By Ellen ‘t Hoen
The COVID-19 pandemic has laid bare the lack of regulation for the sharing of intellectual property (IP) and technology needed for an effective and equitable response to the crisis.
The Pandemic Treaty (or other legal instrument) scheduled for discussion at the World Health Assembly in the fall of 2021 should focus on establishing the norm that the IP and knowledge needed to develop and produce essential pandemic health technologies become global public goods. It should also ensure predictable and sufficient financing for the development of such public goods.
During the COVID-19 pandemic, the world of science delivered knowledge needed to produce safe and effective vaccines within an unprecedented short time frame, thanks to substantial funding from the U.S., U.K., and German governments in particular.
While scientists globally engaged in collaboration and contributed transparently to the knowledge needed to produce COVID-19 vaccines, there was no mechanism in place to ensure that the resulting manufacturing technologies would be globally accessible.
Once that knowledge was transferred to the private sector, these private pharmaceutical companies became the holders of the knowledge, related intellectual property, and regulatory dossiers that are needed to bring the products to market. This happened even though COVID-19 vaccine development benefitted from vast amounts of public financing. This financing was not conditioned on the sharing of intellectual property and know-how.
The companies that now hold that manufacturing knowledge refuse to share it outside their trusted circle of contract manufacturers. Together with the hoarding of vaccines by high-income countries, this has led to grave global inequities in access to COVID-19 vaccines. For example, only enough vaccine has been distributed in Africa to give 2% of the population a single dose, as compared to 70% of adults in Europe being fully vaccinated with both doses. Dr. Tedros, head of the World Health Organization (WHO), has called the inequity in access to COVID-19 vaccines, where wealthy nations reach high levels of vaccinations and poor countries close to none, “vaccine apartheid” and has warned that this inequity is undermining the global recovery.
In the early days of the pandemic, the European Union that funded vaccine research committed to ensuring those vaccines would be global public goods. The President of the European Commission (EC), Ursula von der Leyen, publicly stated on 24 April 2020 at a joint press briefing with the WHO to announce a global fundraising initiative, that COVID-19 vaccines would be “our universal, common good.” Further, the promotion of COVID-19 vaccines as a global public good was determined a “negotiating directive” and was included in the agreement between the Commission and the EU Member States that established the Commission’s mandate to enter into advanced purchase agreements (APAs) with pharmaceutical companies for COVID-19 vaccines on behalf of the member states.
However, the commitment to develop and promote COVID-19 vaccines as global public goods remained aspirational. The final APAs with the companies appear not contain any provisions that would have encouraged the sharing of IP or manufacturing know-how, nor provisions to promote access for low- and middle-income countries to these vaccines in sufficient quantity and at low prices.
Fairly early on in the pandemic, a number of initiatives were taken aimed at voluntary sharing of intellectual property, including know-how and transfer of technology. In May 2020, the WHO established the COVID-19 Technology Access Pool (C-TAP). C-TAP was set up to offer a platform for developers of COVID-19 therapeutics, diagnostics, vaccines, and other health products to share their IP, knowledge, and data with quality-assured manufacturers through public health-driven voluntary, non-exclusive, and transparent licenses. In June 2021 the WHO announced plans for mRNA technology transfer hubs in Africa modelled after the influenza vaccines technology transfer hubs the WHO had launched in 2007. The Medicines Patent Pool expanded its mandate to be able to work on COVID-19 and is working with C-TAP and the mRNA hubs. Multinational pharmaceutical companies have declined collaboration with C-TAP and with the WHO mRNA hubs on COVID-19 vaccines. Recently the German drug developer BioNTech has announced collaboration with WHO on supporting mRNA vaccine manufacturing capacity in Rwanda and Senegal, but these efforts do not include COVID-19 vaccine technology.
So far, none of these initiatives have resulted in licensing of intellectual property and technology transfer agreements that would enable expanded vaccine production.
Separate from the voluntary IP and know-how sharing initiatives, on 2nd October 2020, South Africa and India proposed a waiver of certain obligations under the TRIPS Agreement for the duration of the pandemic at the World Trade Organization (WTO). The proposal for the COVID pandemic TRIPS waiver was co-sponsored by over 60 delegations. The initiative would focus on encouraging technology transfer and building of manufacturing capacity globally by allowing any company with existing or potential manufacturing know-how to produce COVID-19 related technologies without concerns about possible IP infringement and related legal consequences. According to a not-yet-published status report by the Chair of the TRIPS Council of 20 July 2021 (JOB/IP/47/Rev.1), despite various formal and informal meetings of the WTO TRIPS Council on the subject, no progress on the TRIPS waiver proposal could be reported.
The COVID-19 pandemic demonstrates that it is difficult to regulate the open sharing of IP/know-how and technology while a global health emergency is unfolding. It would therefore be desirable to have a global legal framework in place that provides for the sharing of such technology and manufacturing know-how, which is triggered by the occurrence of a pandemic. The World Health Assembly special session this November presents an opportunity to start the process to create such a legal framework.
This framework should oblige States Parties to:
- Incentivize the voluntary sharing of IP / know-how (e.g., via buy-outs);
- Compel the mandatory sharing of IP / know-how (e.g., via funding conditionalities);
- Support (including financing) global pandemic IP / know-how sharing, including regulatory data and technology transfer platforms analogous to C-TAP and the MPP;
- Support, including financing, the development and scale-up of production capacity to ensure sufficiency in all regions of the world;
- Support the adequate supply of necessary inputs (e.g., raw materials) for that production;
- Ensure an optimal distribution of pandemic health technologies for public health needs in all regions of the world; and
Support, including financing, the development of new pandemic health technologies, under the condition that the IP/know-how developed with public funding is shared openly.
The practical implementation of this framework will likely require the involvement of a range of actors and agencies beyond the WHO, including the WTO and international financing mechanisms. Nevertheless, a multilateral recognition of the need to ensure the sharing of pandemic health technologies and the IP associated with it could prevent a situation in which the inequitable access to lifesaving technologies is a serious impediment to addressing pandemics.
Ellen ‘t Hoen, LLM, PhD is a lawyer and an independent consultant in medicines policy and law.