Kamal Ghorui
NW DELHI: A patient advocacy group has cautioned the government over the free trade agreement (FTA) with the EU, urging it to make the full text public and place it before the Parliament for a detailed discussion, prior to its signing. The group said such scrutiny is essential to enable an informed debate on the FTA’s implications for the pharmaceutical sector. Even though the pact does not explicitly talk about patent-related provisions, it provides a high level of protection and enforcement of intellectual property (IP) rights, including copyright, trademarks, designs, trade secrets and plant variety rights.
The Working Group on Access to Medicines and Treatment said `trade secrets’ could be a challenge specifically for biologics, and overall, may have implications for data exclusivity. “The govt should clarify and ensure that the final text does not include any TRIPS-plus provisions, particularly patent term extensions and data exclusivity, which would compromise the availability of affordable medicines’’, KM Gopakumar, co-convenor, Working Group on Access to Medicines and Treatment told TOI. 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 on patients in India, but millions worldwide who depend on Indian generic production, the group said. The agreement clearly demonstrates that India has agreed to IP protection and enforcement standards that go beyond the minimum obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement). However, notably the press release (by EU) does not mention patent related provisions, nor does it clarify whether the agreement includes controversial TRIPS-plus measures such as patent term extensions, pharmaceutical data exclusivity, or other forms of market exclusivity for medicines, he added. Earlier, when negotiations were relaunched in 2022, the European Union’s proposed IP text explicitly sought patent term extension and data exclusivity protection for pharmaceutical products. In the previous rounds of negotiations, particularly during 2007-2013, India had rejected these TRIPS-plus demands following strong opposition from civil society, patent groups, and public health advocates.“We caution against repeating the approach adopted in the FTAs with EFTA and the UK that risk having a direct or indirect impact on access to affordable medicines’’, a statement from the patient advocacy group said. Further, it is also important to note that the EU–Mercosur agreement, reflects a shift away from the inclusion of patent related TRIPS-plus provisions in FTAs. This precedent should be followed in the EU-India agreement too, it added.
