EU-India Draft Free Trade Agreement: Generic medications under threat, says UN health expert

GENEVA (10 December 2010) – The United Nations Special Rapporteur on the right to health, Mr. Anand Grover, warned that the EU-India draft free trade agreement could prevent millions of people gaining access to necessary, life-saving and life-prolonging medicines. India is currently the largest supplier of generic medicines to the developing world, but the free trade agreement (FTA) under negotiation between India and the European Union threatens the production of generic medicines.

“Millions in the developing world depend on India for generic medicines at affordable costs. Restriction of generic drug production in India will have a devastating public health impact around the world and adversely affect the right to health of millions of patients.

India’s ability to provide low-cost generic medicines is predominately due to its intellectual property laws—specifically, pre-TRIPS (Trade-related aspects of Intellectual Property Rights) and presently TRIPS-compliant patent law—which allow for local generic production of safe and efficacious medicines. However, some aspects of the FTA currently in negotiation between India and the European Union threaten this system.

Available leaked texts of the European Union–India draft FTA contain provisions to protect and enforce intellectual property, which are beyond countries’ obligations under TRIPS. If the intellectual property provisions remain in the FTA as drafted, the production of generic medicines in India will be severely hampered. As a result, millions of people in India and around the world may not be able to access to necessary, life-saving and life-prolonging medicines. People living with HIV would be disproportionately affected, because the majority of antiretroviral treatments used to treat HIV around the world are provided through generic medicines produced in India.

FTA provisions threatening the right to health
Among the provisions which jeopardize medication supplies, data exclusivity provisions in the draft FTA are particularly concerning. Data exclusivity provisions prevent the drug regulatory authority of countries from relying on test data submitted by a first entrant to approve subsequent generic versions of the medicine for a specified time. The introduction of data exclusivity has been shown to delay and restrict market entry of generic medicines and, as a result, increase prices and reduce access to medicines.

Alongside this, the draft FTA calls for stronger intellectual property enforcement provisions and border control measures. Border seizures of non-infringing goods in Europe over the past few years have demonstrated how such provisions have delayed access to medicines for patients in other developing countries.

The draft FTA also contains ‘investment provisions’ that would effectively result in States having to pay compensation for expropriation of property, where the State has made use of legal ‘TRIPS-flexibilities,’ such as compulsory licensing. Such provisions would obviously deter a State from using TRIPS-flexibilities to increase access to medicines.

The right to health
Though this agreement has taken shape over the course of many years, the process has suffered from lack of transparency and lack of consultation and participation. At no point has either party voluntarily opened negotiations to the public, or made available official draft texts for comment. This ignores the rights to information and to participation in the conduct of public affairs, which are essential dimensions of the right to health, as well as self-standing rights.

The United Nations Committee on Economic, Cultural, and Social Rights has also noted that State parties must respect the enjoyment of the right to health in other countries, and take steps to ensure that international agreements do not infringe or adversely impact upon the right to health.

The EU-India draft FTA, as it stands, places trade interests over human rights and, in effect, may not be in compliance with the International Covenant on Economic, Social and Cultural Rights and other international instruments concerning the right to health. Provisions pertaining to intellectual property in the draft FTA should be urgently reconsidered.”

Anand Grover was appointed the Special Rapporteur on the right to everyone to the enjoyment of the highest attainable standard of physical and mental health in August 2008 by the United Nations Human Rights Council. He is independent from any government or organization.

Learn more about the mandate and work of the Special Rapporteur: http://www2.ohchr.org/english/issues/health/right/

For more information and press inquiries, please contact: Yoonie Kim (Tel: +41 22 917 96 43 / email: srhealth@ohchr.org)