) conforming to the Joliet specification Digital Versatile Disc-Random Access Memory (DVD-RAM) Universal Disc Format (UDF) standard Single and dual layer Recordable Digital Versatile Discs Universal Serial Bus (USB) 2.0 or 3.0 drive Media and files should not be password protected Files stored on the media should not be zipped All information should be provided on a single disc/drive Media should be scanned using current viagra-scanning software and should be certified viagra-free All media should be labelled. The label on the disc/drive should contain the following information.

PM(NOC) Regulations Stakeholder name Court file number "This media has been viagra-scanned and we certify that it is viagra free" Subsequent to burning the CD/DVD or transferring data to a drive, stakeholders should ensure that all files can be opened and no files are corrupt Information provided on approved media formats should be sent to the below address, to the attention of the OPML:Office of Submissions and Intellectual PropertyResource Management and Operations Directorate Health Products and Food Branch Health Canada Finance Building 101 Tunney's Pasture Driveway Address Locator. 0201A1 Ottawa, Ontario K1A 0K9 3.4.2 How to provide other informationAs is currently required, other information related to the PM(NOC) Regulations should be submitted in either the electronic Common Technical Document (eCTD) format or the non-eCTD electronic-only format in module 1.2.4.1 - Patent Information. In accordance with Health Canada's Guidance Document. Preparation of Drug Regulatory Activities in the Electronic Common Technical Document Format, regulatory transactions accepted in the eCTD format include. Written correspondence related to the PM(NOC) Regulations NOA packages (e.g.

Proof of service of the NOA on the first person and a copy of the NOA) under the PM(NOC) Regulations Form IVs, including updates, filed in accordance with the PM(NOC) Regulations Form V. Declaration re. Patent Lists (Form Vs), including updates, filed in accordance with the PM(NOC) Regulations, and Consent letters (under the PM(NOC) Regulations)For eCTD submissions, the regulatory transactions listed above should be submitted via the Common Electronic Submissions Gateway, as indicated in the Frequently Asked Questions - Common Electronic Submissions Gateway and the CESG Health Canada Reference Guide. For non-eCTD submissions, the above-noted information should be sent on an acceptable media format as indicated in the Guidance Document. Preparation of Drug Regulatory Activities in the 'Non-eCTD Electronic-Only' Format.As with other drug submission information submitted electronically, any information received after 5:00 pm Eastern Standard Time, on a weekend, or on a Statutory Holiday will be considered received on the next business day.4.

Section 4 of the PM(NOC) Regulations4.1 GeneralThe requirements that must be met before a patent can be added to the Patent Register are provided by section 4 of the PM(NOC) Regulations. Section 4 describes. The timing requirements for filing patent lists. The required content of patent lists. The drug submissions for which patent lists may be filed.

And eligibility requirements relating to the claims of the patent.The following sections provide more detailed guidance regarding these requirements. A patent list must be submitted using the Form IV. Patent List template, available on the Health Canada website. Refer to Appendix A for instructions on how to complete the form. First persons are requested to complete one form per patent, per submission, per DIN.

4.2 Timing requirementsA first person wishing to file a patent list for a particular drug must meet the timing requirements set out in subsections 4(5) and 4(6) of the PM(NOC) Regulations. The timing requirements continue to apply during the reconsideration process set out in Health Canada's Guidance Document Reconsideration of Decisions Issued for Human Drug Submissions. 4.2.1 Patent Lists at time of filing a submissionPursuant to subsection 4(5) of the PM(NOC) Regulations, a first person wishing to submit a patent list must do so at the time it files the new drug submission (NDS) or supplement to a new drug submission (SNDS) to which the patent list relates. Only patent lists that accompany the drug submission will be accepted and patent lists submitted separately will be refused as not meeting the timing requirements.4.2.2 Patent Lists after time of filing a submissionPursuant to subsection 4(6) of the PM(NOC) Regulations, a first person may also submit a patent list in respect of a previously filed drug submission provided that the following conditions are met. the Canadian filing date of the patent precedes the drug submission filing date, and the patent list is submitted to the RMOD within thirty days after the issuance of the patent.In these circumstances, a first person must, in addition to submitting all of the information required under subsection 4(4), identify the submission number to which the newly granted patent relates.

4.3 Content requirements and prioritisationAll patent lists received by the RMOD will be evaluated for completeness against the list of required information set out in subsection 4(4) of the PM(NOC) Regulations. It should be noted, however, that the RMOD does not have a duty to make corrections or suggestions or inform first persons of any deficiencies in the content of patent lists. In the case of a newly-issued patent, it is recommended that patent lists be submitted to the RMOD as soon as possible. Where deficiencies are identified, first persons may have an opportunity to correct a patent list or submit additional patent lists before the end of the 30-day period. For more information on how to complete a Form IV, please consult Appendix A.

In order to expedite the evaluation by the RMOD, first persons are encouraged to include (i.e. As part of the cover letter) with their patent lists a list of eligible patent claims and a description of how such claims correspond to the drug submission in respect of which the patent list is filed, as well as page references to relevant portions of the drug submission, where applicable. The RMOD will prioritise evaluations for submissions for which an NOC has already issued.4.4 Drug submissions eligible for filing a Patent List In accordance with subsection 4(1) of the PM(NOC) Regulations, a patent list may be filed in relation to an NDS or an SNDS. Both “new drug submission” and “supplement to a new drug submission” are defined in subsection 3(1) of the PM(NOC) Regulations. Pursuant to these definitions and to subsections 4(2) and 4(3), only the following clearly defined submission types provide an opportunity to add a patent to the Patent Register.

An NDS, except an NDS based solely on the change of name of the manufacturer (see definition of “new drug submission” in subsection 3(1)) An SNDS for a change in formulation An SNDS for a change in dosage form An SNDS for a change in use of the medicinal ingredient4.5 Product specificity requirementsIn addition to the timing, content and submission requirements outlined in the previous sections, section 4 of the PM(NOC) Regulations sets out additional product-specificity requirements which are to be considered in determining the eligibility of a patent to be added to the Patent Register. As discussed in the RIAS accompanying the October 5, 2006 amendments, in order for a patent to qualify for protection under the PM(NOC) Regulations, it must be relevant to the drug product the first person is approved to sell. The amendments entrench the concept of drug product specificity as the key consideration required of the Minister in applying the eligibility requirements under the PM(NOC) Regulations. In turn, the amended language more precisely reflects the intended link between the subject matter of a patent on a patent list and the content of the underlying submission for the NOC in relation to which it is submitted. 4.5.1.

Patent List in relation to a New Drug SubmissionIn order to be eligible to be added to the Patent Register, the patent must contain a claim for the medicinal ingredient, a claim for the formulation containing the medicinal ingredient, a claim for the dosage form, or a claim for the use of the medicinal ingredient, which has been approved through the issuance of an NOC in respect of the submission. The RMOD considers the following three questions when applying the requirements of section 4 of the PM(NOC) Regulations. What does the patent claim?. What is approved in the submission?. Does the patent claim what is approved in the submission?.

In general, the RMOD will not consider the following types of patents as being eligible to be added to the Patent Register. a purely process patent a patent for a medical device a patent for an intermediate used in the manufacture of the medicinal ingredient a patent for a metabolite of the medicinal ingredient, and a patent for an impurity present in the final drug productClaim for the medicinal ingredientAs specified in the definition of “claim for the medicinal ingredient”, product-by-process patents and patents claiming biological drugs are eligible to be added to the Patent Register provided that all other requirements set out in the PM(NOC) Regulations are met. This definition also clarifies that patents claiming different polymorphs of the medicinal ingredient are eligible for listing. As specified in the RIAS accompanying the October 5, 2006 amendments to the PM(NOC) Regulations, the term “polymorph” is meant to include different crystalline, amorphous, hydrated and solvated forms of the approved medicinal ingredient.A patent claiming an enantiomer is not eligible to be added to the Patent Register in respect of a medicinal ingredient that is a racemate. In addition, a patent that claims varying ratios of enantiomers is not eligible to be added to the Patent Register with respect to a racemate of the medicinal ingredient.

Similarly, a patent directed specifically to a racemic mixture or a mixture of two enantiomers in varying ratios will not be eligible to be added to the Patent Register in relation to a drug containing only one of the enantiomers. In accordance with subsection 4(2.1), a patent that claims a medicinal ingredient is eligible to be added to the Patent Register in respect of a drug that contains that medicinal ingredient in combination with other medicinal ingredients. However, patents claiming a combination of medicinal ingredients contained in a single formulation or dosage form are not eligible to be added to the Patent Register in respect of a drug that contains only one of the claimed medicinal ingredients. Claim for the formulation that contains the medicinal ingredient The formulation claimed in the patent must correspond to the formulation approved in the relevant drug submission. A claim for the formulation may or may not specify non-medicinal ingredients.

Under paragraph 4(2.1)(b), a patent that contains a claim for the formulation is eligible to be added to the Patent Register if the drug contains the non-medicinal ingredients in the claim, even if the drug contains additional non-medicinal ingredients. For example, a patent claiming a formulation that contains non-medicinal ingredient X would not be eligible to be added to the Patent Register in respect of a drug that does not contain non-medicinal ingredient X. Conversely, the same patent would be eligible to be added to the Patent Register in respect of a drug that contains non-medicinal ingredients X and Y. Claim for the dosage formThe dosage form claimed in the patent must correspond to the dosage form approved in the relevant drug submission as noted on the NOC. This would include novel dosage forms, for example, patents that claim.

a patch an extended-release tablet or capsule, and an implantHowever, patents directed solely towards a dispenser, a container or packaging (e.g. An inhaler, an intravenous stand, or a syringe) would not be considered to contain a claim for the dosage form. Claim for the use of the medicinal ingredientThe RMOD will refer to the indication section of the Product Monograph (PM) of the drug to determine whether or not the patent claims an approved use of the medicinal ingredient. However, it is not expected that the language in the patent will be reproduced exactly in the PM. As PMs do not exist for veterinary products, generally the labelling information and package insert will be used.

A patent containing a claim for the use of a medicinal ingredient is eligible to be added to the Patent Register in respect of a drug that contains that medicinal ingredient in combination with other medicinal ingredients, if the drug is approved for the use claimed in the patent. Patents claiming the use of a combination of medicinal ingredients will generally not be eligible to be added to the Patent Register against a drug containing only one of the medicinal ingredients in the combination. However, patents claiming the use of a medicinal ingredient in combination with one or more other medicinal ingredient(s) are eligible to be added to the Patent Register, if said combination use is found in the indication section of the drug's approved PM. However, in order to be eligible, the patent claims must not be limited to the use of the combination in a single formulation or dosage form. For example, a patent claiming the sequential use of medicinal ingredient A in combination with medicinal ingredient B for the treatment of X could be added to the Patent Register in respect of a drug solely containing medicinal ingredient A, if the claimed use of the combination is found in the drug's approved PM.

4.5.2 Patent List in relation to a Supplement to a New Drug SubmissionA new patent may only be added to the Patent Register in respect of the following three specific types of SNDSs. an SNDS for a change in formulation (this includes a change in strength) an SNDS for a change in dosage form, and an SNDS for a change in use of the medicinal ingredientIn addition to this requirement and in keeping with the product-specificity requirements, the patent will only be eligible to be added to the Patent Register if it contains a claim for the very change approved in the supplement. Therefore, if the supplement is for a new formulation, dosage form or use, the patent must contain a claim for the new formulation, dosage form or use in order to be eligible to be added to the Patent Register. Subsection 4(3) of the PM(NOC) Regulations does not allow the addition of patents containing claims solely for the medicinal ingredient (including polymorphic forms). The RMOD considers the following three questions when applying the requirements of subsection 4(3) of the PM(NOC) Regulations.

What does the patent claim?. What is the change approved in the submission?. Does the patent claim the very change approved in the submission?. 4.5.3 Carry-forward provisionSubsection 4.1(2) of the PM(NOC) Regulations is a "carry-forward" provision. Under subsection 4.1(2), a first person who submits a patent list in relation to an NDS referred to in subsection 4(2) may, if the list is added to the Patent Register, resubmit the same list in relation to an SNDS, but may not submit a new patent list in relation to a supplement except in accordance with subsection 4(3).

Similarly, a patent on a patent list that has been added to the Patent Register in respect of a supplement under subsection 4(3) may be "carried forward" in respect of a subsequently approved supplement. The RMOD is required to give effect to the product-specificity requirements in applying the "carry-forward" provision under subsection 4.1(2). As such, patents which are already included on the Patent Register will be "carried forward" to a new DIN, provided the product-specificity requirements continue to be met (e.g. A patent that contains a claim for the medicinal ingredient will be carried forward in respect of a supplement for a new strength or dosage form).In all cases, the RMOD will apply the same timing requirements to patent lists submitted under the "carry-forward" provision as are applied to patent lists submitted under section 4 of the PM(NOC) Regulations. When submitting a patent list with a supplement and the patent is already included on the Patent Register, the RMOD recommends that the first person submit such a patent list under the "carry forward" provision, unless the patent contains a specific claim for the changed formulation, the changed dosage form or the changed use, for which the supplement was submitted.4.5.4 ConsultationAs permitted by subsection 3(8) of the PM(NOC) Regulations, the RMOD may consult with officers or employees of the Patent Office in the CIPO regarding the claims construction of the patent.

The CIPO may be consulted to verify if a patent has lapsed. The RMOD may also consult with the relevant review area within the HPFB, where necessary, regarding the information in the drug submission (e.g. Regarding the approved use of the medicinal ingredient).4.6 ProcessFor patent lists submitted at the time of filing of a drug submission and for newly-issued patents submitted for drug submissions under review, the RMOD will conduct a preliminary evaluation to ensure that the patents meet all eligibility requirements. If a patent is preliminarily found to be eligible, the RMOD will inform the first person in writing, indicating that the eligibility determination is subject to a final review at the time of issuance of the NOC. The RMOD will conduct a final check of the eligibility of the patent prior to addition to the Patent Register, as what is approved may be different from what was initially submitted.

This final check is to ensure that no significant changes were made to the drug submission during the review process that would affect the patent eligibility, for example, changes to the indication, dosage form, route of administration or strength of the drug. The final patent check will also ensure that there have been no changes to the jurisprudence which would affect the eligibility of the patent for addition to the Patent Register. This check does not delay the issuance of the NOC. If the RMOD preliminarily determines a patent to be ineligible, the RMOD will notify the first person, in writing, that the patent has been found ineligible to be added to the Patent Register. The first person will then be provided with an opportunity to submit written representations as to the patent's eligibility to be added to the Patent Register.

If representations are provided, they will be taken into consideration by the RMOD and a final decision regarding the patent eligibility will subsequently be communicated to the first person.4.7 Certificates of Supplementary Protection A CSP provides an additional period of protection, of up to 2 years, for drugs containing a new medicinal ingredient, or a combination thereof, protected by an eligible patent. For more information on CSPs, please consult the Health Canada Guidance Document Certificate of Supplementary Protection Regulations. In accordance with subsection 4(3.1) of the PM(NOC) Regulations, a CSP is eligible to be added to the Patent Register in respect of an NDS or SNDS if two requirements are met. The first requirement is that the patent set out in the CSP must be included on the Patent Register in respect of that submission or supplement. The second requirement is that the submission or supplement relates to a drug with respect to which the CSP grants rights, privileges and liberties referred to in section 115 of the Patent Act.Section 115 of the Patent Act provides that the scope of the CSP is the same as that of the patent, but only with respect to the making, constructing, using or selling of any drug that contains the medicinal ingredient or combination of medicinal ingredients set out in the certificate, by itself or in addition to any other medicinal ingredient.

The following scenarios are provided as examples. Example 1a. CSP No. 1 is issued in relation to medicinal ingredient X and the NDS for Drug A. The patent set out in CSP No.

1 is included on the Patent Register in respect of Drug A. The scope of the CSP includes Drug A because Drug A contains medicinal ingredient X. As both requirements of subsection 4(3.1) are met, CSP No. 1 is eligible to be added to the Patent Register in respect of Drug A.Example 1b. The patent set out in CSP No.

1 is included on the Patent Register in respect of Drug B. Drug B contains medicinal ingredient X in combination with medicinal ingredient Y. The scope of CSP No. 1 includes Drug B because Drug B contains medicinal ingredient X. As both requirements of subsection 4(3.1) are met, CSP No.

1 is eligible to be added to the Patent Register in respect of Drug B. Example 2. CSP No. 2 is issued in relation to medicinal ingredient W and the NDS for Drug C. However, the patent set out in CSP No.

2 is not included on the Patent Register in respect of Drug C. Therefore, the requirement of paragraph 4(3.1)(a) is not met and CSP No. 2 is not eligible to be added to the Patent Register.Example 3. CSP No. 3 is issued in relation to the NDS for Drug D, containing medicinal ingredient Y.The patent set out in CSP No.

3 is included on the Patent Register in respect of Drug D, containing medicinal ingredient Y. Drug D is within the scope of CSP No. 3 because it contains the medicinal ingredient set out in the CSP. Therefore, CSP No. 3 is eligible to be added to the Patent Register in respect of Drug D.

The patent set out in CSP No. 3 is also included on the Patent Register in respect of another drug, Drug E, containing medicinal ingredient Z. CSP No. 3 does not grant rights, privileges and liberties in respect of Drug E in accordance with section 115 of the Patent Act, as Drug E does not contain the medicinal ingredient Y or the "same" medicinal ingredient, per the Certificate of Supplementary Protection Regulations and section 105 of the Patent Act. Therefore, CSP No.

3 is not eligible to be added to the Patent Register in respect of Drug E because the requirement of paragraph 4(3.1)(b) of the PM(NOC) Regulations is not met. 4.7.1 ProcessOnce issued, all CSPs will be assessed by the RMOD in accordance with subsection 4(3.1) of the PM(NOC) Regulations for eligibility to be added to the Patent Register without requiring a separate form or request from the first person. To assess the eligibility of a CSP, the RMOD will first determine if the patent set out in the CSP is included on the Patent Register. If the patent is included on the Patent Register, the RMOD will assess whether the drug on the Patent Register is a drug with respect to which the CSP grants rights, privileges and liberties referred to in section 115 of the Patent Act. If the patent is not on the Patent Register, the CSP is not eligible to be added to the Patent Register, and the RMOD will not provide an assessment in writing.

For CSPs found eligible for addition to the Patent Register, the RMOD will insert the CSP number and expiry date in the office use section of the corresponding patent list(s) and will update the Patent Register. The first person will also be notified in writing. The expiry date of the CSP will be reflected in a separate field on the Patent Register from the expiry date of the patent. If the patent set out in the CSP is included on the Patent Register, but the RMOD determines that the CSP is not eligible to be added to the Patent Register, the first person will be notified in writing. The first person will have the opportunity to provide representations.

The RMOD will consider any representations before a final decision is made. It is possible that a CSP will be added to the Patent Register before publication of the CSP issuance on the Register of Certificates of Supplementary Protection and Applications. When completing a Form IV for a patent that is set out in a CSP, first persons should provide the information relating to the patent only. For example, enter the patent number and the expiry date of the patent in Part 3 of the form, and not the CSP number or expiry date. The RMOD will insert the information in relation to the CSP in the office use section of the form.

In accordance with subsection 4(1.1) of the PM(NOC) Regulations, a patent list may include a patent that has expired if it is set out in a CSP that has taken effect. As such, if a patent has expired and the term of a CSP is in effect when submitting a Form IV with a submission, the first person should continue to enter the patent information on the form, as described above.4.8 Addition of patent(s) and CSP(s) to the Patent RegisterAs provided for in subsection 3(7) of the PM(NOC) Regulations, no patent on a patent list or CSP shall be added to the Patent Register until the drug submission in respect of which the patent list was submitted receives an NOC. In addition to this requirement, the RMOD will not add any patent or CSP until it has completed a final evaluation and is satisfied that the patent or CSP meets the eligibility requirements set out in section 4, described above. The RMOD will prioritise evaluations for submissions for which an NOC has already issued. It is recognised that certain terminology proposed by the company at the time of filing a drug submission does not become final until review and approval through the issuance of an NOC.

Therefore, at the time of NOC issuance, it is possible that the information on Part 2 of the Form IV does not match the NOC, e.g. The medicinal ingredient, brand name, strength, route of administration and dosage form. If this information does not match the NOC, the first person is expected to request updates to the patent list, in accordance with the obligations set out in subsection 4(7). The RMOD will not update a patent list without written permission from the first person. Replacement Form IVs should not be provided by first persons.

Upon receipt of the written permission, the RMOD will make the requested changes to the Form IV to align the terminology on the Form IV with that approved on the NOC. Where permission is not received in a timely manner, there may be delays in adding the patent lists to the Patent Register.4.9 Accuracy of Patent List informationPursuant to subsection 4(7), first persons are required to keep the information on their patent lists up to date. The update of information, however, does not provide an opportunity to add a new patent. A first person should notify the RMOD in writing of any updates to the information included on the patent lists. Examples of an update include a change to the company name or address, the name and address for service of an NOA, patent lapse, or the dedication of the patent to the public interest.

The onus is on the first person to ensure that the information on the patent list and the Patent Register is accurate and current. Please note that due to the complexities of corporate mergers and acquisitions, information is not automatically updated when an NOC is issued for a company name change or merger. To ensure receipt of an NOA from a second person, the company name and address for service must be current. First persons wishing to update a patent list should forward to the RMOD a letter outlining the requested changes. First persons are requested not to provide the RMOD with new forms.

The RMOD will not assume any responsibility for errors arising from the failure of the first person to provide up-to-date information. First persons are encouraged to view the Form IVs on the Patent Register, available online, to ensure the accuracy of the information.4.10 Re-issued patentsIf a patent that is included on the Patent Register is re-issued by the CIPO, the RMOD recommends that the first person submit a new Form IV within 30 days of the date of re-issuance. The granted date entered on the patent list should be the date the patent was re-issued. The RMOD will conduct a review to determine whether the patent remains eligible to be included on the Patent Register. If the RMOD is of the view that the patent is no longer eligible, the RMOD will notify the first person, in writing, that the patent has been found ineligible for inclusion on the Patent Register.

The first person will then be provided with an opportunity to submit written representations as to the patent's eligibility for inclusion on the Patent Register. If representations are provided, they will be taken into consideration by the RMOD and a final decision regarding the patent eligibility will subsequently be communicated to the first person.5. Section 5 of the PM(NOC) Regulations5.1 Scope and application of Section 5In accordance with subsection 5(1), when a second person files a submission seeking an NOC for a drug and the submission directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada by a first person and in respect of which there are patents and/or CSPs included on the Patent Register, the second person must include in the submission the required statements or allegations set out in subsection 5(2.1) of the PM(NOC) Regulations. Subsection 5(2) applies when a second person files a supplement for a change in formulation, a change in dosage form, or a change in use of the medicinal ingredient and the supplement directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada by a first person and in respect of which there are patents and/or CSPs included on the Patent Register. While the terminology in section 5 is intended to capture abbreviated new drug submissions (ANDSs) and supplements to abbreviated new drug submissions (SANDSs), the language of section 5 of the PM(NOC) Regulations is not exclusive to ANDSs and SANDSs.

It is also intended to capture NDSs and SNDSs that directly or indirectly compare the drug with, or make reference to, another drug marketed in Canada, including biosimilar drug submissions and submissions relying on third-party data.A biosimilar must be subsequent to a biologic drug that is approved in Canada and to which a reference is made. Sponsors may use a non-Canadian sourced version as a proxy for the Canadian drug in the comparative studies. If the Canadian drug is marketed in Canada and has patents or CSPs included on the Patent Register, NDSs and SNDSs submitted in accordance with Health Canada's Guidance Document. Information and Submission Requirements for Biosimilar Biologic Drugs are considered to make a comparison or reference within the meaning of section 5. Sponsors of such submissions will be required to comply with the requirements for second persons under the PM(NOC) Regulations.NDSs which seek approval based on independent clinical trials and not on a comparison or reference to a drug which has patents and/or CSPs included on the Patent Register are not captured by section 5.

In addition, submissions that do not result in a subsequent entry version of the drug which has patents and/or CSPs included on the Patent Register are not captured by this section. For example, a submission for a drug indicated for use in combination with a drug on the Patent Register will not be required to comply with section 5 of the PM(NOC) Regulations. 5.1.1 Administrative drug submissionsWhen a manufacturer files a drug submission in accordance with Health Canada's Guidance Document Administrative Processing of Submissions and Applications. Human or Disinfectant Drugs, the administrative drug submission does not trigger application of section 5 of the PM(NOC) Regulations. Rather, only the originating submission which directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada under an NOC issued to a first person, will trigger the application of section 5 of the PM(NOC) Regulations.

Subsequently filed administrative drug submissions that cross-reference the originating drug submission will not re-trigger section 5 of the PM(NOC) Regulations and should not include a Form V. An NOC will be issuable in respect of an administrative drug submission after the requirements of the Food and Drug Regulations have been met and only after the originating drug submission receives its NOC. In the case where the originating drug submission is placed on Intellectual Property (IP) Hold, the administrative drug submission will also be placed on IP Hold. If consent is received from the patent owner under subsection 7(2) of the PM(NOC) Regulations, or subsection 7(3) of the pre-September 21, 2017 version of the PM(NOC) Regulations, and the NOC issues for the originating drug submission, the NOC for the administrative drug submission will also issue, as the requirements of the PM(NOC) Regulations have been met for the originating drug submission. In accordance with subsection 5(4) of the PM(NOC) Regulations, the date of filing on which the Patent Register is frozen is specific to the originating drug submission.

As such, any patent added to the Patent Register in respect of the first person's drug on or after the date of filing of the originating drug submission need not be addressed in respect of the administrative submission. The Patent Register is, in effect, "frozen" as of the date of filing of the originating drug submission.Example 1. Generic A files an ANDS for its drug X on January 2, 2018 and addresses the patents included on the Patent Register in respect of the first person's drug prior to January 2, 2018 as required by section 5 of the PM(NOC) Regulations. Subsequently, Generic A receives an NOC for its drug X. Generic B then enters into a licensing agreement with Generic A and files an administrative ANDS for its identical drug XX, cross-referencing Generic A's ANDS.

Generic A continues marketing its drug X while Generic B is assigned a distinct DIN for its drug XX after the requirements of the Food and Drug Regulations have been met. Subsection 5(1) of the PM(NOC) Regulations is not re-triggered in respect of Generic B's administrative ANDS for its drug XX. Therefore, Generic B does not need to address the patents included on the Patent Register in respect of the first person's drug prior to receiving an NOC for its drug XX. Example 2. Generic C files an ANDS for its drug Y on January 2, 2018 and elects to await expiry of the patents included on the Patent Register in respect of the first person's drug prior to January 2, 2018.

Subsequently, upon meeting the requirements under the Food and Drug Regulations, Generic C's ANDS for its drug Y is placed on IP Hold. Generic D then enters into a licensing agreement with Generic C and files an administrative ANDS for its identical drug YY, cross-referencing Generic C's ANDS. An NOC is issuable in respect of Generic D's administrative ANDS for its drug YY after the requirements of the Food and Drug Regulations have been met and only after Generic C receives an NOC for its ANDS for its drug Y. Therefore, Generic D's administrative ANDS will be placed on IP Hold until the NOC issues for Generic C's drug.5.2 Submission of a Form V. Declaration re.

Patent ListUnder subsections 5(1) and 5(2) of the PM(NOC) Regulations, a second person must include in the submission or supplement the required statements or allegations set out in subsection 5(2.1) for each patent and CSP included on the Patent Register in respect of the first person's drug. The required statements and allegations are set out in the Form V. One Form V must be submitted for each patent included on the Patent Register, and for each strength of the second person's drug. Refer to Appendix B for instructions on how to complete the Form V. Every required Form V must be a part of a drug submission.

Filing of a Form V prior to the filing of a drug submission or supplement is not permitted. However, revised Form Vs are accepted by the RMOD. A submission or supplement requiring a Form V will be considered administratively incomplete without one. It will be placed on Patent-Form V Hold and will not be transmitted to the relevant reviewing bureau/centre until the required Form V has been received by the RMOD. The filing date of the submission is as defined above in section 2 of this document.A second person will be required to address all patents that are added to the Patent Register before the date of filing of its submission or supplement.

If a second person cancels its submission or supplement and subsequently re-files, or the relevant directorate issues a rejection letter (e.g. A screening rejection letter, a notice of non-compliance-withdrawal or a notice of deficiency-withdrawal), the original date of filing is lost and the new date of filing becomes the date on which the submission or supplement is re-filed and considered administratively complete. 5.3 Freezing the Patent Register. Addressing additions to the Patent Register on or after the date of filing of a second person's submission or supplementUnder subsection 5(4) of the PM(NOC) Regulations, a second person is not required to address a patent, or associated CSP setting out that patent, added to the Patent Register in respect of the first person's drug on or after the date of filing of the second person's submission. The Patent Register is, in effect, "frozen" in respect of the patents included on the Patent Register as of the date of filing of the second person's submission.The date of filing on which the Patent Register is frozen is specific to a second person's submission or supplement.

Each second person benefits from the same freezing mechanism as of the date of filing of their respective submissions or supplements with the HPFB. The PM(NOC) Regulations address the possible situation where a CSP is added to the Patent Register after the second person has filed its submission or supplement, but where the patent set out in the CSP was added to the Patent Register before the second person filed its submission or supplement. If this occurs, the PM(NOC) Regulations prohibit the issuance of an NOC to the second person until the expiry of the CSP, if certain conditions are met. The CSP must set out a patent in respect of which the second person was required to make a statement or allegation but did not make an allegation, or a patent in respect of which the Court has made a declaration of infringement. In addition, the CSP must be included on the Patent Register in respect of the same submission or supplement as the patent.

5.4 Certification of date of filingWhen a second person's submission or supplement is considered administratively complete, the RMOD will issue to the second person an acknowledgement and certification letter to certify the date of filing of the submission. This letter will be identified by the title "Acknowledgement and Certification of Information Received". Under subparagraph 5(3)(c)(i) of the PM(NOC) Regulations, this certification must be served with an NOA on the first person. Please note that the acknowledgement and certification is not the same as a regular acknowledgement letter, which does not have the title "Acknowledgement and Certification of Information Received". The acknowledgement letter does not certify the date of filing of the submission.5.5 Deemed date of filing under Canada's Access to Medicines RegimeIn cases where a second person has filed a submission or supplement under Canada's Access to Medicines Regime (CAMR), also known as An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), subsection 5(5) of the PM(NOC) Regulations provides for a deemed date of filing in order to comply with the data protection provisions under section C.08.004.1 of the Food and Drug Regulations.

CAMR provides a framework within which eligible countries can import less expensive generic versions of patented drugs and medical devices. Notwithstanding that a second person may receive authorization to export a given drug under a compulsory license granted by the Commissioner of Patents, the HPFB will not grant an NOC providing Canadian market authorization unless the requirements for both data protection under section C.08.004.1 of the Food and Drug Regulations, and the PM(NOC) Regulations have been met. Subsection C.08.004.1 of the Food and Drug Regulations provides an eight-year period of market exclusivity for innovative drugs. In addition, a subsequent-entry manufacturer is prevented from filing a submission for a copy of that innovative drug for the first six years of the eight-year period. The eight-year period may be extended by six months through a pediatric extension.

The introduction of the six-year no filing period requires an exception to allow for the filing of drug submissions within the framework of CAMR. The addition of subsection 5(5) to the PM(NOC) Regulations provides this exception. For the purpose of subsection 5(3), which governs the service of an NOA, and subsection 5(4), which governs the freezing of the Patent Register, there is a deemed date of filing for submissions and supplements filed under CAMR, and referred to in paragraph C.07.003(b) of the Food and Drug Regulations. That date of filing is deemed to be six years after the date of issuance of the first person’s NOC provided that. The drug to which the second person makes a comparison or reference is an innovative drug within the meaning of subsection C.08.004.1(1) of the Food and Drug Regulations, and the date that the submission or supplement is received by the HPFB is less than six years from the day on which the first NOC was issued in respect of the innovative drug.The result is that, under subsection 5(3) of the PM(NOC) Regulations, a second person may not serve an NOA before the deemed filing date of its submission or supplement, which is six years after the date of issuance of the first person's NOC.

In addition, under subsection 5(4), the Patent Register will be frozen six years after the date of issuance of the first person's NOC. During that time, a first person may continue to add patents to the Patent Register in accordance with the PM(NOC) Regulations. 5.6 Notice of Allegation and information to be served on a First Person5.6.1 Timing of serviceUnder paragraph 5(3)(a) of the PM(NOC) Regulations, a second person who makes an allegation under paragraph 5(2.1)(c) must serve on the first person an NOA relating to the submission or supplement that forms the basis of the allegation, but may not do so before the filing date of the submission or supplement.The address for service of the first person is located on the patent list. Service by registered mail (as defined by Canada Post) is deemed to be effected on the addressee five days after mailing. 5.6.2 Contents of Notice of Allegation and documents served with a Notice of AllegationUnder subparagraph 5(3)(b)(i) of the PM(NOC) Regulations, an NOA must include a description of the medicinal ingredient, dosage form, strength, route of administration and use of the drug in respect of which the submission or supplement has been filed.

The RMOD will verify that this information corresponds with that of the submission or supplement on file with the HPFB. The RMOD will also verify that the manufacturer in the submission is the same as the second person who has served the NOA. If any piece of information is missing from the NOA, or does not correspond with the information in the submission or supplement, the RMOD will notify the second person of the deficiencies identified in the NOA. As a transparency measure, the RMOD will also copy the first person on this correspondence. The second person will be required to serve an NOA reflecting all of the correct information outlined in subparagraph 5(3)(b)(i) of the PM(NOC) Regulations.

A certification of the date of filing of the submission or supplement is required to be served with the NOA. As discussed above, the certification of the date of filing of the submission or supplement is provided by the RMOD in the form of the "Acknowledgement and Certification of Information Received" letter.5.6.3 Information to provide to the RMODIn accordance with paragraph 5(3)(e) of the PM(NOC) Regulations, the second person must provide to the RMOD proof of service of the NOA, along with a copy of the NOA. A copy of the documents required to be served with the NOA under paragraphs 5(3)(c) and 5(3)(d) do not need to be provided to the RMOD. It is recommended that second persons provide the proof of service and a copy of the NOA to the RMOD as soon as possible following service on the first person to allow the RMOD a period of time to review the NOA. Allowing for a period to review the NOA to ensure the information required by subparagraph 5(3)(b)(i) is included in the NOA and corresponds with the submission or supplement may provide an opportunity for second persons to address any deficiencies before an action is brought by the first person or patent owner.5.6.4 Retraction of a Notice of AllegationUnder subsection 5(6), a second person who has served an NOA on a first person must retract that NOA and serve a notice of retraction on the first person within 90 days after either.

the date on which the Minister notifies the second person under paragraph C.08.004(3)(b) or C.08.004.01(3)(b) of the Food and Drug Regulations that the submission or supplement does not comply with the requirements of section C.08.002, C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, or the date of the cancellation by the second person of the submission or supplement to which the allegation relates.The types of notices requiring a retraction of an NOA include, for example, a screening rejection letter, a notice of non-compliance-withdrawal or a notice of deficiency-withdrawal. A copy of the retraction or withdrawal of the NOA should be provided to the RMOD. The RMOD will acknowledge the retraction or withdrawal in writing, and will copy the first and second person.5.7 Second Person company name changes prior to NOC issuanceA second person's submission may be transferred to another manufacturer prior to NOC issuance, if there is a company merger or licensing agreement. If an NOA has been served on the first person, the new second person should notify the first person of its new name in order to ensure transparency. 6.

Sections 6 and 7 of the PM(NOC) Regulations6.1 ActionsWhen a first person is served with an NOA, the first person or patent owner may bring an action against the second person in the Federal Court for a declaration that the making, constructing, using or selling of the second person's drug would infringe any patent or CSP that is the subject of an allegation. The first person or patent owner has a period of 45 days after the date of service of the NOA to bring the action. If an action is brought, the Minister is prohibited from issuing the NOC to the second person for up to 24 months (the statutory stay).6.2 Intellectual property holdOnce the examination of a second person's submission has been completed, the submission will be placed on IP Hold if the requirements of the PM(NOC) Regulations have not been met. The manufacturer will be notified in writing of the date on which the examination was completed and that the submission has been placed on IP Hold. An invoice for the review of the submission will also be issued, where applicable.

Once the requirements of the PM(NOC) Regulations have been met, the submission may remain on IP Hold until the expiration of any data protection period for the first person’s drug under section C.08.004.1 of the Food and Drug Regulations. Where there is a notifiable change submission, it will be placed on IP Hold while the related submission is on IP Hold. The manufacturer will not be notified in writing when a notifiable change submission has been placed on IP Hold. Second persons are encouraged to view the status of their submissions in the Drug Submission Tracking System – Industry Access. The status of the notifiable change submission will be updated to IP Hold when the review of the submission is complete.

In accordance with subsection 8(2) of the PM(NOC) Regulations and paragraph 8(1)(a) of the pre-September 21, 2017 version of the PM(NOC) Regulations, the Minister may be requested to certify the date on which a NOC would have been issued to a second person in the absence of the PM(NOC) Regulations.6.3 NOC issuance to a Second Person in the absence of an action for patent infringementA first person or patent owner has a period of 45 days following service of an NOA to bring an action in the Federal Court. If no action is brought, the NOC may be issuable to the second person on the 46th day after the NOA was served, if the requirements of the Food and Drug Regulations have been met. As such, the RMOD will verify on day 46 whether a copy of a statement of claim has been received. The Minister of Health is not a party to actions for patent infringement, therefore a copy of the statement of claim should not be served on the Minister. However, in accordance with section 6.13 of the PM(NOC) Regulations, a copy of the statement of claim must be provided to the RMOD as soon as feasible.

Please refer to section 3.4.1 of this document for information on how to provide the statement of claim to the RMOD. The RMOD will rely on the absence of a statement of claim to establish that no action was brought in the Federal Court. It is recommended that first persons and patent owners provide a copy of the statement of claim to the RMOD within the 45-day period to avoid any unwanted issuance of an NOC to the second person.6.4 Verification of portions of a submission or supplementPre-September 21, 2017 version of the PM(NOC) Regulations Under paragraph 6(7)(a) of the pre-September 21, 2017 PM(NOC) Regulations, a second person may be ordered by the court to produce any portion of the submission or supplement filed for an NOC that is relevant to the disposition of the issues in the prohibition proceeding. In addition, the court may order the production of any changes, as they are made, to the portion during that proceeding. Under paragraph 6(7)(b), the RMOD may be ordered to verify that any portions of the submission or supplement produced by the second person correspond fully to the information in the submission or supplement, usually within 30 days of receipt of the productions.

In such cases, the second person should produce the relevant documents directly to the first person. The first person will then direct the documents to the attention of the RMOD through counsel for the RMOD.September 21, 2017 version of the PM(NOC) Regulations Section 6.05 of the PM(NOC) Regulations provides that, on the request of any party to an action under the regulations, the RMOD must verify that any portion of a submission or supplement that is required to be served with an NOA, or that is produced as a result of an order, corresponds to the information in the submission or supplement. The documents to be verified shall be provided directly to the RMOD as outlined in section 3.4.1 of this guidance document. To ensure a transparent process, the RMOD recommends that the documents to be verified be provided by the first person or patent owner. Where the documents are provided by the second person, the RMOD will not produce a copy to the first person or patent owner.6.4.1 Verification processThe RMOD is required only to verify whether the portions produced by the second person correspond with the relevant submission or supplement on file at the HPFB.

The RMOD is not required to produce additional documentation, or make any statements or characterizations regarding the nature of the portions produced by the second person. In keeping with the pre-September 21, 2017 practice, the RMOD will endeavour to complete verification requests within 30 days. To facilitate the verification process, parties are encouraged to continue to provide good quality copies of documents that are indexed using the format found in the example below, with respect to their location within the original submission or supplement. If the productions are not formatted in a format acceptable to the RMOD, they may be rejected for verification. To this effect, productions to be verified under either version of the PM(NOC) Regulations should be formatted as follows:Index:The documents should be indexed and tabbed.

The index should denote the location of the documents from within the production. It is important to note that providing detailed descriptions and information in the index will assist the RMOD in locating the documents and verifying the production efficiently.Description of Item:If multiple versions of a document were filed in respect of the relevant submission, for example a PM, add the "date of preparation" to the description (see Tab 2 of the example in Appendix C). If multiple documents have similar titles, use a distinguishing name and/or highlight the difference(s) between the documents (see Tab 6 of the example in Appendix C).Location:If a document is located in a Master File, provide the Master File number and note whether the document can be found in the Unrestricted/Open or Restricted/Closed portion of the file (see Tabs 4 and 5 of the example in Appendix C). Pages within a tab:When only certain pages are provided for verification from a larger document, note the page numbers to be verified in the index and the complete number of pages of the document (see Tab 3 of the example in Appendix C). Tabs:Use a naming convention similar to “Tab –3 - [name of document ]” when formatting the electronic production.

If there are multiple documents contained in one tab, use one New Folder per tab (see Tab 7 of the example in Appendix C).6.5 ConsentUnder subsection 7(2) of the PM(NOC) Regulations, or subsection 7(3) of the pre-September 21, 2017 version of the PM(NOC) Regulations, the owner of the patent may provide consent to the making, constructing, using or selling of the drug in Canada by the second person. The consent letter must be signed by the owner of the patent or by a person authorized to act on the owner’s behalf. If the letter is signed by a person authorized to act on behalf of the patent owner, this must be stated in the letter. The letter should indicate the following. The patent and/or CSP numbers for which consent is being provided the second person's submission number the medicinal ingredient the second person's name, and a statement that for the purposes of subsection 7(2) or 7(3) of the PM(NOC) Regulations, as the case may be, the owner of the patent consents to the making, constructing, using or selling of the drug in Canada by the second person.6.6 Renouncing the 24-month stayParagraph 7(1)(d) of the PM(NOC) Regulations prohibits the Minister from issuing an NOC to a second person for a 24-month period from the day on which an action is brought under subsection 6(1).

However, a party who brings an action may renounce application of this 24-month period under paragraph 7(5)(b). To do so, each of the parties who bring an action must provide to the RMOD a notice that they renounce the application of the 24-month stay, at the time the action is brought.The notice should indicate the following. the second person's submission number the patent and/or CSP numbers the court file number, and a statement that the application of paragraph 7(1)(d) of the PM(NOC) Regulations is being renounced in accordance with paragraph 7(5)(b) of the PM(NOC) Regulations.7. Maintenance of the Patent RegisterThe RMOD is responsible for maintaining the Patent Register in accordance with subsection 3(2) of the PM(NOC) Regulations. The RMOD is required to add any patent on a patent list or CSP that meets the requirements for addition to the Patent Register and to refuse to add any patent or CSP that does not meet the requirements for addition to the Patent Register.

The RMOD must also delete any patents or CSPs from the Patent Register as outlined in the PM(NOC) Regulations, as follows. If the patent or CSP was added to the Patent Register due to an administrative error if the patent or CSP has been declared invalid or void under subsection 60(1) or 125(1) of the Patent Act if the patent or CSP has been declared under subsection 6.07(1) to be ineligible for inclusion on the Patent Register if the first person requests that the patent or CSP be deleted from the Patent Register if the patent has expired, unless a CSP in which that patent is set out is included on the Patent Register in respect of the same submission, or if the CSP has expired.A patent or CSP declared ineligible for inclusion on the Patent Register will not be deleted until the period for appealing the decision to the Federal Court of Appeal ends, or until the conclusion of any appeal to the Federal Court of Appeal. This same delay does not apply to patents or CSPs declared invalid or void, which will be deleted after an initial finding. If a patent or CSP was deleted because of a finding of invalidity or ineligibility, it will be added back to the Patent Register, with a new date added, if the decision is subsequently reversed or set aside on appeal. Second persons who file submissions in the interim when the patent is not on the Patent Register will not need to address the patent.

The first person will be notified in writing once a patent or CSP has been deleted from the Patent Register in accordance with paragraph 3(2)(c). Subsection 3(2.3) provides the RMOD with discretion to review the eligibility of all the patents on the Patent Register. This may occur when, for instance, the eligibility requirements are called into question by new jurisprudence. If it is necessary to undertake a review of the Patent Register under subsection 3(2.3) of the PM(NOC) Regulations, the RMOD will notify first persons in writing if a patent or CSP has been found not to meet the requirements for inclusion on the Patent Register. If, during the course of such a review, an inquiry is received from an interested party regarding the inclusion of the patent on the Patent Register, a copy of the inquiry will be provided to the first person.

As such, inquiries should not be marked confidential. The first person will then be provided with an opportunity to submit written representations as to the patent or CSP’s eligibility for inclusion on the Patent Register. If representations are provided, they will be taken into consideration by the RMOD and a final decision regarding the patent eligibility will subsequently be communicated to the first person and the inquirer. Note, however, that the mere receipt of an inquiry will not be considered as a sufficient basis to trigger a review of the entire Patent Register.AppendicesAppendix A - How to complete a Form IV. Patent List Please submit one Form IV per patent, per submission, per DIN.

Part 1Select whether the patent list is being filed with the submission, or whether it is a newly issued patent for listing against a previously filed submission. The PM(NOC) Regulations require that all patents submitted for listing must be linked with a submission for an NOC. Therefore, in the case of a newly issued patent, the first person must provide the submission number. However, if the Form IV is being filed with the submission, the RMOD will insert the submission number on the form.Select "NDS" if the Form IV is to be added to the Patent Register in accordance with subsection 4(2) of the PM(NOC) Regulations. Select "SNDS" if the Form IV is to be added to the Patent Register in accordance with subsection 4(3) of the PM(NOC) Regulations, and then select the appropriate option(s).

Change in formulation, change in dosage form or change in use. Select "Carry forward, in accordance with section 4.1(2)" if the patent is already included on the Patent Register and the patent is being resubmitted in relation to the submission or supplement. Note. When submitting a patent list with an SNDS for a change in formulation, change in dosage form or change in use of the medicinal ingredient, and the patent is already listed on the Patent Register for the same product, the RMOD recommends that the first person submit such a patent under the "carry forward" provision, unless the patent contains a specific claim for the changed formulation, dosage form or use for which the supplement was submitted.Part 2Enter the information about the drug as it appears, or as it is expected to appear, on the NOC. Medicinal ingredient(s).

Enter the medicinal ingredient(s) contained in the drug as it appears, or as it is expected to appear, on the NOC.Brand Name. Enter the brand name under which the drug is (or will be) marketed. If the brand name has not yet been determined, it may be left blank and will be entered by the RMOD when the NOC is issued.Human or Veterinary. Indicate human or veterinary. Strength per unit.

Provide the strength of the medicinal ingredient(s) (e.g. 10 mg, 100 mg, 0.5 mg/10 ml). Please note that one Form IV should be submitted per DIN. If there is more than one medicinal ingredient, list the strengths in the order that the medicinal ingredients appear in the medicinal ingredient field. Therefore, the names of the medicinal ingredients do not need to be repeated in the strength field.

Dosage Form. Provide the physical form of the drug (e.g. Tablet, capsule, solution, powder) as it appears, or as it is expected to appear, on the NOC. Route(s) of Administration. Provide the route of administration of the drug (e.g.

Oral, nasal, subcutaneous) as it appears, or as it is expected to appear, on the NOC. DIN. In the case of the first submission for an NOC for a drug, the DIN will not be known by the first person. Therefore, this field should be left blank and the RMOD will insert the DIN once the NOC issues. In all other cases, the DIN for the drug should be provided.

Please note that one Form IV per DIN should be submitted.Use(s) of the Medicinal Ingredient(s). Enter the specific use(s) of the drug for which approval is being sought, or which has been approved, in the submission or supplement to which the patent list relates. Part 3Enter the information about the patent. Patent Number. Enter the Canadian patent number being submitted for addition to the Patent Register.

If a CSP has issued in respect of the patent, enter the patent number only in this section. The RMOD will insert the CSP number and expiry date in the office use section, where applicable. Code. Indicate whether the first person is the owner of the patent, has an exclusive licence or has obtained consent from the owner of the patent to have it included on the patent list. A.

Applicant is the owner of the patent B. Applicant has an exclusive license C. Applicant has obtained the consent of the owner of the patent for the inclusion of the patent on the above patent list Filing Date of Patent Application. Indicate the Canadian patent application filing date. Date Granted.

Enter the date on which the Canadian patent was granted by the CIPO. Expiration Date. Enter the date on which the patent term will expire. The term of a patent is 20 years from date of filing for patent applications filed on or after October 1, 1989. For patent applications filed before October 1, 1989, the expiry date is the later of 17 years from date of grant of the patent or 20 years from the date of filing.

If a CSP has issued in respect of the patent, enter the expiration date of the patent in this section. The RMOD will insert the CSP number and expiry date in the office use section, where applicable. Part 4Enter the address in Canada for service, on the first person, of an NOA referred to in paragraph 5(3)(a) or the name and address for service in Canada of another person on whom service may be made with the same effect as if service were made on the first person. A post office box (P.O.) box is not an acceptable address, as it cannot accept registered mail. The RMOD recommends using contact person titles (e.g.

Director, Regulatory Affairs) rather than a name in this section to reduce the number of changes required to the form due to corporate staffing changes.The onus is on the first person to keep this information up-to-date, in accordance with subsection 4(7) of the PM(NOC) Regulations. Part 5Enter the manufacturer and contact information and provide a certification that the information included on the patent list is accurate and that the patent on the list meets the eligibility requirements of subsection 4(2) or 4(3) of the PM(NOC) Regulations. The RMOD will use the contact information provided in this section to correspond with the first person regarding the patent list.Part 6 This section is for office use only. Appendix B - How to complete a Form V. Declaration re Patent List Please submit one Form V per patent, per submission, per DIN.

Part 1Select whether the form is an amendment to a previously filed Form V, or if the Form V is being filed with the submission. Part 2 Enter the information about the second person's drug. Medicinal ingredient(s). Enter the medicinal ingredient(s) contained in the second person's drug as it appears, or as it is expected to appear, on the NOC. Brand Name.

Enter the brand name of the second person's drug as it appears, or as it is expected to appear, on the NOC. Drug Use. Indicate human or veterinary. Strength per unit. Provide the strength of the medicinal ingredient (e.g.

10 mg, 100 mg, 0.5 mg/10 ml). Please note that one Form V should be submitted per DIN. If there is more than one medicinal ingredient, list the strengths in the order that the medicinal ingredients appear in the medicinal ingredient field. Therefore, the names of the medicinal ingredients do not need to be repeated in the strength field. Dosage Form.

Provide the physical form of the drug (e.g. Tablet, capsule, solution, powder) as it appears, or as it is expected to appear, on the NOC. Route(s) of Administration. Provide the route of administration of the drug (e.g. Oral, nasal, subcutaneous) as it appears, or as it is expected to appear, on the NOC.

Use(s) of medicinal ingredient(s). Enter the specific uses of the drug for which approval is being sought in the second person's submission. Part 3Enter the information about the first person's drug. Part 3.1Provide the Canadian patent number and expiry date of each patent included on the Patent Register for the first person's drug. Please note that one Form V should be submitted per patent, per DIN.

If there is a CSP number included on the Patent Register, enter the number and expiry date.Part 3.2In this section, the second person must select one of the statements or at least one of the allegations required by subsection 5(2.1) of the PM(NOC) Regulations. Part 4Provide the name and address of the manufacturer of the drug (the name of the company that is seeking the NOC) and contact information, which will be used by the RMOD to correspond with the second person regarding the form. Any NOA served should be from the company seeking the NOC.Part 5This section is for office use only. Appendix C - Sample productions for verification Sample Index Example Tab Sequence Section Description of Item Location 1 0002 3.2.S.1.2 Quality - Body of Data - Drug Substance - Stability - Stability Data - Supplier Commitment [Submission no.] 2 0005 1.3.1 Non-Annotated Product Monograph [date of preparation] [Submission no.] 3 0004 3.2.S.3 Characterization, pp. 416-423 of 739 [Submission no.] 4 0000 1.0.4 Master File [Master File No.] - Administrative Information and Prescribing Information - Quality Overall Summary Master File [Master File No.] - Open Portion or Closed Portion 5 The portions of [drug manufacturer name]'s Master File [Master File No.] that comprise the Productions are the following.

0001 3.2.S.1 General Information, pp. 6-7 of 739 Unrestricted Part or Restricted Part 6 0009 5.3.1.2 Comparative Bioavailability and Bioequivalence Study Reports. Comparative, Randomized 2-way Crossover Bioavailability Study of Tablets Under Fed Conditions, Drug Concentration by Formulation [Submission no.] Comparative Bioavailability and Bioequivalence Study Reports. Comparative, Randomized 2-way Crossover Bioavailability Study of Tablets Under Fasting Conditions, Drug Concentration by Formulation 7 0003 3.2.1.5 Drug Product - Specification(s) [drug name] - 10-mg-release-specifications [Submission no.] Drug Product - Specification(s) [drug name] - 15-mg-release-specifications [Submission no.] Drug Product - Specification(s) [drug name] - 20-mg-release-specifications [Submission no.].