GTRI says that by opposing demands of developed nations on issues like ‘data exclusivity’ and ‘patent linkage’ in FTAs, India ensures that generic drug makers get greater market access and cost of life-saving medicines gets reduced
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India’s stand on intellectual property rights (IPRs) and pharma issues in proposed trade agreements balances innovation with public health needs, ensures availability of affordable medicines and promotes growth of generic medicine industry, a GTRI report said on Friday.
Think tank Global Trade Research Initiative (GTRI) said that by opposing demands of developed nations on issues like ‘data exclusivity’ and ‘patent linkage’ in free trade agreements (FTAs), India ensures that generic drug manufacturers get greater market access and cost of life-saving medicines gets reduced significantly.
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“India’s approach underscores a commitment to balancing innovation with public health needs, adopting a flexible interpretation of TRIPS to align with its developmental goals, and preventing the establishment of unfair monopolies, especially in the pharmaceutical sector,” the GTRI paper said. It added that this stance reflects a broader effort to protect traditional knowledge and ensure the availability of affordable medicines, addressing significant global challenges in healthcare and IPRs.
The issue assumes significance as developed countries always pressure developing nations like India to take commitments in an FTA on IPR matters over and above agreed under the Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement of the World Trade Organisation (WTO). In trade parlance, it is called TRIPs-plus. TRIPs agreements play a crucial role in shaping these rights globally, ensuring fair protection for innovator companies while also allowing for the flourishing of generic drug industries.
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“India’s stance reflects its commitment to balancing these interests and fostering economic ties through trade agreements… India’s always stand against TRIPS-plus provisions. India has consistently safeguarded the interests of its domestic generic drug industry in FTAs,” GTRI Founder Ajay Srivastava said. When countries sign TRIPs agreements, they commit to modifying their laws related to patent, copyright, trade mark and other relevant laws to align with TRIPs provisions.
In India, amendments were made to the 1970 Patent Act in 2005 and the Copyright Act in 2010 to accommodate TRIPs requirements, it said. FTA proposals from developed countries include TRIPS-plus provisions on data exclusivity, patent term extensions, ever-greening of patents, broader patentability criteria, and patent linkage.
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“India has taken a firm stance against such provisions,” it added. Data exclusivity involves granting the originator company exclusive rights over the clinical trial data submitted for regulatory approval of a new product.
Grant of data exclusivity would require Indian generic companies to conduct their own clinical trials in India even if the drug is already approved elsewhere. This would mean delay and higher costs in introducing generics. India has rejected this demand of EFTA bloc in the proposed trade pact. The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland.
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A provision under the “TRIPs requires nations to protect undisclosed test data submitted for new chemical entities against unfair commercial use. However, it does not mandate data exclusivity”, the paper said, adding, “India does not explicitly grant data exclusivity. Instead, it relies on Section 3(d) of the Patents Act which protects undisclosed information submitted for regulatory approval”. This provision does not grant a period of monopoly and allows regulators to use data for public health purposes, it said.
India argues its approach safeguards public health access to affordable medicines, aligns with TRIPs flexibility, and encourages domestic innovation. “The Indian approach allows quicker entry of generic medicines, promoting affordability and access. It also discourages evergreening practices where minor changes extend patent protection. Data exclusivity would inflate medicine prices, hurt affordability,” Srivastava said.
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India also challenges the notion of automatic patent extensions for delays in regulatory approval, advocating for a case-by-case evaluation to prevent the unfair prolongation of monopolies. “India scrutinizes patent applications rigorously to avoid evergreening, where minor modifications to existing patents extend monopolies, a practice not explicitly addressed by TRIPs but requiring new inventions for patentability,” he said.
India’s patentability criteria are stricter than the TRIPs minimum standards, excluding non-patentable subjects such as mere discoveries, traditional knowledge, and incremental innovations, it said. It also said that India opposes patent linkage, which connects marketing approval to patent status, arguing that it hampers generic competition and restricts access to essential medicines.
