Recently, Health Policy Watch reported that some European countries at the World Health Organization (WHO) Pandemic Agreement negotiations maintain that intellectual property negotiations belong at the World Trade Organization (WTO) rather than the WHO.
If they mean to say that new WTO laws cannot be established at the WHO, they have a point. But if their objective is to silence IP debates at the WHO in the midst of the current WTO deadlock on whether to extend the Ministerial Decision on the TRIPS Agreement (which only applies to vaccines) to therapeutics and diagnostics, this stratagem is quite cynical.
This resistance to discussing IP at the WHO, often equated with “undermining IP,” is not new. Similar objections arose in 1998 during the formulation of a new WHO medicines strategy. The European Union (EU) echoed concerns raised by the pharmaceutical industry regarding a draft resolution on the WHO’s medicines strategy, arguing that “no priority should be given to health over intellectual property considerations.” The United States (US) took a similar approach, voicing concerns that work on the draft WHO medicines strategy could undermine IP and set out a strategy to obstruct its adoption.
The question of whether the WTO needs new rules to address access to medical products is up for debate. The existing TRIPS Agreement provides ample scope for the protection of public health, including special crisis measures to ensure access to health technologies to respond to a pandemic.
Moreover, the 2001 WTO Doha Declaration on TRIPS and Public Health explicitly states that the TRIPS Agreement “does not and should not prevent members from taking measures to protect public health”. The Declaration also affirms that TRIPS “can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all”.
The Pandemic Agreement currently being negotiated at the WHO can play a key role in operationalising these flexibilities. A pertinent analogy is the 2013 Marrakesh Treaty, known as the “Treaty for the Blind”, which facilitated access to published works for visually impaired individuals. Negotiated under the auspices of the World Intellectual Property Organization (WIPO), the treaty created binding obligations for WIPO member states to implement mandatory TRIPS exceptions and limitations to copyright to ensure the availability of reading materials for blind and vision-impaired individuals.
Preventing discussions on IP in the context of pandemic preparedness and response at the WHO would be a grave mistake. We do not need further evidence than the gross inequities in access to pandemic countermeasures we have seen during the COVID-19 pandemic to know that a robust public health approach to IP protection is necessary to ensure equitable access globally.
WHO’s medicines strategy and intellectual property
The assertion that IP discussions belong exclusively to the WTO and not the WHO reflects a lack of understanding of the WHO’s long-standing role in IP and health debates over the past three decades. Discussions on the impact of IP rules on public health have been occurring at the WHO since before the WTO was even fully operational.
In 1986, when the WHO adopted the Revised Drug Strategy (RDS) to improve access to essential medicines and promote rational medicine use, developing countries raised concerns about the potential impact of the General Agreement on Tariffs and Trade (GATT) – which would later form the WTO in 1995 – on essential medicines policies. The WHO’s RDS relied heavily on the availability of generic medicines, which countries feared could be threatened by the new IP rules being negotiated under the GATT. While the IP issue was raised, it was not a central focus at the time.
Ten years later, this had changed. The International Conference on National Medicinal Drug Policies, which reviewed the RDS, recommended in 1995 that international efforts be made to “analyse and address” the consequences of international trade agreements such as the GATT on “access, rational use of drugs, quality, safety and efficacy, local industrial development and other aspects of the national medicinal drug policy”.
“Health issues should be considered as the policies are being formulated,” the RDS review added.
In 1995, the WTO had just been established, and with it came the obligation for its Members to introduce 20-year patents “in all fields of technology”, including for pharmaceutical products.
WHO member states debated the consequences of the new WTO rules at the World Health Assembly (WHA) in 1996, and set out a role for the WHO to look into the effects of the new global trade rules on public health, and especially their effect on access to medicines.
The resolution on the Revised Drug Strategy (WHA49.14) adopted by the WHA tasked the WHO included a requested thefor WHO to study and report on the impact of the WTO’s activities on national drug policies and essential drugs and formulate recommendations for collaboration between the WTO and WHO.
In 1997, the WHO’s Drug Action Program published the study “Globalization and Access to Drugs: Perspectives on the WTO TRIPS Agreement,” written by German Velasquez and Pascale Boulet, known as the “Red Book”. The study marked the first comprehensive review of the new WTO rules and their implications for access to medicines.
In 1999, the World Health Assembly adopted resolution WHA52.19 on the Revised Drug Strategy that further strengthened the WHO’s mandate to work on trade issues. It noted the importance of “ensuring that public health interests are paramount in pharmaceutical and health policies”. Specifically, it instructed the WHO to:
“Cooperate with Member States, at their request, and with international organizations in monitoring and analysing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, so that Member States can effectively assess and subsequently develop pharmaceutical and health policies and regulatory measures that address their concerns and priorities, and are able to maximize the positive and mitigate the negative impact of those agreements.”
The phrase “relevant international agreements, including trade agreements”, was widely understood as a reference to the WTO TRIPS Agreement.
As a result, the WHO expanded its work on IP and health, an ongoing effort which continues to this day. The most recent example of this work is the WHO’s collaboration with UNITAID to provide guidance to countries on accessing affordable generic versions of COVID-19 therapeutics that are under patent protection in their territories.
The 2008 WHO Global Strategy on Intellectual Property
Perhaps the most noteworthy contribution of the WHO in the area of IP was the work of the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) established by the WHA in 2003 (WHA56.27). The CIPIH report, published in 2006, paved the way for the adoption of a WHA resolution (WHA59.24) on “Public health, innovation, essential health research and intellectual property rights” that same year.
Subsequently, the World Health Assembly adopted the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA-PHI) in 2008. This comprehensive strategy outlined the WHO’s work on IP and presented actionable steps to be taken by member states.
In 2015, the WHA extended the GSPOA’s timeframe to 2022. The Strategy’s impact was far-reaching, kickstarting the establishment of the Medicines Patent Pool by UNITAID and WHO and the discussions on an R&D treaty, ultimately leading to experimentation with innovative R&D financing mechanisms.
The GSPOA continues to serve as the cornerstone of the WHO’s work on IP and public health to this day.
For the past decade, WHO has actively participated in the Trilateral Collaboration alongside the WTO and WIPO. This collaboration encompasses the preparation of reports on IP, access to medical technologies, and innovation, the most recent of which was published in 2020. The WHO would struggle to contribute meaningfully to the Trilateral collaboration if it cannot discuss IP in-house.
IP issues and access to medical products resurfaced as an urgent matter during the COVID-19 pandemic. In the early days of the pandemic, the WHO moved swiftly to establish the COVID-19 Technology Access Pool (C-TAP) in May 2020 to facilitate the voluntary sharing of IP as well as technical know-how for scaling up the production of medical products needed to respond to the pandemic. C-TAP is currently being repurposed to address future pandemics more broadly, an issue that is also on the table at the Pandemic Agreement negotiations.
In summary, the WHO has a longstanding history of debating and advising on the impacts of IP on innovation and public health. Those who now argue that intellectual property policy is the exclusive domain of the WTO are either ill-informed or ill-intentioned.
This article was first published by Health Policy Watch on 17 November 2023.
