Data exclusivity pertains to a clause in the draft agreement that puts a minimum six-year embargo on clinical trial data generated during the testing and development of a drug. File
| Photo Credit: The Hindu
India has rejected the demand for ‘data exclusivity’, as part of ongoing discussions with the European Free Trade Association (EFTA) towards a free trade agreement, Sunil Barthwal, Secretary, Department of Commerce, said on the sidelines of a press briefing on Thursday.
Data exclusivity pertains to a clause in the draft agreement that puts a minimum six-year embargo on clinical trial data generated during the testing and development of a drug. Thus, manufacturers interested in making a copy-cat product would have to generate such data on their own, which is an expensive proposition, or wait out that period before applying to register and sell their version in India. Crucially, this could also apply to drugs that are not patented in India.
India’s generic drug industry has over the years made affordable versions of expensive drugs and become a large, global supplier itself, and such a clause could hamper the industry.
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Demands for data exclusivity have consistently cropped up since 2008 from the European Union and the EFTA — Switzerland, Norway, Iceland, Lichtenstein — as part of trade negotiations with India, but these have been consistently rejected. Switzerland is home to several prominent pharmaceutical companies, some of whom have been involved in litigation in India over generic drugs.
However, as The Hindu reported on Tuesday, a leaked draft of the Trade and Economic Partnership Agreement (TEPA), available on the website bilaterals.org, an organisation that tracks international free trade agreements, suggested that this clause was present in the negotiating text even as India and the EFTA indicated that negotiations were at an “advanced stage”.
“We rejected their demand. We are with our generic industry….There is no fear for any generics industry in India. It is our very important objective for the country as a whole to see that generic drug industry is flourishing. It is contributing significantly in our exports [as] they are also growing. So, we are there to protect the interests of the generic drug industry throughout, so there is no FTA agreement in which we will be going against the industry’s interest,” Mr. Barthwal told reporters.
Concerns that such a clause would affect the availability of new drugs had prompted medical rights group Medicins Sans Frontiers (MSF) to write to Prime Minister Narendra Modi earlier this week on the potential harm from India accepting data exclusivity provisions.
“We welcome the Indian Commerce Ministry’s strong stand against the inclusion of data exclusivity in its trade talks with EFTA,” Farhat Mantoo, Executive Director, MSF South Asia, said in a statement. “We appeal to India to continue to reject all harmful intellectual property provisions in this and other trade deals that may limit India’s supply of affordable generic medicines for millions of people in India and around the world,” Dr. Mantoo said.
“For MSF in particular, these possible changes to India’s national patents and drug regulatory laws could have a significant impact for the future supply of potentially lifesaving medicines. This is because MSF relies on quality-assured vaccines and medicines made in India to treat the people in our care, with its spending on generic medicines procured from India estimated at 95% for HIV, 90% for hepatitis C antivirals, 36% on TB treatments, and 30% on vaccines,” their letter had noted.
