BRUSSELS - As negotiations on a European Union (EU)-India free trade agreement (FTA) resume in Brussels today, the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) is calling on Europe’s highest trade official to halt actions that will dramatically restrict access to affordable generic medicines produced in India. 

“European Trade Commissioner Karel De Gucht is attempting to give Europe’s pharmaceutical industry a backdoor to monopolies that lead to high drug prices and will keep pills out of reach of patients,” said Dr. Tido von Schoen-Angerer, director of MSF’s Campaign for Access to Essential Medicines. “India has a patents law that is strict about what does and what doesn’t deserve a patent, but Europe is using dirty legal tricks to get around this law and block cheaper generic medicines.”

Europe is pushing ‘data exclusivity’ policies that would hamper generic competition for up to ten years. These would block the standard practice—recommended by the World Health Organization—of generic makers using existing studies on identical products to get their medicines approved for sale.  For example, in 2008 India rejected a patent on nevirapine syrup, an AIDS medicine for children, which meant generic producers could produce and sell more affordable versions of the syrup.  If data exclusivity had been in place in India, as the EU now wants, producers would have had to wait up to ten years before selling the drug, even though it did not deserve a patent in the first place. 

“Our medical programs depend on a constant supply of affordable medicines,” said Ariane Bauernfeind, operational coordinator for MSF projects in South Africa, Malawi, Lesotho, and Zimbabwe. “For people with HIV/AIDS who need medicines to stay alive, a ten-year wait to get a newer drug is not viable. They’ll die waiting. Half of all children born with HIV/AIDS won’t make it to their second birthday without treatment.  We can’t let the EU shut down our supply of affordable newer medicines.”

Trade Commissioner Karel De Gucht is also pursuing policies harmful to access to medicines through ACTA, the Anti-Counterfeiting Trade Agreement that has been negotiated in secret.  The deal claims to be an effort to protect consumers from fake medicines, but it will inhibit the production of legitimate, affordable, and safe medicines by giving companies far reaching powers to block competitors’ products.

“The EU has been far less than truthful in response to our concerns, “said von Schoen-Angerer, as MSF delivered an open letter to the Trade Commissioner. “The devil is in the details, and we demand Trade Commissioner De Gucht quit the spin that hides the health impact his policies will have for people across the developing world. People whose lives depend on Indian generics have taken to the streets in Delhi, Bangkok, Jakarta, and Kathmandu, amplifying the message that EU Trade Commissioner De Gucht needs to back off.” 

India has been called the ‘pharmacy of the developing world,’ because it produces affordable versions of medicines that are the cornerstone of treatment programs everywhere. MSF sources more than 80 percent of the medicines it uses to treat more than 160,000 people with HIV/AIDS, from producers in India. A recent study in the Journal of the International AIDS Society, found that more than 80 percent of all donor-funded HIV medicine purchases for developing countries from 2003-2008 were for generic drugs from India. 

Until 2005, India country did not grant patents on medicines.  Since 2005, WTO rules have required India to start granting such patents and a number of newer HIV drugs are already patented, raising serious concerns about their affordability. Fortunately, for access to medicines, the Indian patent law reserves patents only for drugs that show a therapeutic benefit over existing ones. But the EU intends to override India’s public health safeguards and the right of the country to balance patents and public health concerns.