India’s position on intellectual property rights (IPRs) and pharmaceutical issues in proposed trade agreements strikes a balance between fostering innovation and addressing public health needs. This stance ensures the availability of affordable medicines and supports the growth of the generic medicine industry, according to a report by the Global Trade Research Initiative (GTRI). By resisting pressures from developed nations regarding concepts like ‘data exclusivity’ and ‘patent linkage’ in free trade agreements (FTAs), India facilitates greater market access for generic drug manufacturers, leading to a significant reduction in the cost of life-saving medications.
“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.
This position underscores a broader endeavour to safeguard traditional knowledge and guarantee access to cost-effective medications, tackling substantial global healthcare and IPR challenges.
The significance of this issue is highlighted by the consistent pressure exerted by developed nations on developing countries like India to make additional commitments regarding IPR matters in FTAs beyond those agreed upon in the Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement of the World Trade Organization (WTO). This phenomenon is commonly referred to as “TRIPs-plus” in trade terminology. TRIPs agreements are pivotal in shaping these rights on a global scale, aiming to provide equitable protection for innovator companies while simultaneously fostering the growth of generic drug industries.
“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.
Upon signing TRIPs agreements, countries pledge to adjust their laws pertaining to patents, copyrights, trademarks, and other pertinent legislation to conform with TRIPs provisions. In India, revisions to the 1970 Patent Act were implemented in 2005, followed by amendments to the Copyright Act in 2010 to adhere to TRIPs requirements. Proposed FTA terms from developed nations often encompass TRIPs-plus provisions, encompassing aspects such as data exclusivity, patent term extensions, patent evergreening, expanded patentability criteria, and patent linkage.
“India has taken a firm stance against such provisions,” it added.
Data exclusivity entails providing the originating company exclusive rights to the clinical trial data submitted for regulatory approval of a new product. If data exclusivity is granted, Indian generic companies would be compelled to conduct their own clinical trials in India, even if the drug has already received approval elsewhere. This would result in delays and increased costs in introducing generic versions of the drug.
India has declined the request made by the European Free Trade Association (EFTA) bloc in the suggested trade agreement. The European Free Trade Association (EFTA) members consist of Iceland, Liechtenstein, Norway, and Switzerland.
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 asserts that its approach safeguards public access to affordable medicines, aligns with the flexibility permitted by TRIPs, and fosters 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 contests the concept of automatic patent extensions due to regulatory approval delays, advocating instead for a case-by-case assessment to prevent unjust extensions of monopolies.
“India scrutinises 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 standards surpass the minimum requirements set by TRIPs, disallowing non-patentable subjects such as simple discoveries, traditional knowledge, and marginal innovations. Additionally, India opposes patent linkage, which ties marketing approval to patent status, contending that it impedes generic competition and limits access to vital medications.
