Led by the World Health Organization, a long list of countries, industry groups, and nongovernmental organizations committed to joining a project for developing and producing new drugs, vaccines, and tests for Covid-19 — and ensure worldwide access to the products.
The orchestrated move, which is being called the Access to COVID-19 Tools Accelerator, comes as the pandemic has infected more than 2.7 million people and claimed approximately 191,000 lives, sparking urgent calls for global cooperation in devising a medical response.
As part of the effort, a key goal is to level the global playing field so that any products will be available to rich and poor populations alike, a contentious issue that for many years has often pitted low-income countries against the pharmaceutical industry, in particular.
“The world needs these tools, and it needs them fast,” remarked WHO Director-General Tedros Adhanom Ghebreyesus during a 90-minute presentation. “Past experience has taught us that even when tools are available, they have been not been equally available to all. We cannot allow that to happen. … Our shared commitment is to ensure all people have access to all the tools to defeat Covid-19.”
The project, however, is still in the early stages. On May 4, countries and organizations are encouraged to start pledging contributions with an eye toward commitments worth about $8 billion in initial funding, according to the European Commission President Ursula von der Leyen. At that point, additional milestones will be announced as part of an ongoing “rolling replenishment.”
Among those involved are France; Germany; the U.K.; Saudi Arabia; South Africa; Italy; Norway; Spain; Malaysia; the World Bank; the United Nations; the Bill and Melinda Gates Foundation; Unitaid; Wellcome Trust; the Global Fund to Fight AIDS, Tuberculosis and Malaria; Gavi, the Vaccine Alliance; Coalition for Epidemic Preparedness Innovations; and the International Federation of Pharmaceutical Manufacturers (here is a list of those who spoke at the launch).
Two economic powers, however, were notably absent from the proceedings: the U.S. and China. The Trump administration recently announced plans to end its funding to the WHO over allegations that the global health agency was too close to China. Nonetheless, the WHO hopes to persuade as many governments as possible to join the accelerator.
A U.S. Department of State spokesperson wrote us that, “America’s world-leading scientists are working hard on a Covid-19 vaccine. We welcome serious efforts to assist in that endeavor, and look forward to learning more about the World Health Organization’s proposal. We remain deeply concerned about the WHO’s effectiveness, given that its gross failures helped fuel the current pandemic.”
For now, though, details were not discussed. Instead, the announcement amounted to a high-level statement of intent rather than a primer on how things will get done.
For instance, it remains unclear about the extent to which the project will include a so-called voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing drugs, vaccines, and diagnostics. The European Union drafted a resolution asking the World Health Assembly to adopt the idea, which was proposed by Costa Rica.
Costa Rica President Carlos Quesada Alvarado referenced the pool in his remarks, and Tedros, as he is known, did indicate the pool would be included in the initiative, but the scope remains unclear. Such a pool is likely to be regarded warily by the pharmaceutical industry, given questions that are may arise about the structure of the pool.
This is not the only effort to attempt to harness the abilities of the pharmaceutical industry to come to the rescue. Last week, the National Institutes of Health on Friday announced it would launch a sweeping public-private partnership between federal researchers and 16 drug makers, aimed at coordinating and accelerating the development of Covid-19 treatments and vaccines.
To be sure, the pharmaceutical industry is facing increased pressure. More than three dozen asset managers, pension funds, and insurers are urging the pharmaceutical industry to cooperate in the fight against Covid-19 by sharing research data and providing affordable worldwide access to medicines, diagnostics, and vaccines.
Some companies have already taken steps. Johnson & Johnson (JNJ) is getting $456 million from the U.S. government to develop a Covid-19 vaccine and has promised the project will be a not-for-profit endeavor. Gilead Sciences (GILD) committed to donating 1.5 million doses of its experimental remdesivir treatment after any regulatory approvals. And AbbVie (ABBV) relinquished global intellectual property rights for an HIV drug after Israel issued a license that would allow generic companies to manufacture copies.
In a statement, Thomas Cueni, who heads the IFPMA industry group, said the “biopharmaceutical industry is acutely aware of the enormous responsibility we have to patients and society to engage in unprecedented levels of collaboration to find a solution to Covid-19. We stand ready to bring to this partnership our unique knowledge and expertise in the discovery and development of medicines and vaccines, as well as our experience building manufacturing capacity and distribution networks.”
Although reactions to the accelerator project were largely positive, skepticism remains. For instance, Frederick Abbott, a professor of international law at Florida State University and a WHO consultant, believes the effort holds potential, but questions over patent rights, marketing exclusivity, and compensation for innovative work need to be addressed for the concept to succeed.
“Innovators should be well compensated for working to develop new technical solutions, but the pandemic cannot be viewed as an event whose impact is to bolster corporate profits. Innovations must be made available at prices that will make them accessible to everyone,” he wrote us. “Some of the institutions involved have long experience in designing push and pull mechanisms for accelerating innovation while making the resulting products affordable.”
Even if billions of dollars are pledged, many questions and barriers persist, according to Brook Baker, a professor at Northeastern University School of Law and a senior policy analyst for the Health GAP advocacy group.
What are those hurdles? As he sees it, drug, device and vaccines makers should provide all of the technology transfer rights to needed for sufficient worldwide manufacturing while eschewing monopoly rights that can lead to excessive prices. And if the private sector does not cooperate, governments may have to exercise emergency powers, he explained.
He also maintained that wealthy nations will have to disavow any interest in gaining preferential access to products. Baker also pointed to the 80 countries, including the entire European Union, that have imposed export controls on Covid-19 medical supplies and argued they need to open trade in ingredients, components, and finished products.
“A high-level framework is important,” he wrote us, “but the call for global solidarity must actually trump commercial prerogatives, nationalism, and demagogic egos.”
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The absence of a commitment to share data and IP rights From organizations like the WHO, NGOs, and countries threatens viability of the COVID-19 Technology pool. (Novartis has made assurances about transparency of its hydroxychloroquine studies, but not to my knowledge via the proposed international COVID-19 technology pool.) Voluntary may work. Conditioning funding on participation will work.
If negative pressure exoventilators with Cuirass were used in lieu of intubated positive pressure ventilators for Covid19 critical patients many more patients would survive.