A leaked version of a proposed agreement between India and the European Free Trade Association is causing alarm among civil society and patient advocacy groups over concerns the deal would delay access to affordable generic versions of newer, lifesavings medicines for several years.
The language in a draft agreement, which is expected to be concluded by April, suggests changes would have to be made to India’s patent and regulatory laws. Specifically, drug manufacturers would be given six years of so-called data exclusivity, which refers to the exclusive rights to the results of preclinical tests and clinical trials for a medicine. This information would not have to be shared with generic companies.
As a result, a brand-name drugmaker would obtain an extended monopoly. And while an agreement would only be reached between India and the EFTA — whose membership includes Switzerland, Iceland, Liechtenstein, and Norway — the implications are widespread. That’s because India’s National Drug Regulatory Authority would be prevented from granting any authorization to would-be generic rivals.
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