A draft free trade agreement between the European Union (EU) and India could deprive millions of people in the developing world of life-saving and life-prolonging medicines, particularly the HIV-infected, an independent United Nations human rights expert warned today, calling for its urgent revision.
“The EU-India draft FTA, as it stands, places trade interests over human rights,” UN Special Rapporteur on the right to health Anand Grover said in a news release.
“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.”
He notes that India can now provide low-cost generic medicines thanks to its intellectual property laws that allow for local generic production of safe and efficacious medicines, but available leaked texts of the draft FTA contain intellectual property provisions that go beyond current obligations.
“If the intellectual property provisions remain in the FTA as drafted, the production of generic medicines in India will be severely hampered,” Mr. Grover said. “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.”
Among provisions jeopardizing medicine supplies, he cited data exclusivity, which prevents a country’s drug regulatory authority 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.
The draft also calls for stronger intellectual property enforcement 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.
Furthermore, the draft contains ‘investment provisions’ that would effectively result in a State’s having to pay compensation for expropriation of property, where it has used such legal steps as compulsory licensing. Such provisions would obviously deter a State from using increasing access to medicines.
The UN Committee on Economic, Cultural, and Social Rights stresses 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 on the right to health.
Mr. Grover, who reports to the Geneva-based UN Human Rights Council, said the draft therefore may not be in compliance with this stipulation and other international instruments on the right to health.
“Provisions pertaining to intellectual property in the draft FTA should be urgently reconsidered,” he urged.