Use of TRIPS flexibilities, including compulsory licensing and rejection of data exclusivity clauses, in trade agreements by India to ensure sustained access to life-saving medicines for people living with HIV
NEW DELHI/GENEVA, 6 July 2011--UNAIDS welcomes the assurance given by India's Commerce Minister, Mr Anand Sharma, that India will reject any efforts to include 'data exclusivity' clauses in bilateral trade agreements. This assurance came at a meeting between Mr Sharma and UNAIDS Executive Director Michel Sidibe, held today at the Ministry of Commerce and Industry. "We reject data exclusivity clauses in free trade agreements," said Mr Sharma. Welcoming the Minister's assurance, Mr Sidibe said:
"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."
India's pharmaceutical industry produces more than 85% of the first-line antiretroviral drugs used to treat people living with HIV. The cost of the least expensive first generation treatment regimen has dropped to less than US$ 86 per patient per year. But as increasing numbers of people move towards more efficacious and tolerable first-line treatment, drug prices could double compared to first-generation regimens. In addition, as patients develop drug resistance and require more expensive and patent-protected second- and third-line antiretroviral medicines, some projections indicate treatment costs escalating by as much as twenty-fold. "The Government of India reaffirms its full commitment to ensure that quality generic medicines, including antiretroviral drugs, are seamlessly available, and to make them available to all countries," said Mr Sharma. "India will also use the flexibilities allowed under TRIPS, including the use of compulsory licensing, to ensure that people living with HIV have access to all life-saving medicines," Mr Sharma added. "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," Mr Sidibe said.
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. The Government of India provides free antiretroviral treatment to more than 420 000 people living with HIV in India.
Current treatment approaches are not sufficient to provide access to all who need it. UNAIDS and other partners advocate for Treatment 2.0--a framework that seeks to simplify the way treatment is currently provided. For this approach to succeed, TRIPS flexibilities as well as innovation and protection of intellectual property rights will play an important role for treatment access in the future.
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