Benjamin Blasco Anna Ferretti Sophie Venet BIO615 Fall 2009

Between 1975 and 2004, 1,556 new chemical entities were marketed globally Only 20 of these –1.3 % – were for tropical diseases and tuberculosis, which account for 12 % of the total disease burden. Of the 1,035 new drugs approved by the US Federal Drug Administration between 1989 and 2000, more than three quarters are classed as having no therapeutic benefit over existing products. Medical innovation is steered towards drugs that give commercial rewards, not the greatest therapeutic benefits from:

Today pharmaceutical companies recoupe their R&D costs through charging high prices (  patent protection needed) What happens to the countries that cannot afford to pay?

 Patents on AIDS drugs had expired or were not in effect when, in 1994, a Brazilian public lab began producing medicine to combat the disease.  Even after a 1996 law was passed that recognized pharmaceutical patents, the country was able to continue manufacturing many key AIDS drugs  Article 71 of the 1997 Brazilian patent law requires that foreign products be manufactured in Brazil within three years of receiving a patent. If a foreign company does not comply, Brazil may authorize a local company to produce the drug without the consent of the patent holder,  A 1999 presidential decree given by Brazil's President Fernando Enrique Cardoso declared a national emergency in regards to the AIDS epidemic amongst its citizens. The decree allows for local Brazilian manufacture of foreign patented medicines by a government granted license, but only for cases of national emergency.

 In early 2001, the U.S., pushed by domestic pharmaceutical lobbies filed a complaint with the World Trade Organization saying Brazil had violated the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation.

people on antiretroviral drugs in 2001 Cannot sustain its annual budget of US$303 million to fight AIDS. Local manufacture of foreign patented AIDS medicines decreased the anti-AIDS program cost by more than 70%.

 Debate extends well beyond the production of patented AIDS medicines. Brazil's presidential decree uses the 1997 patent law to create an advantage for Brazilian products over imported products → PROTECTIONISM!!?

Brazilian Government US / Big Pharma WTO Actions / Reactions / Issues

 Is the right to life a powerful enough human rights issue to be able to violate drug patent laws?

 How drug companies could be given incentives to innovate, while allowing poor countries access to desperately needed drugs????

 How can a third-world government put health before trade when considering political and economical pressures???

US/Big Pharmas: – Black list, trade pressure, economic sanctions – Don’t commercialize newer drugs in Brazil Brazilian government: – Compulsory license International organizations: – Arbitration role – April 2001: U.N. Human Rights Commission resolution for equal access for all persons to preventive, curative or palliative pharmaceutical or medical technologies used to treat pandemics such as HIV/AIDS. Not approved by US…

A country can make or import a generic version of a patented drug if it’s of public health necessity.  1 st case in 2006: Thailand with efavirenz (Merck’s drug)  Followed by Brazil (May 2007)

Patent Protection AcceptRefuse Patent owner can prevent other companies from using its technology If they… Several Companies produce drug and give a fair retribution to the patent owner Patent owner only produces drug Competition Drug prices decrease Monopoly Drug price maintained high

OUTCOME Brazilian Case

WTO clarified the TRIPS which allows nations to copy patented material such as medicine in the event of « a national emergency or other circumstances of extreme urgency » Decision: « Each (WTO) member has the right to determine what constitutes a national emergency » being understood public health crisis like HIV, Malaria, Tuberculosis (…) can be a public emergency Reaction: companies argued it did not change the original agreement / Brazil said wording gives them more flexibility

Question: What about developing countries not being able to produce medicines themselves? Solution: Allow developing nations to import cheap, generic drugs Outcome: Although accepted by 143 countries, proposal blocked by Washington Reason: concerns about agreement being extended to non infectious deseases like cancer

Brazil offers to share its expertise in manufacturing and distributing AIDS drugs with developing countries

South Africa CASE WITHDRWAN FOLLOWING PUBLIC OUTRAGE 39 Western Pharma sued the government to question the constitutionality of compulsory licensing measures

India Novartis attacks Indian patent law threatening future of access to affordable medicines Pharma extend their patent terms by making small, trivial changes to existing medicines and thereby preventing access to generic affordable drugs. Indian patent law states patents will not be granted for new uses or new forms of existing medicines unlesss a significant increase in efficacy can be demonstrated CASE LOST

Doctors Without Borders Call on nine of the world's largest Pharma to help accelerate the availability of new treatments for millions of people living with HIV/AIDS A patent pool is a mechanism whereby a number of patents held by different parties are brought together and are made available to others for production or further development. The patent holders receive royalties paid by those using the patents. CREATE A PATENT POOL