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For Covid-19 Vaccines, Some Are Too Rich — and Too Poor

"CAPE TOWN — A few months from now, a factory in South Africa is expected to begin churning out a million doses of Covid-19 vaccine each day in the African country hardest-hit by the pandemic. But those vials will probably be shipped to a distribution center in Europe and then rushed to Western countries that have pre-ordered them by the hundreds of millions. None have been set aside for South Africa. The country, which will help manufacture the vaccine and whose citizens have enrolled in clinical trials, does not expect to see the first trickle of doses until around the middle of next year. By then, the United States, Britain and Canada may already have vaccinated more than 100 million people. The first year of the Covid-19 pandemic revealed that a country’s wealth would not spare it from the virus. Overconfidence, poor planning and ignored warnings felled some of the world’s richest nations. But now, money is translating into undeniable advantages. Over the past few months, rich nations like the United States and Britain have cut deals with multiple drug manufacturers and secured enough doses to vaccinate their citizens multiple times over. China and Russia have conducted their own trials and begun mass vaccination programs. Yet countries like South Africa are in a singular bind because they cannot hold out hope for charity. Although its government is nearly insolvent and half of its citizens live in poverty, South Africa is considered too rich to qualify for cut-rate vaccines from international aid organizations. “Where you’re not rich enough but you’re not poor enough, you’re stuck,” said Salim Abdool Karim, an epidemiologist who leads the country’s coronavirus advisory council."

Unaffordable prescription drugs: the real legacy of the Hatch-Waxman Act

By ALFRED ENGELBERG -This is a 2880 word article by Al Engleberg in Stat, on the Hatch Waxman Act, a law that he played an important role in shaping. The article ends with several of Al's endorsed reforms, including those directed at "minor changes" to a drug. One is to stop granting patents for minor changes, and to eliminate the presumption of validity in USPTO inter partes reviews. He wants FDA regulations changed "to prevent non-essential changes to a drug that serve to delay generic competition." Third, he wants to eliminate injunctions "for infringement of patents claiming minor changes to a drug after the patents claiming the drug itself or its medical use have expired." This last reform is a limitation on the remedy to infringement. Patent holders could seek compensation or remuneration for the use of the patented inventions, but not block their use. Governments that are WTO members can implement such a limitation on the availability of injunctions, under Article 44 of the TRIPS, and there are already such limitations in U.S. law, for some other purposes, such as the government's use of a patented invention, or a limitation on remedies when a biologic drug maker does not provide timely disclosure of patent landscapes to competitors. Engleberg notes that the Supreme Court has held that "aninjunction for patent infringement is discretionary and should not be granted when it would do a disservice to the public interest," (the eBay v Mercexchange case), and he proposes "Congress can make a legislative determination that it is not in the public interest to enjoin generic competition after the patent claiming a new drug or its medical use expires — at least in those instances where an injunction is sought due to the existence of a secondary patent claiming subject matter that is not material to the safety or efficacy of a drug as originally approved."

MSF statement supporting the extension of TRIPS (affordable drugs for the poorest countries) exemption for least-developed countries

Backgound: Least-developed country (LDC) members of the World Trade Organization (WTO) have requested an extension that would enable them to remain exempt from implementing some intellectual property rules expiring next year, including for medicines. MSF urges all WTO members to support this +request. MSF works in more than 20 LDCs, facing multiple challenges including disease outbreaks, conflicts and natural disasters. The COVID-19 pandemic has heavily hit some LDCs already facing long-term challenges of fragile health care systems and lack of access to affordable medical tools.

ip-health mailing list Archives

Discussions of Intellectual Property and Health Care "To see the collection of prior postings to the list, visit the Ip-health Archives." This is one of the very best places to learn about the battle -access to medicines vs drug patents and the drug cartel. If you saw the film "Fire in the Blood" you saw how, in this era of global epidemics and corporate greed people must stand up for the rights of human beings to lifesaving drugs at affordable and not extortionate prices. This URL brings one straight to the list archives.

"Fire in the Blood": Millions Die in Africa After Big Pharma Blocks Imports of Generic AIDS Drugs (Democracy Now)

(From Democracy Now) The new documentary, "Fire in the Blood," examines how millions have died from AIDS because big pharmaceutical companies and the United States have refused to allow developing nations to import life-saving generic drugs. The problem continues today as the World Trade Organization continues to block the importation of generic drugs in many countries because of a trade deal known as the Trips Agreement. We're joined by the film's director, Dylan Mohan Gray, and Ugandan AIDS doctor Peter Mugyenyi, who was arrested for trying to import generic drugs, and is

Access to Medicines: Panel Discussion at Georgetown University about the "Crime of the Century" the disastrous murder by drug prices, of millions shown and discussed in the award winning film, Fire in the Blood

Doctors Without Borders and the O'Neill Institute for National and Global Health Law at Georgetown University screen (the 2013 film) Fire in the Blood and a discussion of challenges and opportunities for access to medicines, featuring a panel of distinguished speakers representing a range of expertise in the field of access to medicines.

Health Policy Watch: World Health Assembly Prepares For Show Of Unity On Global COVID-19 Response – But Potential Dispute Over Taiwan

Analysis 15/05/2020 • Elaine Ruth Fletcher The world seems set to make at least a symbolic display of unity in the battle against the COVID-19 pandemic at the upcoming World Health Assembly (WHA), which begins on Monday. The WHO’s 194 member states are expected to overwhelmingly approve a European Union-led Resolution that aims to step up the global COVID-19 response, and ensure equitable access to treatments and future vaccines. But the show is unlikely to go off as smoothly as some might hope, and not only because the 73rd Assembly is meeting for the first time ever in a virtual format.

Open letter asking 37 WTO Members to declare themselves eligible to import medicines manufactured under compulsory license in another country, under 31bis of TRIPS Agreement

Background In 2001, the World Trade Organization (WTO) began negotiations on the rules regarding patents and access to medicine. While several issues were clarified and resolved in the November 2001 “Doha Declaration on TRIPS and Public Health”, the negotiations took nearly two more years to adopt on August 30, 2003, a decision that was a limited “waiver of the export restriction” on medicines and diagnostic tests manufactured under a compulsory license. The final resolution was complicated. Among the controversial features was the definition of an “eligible importing member”, which allowed WTO members to declare themselves ineligible in some cases or in all cases. In 2017, this decision became a formal amendment to the TRIPS agreement. Today 37 members of the WTO are listed as ineligible to import medicines manufactured in another country under a compulsory license, including the governments of Australia, Canada, Iceland, Japan, New Zealand, Norway, Switzerland, the United Kingdom, United States, and the European Union, including the following member states: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden. On April 7, 2020, more than 30 groups and three dozen experts on health, law and trade sent an open letter to those 37 WTO members, asking that “countries to notify the WTO that they have changed their policy and now considers itself an eligible importing country, and in addition, to also use whatever legal means are available to revoke the opt-out as importing members, for goods manufactured under a compulsory license.”

Lowered insulin price should be made permanent

the Lilly company has temporarily lowered the price of insulin to $35/month. As anybody who reads the paper knows, LOTS of Americans, both young and old, are dying because they cannot afford insulin's insane price.

Our right to regulate drug prices was signed away when we joined the WTO.

The TRIPS agreement is part of the WTO. It was meant to jack up the prices of drugs all around the world. GATS (another WTO agreement) gave countries another bargaining chip they could use, jobs. . A logical approach would be for us to dump both GATS and TRIPS at the same time. That would give the poor countries (And US) back our right to regulate prices and get affordable drugs, we could keep the potentially millions of jobs that could end up being traded away in GATS. We would also get back our right to have affordable healthcare, and prevent Medicare and Social Security from being privatized.

A Country in Denial, and not just about COVID-19

With our for-profit system being too expensive for the vast majority of Americans to afford without being bankrupted, due to very very high rates of uninsurance and underinsurance, a very great fear is that this COVID-19 epidemic will be the straw that breaks the camels back.

Indian Company Offers to Supply AIDS Drugs at Low Cost in Africa (New York Times, Feb. 7, 2001)

(This is the story depicted in the Fire in the Blood film) By Donald G. McNeil Jr. In a move that could force big drug multinationals to cut the prices of their AIDS drugs in poor countries, an Indian company offered today to supply triple-therapy drug ''cocktails'' for $350 a year per patient to a doctors' group working in Africa. The Indian company, Cipla Ltd. of Bombay, a major manufacturer of generic drugs, made the offer to Doctors Without Borders, which won the Nobel Peace Prize in 1999 for its work in war-torn and impoverished areas. In Africa the group sets up small pilot programs to develop models for broader approaches to combat AIDS, and would distribute the Cipla drugs free. As part of its program, Cipla would also sell the drugs to larger government programs for $600 a year per patient, about $400 below the price offered by the companies that hold the patents. ''This is the way to break the stranglehold of the multinationals,'' said Dr. Yusuf K. Hamied, chairman of Cipla, who will meet with the doctors' group on Feb. 15 to discuss strategy. For two years, Doctors Without Borders has led an aggressive campaign to force multinationals to cut prices on life-saving drugs for the world's poorest patients. Other parties in the campaign are the Philadelphia and Paris chapters of the AIDS Coalition to Unleash Power, and the Consumer Project on Technology, a Washington group started by Ralph Nader. The normal cost of the AIDS cocktail in the West is $10,000 to $15,000 a year. Last May five multinationals, backed by the World Health Organization and other United Nations agencies, offered to sell their components to poor nations at sharply reduced prices. But Cipla and other makers of generic drugs in Brazil, Thailand and other countries have not been part of the talks with W.H.O., a situation that Cipla hopes to change with its aggressive entry onto the scene. The country-by-country negotiations about how the multinationals distribute the drugs have gone slowly, and so far only Uganda, Senegal and Rwanda have agreements. The companies refuse to release figures, but the cost of a typical cocktail in Senegal is $1,000 a year, according to Doctors Without Borders. Dr. Bernard Pecoul, director of the Access to Essential Medicines project for Doctors Without Borders, said the Cipla offer, which he learned of only today, ''will let us start up our pilot projects on a larger scale.'' The doctors' group has 40 AIDS projects around the world, about half in Africa, where the infection rate reaches as high as 36 percent. Only five of these pilot programs are giving out antiretroviral cocktails. With the Cipla offer, or matching ones from other companies, up to 20 could be distributing the drugs by the end of year. Cipla is offering to sell the agency as many doses as it is wants at $350 a year. Dr. Hamied said that his company would lose money at that price, but that he would supply ''10,000 doses or 20,000 or 30,000, however many they want.'' The $600 price to governments is near Cipla's break-even point, he said, but costs could drop with greater production. If that happens, he would cut prices further. In India he sells the same cocktail for about $1,100 a year. But he denied that he was trying to grab market share in Africa. ''What do I want with market share?'' he asked. ''I don't have a monopoly, and the only way to make real money in drugs is with a monopoly. In this disaster, there is room for everybody.'' Wide distribution of the drugs in Africa is not without critics, given the attendant need for careful monitoring. Some experts argue that it would be better to spend the money on providing clean water, controlling malaria and increasing the use of condoms. But Doctors Without Borders says that the dangers and side effects of the drugs pale beside the immensity of the epidemic itself, and that Western testing standards are overcautious. The typical AIDS cocktail is a combination of any three of about nine protease inhibitors or reverse transcriptase inhibitors. The chemicals suppress the human immunodeficiency virus but, as with any chemical therapy, they are toxic and can damage the liver. In the West, doctors carefully monitor the levels of the drug in the blood, test for organ damage and check the levels of the virus in the bloodstream. If the virus mutates to resist the therapy, the combinations are changed. Careful monitoring may not be possible in many African settings. But with 25 million Africans infected with the AIDS virus, Doctors Without Borders and other agencies argue, imperfect treatment is better than none. Dr. Pecoul pointed out that large numbers of infected Africans live in urban areas where, ''with a quite simple clinic, you can deal with anti retrovirals.'' He is also ''not convinced'' that the batteries of tests routinely ordered for Western patients are really necessary. ''Some people suggest that H.I.V. testing and clinical followup can be enough,'' he added. The Cipla drug combination is two tablets of 40 milligrams of stavudine, two tablets of 150 milligrams of lamivudine and two tablets of 200 milligrams of nevirapine. In the United States and many other countries, the Bristol-Myers Squibb Company holds the patent on stavudine, also known as Zerit or d4T; Glaxo-Wellcome of Britain holds the patent on lamivudine, also known as Heptovir or 3TC, and Boerhinger Ingelheim G.m.b.H. of Germany holds the patent on nevirapine, or Viramune. Western drug companies have shown themselves determined to defend their patent rights to be sole distributors throughout the world, and Dr. John Wecker, head of Boerhinger Ingelheim's efforts to negotiate cheaper prices in Africa, said he did not yet know what his company would do if Cipla undercut its prices. ''We offer a standard quality from the original manufacturer and can meet any demand that exists out there that can be delivered with safe procedures,'' he said. He refused repeatedly to say at what price Boerhinger Ingelheim sells nevirapine to Senegal or Uganda, saying, ''Affordability is an issue, but not the major issue.'' Representatives from Glaxo-Wellcome and Bristol-Myers did not return phone calls, but the three companies can be expected to wage a hard fight against the distribution of generic versions of their drugs. Late last year, Glaxo-Wellcome threatened to sue Cipla when it tried to sell Duovir, its generic version of Glaxo's Combivir, a lamivudine/zidovudine combination, in Ghana. Cipla offered the drug for $1.74 a day; Glaxo had cut its price to $2, from $16. But even though the African regional patent authority said Glaxo's patents were not valid in Ghana, Cipla backed down and stopped selling Duovir. Asked what he would do if the three drug companies sued to stop him, Dr. Hamied said: ''We won't fight it. I don't look at it as a fight. There's room for everybody. This is a holocaust in Africa. It's like the earthquake in India right now -- everybody is helping out. I'm not looking to pick anybody's business; there's room for the multinationals at their price and room for us at our price, a partnership.''

The race to patent the SARS virus: the TRIPS agreement and access to essential medicines

by Matthew Rimmer. "[This article considers the race to sequence the Severe Acute Respiratory Syndrome virus (‘the SARS virus’) in light of the debate over patent law and access to essential medicines. Part II evaluates the claims of public research institutions in Canada, the United States, and Hong Kong, and commercial companies, to patent rights in respect of the SARS virus. It highlights the dilemma of ‘defensive patenting’ — the tension between securing private patent rights and facilitating public disclosure of information and research. Part III considers the race to patent the SARS virus in light of wider policy debates over gene patents. It examines the application of such patent criteria as novelty, inventive step, utility, and secret use. It contends that there is a need to reform the patent system to accommodate the global nature of scientific inquiry, the unique nature of genetics, and the pace of technological change. Part IV examines the role played by the World Trade Organization and the World Health Organization in dealing with patent law and access to essential medicines. The article contends that there is a need to ensure that the patent system is sufficiently flexible and adaptable to accommodate international research efforts on infectious diseases.]"

Carrying a Good Joke Too Far: TRIPS and Treaties of Adhesion

"A small, unindustrialized country enters into an agreement with a significantly larger, more industrialized country. The agreement must be signed before the small country is permitted to join an exclusive, wealth- generating organization. The small country is facing an epidemic of epic proportions. Already, twenty-two million of its citizens have died as a result of a deadly virus and over thirty million of its citizens are infected. Almost three million die every year. Thirteen million children are orphaned; 15,000 new people acquire the virus every day. The average fifteen-year-old citizen has more than a fifty percent chance of dying of the virus and is more likely to die of the virus than all other causes combined. Finally, while the virus attacks indiscriminately, it impacts the country's economic driving force-its farmers, teachers, blue-collar workers, young adults, and parents -particularly hard. The disease is treatable, but at a cost well out of reach of the country's citizens. The country attempts to address this crisis by implementing two methods, parallel importation and compulsory licensing, which will drastically reduce prices and ensure the supply of drugs at affordable prices. Upon enactment, the larger industrialized country demands that the smaller country halt implementation because the methods violate its obligations under the agreement." (Sound familiar? It should.)

The WhistleBlower: Confessions of a Healthcare Hitman

By Peter Rost, MD This book is about drug prices, by a former Pfizer VP of marketing- An inside view of the drug industry, an industry that both saves the lives of people who have enough money to buy its increasingly expensive products, and also lobbies all around the world to keep its prices high. I'd also recommend watching the film "Fire in the Blood", which Peter Rost, the book's author, appears in, if you are interested in this subject.