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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.

FIRE IN THE BLOOD Preview Clip #1: Thematic Overview

FIRE IN THE BLOOD: http://www.fireintheblood.com https://www.facebook.com/fireintheblood Sundance Film Festival Official Selection 2013 A shocking exposé of how pharmaceutical companies use patent law to keep profits unconscionably high even at the expense of peoples' lives, and a plea for universal access to affordable, life-saving generic medicines. An intricate tale of "medicine, monopoly and malice", FIRE IN THE BLOOD tells the story of how Western pharmaceutical companies and governments aggressively blocked access to affordable AIDS drugs for the countries of Africa and the global south in the years after 1996 - causing ten million or more unnecessary deaths. It is also the inspiring story of the improbable group of people who decided to fight back. Shot on four continents and including contributions from global figures such as President Bill Clinton, Bishop Desmond Tutu and economist Joseph Stiglitz, FIRE IN THE BLOOD is the never-before-told true story of the remarkable coalition which came together to stop 'the Crime of the Century' and save millions of lives.

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.

Gilead Outrageously Seeks Super-Monopoly Protections for Covid-19 Drug remdesivir

Statement of Peter Maybarduk, Director, Public Citizen’s Access to Medicines Program Note: The U.S. Food and Drug Administration today granted experimental COVID-19 treatment remdesivir a special orphan status intended for drugs that treat rare diseases. The status sets up remdesivir’s manufacturer Gilead Sciences to receive additional federal tax credits in the United States and a bonus lucrative seven-year market exclusivity, allowing Gilead to exclude generic and more affordable competition while charging high monopoly prices, if the drug is approved. Gilead’s pursuit of an orphan designation is unconscionable and could be deeply harmful. Remdesivir is one of relatively few medicines that may prove effective in treating COVID-19 this year. The government should be urgently concerned with its affordability for citizens. Instead, the FDA has handed Gilead, one of the most profitable pharmaceutical corporations on earth, a long and entirely undeserved seven-year monopoly and with it, the ability to charge outrageous prices to consumers. Gilead has gamed the system by rushing through its “rare disease” orphan drug application while there are, for this brief moment, fewer than 200,000 COVID-19 U.S. cases. Its action is disingenuous and outrageous, and underscores the need for the federal government to step in.

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.]"

The Hidden Holocaust -

25 years ago a scheme, to make drugs much more expensive, came into force - along with the WTO. with the creation of the WTO -and tellingly, this was also in the middle of an epidemic, like today.

Market Spiral Pricing of Cancer Drugs

By Donald W. Light. "Companies are spiraling up high prices, not because of costs or better value, but because they can get away with it, in - only the USA. Senior oncologist, Hagop Kantarjian, and I show that very high prices for cancer & specialty drugs are not due to high costs of research, nor to added clinical value. Companies are simply spiraling up prices already 2-3 times greater than other capitalist countries allow, because we allow them to. High co-pays hurt patients and impede good clinical care. This exploitation of serious ill patients and taxpayers is ethically troubling and must stop."

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.)