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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.

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.

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.”

Foreign Free Riders and the High Price of US Medicines

We can find no evidence to support the widely believed claims from industry that lower prices in other industrialised countries do not allow companies to recover their R&D costs; so they have to charge Americans more to make up the difference and pay for these "foreign free riders." We also explain why the claims themselves contradict the economic nature of the pharmaceutical industry. The latest report from the UK Pharmaceutical Price Regulation Scheme shows that drug companies in the United Kingdom invest more of their revenues from domestic sales in research and development than do companies in the US. Prices in the UK are much lower than those in the US yet profits remain robust. Companies in other countries also manage to recover their research and development costs, maintain high profits, and sell drugs at substantially lower prices than in the US. For example, in Canada the 35 companies that are members of the brand name industry association report that income from domestic sales is, on average, about 10 times greater than research and development costs. They have profits higher than makers of computer equipment and telecommunications carriers despite prices being about 40% lower than in the US.

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.

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.]"

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."

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.