Geneva, 11 May (TWN): Concern is apparent among World Health Organization Member States over whether there will be timely, fair, equitable and transparent access to affordable medical products, and the removal of obstacles to that access.
This is especially so among developing countries as negotiations on a Chair’s Proposal for a CONSOLIDATED zero draft on WHA73: “Covid-19 Response” progress, ahead of the 73rd World Health Assembly scheduled to take place on 18 May 2020.
Dr. Canice Nolan of the Permanent Mission of the European Union to the WHO is chairing this process.
The Chair’s proposal builds on an original 6-page draft resolution presented by the European Union which, following a week-long discussion with Member States, resulted in a heavily bracketed 21-page document. On 4 May, the Chair circulated a revised 4-page resolution for informal discussions, which as at 8 May had ballooned to 21 pages again.
The Chair’s text is extensively bracketed (indicating lack of consensus), with several proposals from the Chair aimed at reaching a compromise. According to a diplomatic source, informal consultations are expected to continue for most of Monday (11 May), after which the “silence procedure” would be applied.
(Silence procedure was first adopted at the UN General Assembly to address decision-making during the COVID-19 pandemic, whereby a resolution is adopted if there is no objection from any Member State. There is no need to do anything if a country supports a resolution. See https://www.un.org/pga/74/2020/04/09/procedure-for-taking-decisions-of-the-general-assembly-during-covid-19/ )
The Chair’s proposal is presently co-sponsored by Australia, the EU and its Member States, Monaco, Montenegro, New Zealand, North Macedonia, San Marino, the United Kingdom and Zambia.
Though the Chair’s text “Calls for, in the spirit of unity and solidarity, intensification of cooperation and collaboration at all levels to contain, control and mitigate the COVID-19 pandemic” it primarily reinforces “business as usual” approaches, featuring an over reliance on unaccountable voluntary approaches and initiatives, while sidelining the role of WHO Member States.
Flexibilities in the Agreement on Trade-related Aspects of Intellectual Property (TRIPS)
The Chair’s proposal, as with the original EU resolution, avoids any mention of the World Trade Organization’s Doha Declaration on the TRIPS Agreement and Public Health, and neither is there any text calling on Member States to utilize TRIPS flexibilities to address intellectual property barriers and promote access to medical products.
Instead, reference to “flexibilities” in the Chair’s text is seen in the context of ensuring consistency with the provisions of “relevant international treaties”, introducing ambiguity. The relevant proposed Operational Paragraph (OP) by the Chair is as follows:
“Chair’s proposal OP4: Calls for [the unconditional)……] timely and equitable access to and fair distribution of all quality, safe, efficacious and affordable essential health technologies and products including their precursors [required in the response to the Covid 19 pandemic as a global priority] and the urgent removal of arbitrary and unjustified obstacles thereto [and unilateral coercive measures and sanctions…..], consistent with the provisions and flexibilities of relevant international treaties.”
This gap is astonishing given that TRIPS flexibilities are presently the main legal options available to all WHO Member States to address intellectual property barriers. Already, concerns over the potential impact of intellectual property on access have led several developed and developing countries to take steps to facilitate compulsory licensing. For example, Australia, Canada and Germany have revised their national patent laws to simplify the issuance of a compulsory license during a public health emergency. Israel issued a compulsory license with respect to lopinavir/ritonavir for use as treatment for COVID-19 while Chile, Ecuador and Colombia have issued national decrees or resolutions to facilitate the use of compulsory license if it is required.
It is also common for WHO resolutions that address “access” issues to include reference to the Doha Declaration, and encourage Member States to use TRIPS flexibilities to promote access to affordable medical products.
For instance, Resolution WHA67.6 on Viral Hepatitis urges the Director-General “to support Member States with technical assistance in the use of the flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights when needed, in accordance with the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property”.
It also calls on WHO Member States “to consider, as necessary, national legislative mechanisms for the use of the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights in order to promote access to specific pharmaceutical products”.
Resolution 59.24 which adopted the WHO’s Global Strategy on public health, innovation and intellectual property reiterates that “the Doha Ministerial Declaration on the TRIPS Agreement and Public Health confirms that the Agreement does not and should not prevent Members from taking measures to protect public health”. It also further notes that “the Declaration, while reiterating commitment to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) affirms that the Agreement can and should be interpreted and implemented in a manner supportive of the rights of WTO Members to protect public health and, in particular, to promote access to medicines for all”.
According to diplomatic sources, to address this glaring omission, Zimbabwe has proposed the inclusion of a preambular paragraph on the Doha Declaration as well as calling on WHO Member States to utilize TRIPS flexibilities in a separate operative paragraph.
Global Public Goods for Health
The original EU resolution included an operational paragraph which recognized “immunization” as a “global public good for health”. It “Recognizes population-wide immunization against COVID-19 as a global public good for health and the crucial role of quality, safe, and efficacious vaccines therein”. The Chair’s text of 4 May also recognized “population-wide vaccination” as a “global public good for health which is necessary to prevent, contain, and stop transmission in order to bring the pandemic to an end, once safe, quality, efficacious and affordable vaccines are available”.
However, the notion of “global public good” has been opposed by several countries, especially the United States and Switzerland. An argument put forward was that it is an “academic” term and the implications of the use are uncertain, sources say.
Many other countries supported its inclusion, for instance Algeria has argued that without its inclusion, the fundamental goal of the entire resolution would be deleted, sources say.
According to diplomatic sources, the Chair clarified that it recognized that “population-wide vaccination” was a global public good for health but the vaccine itself was not.
In the latest Chair’s proposal, reference to “global public good” is proposed to be replaced with text that recognizes the benefit of population-wide vaccination/immunization.
This shift is in line with the explanation of the Chair that the vaccine itself was not a global public good for health, meaning the production and distribution of future COVID-19 vaccines would be governed by the rules of intellectual property and commercial interest.
Lack lustre voluntary approaches to sharing intellectual property
Recently several countries have had to contend with intellectual property as a possible barrier to access. For instance, in the US, the Governor of Kentucky called on multinational company 3M to release its patent for the N95 respirator — a desperately needed type of protective gear that’s difficult to get during the coronavirus pandemic — so that more manufacturers can start making it. (See https://eu.courier-journal.com/story/news/2020/04/03/beshear-calls-3-m-release-patent-n-95-respirator-amid-pandemic/5112729002/ )
In another example, when the Netherlands faced shortage of diagnostic tests due to Roche’s reluctance to provide the recipe for the liquid used in the test, the Dutch Health Minister floated the idea of issuing a “compulsory license” while the European Commission explored interventions for possible abuse of Roche’s market position, leading to Roche agreeing to release the recipe for others to make.
Despite the potential of intellectual property barriers, especially as therapeutics and vaccines are developed, and the public commitments to “unprecedented level of partnership” by the International Federation of Pharmaceutical Manufacturers as part of the Access to COVID-19 Tools (ACT) accelerator, proposals in the Chair’s text are spectacularly lack lustre, reinforcing existing flawed “business as usual” voluntary approaches.
In the section calling on international organizations and other stakeholders including civil society and the private sector, the Chair’s proposal is as follows:
“Chair’s proposal OP7.2: Work collaboratively at all levels to develop, test, and scale-up production of safe, effective, quality, affordable diagnostics, therapeutics, medicines and vaccines for the COVID-19 response, including, but not limited to the, optimal use of existing mechanisms for voluntary pooling of patents and for licensing, to facilitate [fair distribution of] and timely, equitable and affordable access to them, [consistent with the provisions [and flexibilities] of relevant international treaties,]”.
Existing approaches to voluntary licenses (VLs) have not always resulted in fair, equitable or affordable access to medical products. In many developed and developing countries access to essential HIV, tuberculosis and hepatitis C medicines remains a challenge despite the existence of such licenses. These VLs tend to limit the number of countries that can be supplied by the licensee, with upper-middle income countries such as Brazil, Malaysia, Thailand as well as developed countries being routinely excluded. The VLs are usually only granted to a select group of generic manufacturers, with terms and conditions (that may be non-transparent) intended to lock-in the manufacturer and manage competition. Finally, if a pool is voluntary any key intellectual property holder may refuse to share its technology or pursue its own VL strategy, as some companies have previously done.
The shortcoming of VLs is evident in Gilead Sciences’ recent announcement with respect to remdesivir, a therapeutic recently approved by the US Food and Drug Administration for emergency use for treatment of COVID-19 patients. Gilead announced that it was donating its entire current supply of 1.5 million doses to the US, and that it was negotiating VLs with select manufacturers for the supply to other countries. The terms and conditions of these licenses are unknown, and neither is Gilead held accountable as to whether its actions will meet global health needs in a timely and equitable manner and at affordable prices, should remdesivir be proven to be effective against COVID-19.
Professor Brook Baker from Northeastern University School of Law, in his analysis of Gilead’s announcement states that “the US has totally bolloxed the distribution of Gilead’s donated remdesivir by totally non-transparent and inequitable distribution … We can already imagine it is entering into, or has already entered into, sweetheart deals with the US and Europe with only token provision for LMICs (low and middle income countries). Although Gilead states that it is working with UNICEF for distribution, it is not clarifying quantities and selection criteria for distribution”.
If the true spirit of “unprecedented” collaboration and solidarity is to prevail, the private sector should be required at the very least concretely commit to non-exclusive, transparent, globally competitive, pro-public health licensing practices with effective technology transfer, for all COVID-19 related medical interventions, to facilitate timely and equitable access by all WHO Member States.
In addition, the Chair’s text OP6.12 calls on the Member States to: “Collaborate to promote both private sector and government-funded research and development, including open innovation, across all relevant domains on measures necessary to contain and end the COVID-19 pandemic, in particular on vaccines, diagnostics, and therapeutics and share relevant information with WHO”.
While the text asks Member States to collaborate to promote private and government funded R&D including open innovation, similar corresponding language on “open innovation” is absent from the part concerning commitments of the non-state actors including the private sector.
Marginalization of Member States
WHO strategies, plans and frameworks on significant matters are usually conducted through inter-governmental Member State processes. The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, the Pandemic Influenza Preparedness Framework and the Framework of Engagement with Non-State Actors, are just some examples where Member State-led processes have produced positive outcomes.
It was only through intergovernmental negotiations that in 2011, the WHO adopted a historic landmark agreement setting out international rules in the WHO with regard to access to influenza viruses of pandemic potential, and fair and equitable sharing of benefits arising from their use on an “equal footing”. With this Pandemic Influenza Preparedness Framework, WHO has entered into binding contracts with biopharmaceutical manufacturers, securing firm commitments to deliver diagnostics, anti-viral products and vaccines during the time of a pandemic.
According to WHO, through 13 signed Standard Material Transfer Agreement (SMTA) as at May 2019, it has secured approximately 420 million doses of pandemic vaccine and 10 million treatment courses of antivirals that the Organization would be able to send to countries in need at the time of a flu pandemic. The SMTA also provides the option of manufacturers providing royalty free licenses to manufacturers in developing countries for the production of pandemic influenza vaccines, adjuvants, antiviral products and diagnostics needed in a pandemic.
However, the COVID-19 Chair’s text departs from this norm, sidelining the role of WHO Member States.
The Chair’s proposal in OP8.7 states:
and in consultation with Member States, identify and provide options
that respect the provisions and flexibilities of relevant international
treaties, and with inputs from relevant international organizations
and the private sector as appropriate, to be used in scaling up development,
manufacturing and distribution capacities needed for equitable and
timely access to quality, safe, affordable and efficacious diagnostics,
therapeutics, medicines, and vaccines for the COVID-19 response taking
into account existing mechanisms, tools, and initiatives such as the
Access to COVID-19 Tools (ACT) accelerator and relevant pledging appeals,
such as “The Coronavirus Global Response” pledging campaign”.
In this text, in identifying options for scaling up development, manufacturing and distribution capacities, the WHO Secretariat is only required to undertake “consultation” with Member States. This means active engagement or negotiation among Member States is not required and neither do the views of Member States need to be adequately reflected in the plan that is to be developed by the Secretariat.
Often “consultations” result in outcomes that favor the interest of powerful developed nations for they are more able to influence the formulation of the plan through the Secretariat, while developing countries will have a more limited role. Worryingly, beyond consultation, according to the Chair’s proposal, the Secretariat does not even need to submit the plan for approval by WHO’s governing bodies. Hence, WHO Member States will not have any effective oversight over the Secretariat’s plans for scaling up production and timely access.
The proposed text also only requires the Secretariat to obtain inputs from relevant international organizations and the private sector. In doing so, it ignores the role of civil society and other non-state actors such as Médecins Sans Frontières (MSF), the Drugs for Neglected Diseases initiative (DNDI) and many other civil society organizations.
In addition, the Chair’s text requires that the WHO Secretariat to take into account the “existing mechanisms, tools, and initiatives such as the Access to COVID-19 Tools (ACT) accelerator and relevant pledging appeals, such as “The Coronavirus Global Response” pledging campaign” when identifying and providing options for scaling up of production and timely access.
The ACT-Accelerator is a partnership of private sector, donor and funding agencies including the Coalition for Epidemic Preparedness Innovations, GAVI-the Vaccine Alliance, the Global Fund, Unitaid, the Wellcome Trust, Bill and Melinda Gates Foundation, the International Federation of Pharmaceutical Manufacturers (IFPMA), the Developing Countries Vaccine Manufacturers’ Network and the International Generic and Biosimilar Medicines Association.
The FAQ on the ACT -Accelerator on the European Commission website states “the ACT-Accelerator framework could report to a global body such as the G20, possibly extended to the African Union, the Asia-Pacific Economic Cooperation, the World Health Organization and the World Bank Group on: 1) Progress made in the three priorities i.e. vaccines, therapeutics and diagnostics as well as work on strengthening health systems for coronavirus; 2) Identification of additional resources needed in the future; 3) Envisaged action to raise such resources (through pledging or otherwise)”.
Hence, the Chair’s text is attempting to legitimize the ACT-Accelerator, which was neither established by WHO Member states, nor is it accountable to the Member States.
Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO, said that the COVID-19 pandemic is an “unprecedented global crisis that has been met with an unprecedented global response.” While “unprecedented” the approaches of several of the organizations that are part of ACT-Accelerator have often failed to deliver timely fair and equitable access to medical products.
For instance, IFPMA is known for its aggressive position in favour of strengthened intellectual property, often hostile to countries using legal options such as compulsory license that are valid under the WTO-TRIPS Agreement, to promote access to medicines.
GAVI’s Chief Executive Seth Berkley has announced an Advance Market Commitment program that involves incentivizing vaccine makers by agreeing to buy large amounts of a vaccine at a set price, pointing to the success of a similar program for pneumococcal vaccines.
In a POLITICO Pro report, Dimitri Eynikel, MSF’s access campaign and EU policy adviser, suggests caution, citing precisely the pneumococcal campaign, which he said “hasn’t always delivered quantities of vaccines that were needed”.
In these extraordinarily difficult times, the “business as usual” approaches are unlikely to deliver equitable access to much needed medical products. +