Though we are only at the earliest stage of the establishment of patent monopolies over genes, cell lines, and even organisms, the current struggle over access to AIDS drugs is a harbinger of problems ahead. AIDS drug costs are a clear example of the use of patent monopolies to drive up the price of therapy.
The role of drug patents in preventing access to effective drugs came into public view in the recent South African and Brazilian struggles. The South African government, reacting to the monopoly pricing of AIDS drugs, threatened to weaken some patent constraints on access to AIDS medicines in view of the fact that almost four million South Africans are infected by HIV. Their actual proposal was, in fact, quite mild: to be able to re-import commercial AIDS drugs from other countries, where, for marketing reasons, the drug industry has priced them lower than in South Africa. (The government has the legal right to do this under the TRIPs––Trade Related Intellectual Property––provision of the WTO.)
The 41 members of the South African Pharmaceutical Manufacturers Association (PMA), including all the major multi-national drug firms, instituted legal action against the South African Ministry of Health’s decision.
All of the drugs developed to combat AIDS by American and multinational pharmaceutical companies are protected by multiple patent filings. These companies aggressively defend their patents in the courts to insure monopoly control over production and distribution of the patented drugs. The patent monopolies are used to prevent competition, in particular, production of more efficacious drugs at lower cost, and are key to the pharmaceutical industry being the most profitable sector of US business.
However, as a result of direct social action in South Africa, the PMA had to back down from its challenge. Thousands of protesters, led by people with AIDS, trade unionists, and leaders of the Anglican and Catholic Churches, demonstrated against the PMA in Pretoria in March 2001. The second stop on their march was the US Embassy. The Coalition of South African Trade Unions stated, "The drug companies’ patents cannot be allowed to hold at ransom the health of our nation."
AIDS support groups around the world backed the South African marchers. The French group Médicins Sans Frontières organized a global petition drive against the PMA's suit. A group in New Haven, Connecticut, led by unionized graduate students and employees, and including one of the AIDS drugs patent holders, called upon the NIH to set aside patent rights held by the NIH. Jamie Love of the Nader-sponsored Consumer Project on Technology was very active in Washington, DC. ACT-UP and other AIDS activists held a rally in New York in June 2001, protesting, in particular, USAID’s Andrew Natsios' critique of donating money for low-cost drugs.
A second front in South Africa was opened by the Indian company Cipla, Ltd, which offered to supply South Africa with low-cost AIDS cocktails, at around $350 per person per year, as opposed to GlaxoSmithKline's price in the US of $10,000 per person per year. This triggered a wave of criticism from the PMA, but also has forced pharmaceutical companies to lower their prices somewhat, and to call for additional national and UN donations of funds for the purchase of drugs.
The majority of AIDS drugs are directed against an enzyme, which the virus-infected cells synthesize. The HIV enzyme, needed for the formation of new viral particles, is a protease, which cuts and trims the other proteins needed to assemble the virus particles. The drugs are small organic molecules, which inhibit the protease, often by resembling their targets. The basic knowledge to design such inhibitors came from publicly funded research in universities and medical schools. Though pharmaceutical industries have considerable expertise in the design, production, and testing of such drugs, this capability exists in many centers and nations around the globe.
The Brazilian health ministry has developed a sophisticated understanding of international drug monopolies and has a homegrown pharmaceutical industry. In response to Brazil's plan to provide AIDS drugs free of charge to their needy, the US has taken Brazil to the World Trade Organization, charging that free distribution of drugs to people with AIDS discriminates against US commercial activity (despite the TRIPs provision). This crass action represented only the financial interests of US-based pharmaceutical manufacturers.
Until now, the thousands of gene patents that have been issued to companies over the last decade have mostly been major barriers to increased biomedical research. However, in years to come, some of the information derived from genes and genomes could become useful in the design of therapies. In the US, the CRG’s No Patents on Life Working Group, together with the Institute for Agriculture and Trade Policy and other groups concerned about gene patents are working to develop model legislation that excludes genes, cell lines, and other components of living organisms from the patent system. It will be important that those of us who appreciate the scope of the negative consequences of gene patents join up with those who are struggling for access to health care, medical treatment, and effective therapeutics. This will be one of themes discussed on November 3, 2001, at the CRG’s Annual Conference, at which GeneWatch readers are welcome.
Jonathan King is Professor of Molecular Biology at the Massachusetts Institute of Technology and was a coauthor of the No Patents on Life proclamation originally issued at Blue Mountain, NY