Austin, Texas, 27 Apr (Edward Hammond*) – At a dramatic press conference on Friday (24 April) afternoon in Geneva, the World Health Organization (WHO) unveiled what it calls a “landmark collaboration” that aims for “equitable global access to innovative tools for COVID-19 for all.”
Called the Access to COVID-19 Tools Accelerator (“ACT Accelerator”), the collaboration includes WHO, the World Bank, vaccine and pharmaceutical industry groups, and donors including the Bill and Melinda Gates Foundation and Wellcome Trust.
Built on five commitments – to equitable access, partnership, unity, building on past experiences (of inequity in access to drugs), and accountability – the ACT Accelerator partners say that they have come together “in the service of humanity”.
During the announcement, WHO Director-General Dr. Tedros Adhanom Ghebreyesus passed the floor to a number of political leaders who each expressed (by video) their support for the ACT Accelerator and WHO’s role in COVID-19 response more generally.
These included United Nations Secretary-General Antonio Guterres, Emmanuel Macron of France, Cyril Ramaphosa of South Africa, Germany’s Angela Merkel, and Carlos Alvarado Quesada of Costa Rica.
Also joining were the President of the European Commission and leaders of the African Union, G20, APEC, and a number of others.
[Absent from the event were China and the United States, and also the Director-General of the World Trade Organisation. SUNS]
To fund the ACT Accelerator, the EU announced that it would lead an effort to raise EUR 7.5 billion.
The Accelerator is described as “time bound”, suggesting that commitments and collaborations will cease when the pandemic subsides and/or is declared over by WHO.
The launch was a notable show of support for WHO, particularly by Africa and Europe, bolstering the organization, which has recently suffered criticism and funding cuts by US President Donald Trump.
South Africa’s Ramaphosa praised WHO’s “excellent stewardship” during the pandemic and declared South Africa to be “delighted” with the personal leadership of Tedros.
If achieved, the objectives of the ACT Accelerator, particularly equitable access for all persons to COVID-19 antiviral drugs and vaccines (when they become available) and other “tools”, would represent a dramatic step forward from the present situation of high prices, scarcity, and fractured distribution systems distorted by competition between governments to access limited resources.
In particular, the Accelerator’s statement of “Vision and Mission” notes that developing new products “will not be enough”, and that “lessons from the past … have shown that even when effective tools are available to the world, too often some are protected, while others are not”, and that “this inequity is unacceptable”.
The high-minded commitments of the ACT Accelerator, however, are not backed with written details on how the collaboration and financial relationships will be structured nor how patents and other intellectual property on COVID-19 therapies will be managed, leaving many open questions about the effort.
Different speakers at the conference had substantially different emphases in their remarks that seemed to reflect that there are many important aspects of the Accelerator that are unresolved.
German Chancellor Merkel suggested that these would be up for discussion at a Global Coronavirus Response Summit on 4 May.
While Ramaphosa and others described the effort as one encompassing diagnostics, antiviral drugs and vaccines, in her remarks, Merkel – as well as British Foreign Secretary Dominic Raab – spoke almost exclusively of vaccines, noting the need to ramp up the pace of research and expand production capacity in many countries.
Neither Merkel nor Raab made any significant remarks on antiviral drugs or diagnostics, and neither appeared to suggest that their commitments to equity and access to COVID-19 vaccines fully extends to diagnostics and drugs, although a written statement by the European Commission said, “All new vaccines, diagnostics and treatments developed for COVID-19 will need to be made available globally for an affordable price, regardless of where they were developed or how they were funded.”
Comments by French President Macron addressed issues more widely as he indicated support for broad access to diagnostics.
On antiviral drugs and anti-inflammatory drugs used to treat acute and critical COVID-19 cases, his comments were more equivocal, noting the need for collaboration, development, and distribution of drugs but without spelling out any specifics on how the Accelerator would change the present situation.
On vaccines, Macron emphasized the need to support speedy development and production, and the need for access by all, but he did not directly address intellectual property and affordability and equity in access.
Costa Rica’s President Carlos Alvarado Quesada spoke more directly to the equity aspects of the COVID-19 response, hewing closer to the ACT Accelerator’s equity rhetoric in its “vision and mission”.
Alvarado Quesada noted that COVID-19 does not distinguish between large and small countries, nor between rich, middle income, and poor countries and that neither should there be distinctions in access to diagnostics, drugs, and vaccines.
In contrast to his European counterparts, Alvarado Quesada went directly into intellectual property questions, noting that Costa Rica has approached the WHO Director-General with a proposal for a joint program to create a repository of COVID-related patents.
The President said that the repository would make that intellectual property available for wider use, but he did not note any specifics on licensing terms or if manufacturing capacities and know-how exist to effectively and affordably utilize any patents that enter the repository.
Notably, the representative of GAVI, the Global Vaccine Alliance, referred to the Alliance’s role in the Accelerator as involving scaling up of vaccine production “at risk”, which suggests it envisions a market-based approach for vaccine distribution.
“At risk” refers to production of a product, typically proprietary, prior to regulatory approval, the risk being one that approval is not granted. Production “at risk” implies that the manufacturer expects to recoup production costs through product sales channels post-approval.
This approach could be substantially different than alternative models for vaccine production such as government contracting of large-scale manufacturing, public enterprises, etc.
SHORTAGES AND INTELLECTUAL PROPERTY CAST A SHADOW
The geography and capacities for global manufacturing for COVID-19 vaccines remain unclear.
Different candidate vaccines rely on different manufacturing technologies, many of which are proprietary and some of which – such as the vaccine developed by the US health ministry and the company Moderna – have never before been used in commercial scale vaccine production.
Thus, capacity and potential locations for making the COVID-19 vaccine won’t be fully known until it is clearer which candidate vaccines will receive regulatory approval.
Individual manufacturers, including very large makers such as Johnson & Johnson, GlaxoSmithKline (GSK), and Sanofi have admitted that they do not themselves possess sufficient manufacturing capacity, assuming that their candidate vaccines are approved.
On 25 April, The Guardian (UK) reported that GSK Vaccine’s chief medical officer said that his company and Sanofi’s combined output cannot produce enough vaccine for even 20% of the world’s population within a year.
Meanwhile, Johnson & Johnson on 23 April stated that it hoped to produce “more than one billion” doses of its vaccine, which relies on proprietary production methods, beginning in 2021.
Thus even the combined optimistic outlook on potential production of the three giants by the end of 2021 still falls several billion doses short of what is needed, painting an ominous picture for middle- and lower-income countries seeking vaccines on the open market if other vaccines and additional manufacturing do not emerge.
But there are no details on how the ACT Accelerator will do this, and fears that intellectual property and national- level export prohibitions will leave many developing countries in an extremely difficult position.
As the WHO event unfolded, civil society organizations (CSOs) released a letter to Guterres and Tedros requesting the Secretary-General and Director-General to operationalize fair and equitable benefit sharing for COVID-19- related medical products.
Signed by 268 CSOs primarily from the South, the letter notes the obligations to share benefits arising from the use of biodiversity in the Convention on Biological Diversity and the Nagoya Protocol, and that WHO’s research and development blueprint for COVID-19 states that “virus materials, clinical samples and associated data should be rapidly shared for immediate public health purposes and that fair and equitable access to any medical products or innovations that are developed using the materials must be part of such sharing.”
Viruses are included in these obligations and, since the pandemic began, developing countries have responded positively to WHO’s call to share virus and data – uploading more than 900 SARS-CoV-2 genomes to the major database used by COVID-19 researchers.
Yet while countries are sharing viruses, digital sequence information, and other materials, WHO has not moved to concretize “fair and equitable access to any medical products or innovations that are developed”.
The CSOs called on the UN and WHO to secure binding commitments from manufacturers for the rapid supply of existing and future medical products, especially diagnostics, therapeutics and vaccines to developing and least developed countries at an affordable price.
SCOPE LACKS CLARITY
The ACT Accelerator’s commitment and call to action refers to “COVID-19 tools”, leaving its scope unclear. Is it only for diagnostics, antiviral drugs, and vaccines, or does it cover more?
With the exception of Saudi Arabia’s Minister of Economy, Finance and Planning, Mohammed Al-Jadaan, who said his country’s donation would include support for distribution of personal protective equipment (PPE), such as masks and gowns for use by healthcare providers, none of the other speakers mentioned PPE, or hospital equipment such as ventilators used to support critical patients, nor the anaesthetic, sedative, painkilling, and other non-antiviral drugs that are coming into short supply in many countries.
The Saudi Minister, as the current president of the G20, emphasized steps different than the Accelerator in his remarks, saying that the G20 was concerned about future pandemics beyond COVID-19, and that it was working with unspecified “relevant international organizations … with a view to establishing a global initiative on pandemic preparedness and response.”
The G20 President said this effort on future outbreaks would make the world better prepared the next time a pandemic emerges and, surprisingly, he concluded that this other initiative for the future “would be the smartest investment for us all to make today.”
While after the immediate medical emergency is addressed there will no doubt be analysis and actions to improve future pandemic response, the Minister’s remarks on behalf of the G20 were likely felt as cold comfort for middle- and lower-income countries who, rather than thinking of structures for the next pandemic, are scrambling to provide for the urgent needs of their citizens in the present one.
Peter Sands, Director of the Global Fund to Fight AIDS, Tuberculosis, and Malaria, noted the negative “knock on” effects that the pandemic will have on the spread of other diseases and emphasized the need to pursue diagnostics and antivirals with equal vigor as vaccines, recalling that despite many years’ effort there was still no vaccine available for AIDS, TB, or Malaria.
Sands also recalled the stark lessons of the HIV epidemic, in which patents and price gouging by pharmaceutical companies left millions in developing countries, especially Africa, without access to affordable drugs even as the disease continued to spread.
Brief interventions by the International Federation of Pharmaceutical Manufacturers (IFPMA), the International Generic and Biosimilar Medicines Association, and the Developing Countries Vaccine Manufacturers Network expressed general support for the ACT Accelerator and little else.
Ngozi Okono-Iweala, a board member of GAVI and the former Nigerian Minister of Finance, and Andrew Witty, former CEO of GlaxoSmithKline, were appointed by the Director-General to be Special Envoys to advance the Accelerator.
In the midst of the profoundly unsettled and worrying situation about patents, proprietary manufacturing techniques, and capacity shortfalls, on the same day as the ACT Accelerator’s launch, the Director-General of the World Intellectual Property Organization (WIPO), Francis Gurry, released a statement claiming that “there does not appear to be any evidence that IP is a barrier to access” and chastising criticism of the IP system by characterizing concerns as “focusing on access to non-existent vaccines, treatments or cures” and suggesting that criticism would “create a disincentive to investment in needed innovation” in COVID-19-related products.
Gurry’s remarks stood in deep contrast to the public-spirited tenor of WHO’s event and the positions of many leaders and organizations in developing countries, numerous scientists and journalists, and CSOs from North and South, who have identified patents and manufacturing secrets as potentially major impediments to quickly distributing affordable COVID-19 treatments globally.
Gurry’s hawkish position on IP could be contrasted with that of Secretary-General Guterres, whose remarks very strongly called for COVID-19 diagnostics, therapeutics, and vaccines to be considered global public goods.
“These new tools must be a very clear and essential example of a global public good,” the Secretary-General remarked, declaring that they should be universally and affordably available.
The next major event in relation to the ACT Accelerator will be the Global Coronavirus Response Summit on 4 May.
[* Edward Hammond is a policy researcher on issues related to biodiversity, agricultural genetic resources, infectious diseases, laboratory biosafety, and intellectual property.]