India has promised not to link a proposed trade deal with the European Union to any limits on making generic AIDS drugs, according to a joint statement from India's Commerce Minister Anand Sharma and the Joint United Nations Programme on HIV/AIDS. The declaration came in response to growing criticism that pharma was pushing provisions in trade talks that would limit the availability of AIDS meds.
The EU and India began talks in 2007 on a free-trade agreement that would be worth an estimated $134 billion in commerce. But a report last year in the Journal of the International AIDS Society suggested provisions could raise prices delay access to improved meds, and recommended that “inappropriate” trade deals should not be pursued unless new policies are created (see here).
A key point of dispute is between multi-national drugmakers wants greater protection for intellectual property rights, and generic drugmakers, notably those in India. The current EU-India trade deal includes proposals that could delay or restrict competition from generic drugmakers by extending patent and requiring data exclusivity.
In a meeting this week with UNAIDS executive director Michel Sidibe, Sharma vowed that India will reject a trade deal that includes data exclusivity clauses - which refers to protection of clinical trial data - and he added that the government would also be willing to use compulsory licensing, if necessary, to ensure that people with HIV and AIDS have access to generic meds.
“Millions of people will die if India cannot produce generic antiretroviral drugs, and Africa will be the most affected. For me, it is an issue of life or death," Sharma said. "Tthe government of India reaffirms its full commitment to ensure that quality generic medicines, including anti-retroviral drugs, are seamlessly available, and to make them available to all countries."
India’s pharmaceutical industry produces more than 85 percent of the first-line HIV meds and the cost of the least expensive, first-generation treatment regimen has dropped to less than $86 per patient per year, according to UNAIDS. However, the agency frets that prices could rise as more people gravitate towards more effective and tolerable first-line treatments.
An estimated 15 million people are eligible for antiretroviral treatment in low- and middle-income countries, and about 6.6 million people have access to HIV treatment. “India, together with Brazil, South Africa, China and Russia, must forge an alliance with other high-income countries to ensure that no single person in the world dies because they could not afford to buy life-saving medicines or health care,” Sidibe said in a statement.