New Delhi, 27 Apr (K. M. Gopakumar) – The announcement by the World Health Organization of the Access to COVID-19 Tools Accelerator (“ACT Accelerator”) has come within a few days of the adoption by the United Nations General Assembly of its Resolution on “International cooperation to ensure global access to medicines, vaccines and medical equipment to face COVID-19” (A/RES/74/274).
The Resolution, adopted on 20 April, requests “The Secretary-General, in close collaboration with the World Health Organization and other relevant agencies of the United Nations system, including the international financial institutions, to identify and recommend options, including approaches to rapidly scaling manufacturing and strengthening supply chains that promote and ensure fair, transparent, equitable, efficient and timely access to and distribution of preventive tools, laboratory testing, reagents and supporting materials, essential medical supplies, new diagnostics, drugs and future COVID-19 vaccines, with a view to making them available to all those in need, in particular in developing countries”.
The ACT Accelerator initiative focusing on new diagnostics, therapeutics and vaccines, has a mission: “to accelerate equitable global access to safe, quality, effective, and affordable COVID-19 diagnostics, therapeutics and vaccines, and thus to ensure that in the fight against COVID-19, no one is left behind”.
However, it is not clear whether the initiative will carry out product development or facilitate product development through the sharing of tools.
The commitment statement reads: “We commit to the shared aim of equitable global access to innovative tools for COVID-19 for all.”
There is nothing in the statement to say that the initiative would carry out product development. Thus it looks like the European Union’s innovative medicines initiative (IMI) (see https://www.imi.europa.eu/). In 2020 the Second Phase of IMI with a total funding outlay of Euros 3 billion will end.
Though French President Emmanuel Macron announced at the 24 April ACT Accelerator event that the European Union would lead a pledging effort to raise Euro 7.5 billion, there is no guarantee that the target would be achieved. Macron mentioned that a pledging meeting would be organised on 4 May.
Many such initiatives in the past remain underfunded and are yet to reach the market. For example, the Coalition for Epidemic Preparedness Innovations (CEPI), launched in 2017 after the Ebola outbreak of 2014/2015, has not been able to deliver on its promise yet.
The main obstacle for these initiatives is the lack of interest of the big pharmaceutical companies to take forward the research in the absence of profit and proprietary rights.
CEPI is currently also funding some COVID-19 vaccine development efforts.
The ACT Accelerator initiative is silent on the issue of intellectual property.
Though the statement of commitment promises equitable access to research tools, it does not address intellectual property protection on the final product.
It is not very clear whether the final product would be available in the public domain or be protected by patents and other intellectual property.
Another important area of silence is the method of innovation.
While there is promise of equitable access to the tools, there is no indication on whether the innovation would be governed through open innovation or through the conventional ways.
An open innovation approach would facilitate the open sharing of research and development outcomes, open peer reviewing (validation) and bridging the knowledge gap, and collective problem solving.
According to many experts, such an approach would expedite the innovation process. There is no clarity in this regard.
One of the partners in the initiative is the International Federation of Pharmaceutical Manufacturers (IFPMA), the transnational pharmaceutical corporation lobby group, which pushes for maximalist intellectual property protection and enforcement without considerations on access to affordable medicines.
The silence on open sharing of R&D outcomes is noteworthy because on 20 April the Joint Statement by World Trade Organization Director-General Roberto Azevedo and WHO Director-General Dr. Tedros Adhanom Ghebreyesus called upon governments “to implement policy measures that can further facilitate [COVID-19 health technologies] research and development, and to promote their rapid dissemination within countries and across borders so as to ensure equitable access to those technologies. Such initiatives include targeted investment, ensuring open access to clinical test results, the sharing of relevant intellectual property rights, increasing manufacturing capacity, open and transparent procurement regimes, the elimination of tariffs on relevant health technologies, and trade facilitation measures to reduce costs and delays”.
WHO has an R&D Blueprint Team, which in consultation with scientists developed a document titled “A Coordinated Global Research Roadmap” for COVID-19.
The R&D Blueprint activities on COVID-19 research involve setting up various working groups and identifies knowledge gaps and publishes various reports on vaccines, therapeutics and diagnostics (https://www.who.int/teams/blueprint/covid-19).
WHO’s web page on global search on COVID-19 provides details of research publications, international clinical trials, COVID-19 Emergency Listing Procedures and accelerating safe and effective COVID-19 vaccines (https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov), expedite the filling of the knowledge gap and facilitate product development.
However, these two initiatives are yet to proactively engage with the scattered research community and individuals working on COVID-19 for the purpose of coordination and direction of innovation.
In other words, the missing link is an interactive platform for facilitating open innovation. Thus it is not very clear what new value would be added to WHO’s existing activities through the ACT Accelerator.
There is also lack of clarity with regard to the role and function of WHO. The ACT Accelerator statement of purpose declares that the initiative is committed to unprecedented partnership.
It also states: “We commit to create a strong unified voice to maximize impact, recognizing this is not about singular decision-making authority, but rather collective problem-solving, interconnectedness and inclusivity, where all stakeholders can connect and benefit from the expertise, knowledge and activities of this shared action-oriented platform”.
This shows that it is a multi-stakeholder platform and WHO is one among the actors and is not accorded any leading role of coordination and direction of R&D.
It is thus too early to view this new initiative as qualitatively different from similar existing ones.