For the first time ever, the World Health Assembly appears set to meet in a one-day virtual session on May 18, which would be devoted largely to debate the global COVID-19 pandemic, sources told Health Policy Watch on Tuesday.

European Union member states are hopeful that a draft WHA resolution to create a voluntary patent pool of new COVID-19 health technologies could be approved in the rapid-fire session – and they are holding daily worldwide consultations with WHO member states online, with the hopes of sealing a deal on the potentially game-changing resolution in time for the WHA meeting.    

In the 73rd session of the one-day virtual WHA, 10 new members of the WHO’s 34 member governing body, the Executive Board (EB), will be elected, sources said.  

“The current COVID-19 pandemic and related public health restrictions preclude the feasibility of holding the governing body meetings scheduled for May 2020 in their traditional format,” states an excerpt of the draft proposal for the WHA meeting, obtained by Health Policy Watch. “At the same time, convening WHA73 in May would afford Member States the opportunity to collectively address the single most pressing global health issue in a moment of crisis and effectively build global solidarity and strengthen the response.”

The proposed agenda would “provide crucial international focus on Covid-19, while recognizing that consideration the nearly 60 items on the full WHA73 agenda would not be appropriate at this time,” states the proposal by the WHO senior leadership for the virtual meeting. The proposal, has been under review by the WHO Executive Board  – and would become operative by tonight, if no EB member opposition has been expressed.  

In anticipation, informal EU-led consultations with Member States already began yesterday to hammer out the nuts and bolts of the patent pool resolution, with over 130 member states getting online for the first remote debate. The closed-door country negotiations will attempt to reach a polished agreement on the controversial issues associated with access to medicines and patent rights – to avoid airing disputes publicly at WHA. 

Following on calls from Costa Rica and other countries, the EU first tabled the draft resolution on the COVID-19 patent pool to the World Health Assembly (WHA) about two weeks ago. On May 4, the European Commission will also host a fundraiser that aims to raise 7.5 billion Euros to support broad access to COVID-19 health products as well as to prop up the WHO’s efforts to coordinate and lead the response. 

The EU draft WHA resolution calls on Member States to “work collaboratively at international level to develop, test and produce safe, effective, quality diagnostics, medicines and vaccines for the COVID-19 response, and to facilitate the equitable and affordable access of people to them, including through voluntarily pooling their intellectual property for all COVID-19-related medical interventions…under the leadership of the WHO.”

Other key sections of the resolution are directed at the WHO Director-General to draft a plan to achieve equitable access to COVID-19 health products for consideration of the WHO Governing Bodies, in consultation with Member States, the United Nations Secretary-General, as well as from “relevant international organizations including WIPO, GAVI, UNITAID, the Medicines Patent Pool, CEPI, the Global Fund to fight Aids, TB and Malaria, and UNICEF.”

The patent pool, which aims to share any information, data or intellectual property rights (IPRs) for innovations, would enable competitive and rapid production of needed technologies, and thus supposedly increase their affordability. 

Civil society groups have also welcomed the initiative overall 

However, some groups have leveled criticism that the proposal needs to be strengthened considerably to give it teeth.

Notably, Médecins Sans Frontières (MSF), Drugs for Neglected Disease initiative (DNDi), Health Action International (HAI), and Knowledge Ecology International (KEI) – all civil society groups in “official relations” with WHO have submitted comments to the EU and member states about WHA proposals, making some key recommendations with respect to the draft. 

Their amendments aim to strengthen key provisions around:  the WHO’s leadership role;  the specific definition of the IP rights to be pooled;  funding of government “buyouts” of essential patent rights on existing products; and “market entry rewards” or other financial inducements for innovators that openly access new drugs or vaccines; and price transparency for products. 

Among the most key points, they proposed: 

• Definition of IP rights to be pooled, which should include regulatory test data, know-how, cell lines and other biologic resources, copyrights, blueprints and designs for manufacturing diagnostic tests, devices, drugs, or vaccines.
• Creation of an innovation reward fund, or other market entry incentives, to compensate innovators that create open-source products. 
• A global database of prices paid for COVID-19 diagnostic, drugs and vaccines and public contributions to new product R&D.

The KEI proposal also calls for more explicit reference to other existing legal avenues that can facilitate access to therapeutics, notably, the so called “TRIPS flexibilities” created by the World Trade Organization, in the Doha Declaration. These provide mechanisms, like compulsory licenses, that can be used lawfully by countries, to locally produce or import patented health products at a reduced price when a justifiable need exists.

The WHO could also be mandated to help build IP capacity of Member States to ensure that they make more effective use of TRIPS ‘flexibilities’, and gain timely and affordable access to technologies, KEI suggested.

“The WHO could organize a series of virtual workshops to share expertise and best practices on various technical and practical aspects of compulsory licenses and other related topics [like] the ability of Member States to implement limitations on remedies for patent infringement,” said the KEI proposal.

As for other comments, the Netherlands-based Health Action International (HAI) also issued a statement on Tuesday, commending the EU draft proposal. HAI also recommended that WHO undertake  a feasibility study of the proposed patent pool.

Access to medicines is not the main policy challenge right now, says WIPO 

While the World Health Assembly prepares to debate the Draft Resolution from the EU, the World Intellectual Property Organization (WIPO) has said that intellectual property law is not the key barrier to accessing essential medicines, and breaking patent law principles could “disincentivize innovation. 

The WIPO statement last Friday also comes on the heels of a joint statement by the WHO and the World Trade Organization (WTO) which sounded a more positive note on the need to exercise available legal flexibilities in patent law to ensure equitable access to COVID-19 health technologies.

WIPO’s statement argues that the key policy challenge right now is the total absence of proven therapeutics for COVID-19, as well as limited manufacturing capacity for essential medical equipment, or even disrupted supply chains. 

“The main policy challenge is to encourage the innovation that may lead to a vaccine and treatments and cures, as well as innovation that assists in managing the crisis,” said the WIPO assessment. 

“At the present time, it may be noted that there does not appear to be any evidence that IP is a barrier to access to vaccines, or to treatments or cures.”  

Given that the pharmaceutical industry contributes over 70% of the funding for R&D, WIPO also notes that access-focused initiatives, particularly at this stage, could even harm the private sector’s incentive to innovate. 

“Focusing on access, rather than the encouragement of needed innovation, at this stage, may not only represent a misunderstanding of the sequencing of innovation and access, but also create a disincentive to investment in needed innovation.”

WIPO’s statement also seems to run against the current not only of the European Union draft WHA resolution, but also initiatives like last Friday’s European Commission and WHO-led COVID-19 Tools (ACT) Accelerator, which commits to equitable global access to innovative tools for COVID-19 for all, observed Ellen ‘t Hoen, from Medicine Law & Policy, in an interview with Health Policy Watch. 

The ACT Accelerator, together with the European Commission, aims to raise some 7.4 billion Euros in support of broad access to COVID-19 technologies. It will hold a major fundraising on 4 May. The ACT Accelerator has been backed by prominent global health organisations, like the Bill and Melinda Gates Foundation, as well as 11 heads of state, including Germany, France, South Africa, as well as other leaders across Africa, Asia, and the Americas, and Europe. 

The statement also appears to diverge from recent legislative measures that various countries have taken, like Israel, Germany, Canada, Chile, Colombia and Ecuador, to promote emergency access to potential COVID-19 technologies by facilitating the use of compulsory licenses, as well as other legal flexibilities allowed by TRIPS.

WIPO’s assessment also does not acknowledge the huge public sector investment in R&D, including for potential coronavirus drugs, noted, Yuanqiong Hu, Senior Legal and Policy Advisor of MSF’s Access Campaign, in an interview with Health Policy Watch.

“R&D for remdesivir [an antiviral candidate for COVID-19] was almost entirely funded by the government and performed by university scientists and affiliates. You cannot claim that R&D initiatives like remdesivir are mostly funded by the private sector,”  she said. 

–Updated 29.04.2020

Image Credits: National Institute of Allergy and Infectious Diseases.