India Says 'No' to Policy That Would Block Access to Affordable Medicines

Focus Shifts to Remaining Harmful Provisions in EU-India Trade Deal

NEW DELHI/BRUSSELS, June 22, 2011–At the United Nations High Level Meeting on HIV and AIDS in early June, India announced that it will not accept data exclusivity, a provision harmful to access to affordable medicines, as part of a free trade agreement (FTA) currently being negotiated with the European Union (EU).  Although this is an important victory for the global mobilization against the potential negative impact of the FTA on access to medicines, further harmful measures remain on the negotiating table, the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) said today.

“MSF and other treatment providers depend on a sustainable flow of affordable generics from India to treat people across the developing world,” said Dr Tido von Schoen-Angerer, executive director of MSF’s Campaign for Access to Essential Medicines. “Saying ‘no’ to data exclusivity will reach far beyond India’s borders in terms of ensuring access to affordable medicines in developing countries. This is a big victory, but we’re not letting up until we see all the potentially harmful policies off the table.”

By delaying the registration of generic versions of a medicine by up to ten years, data exclusivity would effectively have given a backdoor monopoly status to companies, even for drugs that do not deserve a patent under India’s law. The clause, which was criticized by global health actors, including the Global Fund, WHO, UNAIDS, and UNITAID, threatened to further limit price-busting generic competition in India.  Such competition has reduced the price of HIV medicines by 99 percent over the last ten years.

The announcement by India at the AIDS Summit now means both the EU and India have officially confirmed that data exclusivity will not be part of the FTA text. MSF is now calling on Europe to remove other harmful clauses from the EU-India FTA negotiations.

“Europe is still pushing provisions on the enforcement of intellectual property that are of great concern for procurers and suppliers of medicines, like MSF, as they put us at risk of litigation or court orders that prevent us from delivering medicines to patients,” said Michelle Childs, director of policy/advocacy of MSF’s Access Campaign.

By allowing patent holders to target all persons involved in the production, manufacture and delivery of medicines suspected of infringing an intellectual property right, these provisions could draw in treatment providers like MSF into legal proceedings and increase the risk of medicines being seized at Indian borders.

A second area of concern is the investment chapter of the FTA which includes measures to protect the commercial interests of foreign companies investing in India. Pharmaceutical companies would have the right to bypass Indian courts and sue the Indian government in secret international arbitration panels that do not balance public health against private profit. This could lead to the Indian government facing long legal battles over millions of dollars in damages if, for example, a drug company sees its patent or trademarks (its ‘investment’) threatened by the actions of the government – even if those actions are lawful means to protect public health.

“At the recent AIDS Summit, governments – including European governments – committed to reaching 15 million people with HIV treatment by 2015,” said Michelle Childs. “Yet at the very same time, Europe is also pushing policies that will limit access to low-cost versions of the newer drugs that people need to stay alive. This is unacceptable. The EU must drop the remaining clauses that are harmful to public health.”

In 2010, MSF launched the HANDS OFF campaign to call on the EU to drop the policies harmful to access to medicines being pushed as a part of the EU-India free trade agreement.  MSF sources more than 80% of the HIV medicines it uses to treat more than 170,000 people living with HIV/AIDS from manufacturers of generics in India.

In March 2011, around 4,000 people from across Asia living with HIV/AIDS and other life-threatening diseases marched in the streets of New Delhi to protest the impact the FTA could have on access to affordable medicines.

To read more about MSF’s HANDS OFF campaign, visit