UNITED NATIONS, Jun 7, 2011 (IPS) – Moves by developed nations such as the United States to tighten intellectual property laws are threatening to limit production and distribution of generic drugs, which experts say have been and will remain key in the prevention and treatment of HIV/AIDS and currently account for 80 percent of HIV/AIDS treatment.
These efforts are taking shape in two spheres. The first is in discussions on the outcome document that member states are expected to adopt by the end of this week’s United Nations High Level Meeting on AIDS.
The second is in bilateral trade negotiations between developed and developing nations.
Generic drugs are essential to treating HIV/AIDS on a global scale because of their low cost and because they drive down the cost of brand name drugs. Additionally, according to recent research, treatment is prevention. Studies have shown that treating patients for HIV reduces the risk of their transmitting the disease by 96 percent.
In negotiations over the outcome document, which outlines priorities and strategies in the global effort to combat HIV/AIDS, some developed countries are seeking to make intellectual property laws stricter by extending patents or limiting other public health-related flexibilities within the international Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. These restrictions are known as TRIPS plus provisions and can inhibit the production of generic drugs.
According to Michelle Childs, director of policy and advocacy with the Campaign for Access to Essential Medicines, Médecins Sans Frontières/ Doctors Without Borders (MSF), the United States, the European Union, and Japan are trying to make laws “even stricter and narrow the opportunities for generic producers to make, to export those drugs”.
However, Christopher Matthews, press officer for the EU delegation to the U.N., told IPS that the EU was not advocating TRIPS plus provisions in the outcome document. “The EU recognises the critical importance of affordable medicines in reducing levels of HIV infections and related deaths,” he said.
Meanwhile, according to the 2010 Global Report of the Joint United Nations Programme on HIV/AIDS (UNAIDS), bilateral and regional trade agreements between low or middle-income countries and high-income countries also pose a threat to the production of generic drugs.
These agreements “impose intellectual property protection that is stricter than necessary” and that may limit developing countries’ abilities to “promote access to affordable HIV medicines,” said the report.
For instance, “The EU is currently negotiating a free trade agreement with India, which is the pharmacy of the developing world,” Childs told IPS. In that agreement, the EU is pushing for clauses that “limit the ability for generics to manufacture”, she added.
This information is not confirmed by the EU. By reducing generic competition, TRIPS plus provisions inherently run counter to efforts to keep drugs affordable, a crucial aspect of ensuring that persons with HIV receive treatment.
“Obviously if you can lower the cost of the drugs, you can treat more people,” said Childs.
“We do not want to see bilateral trade agreements add additional restrictions that won’t allow access to patents for generic drug manufacturers or for low-cost proprietary drugs,” Paul DeLay, deputy executive director of UNAIDS, said in an interview with IPS.
“Generic drugs have been critical to the response,” De Lay added.
Not only is the vast majority of treatment now done with generic drugs, but the price of proprietary drugs has also declined dramatically in response to the competition presented by generic manufacturers.
In 2001, brand name antiretroviral (ARV) drugs used to treat HIV cost over 10,000 dollars per person per year- an prohibitive price for treating large numbers of people in developing countries. Then CIPLA, an Indian pharmaceutical company, began to produce the same cocktail of drugs for a dollar a day, Childs said.
Since then, the cost of ARVs has fallen to one percent of their original price. “Generics competition is a price-busting strategy,” Sharonann Lynch, HIV/AIDS policy advisor for MSF’s Campaign for Access to Essential Medicines, told reporters Monday.
However, “You’ve got member states who are acting out of self- interest, and here I would put the U.S.,” she added. These states are “helping to prop up the pharmaceutical interest by pursuing patent protection in these negotiations.”
“There is no excuse where developed countries would be pushing for TRIPS plus provisions that would greatly curtail developing countries to know the strategies that we know work, which is to foster generic competition,” Lynch added.
UNAIDS has said that reaching a treatment target of 15 million people by 2015 would eliminate seven million unnecessary deaths and 12 million new infections by 2020.
This treatment target is still being debated in outcome document negotiations, but the challenge of reaching it will undoubtedly be magnified if drug costs increase.
Besides intellectual property rights and treatment target levels, funding is another hotly debated topic that is left to be resolved by the end of the High Level Meeting. UNAIDS has said six billion dollars per year is needed to reach the 15 million treatment target by 2015. Global HIV/AIDS funding has been declining since 2009.
So although intellectual property rights, and accordingly, generic drugs, remain “a contentious area” in the negotiations, government “squabbling” has not been limited to this topic, said Lynch.
And the non-material cost of these high-level arguments? “People living with HIV are being lost in the shuffle,” Lynch concluded.