- From Marrakech to Doha: Some Reflections on the Foundations of Patent Regime in Pharmaceutical Industry (MoOrG1035a)
Authored by F. Orsi, B. Coriat, O. Weinstein
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Today we were provided with a crash course in patent law (something far removed from my area of expertise). But in the HIV field you really never know what you are going to have to learn about, and that is one of the things that makes this whole area interesting.
The session was devoted to how patent law works, the impact it has on the delivery of antiretroviral drugs, the different models that the developing world is using to buy antiretrovirals and last, but not least, the implications of all these factors on the final cost of the drug -- both for the different countries in the developing world and individuals with HIV infection.
Patents exist to provide incentive to innovate, but there are risks when a society overprotects this right, as we all know with the Microsoft problem. The main risk is that we tend to create monopolies or oligopolies. So patent laws have to provide some balance to avoid becoming anti-competitive and prevent innovation, which is exactly the opposite of what these laws are suppose to protect.
For many years drugs were considered different than other services and goods and not really protected under patent laws. They were considered "basic needs," so governments tended not to regulate them very much. Since a recent conference in Marrakech, which was probably important since the economists were talking about it in the "you know what I am talking about" tone, drugs have become commodities, and the developing world has been forced to comply with the rules of the developed world, thanks to the World Trade Organization (WTO) rulings.
The TRIPs agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) requires member countries to amend their patent laws to ensure the incorporation of minimal patent protection. According to their status and their use of transitional periods, developing countries have been engaged in making these amendments to their laws.
The experts agree that there is space within the text of the agreement which, if exploited fully but responsibly, can help countries safeguard the public good on issues of availability of essential drugs, provisions of compulsory licensing, and parallel imports. Other people disagree vigorously.
The following paragraphs are taken directly from a U.S. press release a couple of weeks ago:
"Recently the United States announced a framework that would allow poor countries unable to produce pharmaceuticals to gain greater access to drugs needed to combat HIV/AIDS, malaria and other public health crisis. This framework would permit a mechanism for easing World Trade Organization (WTO) rules regarding production of these vital medicines. This initiative is part of the Administration's global effort to address the serious health problems, such as HIV/AIDS, afflicting African and other poor developing countries.
"These proposals continue the U.S. leadership provided last fall at the WTO Ministerial in Doha, Qatar, where WTO members developed a landmark political declaration on public health and international trade rules (Trade Related Intellectual Property Rights or TRIPS). This declaration affirmed the ability of countries to use the flexibilities in TRIPS to access disease-fighting drugs. It also recognized that some developing countries have insufficient capacity to manufacture pharmaceuticals to address their health crises."
After partially explaining all this, the presenter described the situation in Brazil, and how this developing country has managed to provide up-to-date HIV treatment in a public health system and even survive economically to talk about it.
Patent laws were not introduced in Brazil until 1996, so medications commercialized before that date were not covered by the new rules. This allowed Brazil to "use" the patents, synthesize drugs in their local labs and develop a system that provides drugs at very reasonable prices. Brazil also negotiates directly with the drug companies and some companies that manufacture generic drugs.
Another speaker showed us that countries with "mixed" models -- like Brazil -- are the ones that in the end pay less for the cost of antiretroviral drugs, and that should be a goal for other governments.
However, the situation is more uncertain in some countries in Asia, like India and China where the regulations will start in 2005, and theoretically they will not be able to make generics of the new antiretroviral drugs, which could lead to dramatic increases in costs.
At the end of the session, we knew a little bit more about economics and its complexities and how they affect antiretroviral therapy.