WHO Member States Near Accord On Resolution For COVID-19 Response; Advocacy Groups Ask – Will It Have Teeth….Or Not? Drug & Diagnostics Development 13/05/2020 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The World Health Assembly in Geneva, Switzerland. World Health Organization member states were close to an agreement Wednesday evening on a European Union-led draft resolution on global COVID-19 response to the upcoming World Health Assembly. If approved, it would pave the way for coordinated planning by the global health community to ensure wide and equitable access by people worldwide to COVID-19 medicines and vaccines, according the latest draft obtained by Health Policy Watch. But a “silence period” in which any of the 194 member states can raise formal objections – before the final draft is officially published – was extended at the last minute until noon Thursday – indicating that the bargaining was by no means over yet – with objections from the United States as a key obstacle. The latest iteration of text submitted by the EU and 9 other co-sponsors including Australia, the United Kingdom, and Zambia, includes pointed references to a voluntary global “patent pool” for new COVID-19 treatments. It also refers explicitly to countries’ rights to entirely upend international patent rules, and purchase or produce generic versions of treatments, when there is an overriding public health need. The so called flexibilities in “Trade Related Aspects of Intellectual Property Rights (TRIPS),” are enshrined in a number of World Trade Organization agreements. They allow countries to legally issue licenses to import or produce generic versions of patented pharma products, when urgent health needs arise. But in reality, countries rarely resort to their use. But it remains to be seen if any of the references to so-called “TRIPS flexibilities” – or even voluntary patent pooling – will remain intact in the final draft. Member states continued negotiating late this evening and Thursday morning. Countries have been meeting daily in private, virtual sessions, for several weeks, since the EU first announced its initiative to bring the world together around a potentially far-reaching resolution entitled “COVID-19 Response.” The response so far has been anything but simple. The United States has opposed many principals of the plan, observers say, even including calls for “universal, timely and equitable access and fair distribution” of COVID-19 remedies, as per a paragraph that asks member states and WHO to work towards: “… the universal, timely and equitable access to and fair distribution of all quality, safe, efficacious and affordable essential health technologies and products including their components and precursors required in the response to the COVID-19 pandemic as a global priority, and the urgent removal of unjustified obstacles thereto; consistent with the provisions of relevant international treaties including the provisions of the TRIPS agreement and the flexibilities as confirmed by the Doha Declaration on the TRIPS Agreement and Public Health (OP4);” As one source, who asked to remain anonymous, cautioned: “This is the text as put forward by the countries that are listed as the co-sponsors. The US has not signed off on this.. Equitable access and fair distribution is not something that the US is a great fan of…The US has proposed alternative text.” TRIPS References Peppered Throughout Draft Proposal A researcher tests the efficacy of a generic drug in the United States. Other, softer references to the global pooling of patents, along with TRIPS provisions for overriding them, are also peppered throughout the proposed draft, which was submitted on Wednesday by the EU chair of negotiations. These include a call to countries to: “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, existing mechanisms for voluntary pooling and licensing of patents to facilitate timely, equitable and affordable access to them, consistent with the provisions of relevant international treaties including the provisions of the TRIPS agreement and the flexibilities as confirmed by the Doha Declaration on the TRIPS Agreement and Public Health (OP 8.2). However, US wants to delete language on the “voluntary pooling of patents,” other sources further told Health Policy Watch late Wednesday night. That is despite the fact that voluntary pooling of innovations is the foundational idea upon which the EU resolution was first initiated. “This is one of those moments when having a clear message from the World Health Organization and its members could have made a difference,” said James Love, head of the access advocacy group, Knowledge Ecology International, bemoaning the direction in which negotiations seemed to be leading. “But, instead, some countries, the US, the UK and Swiss in particular, want to protect drug and vaccine manufacturers, as if there is no real crisis, so we have text that a few experts can argue over, to figure out what it even means. “The big issue will be when a really good drug or a vaccine that works is available, and of course, there will be capacity constraints, and unfair and unequal access, not to mention concerns over pricing. Just acting as if that can be addressed better later, when reality begins to hit you in the face, is hardly what we want from public health leaders.” The proposed EU draft also assigns a central role to the WHO, calling on the WHO Director General to identify options for scaling up access to COVID-19 diagnostics, drugs and [future] vaccines: “… in consultation with Member States, and with inputs from relevant international organizations civil society, and the private sector, as appropriate, identify and provide options that respect the provisions of relevant international treaties, including the provisions of the TRIPS agreement and the flexibilities as confirmed by the Doha Declaration on the TRIPS Agreement and Public Health to be used in scaling up development, manufacturing and distribution capacities needed for transparent 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, for the consideration of the Governing Bodies; (OP 9.8). The (ACT) accelerator, announced just last month by European Commission President Ursula Von Leyen, dozens of other countries, WHO, and major global health donors has raised nearly €7.4 billion for a pool of COVID-19 technologies to date. Another observer, who asked not to be named, described the [EU proposed] text as “tortured and badly written, but not a disaster,” despite nods to industry interests and consultations with the private sector. However, whether that text can now even gain acceptance over US and other objections remains up in the air. And if not, EU and other Member State sponsors face two choices. They can barter away over the weekend at the language of the EU draft, until the US and its allies hopefully agree to a drastically pared-down deal. Or they can submit the EU-sponsored draft to a public vote next week at the full Assembly, presuming that the vast majority of low- and middle-income member states will readily sign onto the deal. But that vote, in and of itself, is likely to be a confusing and chaotic affair due to the fact that the WHA’s 194 members are meeting virtually for the first time ever, on untested and potentially unstable internet platforms. And ever if a large majority of countries see the current text through to approval, opposition by one powerful state such as the US, would thwart the multi-lateral spirit of the agreement. Others Thorny Issues – Reproductive Health Rights and WHO Funding A nurse consults her patient with family planning needs. Sexual and reproductive health has been a controversial issue past UN debates over Universal Health Coverage (UHC).Photo: Dominic Chavez/World Bank A number of other thorny issues also exist in the draft proposal, whose other co-sponsors currently include New Zealand, Monaco, Montenegro, North Macedonia and San Marino, which could stall agreement at the last minute. They include a reference to the importance of maintaining “the continued functioning of the health system in all relevant aspects.. including by undisrupted vaccination programmes, neglected tropical diseases, noncommunicable diseases, mental health, mother and child health and sexual and reproductive health and promote improved nutrition for women and children…” (OP 7.5) References to sexual and reproductive health have often been red-penciled for deletion from international documents by the Administration of US President Donald Trump, which has regarded them as coded references to abortion rights. The text also makes numerous references to ensuring funding flows to WHO, calling on member states to: “provide sustainable funding to the WHO to ensure that can fully respond to public health needs in the global response to COVID-19, leaving no one behind. OP 7.15)”. Such references, if accepted by the United States, might also hint at a softening of earlier positions by the Trump administration whch had said it was temporarily suspending funding to the organization. Then again, maybe those will disappear as well. However, the text also clearly includes some clauses that Washington should be keen to see survive. These include demands that member states “provide WHO timely, accurate and sufficiently detailed public health information related to the COVID-19 pandemic as required by the IHR [International Health Regulations] (OP 7.10).” Another clause calls on the WHO to work with the World Organization for Animal Health (OIE) and the Food and Agriculture Organization (FAO) to identify the elusive source of the virus, and how it lept from animals to humans, “including through efforts such as scientific and collaborative field missions, which will enable targeted interventions and a research agenda to reduce the risk of similar events as well as to provide guidance on how to prevent SARS-COV2 infection in animals and humans and prevent the establishment of new zoonotic reservoirs, as well as to reduce further risks of emergence and transmission of zoonotic diseases. (OP 9.6)” The research would presumably attempt to answer critics, including, but not limited to the White House, who have questioned the Chinese narrative that SARS-COV-2 first reached humans via contact with infected animals at a live market in Wuhan, China. Some have also suggested that the virus may have somehow escaped from a nearby virology laboratory which was studying coronaviruses. Evaluation of the COVID-19 Response by WHO – A Stepwise Process Finally, the draft text contains a proposal, for an “impartial, independent and comprehensive evaluation” of the “WHO-coordinated international health response to COVID-19, including (i) the effectiveness of the mechanisms at WHO’s disposal; (ii) the functioning of the IHR and the status of implementation of the relevant recommendations of the previous IHR Review Committees; (iii) WHO’s contribution to United Nations-wide efforts;…(OP 9.10).” Such an investigation is politically important to the United States – and also to other countries worldwide that have paid a significant price, both human and economic, as a result of the current pandemic. However, one key refinement is a conditional clause that suggests the investigation should be initiated “at the earliest appropriate moment, and “in consultation with Member States,” as part of a “stepwise process.” Those small, diplomatic flourishes of “at the appropriate moment, and “stepwise”, in fact, give the global community a diplomatic breathing space to fight the pandemic first – and review the lessons learned once the fires of immediate danger have subsided a little bit more. If ever the WHA resolution for “COVID-19 Response”, can at least be approved. –Updated 14 May 2020 Image Credits: FDA/Michael Ermarth, WHO, Dominic Chavez/World Bank, World Health Organization . 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