India–UK FTA: A Double-Edged Sword for Access to Medicines
Context
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The India–UK Free Trade Agreement (FTA) includes provisions on Intellectual Property (IP) that may impact the availability, affordability, and production of generic medicines.
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Concerns are being raised by experts, academics, and access-to-medicine advocates.
Key Concerns in the FTA
A. Tilt Towards Patent Holders
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IP clauses favour transnational pharmaceutical corporations.
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Undermines public interest safeguards enshrined in the Indian Patents Act.
B. Voluntary Licensing vs Compulsory Licensing
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Emphasis on voluntary licensing:
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Relies on market forces, not state intervention.
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Often comes with restrictive terms, royalty demands, and territorial limits.
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Does not ensure substantial price reduction.
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Reduces the government's power to issue Compulsory Licenses (CL), which were instrumental in past HIV/AIDS medicine access.
C. Dilution of Patent Working Requirements
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Previously: Annual disclosure by patent holders on the working of the patent in India.
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Now: Disclosure every 3 years.
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Also, confidential information in reports will not be available publicly.
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Implication: Harder to prove unmet needs—a ground for issuing CLs.
D. TRIPS-Plus Provisions
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FTA includes TRIPS-Plus elements, such as:
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Undermining Section 3(d) of Indian Patents Act (anti-evergreening clause).
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Promoting harmonization of patentability standards.
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Allows use of patent search/examination results from partner countries (may push for relaxed standards).
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E. Evergreening Risk
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Vague "best endeavour" clauses in IP chapter can dilute safeguards.
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Could allow extension of patent life for minor modifications (e.g. new dosage forms) — blocking generics.
Supporters' Viewpoint
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Trade proponents argue the FTA:
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Gives zero-duty access for 99% of Indian pharma exports to UK.
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UK pharma market set to grow from $45 bn (2024) to $73 bn (2033).
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India's pharma exports to UK grew by 12.6% in FY24; generics alone at $910 million.
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Reduced regulatory barriers = easier market entry + scope for India–UK healthcare collaboration.
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Broader Implications
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For India: Risks its global leadership in generic medicine production.
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For Global South: Affordability of life-saving medicines in Africa, Latin America, Southeast Asia may be hit.
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Contradicts India’s image as the ‘pharmacy of the developing world’.
Way Forward
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Balance trade interests with public health safeguards.
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Strengthen domestic pharma policies to:
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Support MSMEs.
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Ensure compulsory licensing remains robust.
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Transparent monitoring of FTA implementation.
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Protect Section 3(d) and public disclosure norms to ensure access to generics.
Voluntary Licensing
A voluntary license is a permission given by the patent holder (owner of the invention) to another party, allowing them to make, use, or sell the patented product or technology — with the patent holder’s consent and under agreed terms.
Key Features of Voluntary Licensing:
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Mutual Agreement:
The patent holder voluntarily agrees to license their patent to another person or company — usually in exchange for royalties or a fee. -
Legal and Flexible:
It is a legal contract, and the terms (like duration, territory, royalty amount, etc.) are negotiated between the parties. -
Patent Owner Keeps Rights:
The original patent holder still owns the patent and can give licenses to multiple parties if they want. -
Used for Wider Access:
Voluntary licensing is often used in public health, such as allowing generic drug manufacturers to produce affordable versions of patented medicines, especially in developing countries.
Voluntary License vs. Compulsory License:
| Feature | Voluntary License | Compulsory License |
|---|---|---|
| Based on Consent? | Yes (by patent holder) | No (granted by government) |
| Usually with Royalties? | Yes | Yes, but often at lower rates |
| Common Use? | Pharma, tech, agriculture | Public health emergencies |