Patient advocacy group Working Group on Access to Medicines and Treatment has raised concerns over the latest India-EU free trade agreement (FTA) asking for the government to release the full text of the agreement for public scrutiny and place it before the parliament for detailed discussions prior to signing to enable informed debate on the FTA’s implications for the pharmaceutical sector.
The group said that the India could have agreed to controversial trade-related aspects of intellectual property (TRIPS)-plus measures as part of the deal which will hit the generics industry and impact the availability and affordability of medicines.
“India plays an important role as a supplier of affordable generic medicines to low- and middle-income countries. Any weakening of its patent laws or regulatory framework through FTAs risks having an impact not only patients in India, but millions worldwide who depend on Indian generic production,” the group said.
Intellectual Property Rights
Even though the official FTA statement does not explicitly talks about patent-related provisions, the pact provides a high level of protection and enforcement of intellectual property (IP) rights, including copyright, trademarks, designs, trade secrets and plant variety rights.
“This formulation clearly demonstrates that India has agreed to IP protection and enforcement standards that go beyond the minimum obligations under the WTO‘s TRIPS agreement,” the group said.
To be sure, TRIPS-plus measures ensures more stringent levels of IP protection to countries involved in FTAs. These measures, which are often forced upon by the developed countries during trade deals, include patent term extensions, pharma data exclusivity, or other forms of market exclusivity for medicines.
Previous Negotiation History
The group said that when the India-EU trade negotiations were relaunched in 2022, the EU’s proposed IP text clearly sought patent-term extension and data exclusivity protection for pharma products.
“In the previous rounds of negotiations, particularly during 2007-2013, India had rejected these TRIPS-plus demands following strong opposition from civil society, patient groups, and public health advocates.
We caution against repeating the approach adopted in the FTAs with EFTA (European Free Trade Association) and the UK that risk having a direct or indirect impact on access to affordable medicines,” it said.