Ten million people need AIDS treatment today. In the midst of civil society protests across the world this and next week, UNITAID stresses its concern that ongoing trade negotiations between the European Union and India may limit India’s ability to continue to provide life-saving treatments to developing countries.
Of particular concern are signals that the negotiations may lead to the introduction of measures that go beyond the TRIPS agreement – such as ‘data exclusivity’ – a condition known as TRIPS Plus.
“Negotiating on cars, machinery and other goods may be very well,” said Philippe Douste-Blazy, Chair of the UNITAID Executive Board. “But life-saving medicines are not commodities like any other. We need to promote the right policy environment to ensure that trade interests do not hamper health and human development.”
According to UNAIDS estimates, 10 million people who need AIDS treatment today are not accessing it and that number is slated to grow exponentially. These people will require newer, more robust medicines, whose patent life may last for another 15-20 years. But even for medicines off patent, the introduction of ‘data exclusivity’ will mean that generic producers will not be able to access vital information about registration and clinical trials for as long as ‘data exclusivity’ is in force.
“If the Free Trade Agreement introduces TRIPS Plus measures many of the people on medicines today will not be able to access vital second-line treatment when they become resistant to the medicines they are taking now,” said Jorge Bermudez, Executive Secretary of UNITAID.
India has been dubbed the developing world’s pharmacy because for over ten years it has provided affordable medicines to developing countries, particularly for the treatment of AIDS. According to a study led by Brenda Waning, UNITAID’s Coordinator of Market Dynamics – A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries – Indian-produced generic antiretrovirals (ARVs) have accounted for more than 80% of the donor-funded developing country market since 2006, and comprised 87% of ARV purchase volumes in 2008. In the paediatric AIDS area, Indian-produced generics accounted for 91% of the whole volume in 2008.
Already today, in the pre-EU-India FTA era, there are concerns around the price of new World Health Organization-recommended first-line regimens. As of 2008, the Indian generic global median price for newly recommended tenofovir-based regimens ranged from $246 to $309 per person per year, notably three to four times higher than the price of the most commonly used older regimen (3TC/NVP/d4T30). However, identical regimens, comprised of non-Indian generic and innovator ARVs, are considerably more expensive than the Indian generic versions.
“Treating and stemming AIDS and other diseases ravaging the developing world is a global issue,” added Philippe Douste-Blazy. “India and the European Union must do the responsible thing and ensure a balance between the creation of wealth and the saving of lives.”
UNITAID uses innovative financing (mostly from a solidarity levy imposed on airline tickets in a number of its donor countries) to purchase and distribute medicines and other health commodities to test and treat AIDS, TB and malaria in 94 developing countries.
The vast majority of medicines purchased with UNITAID funds are Indian generic products. These products are quality-assured (prequalified by WHO or by other stringent regulatory authorities) and because they are produced generically, are less expensive, thus allowing UNITAID funds to treat more people for the same outlay.
UNITAID has successfully promoted the emergence of a competitive generic market for second-line antiretroviral medicines, such as lopinavir/ritonavir. Thanks to UNITAID intervention, this crucial component of second-line regimens is now provided by five generic manufacturers at the competitive price of US$ 420-440 per person per year. These gains are at risk of being reversed if strict data exclusivity conditions are applied through this FTA.