India-UK CETA – Intellectual Property Rights and Access to Medicines

Context

• India and the United Kingdom are negotiating a Comprehensive Economic and Trade Agreement (CETA).

• Chapter 13 of the draft text pertains to Intellectual Property Rights (IPR).

• Article 13.6 of the draft: prioritises voluntary licensing over compulsory licensing (CL) as the preferred mechanism for access to medicines.

• This marks a significant policy shift in India’s traditional stance at the WTO and other international platforms.

Core Concerns in Article 13.6

• Article 13.6 states that voluntary licensing is the "preferable and optimal route" to ensure access to medicines.

• Concern:

  • This weakens India’s ability to use compulsory licensing to safeguard public health.

  • Dilutes India’s long-standing push for equitable technology transfer and affordable access to patented medicines.

India’s Position on Compulsory Licensing

• India has used CL provisions to reduce the prices of life-saving drugs.

• Example:

  • In 2012, Natco Pharma was granted a compulsory licence to produce sorafenib tosylate (anti-cancer drug).

  • Bayer’s monthly price: ₹2,80,428; Natco’s price: ₹8,800.

Legal Framework

• India’s Patents Act is TRIPS-compliant and allows CL under specific conditions:

  • If the patented product is not available at a reasonable price.

  • If public demand is not met.

  • If the patent is not "worked" (i.e., not manufactured locally).

Impact of FTAs on Indian Patent Safeguards

• India-EFTA FTA (2024):

  • Diluted the “working” requirement; patent holders now need to report every three years instead of annually.

• India-UK CETA builds upon this dilution, further weakening the grounds for issuing CL.

India’s Global Leadership on CL at the WTO

• India has consistently advocated for:

  • Flexibilities under TRIPS for public health.

  • Doha Declaration (2001): reaffirmed the right of countries to issue CL for public health purposes.

• CETA contradicts this advocacy and undermines India’s credibility.

Limitations of Voluntary Licensing (VL)

• VL depends on the willingness of patent holders and tends to favour their terms.

• According to Médecins Sans Frontières (MSF), VLs often:

  • Restrict raw material sourcing.

  • Impose territorial and pricing restrictions.

  • Do not always ensure affordable access.

Example: Remdesivir during COVID-19

• Gilead Sciences gave VL to Indian manufacturers.

• Despite VL, Remdesivir was costlier in India (on PPP basis) than in the US.

Undermining Technology Transfer Demands

• Since the 1970s, India has demanded equitable technology transfers under international frameworks.

• 1974 UN Resolution on the New International Economic Order (NIEO) supported this demand.

• India’s willingness to prefer voluntary, negotiated transfers weakens its negotiating power.

Climate Technology and IPR Barriers

• India’s Fourth Biennial Update Report (2024) to the UNFCCC:

  • Highlighted slow technology transfer and IPR barriers as obstacles to adopting green technologies.

• Conceding to IPR provisions in CETA affects India’s ability to negotiate climate technology access on concessional terms.

Overview

1. India-UK CETA shifts India’s policy from supporting compulsory licensing to prioritising voluntary licensing.

2. This could affect public access to affordable medicines in India and other developing countries.

3. Weakens India’s ability to negotiate on technology transfer, climate justice, and health equity.

4. Contradicts India’s legal and moral leadership at the WTO and other multilateral platforms.

5. Sets a dangerous precedent for future trade agreements with other developed countries.