India-EFTA trade deal raises concerns on domestic access of generic drugs

Leaked IP chapter suggests potential hindrance to affordable medicine production

The proposed India-European Free Trade Association (EFTA) trade deal’s recommendations under the leaked chapter on intellectual property (IP) are believed to hamper the production of cheap, life-saving generic medicines from India.

EFTA comprises four nations — Iceland, Switzerland, Norway, and Liechtenstein.

According to the international medical humanitarian organisation Médecins Sans Frontières (MSF), also known as Doctors Without Borders, Public Eye, and the Delhi Network of Positive People (DNP+), the draft IP chapter put out by an international trade portal, bilaterals.org, raises one of the key concerns: the proposal to introduce “data exclusivity”. This would delay the registration of generic versions of new medicines or new formulations for a set period, even when there is no patent on the medicine.

“This would result in generic manufacturers either needing to wait out the exclusivity period or repeat expensive clinical trials. In cases where a new medicine is patented, data exclusivity could block compulsory licences that may be granted to generic manufacturers to produce medicines at lower prices,” according to an official statement released by MSF.

The draft may not be the final one, and negotiations towards finalising the trade deal between both sides are still ongoing.

For over a decade, India has been against the inclusion of data exclusivity provisions in free trade agreements (FTAs) to protect the interests of the domestic generic drug industry.

Through data exclusivity, technical data generated by innovator companies get protection, which prevents their competitors from obtaining cheaper versions of the medicine for a certain period or until the innovator companies have “exclusivity rights”.

According to Loon Gangte, founder, DNP+, for the multinational pharmaceutical industry, data exclusivity will expand their monopolies and profiteering by blocking the availability of generics from India.

“MSF has appealed to the Indian government through a letter to the Prime Minister to continue rightfully rejecting the inclusion of IP provisions in the EFTA negotiations that are harmful to access to affordable medicines from India. If accepted, these IP provisions will have drastic consequences on access to medicines and the health of patients in India and beyond,” Farhat Mantoo, executive director, MSF South Asia, said.

Even in the past, India’s discussions on intellectual property rights (IPR) have been a contentious issue in FTA negotiations with countries such as Japan, the UK, and trade blocs such as the European Union.

India and EFTA nations had launched negotiations on a broad-based trade and investment agreement over 16 years ago. As many as 13 rounds of negotiations were held, after which talks were put on hold end-2013.

Thereafter, talks were resumed in 2016, and four more rounds of negotiations took place. The last round of negotiation took place from January 8-13 in New Delhi, which saw discussions on trade in goods and services, rules of origin, IPR, sustainable development, investment promotion, and trade facilitation.

“The third round of goods offer and the second round of services offer have been exchanged,” the Department of Commerce had said last month.