India Rejects European FTA's 'Data Exclusivity' Demand
GS Paper III
News excerpt
India has rejected the demand of the four European nation’s the European Free Trade Association (EFTA) bloc for inclusion of a ‘data exclusivity’ provision in proposed free trade agreements.
More about the news:
- For over a decade, India has been against the inclusion of data exclusivity provisions in FTAs to protect the interest of the domestic generic drug industry.
- India stated that it always protects the interests of the domestic generic drugs industry.
- As per the government officials, India will not go against the interests of its generic drugs industry in any of the Free Trade Agreements (FTA) it is negotiating with its partner countries.
- Demands for data exclusivity have consistently cropped up since 2008 from the European Union and the EFTA as part of trade negotiations with India, but these have been consistently rejected.
- Even in the past, India’s discussions on IPR have been a contentious issue in FTA negotiations with countries such as Japan, the United Kingdom (UK) and trade blocs such as the European Union (EU).
- Switzerland is home to several prominent pharmaceutical companies, some of whom have been involved in litigation in India over generic drugs.
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European Free Trade Association (EFTA)
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Data exclusivity
- Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products.
- In the pharmaceutical sector, drug companies generate data through expensive global clinical trials to prove the efficacy and safety of their new medicine.
- In cases where a new medicine is patented, data exclusivity could block compulsory licences that may be granted to generic manufacturers to produce medicines at lower prices.
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India’s generic drug industry
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Reasons for denying the request for 'data exclusivity' in FTA
- Preserving Competitiveness: 'Data exclusivity' could impede the growth and competitiveness of the Indian generic drug sector by restricting access to crucial technical data, potentially limiting the availability of affordable medicines.
- Supporting Generic Drug Industry: The rejection aligns with India's focus on ensuring the flourishing of its generic drug industry, a vital contributor to the country's exports.
- Affirming Accessibility and Affordability: The decision reinforces India's stance against provisions that may adversely affect its pharmaceutical sector and maintains a commitment to supporting the affordability and accessibility of generic medicines.
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Free Trade Agreements: FTAs are treaties between two or more countries designed to reduce or eliminate certain barriers to trade and investment, and to facilitate stronger trade and commercial ties between participating countries. |
India's Approach to Pharmaceutical Policies:
- Encouraging Generic Entry: 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, hurting affordability.
- Legislative Amendments: In India, amendments were made to the 1970 Patent Act in 2005 and the Copyright Act in 2010 to accommodate TRIPs requirements.
- Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement requires nations to protect undisclosed test data submitted for new chemical entities against unfair commercial use. However, it does not mandate data exclusivity.
- India does not grant data exclusivity, instead relying on Section 3(d) of the Patents Act, which protects undisclosed information, submitted for regulatory approval.
- Stricter Patentability Criteria: India's patentability criteria are stricter than TRIPS minimum standards, excluding non-patentable subjects such as mere discoveries, traditional knowledge, and incremental innovations.
- Opposition to Patent Linkage: India opposes patent linkage, which connects marketing approval to patent status, arguing that it hampers generic competition and restricts access to essential medicines.
Conclusion:
India's refusal to concede to the European Free Trade Association's (EFTA) 'data exclusivity' demand reflects a commitment to safeguarding its thriving generic drug industry. By rejecting provisions that could impede the growth of this vital sector, India affirms its dedication to fostering a flourishing pharmaceutical landscape, supporting affordable medicines and contributing to global health accessibility.
Mains PYQ
Q. Bringing out the circumstances in 2005 which forced amendment to the section 3(d) in Indian Patent Law, 1970, discuss how it has been utilized by the Supreme Court in its judgement in rejecting Novartis’ patent application for ‘Glivec’. Discuss briefly the pros and cons of the decision. (UPSC 2013)
