TRIPS-agreement

Criticism of, and content on the "Trade related aspects of intellectual property rights" 'agreement'
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.

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.”

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.

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.

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.

Global Trade and Public Health

"Global trade and international trade agreements have transformed the capacity of governments to monitor and to protect public health, to regulate occupational and environmental health conditions and food products, and to ensure affordable access to medications". (This basically means they have stolen the right to regulate, or are in the process of stealing it.)

PharmaMyths.net

The drug pricing policy web site of pricing expert Donald W. Light.

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.

High prices, poor access: What is Big Pharma fighting for in Brussels?

Big Pharma's lobby machine ground into top gear to defend its privileges, doing its best to remove or weaken regulatory measures. A close relationship with the Commission –which fails to take undue industry influence seriously– has played a key role, as has the lobbying firepower of Big Pharma. The top ten biggest spending companies, for example, have increased their lobby budget by €2 million since 2015, and Big Pharma's main lobby group EFPIA (European Federation of Pharmaceutical Industries and Associations) sits on eight of the Commission’s advisory groups. Big Pharma has also rolled out a PR offensive harnessing the powerful emotions around illness, designed to deflect criticism and narrow the scope for debate. Thanks to this lobbying arsenal, the industry has succeeded in influencing the review into pharma incentives and rewards (such as intellectual property rules), as well as a change to a type of patent extension called an SPC (supplementary protection certificate) which allows companies to extend the period of monopoly pricing. It has also affected a proposal for EU collaboration to assess how effective new medicines and health technologies are relative to existing ones, something which helps member states negotiate prices. Drug companies promote the use of ‘new’ drugs because they still have patent protection, and are therefore more expensive, over old ones that don't, even if the new product is not an improvement in medical terms.

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.)

Canada's CCPA's (progressive NGO) submission on the USMCA (new NAFTA)

CCPA recommendations for a better North American trade model The all-party House of Commons trade committee is consulting Canadians on their priorities for bilateral and trilateral North American trade in light of the current renegotiation of NAFTA. In the CCPA’s submission to this process, Scott Sinclair, Stuart Trew, and Hadrian Mertins-Kirkwood argue for a different kind of trading relationship that is inclusive, transformative, and forward-looking—focused on today’s real challenges, including climate change, the changing nature of work, stagnant welfare gains, and unacceptable levels of inequality in all three North American countries. The CCPA submission largely repeats advice given to Global Affairs Canada during the department’s consultation on the NAFTA renegotiations, but is updated to take into account some of the proposals put forward by Canada and the U.S. during the first three rounds of talks.

Celebrating Fair Trade in Cancun

This PDF flyer from 2003 was published by IATP and distributed during the WTO Ministerial in Cancun, Mexico. In just a few words it does a good job of explaing some key concepts about the WTO. It also introduces for beginners some of the core concepts of the concept of Fair Trade, a non-exploitative alternative to market totalitarianism.

GATS: Increasing LDC participation through negotiated specific commitments (Art. IV:1) (United Nations)

This is about public procurement of both goods and services by governments at the federal, and increasingly, state or local level. One of the goals of the WTO Government Procuerment Agreement, as well as the GATS is allegedly to assist the poorest countries businesses by bending the rules for a limited time in their favor. Normally, in the case of jobs, the *lowest* bidder (who may not necessarily be a firm from the very poorest countries, it may instead be a highly automated firm or one from another low wage country, but not one of the poorest ones.) gets a legal entitlement to perform work. However under some limited circumstances, LDCs' firms (firms based in the very poorest countries) may be able to bid for contracts and win even if their price is a bit higher than the lowest bidders. (this is called a "set aside" in the US, where they had traditionally been used to funnel work to women and minority owned businesses. These kinds of set asides seem to be subsumed by the newer kind in trade agreements.) Note these dispensations like this LDC Services Waiver which gives the poorest countries opportunities to perform work in the wealthier countries, even if they charge a bit more are only available under limited circumstances and only to the (very poorest) "LDC" countries in order to assist in the policy goal of helping their firms enter the world's markets faster. Similar rules apply to allow the poorest countries access to life saving medicines in medical emergencies.

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.]"

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.