The World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council will meet on 10-11 July. On the agenda is the review of the implementation of the TRIPS Agreement under TRIPS Article 71.1, as proposed by Colombia. It would be the first time such a review is taking place in the 30 years that the TRIPS Agreement has been in force.
The adoption of the TRIPS Agreement in 1994 and subsequent implementation at the national level brought significant changes in intellectual property law and policy in many countries. TRIPS was part of a set of international treaties agreed upon at the conclusion of the Uruguay Round of negotiations within the General Agreement on Tariffs and Trade (GATT) in 1994. This is the same agreement that established the WTO. TRIPS mandated significant changes in national intellectual property legislation, which in particular affected pharmaceuticals. At the time the Uruguay Round launched in 1986, 49 of the 98 members of the Paris Convention (see box) excluded pharmaceutical products from patent protection, 10 excluded pharmaceutical processes and 22 excluded chemical processes. For a historical overview, see here. TRIPS introduced 20-year patents for any type of invention, whether products or processes, including in the pharmaceutical sector, mandatory for all WTO Members (with the exception of least-developed country Members which were allowed to postpone the implementation of this obligation). It therefore had far-reaching consequences for public health.
The Paris Convention
Before the entry into force of the TRIPS Agreement, the Paris Convention for the Protection of Industrial Property, signed in Paris, France, on March 20, 1883, was the only multilateral intellectual property agreement setting obligations on patents. It is administered by the World Intellectual Property Organisation (WIPO) and has today 180 contracting parties. As a result of the Paris Convention, intellectual property systems, including patents, of any contracting state are accessible to the nationals of other states party to the Convention.
This was first demonstrated on a large scale during the HIV/AIDS crisis of the late nineties when countries struggled to gain access to lifesaving antiretroviral medicines that had become the standard of care in wealthy nations. Generic, low-priced versions of antiretroviral medicines were produced in India (which did not have to grant pharmaceutical product patents until 2005), but could not be shipped to many countries where they were needed because of patents granted in these countries. The TRIPS Council took up the issue of the consequences of TRIPS for public health in 1999 which in 2001 led to the adoption of the Doha Declaration on TRIPS and Public Health and in 2017 to the first-ever amendment of the TRIPS Agreement (TRIPS Article 31bis) with a provision for compulsory licensing for export. In particular, the Doha Declaration, which singled out the flexibilities in TRIPS that can be used to overcome patent barriers, contributed to the creation of a global market for generic antiretroviral drugs. It further eased the supply of medicines and brought the price of HIV medications down, saving millions for health systems and donors such as the Global Fund and PEPFAR. It also opened up a policy space that made the creation of the Medicines Patent Pool possible. For an overview of how countries have used TRIPS flexibilities see here.
The recent Covid-19 pandemic again put the spotlight on the challenges of pharmaceutical monopolies in public health. Discussions at the WTO about the TRIPS waiver proposed by India and South Africa in October 2020, resulted in June 2022 in a Ministerial Decision on TRIPS and Covid-19. The Decision primarily reinforced Members’ existing rights to use TRIPS flexibilities. The Decision only concerns vaccines, while it would have been more useful for therapeutics and other health technologies that do not require technology transfer. The Decision was never expanded to include therapeutics and vaccines. See our comment here.
Indeed, COVID-19 and the challenge of accessing the IP necessary to produce vaccines have caused a growing recognition that patents may not be the only barriers to expanding the production and supply of essential products. Better solutions are needed to ensure technology transfer, access to manufacturing know-how, and regulatory data.
Colombia proposed the review of the implementation of the TRIPS Agreement on 15 April 2024 which marked the 30th anniversary of the TRIPS Agreement and was quickly dubbed “Colombia’s birthday present to the WTO” by TRIPS observers.
Colombia’s proposal lists the following themes for the discussions of the TRIPS Council:
- To analyse both domestic and international concentration of production in knowledge intensive sectors over the years, based on relevant metrics.
- A global stocktake on royalties paid in and out by country for the use of Intellectual Property Rights, as expressed in the Balance of Payments of countries.
- A global stocktake on the use of Compulsory Licences since 1996, with a focus on the problem of export limitations faced by ́sandwich ́ countries (not too small, not too large).
- A global stocktake on the residency/nationality of innovators across Members, coupled with an examination of Patenting activity by Office of Subsequent Filing -OSF- (to better understand who is patenting internationally and domestically, and the incentive mechanisms that exist for innovators to go abroad).
- A related discussion on the exploitation of ́disclosures ́ after IPRs finish their terms of protection. As an implementation matter, are these innovations/creations publicly available? Are they used by Members (especially developing ones)? Are they available for training of artificial intelligence models? (optional trigger questions).
- The utilization of Article 44(2) of TRIPS by WTO Members.
- However, the final list of topics for the review will be determined by the WTO Members. In the wake of the Covid-19 pandemic, IP and public health, access to data and know-how, technology transfer, and the use of compulsory licensing are likely to feature. These are also central topics in the Pandemic Accord negotiations which will continue at the World Health Organization on 15-16 July.
We would like to propose that the TRIPS review includes the following themes:
- An assessment of implementation of TRIPS flexibilities in national law and regulations. Certain countries and regions make it needlessly difficult to use TRIPS flexibilities. Greater insight into why some national rules are restrictive towards using the TRIPS flexibilities would be useful. Part of this exercise should be examining regulatory barriers such as test-data exclusivity to registering pharmaceutical products produced under a compulsory licence. We have advocated for model laws for national implementation of TRIPS flexibilities that take public health needs into account.
- Revisit TRIPS Article 31bis and examine an exception under Article 30 as a solution to the Article 31(f) export restriction on products produced under a compulsory licence.
- An assessment of how TRIPS Objectives and Principles have been implemented in national law and policy, in particular:
- the commitment to “the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.” (Article 7).
- measures taken to “prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.” (Article 8) Discuss options for ensuring access to know-how for example through conditioning public funding of innovations.
It is unclear whether external stakeholders will be invited to contribute to the TRIPS review process. The TRIPS Council is not open to participation by external stakeholders. The Informal Thematic Session for External Stakeholder Input, which was held on 28 September 2023, to discuss expanding the Covid-19 Ministerial Decision to therapeutics and diagnostics, was an exception. The Thematic Session was well received by WTO Members and may offer a model for input by external stakeholders during the TRIPS review.