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AIDS Treatment Revolution: Expand Generic Competition

Today, on World AIDS Day, President Barack Obama spoke of an “AIDS-free generation.” It’s an audacious and wonderful goal, aiming to build on the decade-long revolution in treatment for people living with HIV/AIDS in developing countries. Dramatically lowered prices for AIDS drugs driven by generic competition have enabled that revolution, which has already saved the lives of millions. President Obama agrees that “treatment is also prevention.” New science suggests that treatment can reduce the risk of transmission by 96 percent.

Unfortunately, patent monopolies and high treatment costs for newer medicines threaten to block the remarkable progress already achieved and impede the goal of “getting to zero.”

To continue the treatment revolution and seek an end to AIDS, we need to expand generic competition.

Case in point: the critical AIDS drug known as Kaletra (lopinavir + ritonavir), sold by the Chicago-based pharmaceutical giant Abbott Laboratories. Abbott’s anti-competitive actions are keeping prices for this important medicine high and limiting the ability of donors and governments to scale up treatment.

Now, a global coalition of health groups is advocating measures to crack down on Abbott’s unjust activities and facilitate competition in the market for Kaletra.

Generic competition has driven down prices for AIDS drugs from more than $10,000 a year per person to less than $100. Yet Abbott prices Kaletra (sometimes known as Aluvia) at $400 in the world’s poorest countries, and much higher — from $1,000 to around $4,000 — in other developing nations.

When it comes to access to essential medicines, price is a life-and-death matter.

As prices for older AIDS drugs have tumbled, treatment has skyrocketed. More than six million people with HIV/AIDS in developing countries are now receiving treatment; very few would be receiving life-saving medicines without the plunge in prices.

As those already receiving treatment develop resistance to older therapies, they increasingly need access to newer medicines, including Abbott’s Kaletra. But in countries around the world, Kaletra breaks the budget of national AIDS programs. Aid dollars – including from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) – are not sufficient to pay for such a high-priced drug and maintain, let alone expand, current treatment levels. Even in middle-income countries, the price forces impossible choices for health departments allocating fixed budgets insufficient to meet all of their public health obligations.

Abbott’s abusive practices involve more than high price. A U.S. federal grant facilitated the invention of one of Kaletra’s essential components, ritonavir. Ritonavir can work as an effective booster with other drugs, but Abbott’s monopolistic policy commonly prevents it from being used to enhance the effectiveness and lower the cost of other medicines. Ending the anti-competitive tie on ritonavir would enable new, improved co-formulations with other AIDS drugs. But Abbott has refused to negotiate licenses with the Medicines Patent Pool (established by the intergovernmental UNITAID), stifling progress for new fixed-dose combination treatments and the production of cheaper generic equivalents.

This World AIDS Day, health groups in a dozen countries are waging an unprecedented global campaign to challenge the giant pharmaceutical company’s political and economic power, free up ritonavir and seek generic competition for Kaletra.

Health groups in Vietnam, Indonesia and the United States are filing license requests with their governments. Compulsory licensing authorizes generic competition for products that remain on patent, in exchange for a royalty payment. It is a legal tool permissible under international trade and national law (and frequently used in the United States). Health organizations in Brazil and India are filing formal challenges to Abbott’s patent claims, arguing that the company has not met national standards for patentability and therefore is not entitled to its patent monopoly. Colombian health advocates await a forthcoming judgment on their lawsuit for a compulsory license, as the government of Ecuador and health advocates in Thailand seek to expand licenses already in effect. Peruvian groups have asked Abbott to abandon new patent applications. Treatment providers in Sint Maarten (Kingdom of the Netherlands) and Malaysia and health groups in China have each filed request letters with Abbott seeking licenses to permit generic competition.  More than 250 Vietnamese groups joined a similar letter to Abbott.

“Acting in concert around the world, we will be better able to fight Abbott’s abuses,” says Luz Marina Umbasia, a lawyer with Colombian treatment groups. Working together we can stand up to Big Pharma, promote competition and expand access to the medicines we need to end AIDS.