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.”

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."

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."

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.

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.

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.

"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

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.

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.