Why in the News?
Concerns have emerged over India’s commitments in the India-UK Comprehensive Economic and Trade Agreement (CETA), particularly Article 13.6 on intellectual property. Critics argue it weakens India’s long-standing stance on compulsory licensing, favouring voluntary mechanisms instead.
How does Article 13.6 affect medicine access in India?
- Dilution of Compulsory Licensing Rights: The Article 13.6 of CETA favours voluntary licensing over compulsory licensing, reducing India’s legal room to ensure affordable drug access, especially during public health emergencies.
- Reduced Policy Space in Patent Law: Provisions like weakening the “working requirement” restrict India’s ability to revoke non-working foreign patents, hampering local production of essential medicines.
- Dependence on Foreign Patent Holders: Voluntary licensing shifts control to multinational corporations, allowing them to set restrictive terms, often limiting distribution, pricing, and manufacturing flexibility for Indian firms.
- Loss of Global TRIPS Advocacy Role
India’s past leadership in pushing for TRIPS flexibilities (Doha Declaration) is undermined, affecting its credibility in representing developing countries’ interests in global forums. - Risk to Access and Affordability of Medicines: The FTA could hinder production of low-cost generics, making life-saving drugs less accessible to Indian citizens and low-income countries relying on Indian pharma exports.
What is Voluntary Licensing?Voluntary licensing is when the patent holder (usually a pharmaceutical company) gives permission to another company (often in another country) to produce and sell its patented product, usually generic versions under agreed terms and conditions. What is Compulsory Licensing?Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent holder, usually under specific public interest grounds such as health emergencies. |
Which global rules backed India’s earlier patent stand?
- TRIPS Agreement (WTO): Allowed for compulsory licensing under public health grounds, helping India prioritize affordable access over strict patent monopolies.
- Doha Declaration on TRIPS and Public Health (2001): Reaffirmed countries’ right to protect public health and promote access to medicines, supporting India’s flexible patent stance.
- Paragraph 6 System (WTO, 2003): Enabled countries like India to export generic medicines to nations lacking manufacturing capacity, aligning with its role as the “pharmacy of the world.”
- Indian Patent Act, 1970 (amended in 2005): Incorporated TRIPS flexibilities such as compulsory licensing and strict patentability criteria (e.g. Section 3(d)) to prevent evergreening.
- UN High-Level Panel on Access to Medicines (2016): Emphasized that IP rights should not override public health, validating India’s position on balancing innovation and accessibility.
What should be done?
- Reaffirm TRIPS Flexibilities in Trade Negotiations: India must ensure that all future FTAs explicitly protect its right to use compulsory licensing and patent law flexibilitiesunder the TRIPS Agreement.
- Strengthen Domestic Patent Law: Amend and reinforce provisions like the “working requirement” to protect public health and allow challenges to non-working or unaffordable patents.
- Enhance Public Health Safeguards in FTAs: Negotiate clear exceptions for essential medicines and green technology, ensuring that IP provisions do not override public interest obligations.
- Build Strategic Alliances with Global South: Collaborate with developing countries to collectively oppose IP-heavy provisions in trade deals and promote affordable access to medicines globally.
- Promote Indigenous Innovation and R&D: Invest in public sector research and incentivize Indian pharma and green tech innovation to reduce dependency on foreign patents and strengthen self-reliance.
Mains PYQ:
[UPSC 2024] Discuss the implications of Intellectual Property rights with respect to life materials? Although, India is second in the world to file patents, still only a few have been commercialized. Explain the reasons behind this less commercialization.
Linkage: This question directly asks about “Intellectual Property rights with respect to life materials” and patents. The article talks about the implications of India’s CETA commitments on its patent regime concerning “patented medicines” and the “patent system”. The “slip up” in the trade pact is precisely about India compromising its traditional stance on IPR, particularly regarding access to medicines, which is a direct implication of intellectual property rights on life materials.
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