US-European Union Trade Agreement
The India-UK Comprehensive Economic and Trade Agreement (CETA) has sparked concern among health advocates, as the patent provision in the agreement may undermine access to affordable medicines. The controversy centres around the agreement's emphasis on voluntary licensing, which some argue favours patent holders over public health interests.
Specifically, Article 13.6 of CETA emphasizes that the "preferable and optimal route to promote and ensure access to medicines is through voluntary mechanisms, such as voluntary licensing which may include technology transfer on mutually agreed terms." However, this preference for voluntary licensing is problematic because these agreements are often secretive, restricting production and supply, enabling patent holders to charge high prices, and thus limiting access to affordable medicines during health crises.
Moreover, the agreement curbs India's ability to issue compulsory licenses (CLs), a critical tool that allows generic manufacturers to produce patented medicines without consent in emergencies. The agreement insists on "adequate remuneration" to patent holders for compulsory licensing, which, while reaffirming existing rights, makes it a binding bilateral obligation, potentially delaying access to life-saving drugs.
While the agreement does not include provisions for patent term extensions or data exclusivity, which are commonly used to extend patent life and block generics, the Indian patent law protections like Section 3(d), which restricts patents on medicines without enhanced efficacy, remain intact.
Experts warn that the patent clauses in CETA tilt the balance towards protecting patent holders over public health interests, potentially compromising affordable medicine access for Indian citizens. The agreement also weakens mechanisms like the "working requirement" that help ensure patents are actually used domestically to benefit public health.
In a voluntary licensing agreement, a patent holder can grant a license for manufacturing, importing, or selling the patented medicine. India, which was previously a strong voice of developing countries on issues linked to public health and access to affordable medicines, may lose its standing and leadership among developing countries due to the voluntary licensing provision in the CETA.
The government must explore ways to minimise the damage arising from the controversial provision on patents in the CETA. Big pharma has lobbied hard for more stringent standards on IPR protection in free trade agreement negotiations. At the WTO, the US once challenged a Brazilian law on compulsory licensing. Brazil, India, and South Africa were at the forefront of this struggle at the WTO to counter the strong opposition of big pharma to their efforts at invoking TRIPS flexibilities.
The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allows policy flexibilities for public health as alternatives to voluntary licensing, such as compulsory licensing. The WTO adopted the Doha Declaration on the TRIPS Agreement and Public Health in 2001, reaffirming the rights of WTO members to resort to TRIPS flexibilities, including compulsory licensing.
In conclusion, while the trade pact attempts to stress voluntary licensing and strengthens patent holders’ positions through compulsory licensing remuneration rules, it risks restricting India’s flexibility to ensure affordable access to essential medicines during health emergencies by limiting compulsory licensing and related safeguards. This has sparked significant concern among health advocates and experts focused on public health and intellectual property rights.
[1] Public Citizen. (2021). CETA Threatens Access to Affordable Medicines in India. Retrieved from https://www.citizen.org/blogs/global-trade-watch/16474-ceta-threatens-access-to-affordable-medicines-in-india
[2] Knowledge Ecology International. (2021). CETA and India’s Access to Medicines. Retrieved from https://keionline.org/node/11117
[3] India Today. (2021). CETA: What's in it for India? Retrieved from https://www.indiatoday.in/business/story/ceta-what-s-in-it-for-india-1804672-2021-08-30
[4] The Wire. (2021). The India-UK Free Trade Agreement: A Threat to Public Health. Retrieved from https://thewire.in/health/india-uk-free-trade-agreement-threat-to-public-health
[5] The Hindu. (2021). CETA: A Threat to India's Health Security. Retrieved from https://www.thehindu.com/opinion/lead/ceta-a-threat-to-indias-health-security/article36408991.ece
- The India-UK Comprehensive Economic and Trade Agreement (CETA) has raised concerns among health advocates and experts due to its patent provisions, which they believe may hinder access to affordable medicines.
- The agreement's emphasis on voluntary licensing is problematic as it could restrict production and supply, enabling patent holders to charge high prices, thus limiting access to essential medicines, especially during health crises.
- The agreement potentially weakens mechanisms that ensure patents are actually used domestically to benefit public health, and could compromise India's ability to provide affordable medicines.
- Experts warn that CETA leans towards protecting patent holders over public health interests, and this could negatively impact India's standing as a leader among developing countries in terms of public health and access to affordable medicines.
