New EU-India Trade Agreement Threatens Generic HIV/AIDS Medicine Supply

Access to life-saving, low-cost generic medicines is critical to HIV/AIDS patients everywhere, but especially in developing countries. Over five million people battling the disease, across Asia, Africa and Latin America, rely on generic drug manufacturers, primarily in India. Indian pharma producers supply 50 percent of the world's AIDS medicines and an amazing 90 percent of the developing world's needs.

That supply chain is now threatened by a new free trade agreement (FTA) being negotiated between the European Union (EU) and India. Changes to intellectual property rules in the agreement, pushed by the EU, may severely limit or delay these Indian companies from continuing their public health mission.

Last week, representatives of Médecins Sans Frontières (Doctors Without Borders), the international medical humanitarian organization, protested along with thousands of people in New Delhi, urging the Indian government to resist pressure from the European Union to accept the new provisions.

“More than 80 percent of the AIDS drugs our medical practitioners use to treat 175,000 people in developing countries are affordable generics from India,” said Paul Cawthorne, of MSF’s Campaign for Access to Essential Medicines. “Beyond AIDS, we rely on producers in India for drugs to treat other illnesses, such as tuberculosis and malaria. We cannot afford to let our patients’ lifeline be cut.”

The provision in question is known as data exclusivity, a post-patent protection meant for the original drug creators and manufacturers as a way to delay production of generic versions of the drug. It blocks generic manufacturers from accessing and using the original patient clinical trial data and forces them to produce their own clinical evidence of efficacy or wait the five to ten years to use the data and gain approval to market the generic equivalent.

“Data exclusivity has proven to be damaging to public health in free trade agreements in other countries,” said Anand Grover, the UN Special Rapporteur on the Right to Health. “It would be a colossal mistake to introduce data exclusivity in India, when millions of people across the globe depend on the country as the ‘pharmacy of the developing world’.”

European drug giants have been pressuring the EU to grant these protections, despite the pleas from public health officials and advocates. “India’s law has long annoyed multinational pharmaceutical companies, and Novartis and Bayer have even tried to overturn the law in the Indian courts,” said Loon Gangte, of the Delhi Network of Positive People. “They have failed so far, but companies have now convinced European governments to take up their fight for pharmaceutical profits.”

While government officials have denied that the new provisions in the FTA would change India's ability to produce cheap and effective medicines, they also have not been willing to release any of the draft documents currently being discussed. This worries global health support groups, such as UNITAID.

"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. India and the European Union must do the responsible thing and ensure a balance between the creation of wealth and the saving of lives."

Photo credit: Jorge Fusaro