TRIPS and public health
The 2001 Doha Declaration on the TRIPS Agreement and Public Health stressed the need for the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to be part of wider action to address public health problems afflicting developing economies and least-developed countries, confirming the right of WTO members to take measures to protect public health. It led to a legal amendment of the Agreement that provided a new pathway for access to affordable medicines.
The 2022 Decision adopted at the WTO's 12th Ministerial Conference clarified the scope available to WTO members to limit the exclusive effect of patent rights in order to support equitable access to COVID-19 vaccines. After MC12, members discussed whether to extend this decision to COVID-19 therapeutics and diagnostics but could not reach consensus on this issue.
Background information on compulsory licensing
Amendment to the TRIPS Agreement
Implementing compulsory licences for export of pharmaceutical products
WTO Secretariat submissions to the WHO INB and WGIHR
- 2nd submission to the INB (22 September 2022)
- 3rd submission to the INB (10 November 2023)
- Statement at INB3 (5 December 2022)
- Statement at INB4 (27 February 2023)
- Statement at INB5 (12 June 2023)
- Statement at joint INB-WGIHR meeting (24 July 2023)
- Statement at INB7 (6 November 2023)
- Statement at WGIHR6 (7 December 2023)
- Statement at joint INB-WGIHR meeting (23 February 2024)
Doha Declaration on the TRIPS Agreement and Public Health
A longstanding debate over the interplay between intellectual property (IP) and public health, especially innovation and access to medicines, intensified in the run-up to the WTO’s Doha Ministerial Conference in 2001, partly fuelled by concerns over new lifesaving treatments for HIV-AIDS. Adoption of the Doha Declaration on the TRIPS Agreement and Public Health addressed critical concerns about the role of TRIPS in relation to medicines and clarified core principles, noting the significance of IP for the innovation of new medicines but also concerns about its effect on prices.
The Declaration affirmed that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health and the right of members to fully use flexibilities in the Agreement for this purpose. It lists several flexibilities, notably compulsory licencing and exhaustion of IP rights. In articulating the role of “flexibilities”, it highlights the importance of national choices in implementing the TRIPS Agreement in ways that promote public health.
TRIPS amendment: compulsory licences for export of pharmaceutical products
WTO members have the right under the TRIPS Agreement to grant compulsory licences under their domestic laws, entitling third parties to use IP rights without the consent of right holders. The Doha Declaration confirmed and clarified this right. Most patent laws have provision for overriding patent rights in the public interest, a range of measures including compulsory licences at the request of interested parties, government use authorisations and use by governments as such.
Originally TRIPS rules specified that such authorised use of patented technology should be mainly to serve the domestic market, unless it was remedying anti-competitive behaviour. The Doha Declaration recognized that this limitation could hamper effective use of compulsory licensing by countries with insufficient or no manufacturing capacities in the pharmaceutical sector.
To set aside this limitation, WTO members agreed in 2005 to amend the TRIPS Agreement legally, creating an additional, novel form of compulsory licence tailored to the export of medicines to countries in need. This amendment entered into force in 2017 after two-thirds of WTO members formally accepted it. This special compulsory licence for export mechanism is sometimes termed the "paragraph 6 system", referring to its origins in the Doha Declaration.
The amendment added Article 31bis to the Agreement, giving full formal legal effect to this system and allowing low-cost generic medicines to be produced and exported under a compulsory licence exclusively for the purpose of serving the needs of countries that cannot manufacture those products themselves. For the minority of WTO members yet to accept the amendment, an interim waiver continues to apply.
MC12 TRIPS Decision
The June 2022 WTO Ministerial Conference adopted the Ministerial Decision on the TRIPS Agreement. This Decision addressed two specific problems identified during the COVID-19 pandemic: uncertainty over the scope for domestic measures to override patent rights particularly in a health emergency, and the demand-driven nature of exports under Article 31bis special compulsory licences, which could constrain humanitarian exports in the fluctuating situation of a pandemic. Hence the Decision clarified the wide range of mechanisms members have in place to override patent rights in the public interest, in line with existing TRIPS rules. It also provided a flexible mechanism for production of COVID-19 vaccines for export, an adapted and streamlined form of the existing special compulsory licence.
The Decision therefore works within the TRIPS framework to provide tools to diversify vaccine production capacity and to address the needs of members with insufficient or no manufacturing capacity. The adapted export mechanism acknowledges the role of humanitarian and international access programmes while also ensuring that such humanitarian exports reach those in need and are not diverted to better resourced communities.
Compulsory licensing measures, notably government use or government authorised use of patented medical technology, were strengthened or deployed in practice by a number of governments during the pandemic. The 2023 update to the COVID-19 extract from the WHO/WIPO/WTO trilateral study, Promoting Access to Medical Technologies and Innovation (second edition, 2020), describes measures taken by Canada, the EU, France, Germany, Hungary, Italy, the Russian Federation and the United States.
The MC12 Decision addressed COVID-19 vaccines, given the particular focus of concern about equitable access at the height of the pandemic. Members also undertook to decide on its possible extension to cover the production and supply of COVID-19 diagnostics and therapeutics. The TRIPS Council held substantive discussions about this extension, with inputs from intergovernmental organizations, civil society, business representatives and academia during a thematic session in September 2023.
On 13 February 2024, the TRIPS Council reported that despite considerable efforts to support a fact- and evidence-based discussion, members could not reach consensus on extending the decision.
MC12 Declaration on COVID-19 and future pandemics
The MC12 Declaration addresses the global response to the COVID-19 pandemic and establishes a framework to guide the WTO’s work in order to render the multilateral trading system more resilient and better prepared for future crises. It outlines strategies for achieving equitable access to vaccines, strengthened healthcare systems and timely information sharing about government measures. The Declaration also mandates the WTO to cooperate with the WHO and other international organizations on an international pandemic response. Related work in the TRIPS Council includes sharing of information and experiences regarding COVID-related IP measures taken by members during the pandemic, as well as the consideration of submissions made by members. On 13 February 2024, the TRIPS Council reported on progress to date and committed to continue its work in this area.
TRIPS, the IP system and COVID-19
A dedicated web page provides extensive information on the relationship between IP rights and the COVID-19 pandemic response as well as the work of the TRIPS Council. It also includes a list of members' IP measures in response to COVID-19.
The WHO, WIPO and the WTO work together to address the intersection of public health, trade and IP. This trilateral partnership aims to support members in their efforts to foster innovation and ensure equitable access to essential medical technologies. To ensure policy coherence, the three secretariats have strengthened their trilateral co-operation, with a view to fostering a better understanding of the linkage between public health, trade and intellectual property policies and enhancing a mutually supportive implementation of those policies.
WTO contribution to negotiations at the WHO
At the second special session of the World Health Assembly in December 2021, WHO member states agreed to establish an Intergovernmental Negotiating Body (INB) to negotiate an international instrument to strengthen pandemic prevention, preparedness and response. Negotiations were launched in February 2023, with the aim to submit a final draft for consideration by the 77th World Health Assembly in May 2024. In parallel, the Working Group on Amendments to the International Health Regulations (2005) (WGIHR) considers proposed amendments to the IHR (2005) to strengthen the global response to communicable diseases and pandemic threats.
The WTO Secretariat takes part in both workstreams. It has made written submissions to the INB, in which it shared information about trade agreements, work at the WTO and information resources that are relevant to the trade-related elements under consideration in the negotiations at the INB. The WTO Secretariat has also made oral statements at the INB and the WGIHR.