A public health advocacy group on Tuesday expressed “serious concern” about the lack of clarity about measures related to intellectual property in the free trade agreement finalised between India and the European Union.

The Working Group on Access to Medicines and Treatment noted that the European Commission’s press release about the agreement said that the deal provides for a “high level of protection and enforcement of Intellectual Property [IP] rights”, including copyright, trademarks, designs, trade secrets and plant variety rights.

This indicates that India has agreed to standards of intellectual property protection that go beyond the minimum obligations under the World Trade Organization’s Trade-Related Aspects of Intellectual Property, the collective said.

“However, notably, the press release 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,” the group said.

Patent term extensions lengthen the tenure of a patent on a medical product so as to compensate inventors for the loss of the term period while the product is awaiting regulatory approval. Data exclusivity grants the first applicants for patents, usually major multinational pharmaceutical corporations, exclusive protection over clinical trial data submitted by them for an extended period.

Including these measures in the India-EU agreement would “compromise the availability of affordable medicines”, the public health group said.

The Working Group on Access to Medicines and Treatment noted that the proposed intellectual property-related text proposed by the European Union in 2022 had “explicitly sought patent term extension and data exclusivity protection” for pharmaceutical products.

However, it added that during earlier rounds of negotiations, especially between 2007 and 2013, India had “rejected these TRIPS-plus demands” following opposition by patient groups and public health advocates.

“We caution against repeating the approach adopted in the FTAs [free trade agreements] with EFTA [European Free Trade Association] and the UK that risk having a direct or indirect impact on access to affordable medicines,” the collective said.

The public health group also urged India to follow recent practice that “reflects a shift away from” including patent-related TRIPS-plus provisions in free trade agreements.

The Working Group on Access to Medicines and Treatment called on the Union government to ensure that the final text of the India-EU free trade deal does not include any TRIPS-plus provisions, particularly patent term extensions and data exclusivity.

It also asked the Union government to release the full text of the agreement in public, and to place it before Parliament.

“India plays an important role as a supplier of affordable generic medicines to low- and middle-income countries,” the advocacy group noted. “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.”

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