New Indian patent law could threaten ARV access

A piece of legislation currently under consideration in India's parliament has unleashed a flurry of protest all over the African continent. For the past month a worldwide storm has been brewing among AIDS activists, who have expressed outrage at amendments in India's patent laws that will prohibit the production of cheaper, generic versions of patented drugs, including antiretrovirals (ARVs). As one of the largest producers of generic medicines, two-thirds of which are exported to developing countries, India has played a crucial part in supplying affordable ARVs to African countries rolling out national treatment programmes. The country's generic drug industry is also the only supplier of three-in-one fixed-dose combination drugs, which are easier to use and adhere to. Protestors in Kenya, Tanzania and Uganda marched to the Indian High Commissions in their countries this weekend to express their concern. Petitions have also been flowing fast and furiously among West African activists. Dr Nafis Sadik, the UN Special Envoy for HIV/AIDS in Asia and the Pacific, and Stephen Lewis, the UN Special Envoy for HIV/AIDS in Africa, also waded into the debate by sending a joint letter calling for continued access to generic drugs to the Indian government. "People Living With AIDS stand poised between life and death. The Parliament of India can make it possible for millions of people to embrace life," part of the letter read. In Kenya, "about 80 percent of all ARVs that we have available come from India ... our lives are at risk" James Kamau, steering committee member of the Pan African Treatment Access Movement (PATAM), told PlusNews. "The protests we had were to inform people about this patent issue, and what it means for us as people who are living with HIV/AIDS," he added. A recent statement by the international NGO, Medecins Sans Frontieres (MSF), pointed out that that half the 700,000 people receiving ARV medication in developing countries relied on drugs manufactured by the Indian generic industry. Consequently, the proposed amendments "will drastically restrict, perhaps even prevent, the production and supply of vital therapies by Indian pharmaceutical companies to other developing countries," it said. As a member of the World Trade Organisation (WTO), India "has to amend its patent laws to bring it in line with the TRIPS [Trade Related Aspects of Intellectual Property Rights] agreement," Jonathan Berger of South Africa's AIDS Law Project pointed out to PlusNews. Nevertheless, India had proposed unnecessary measures, with "greater patent protection than what it is required to do under the WTO agreement". "We are not opposed to [India] complying with its WTO obligations, but we have to question their motives, and whose interests they are advancing ... the bottom line is that India does not need to do all that it is currently doing," he commented. According to Berger, India had failed to take "full advantage" of key opportunities in the WTO rules, which allowed poorer countries to access cheaper medication. However, the impact of the new patent laws might not be immediate, as older generic combinations, developed before 1995 and often used as the 'first line' of ARV therapy, would not be affected. In South Africa, for example, Indian drug firm Cipla would still be able to provide Stavudine, a generic drug, to the national treatment programme. But Berger warned this meant that "as people need access to newer drugs, the competition will have dwindled - we may never see the drugs being made more [affordable]". "The first line will remain cheap, but when I start taking the second line, it will cost me about US $2,000. Where am I going to get that kind of money? How can I continue with treatment?" Kamau said. He noted that the impact of India's move "wouldn't be as strong" if countries with the potential to produce and export [generic ARVs], like Brazil, Thailand, South Africa and China, were able to play a much stronger role".