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For science to take off, politics must follow.

Political will shapes scientific response and dictates public health policy. Without will, well-meaning initiatives risk languishing.

This week we bring you an analysis which tries to examine the reasons that are holding back the WHO COVID-19 technology access pool. Read on.

Our view is that it is not the inequitable access to vaccines, but production concerns in Europe which may well be a catalyst setting into motion a domino effect pushing the C-TAP into action.

We find it very interesting to pick apart the politics from the science, but often it is hard to do so. We look forward to hearing from you, share your insights, views and information to help us look at these issues in a clinical manner.

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1. Story of the week

WHAT IS HOLDING BACK THE C-TAP?

Production concerns in the manufacturing of COVID-19 vaccines have underscored the need for technology transfer. This means greater relevance for the C-TAP, however it continues to lack support.

The shortages of COVID-19 vaccines have brought into focus the importance of technology transfer needed to speed up the production of vaccines to meet unmet demand. This may give a much-needed impetus to WHO’s COVID-19 Technology Access Pool, which was first suggested by Costa Rica in March 2020, subsequently launched in May 2020 by WHO, but an initiative that has failed to take off. So far.

A number of factors have ensured that there has been very little appetite for a voluntary mechanism that seeks to promote sharing of technology, know-how to improve access to COVID-19 medical products. Apart from the industry’s reluctance for such an approach, it appears that the initiative also lacked sufficient buy-in internally at WHO. The ACT Accelerator backed mostly by rich countries and the private sector, also seems to have edged out the C-TAP as a preferred approach to address the pandemic.

“There hasn’t been a critical mass to drive this mechanism. The C-TAP does not have enough number of interested stakeholders,” a source associated with the process told Geneva Health Files on the condition of anonymity.

In this story we try to examine what are the potential obstacles in getting C-TAP to fly. We spoke to half a dozen experts to understand what has been limiting the initiative even before it has taken off, and why this could potentially change.

Image credit: Photo by Ann H from Pexels

WHO Director General, Tedros Adhanom Ghebreyesus, has called this lack of equitable access to vaccines as one created by “artificial scarcity”. In his piece in Foreign Policy earlier this month, Tedros said, “Governments and companies must come together to overcome this artificial scarcity. There are many steps that can be taken to ramp up vaccine production and broaden distribution. These include openly sharing vaccine manufacturing technology, intellectual property, and know-how through the COVID-19 Technology Access Pool, temporarily waiving intellectual property barriers, and expanding voluntary contracting between manufacturers.”

“Open-sourcing will enable immediate use of untapped production capacity, through such initiatives as the Developing Countries Vaccine Manufacturers Network, and help build additional manufacturing bases—especially in Africa, Asia, and Latin America—which will be essential to meeting ongoing demand for COVID-19 booster shots and future vaccines. Expanding production globally would make poor countries less dependent on donations from rich ones,” he added.

Tedros in Foreign Policy

These efforts to push C-TAP follow a number of such calls by WHO in recent weeks. So, while ostensibly, the WHO has lent voice and weight to this initiative, there is a view that the C-TAP has not been supported much in terms of allocating real resources, some people familiar with the matter told Geneva Health Files.

The industry’s early and brash dismissal of the initiative (one industry leader called it “dangerous” and “nonsense”) ensured that there has been essentially no sharing of knowledge more than a year into the pandemic.

Now, with even the European Commission admitting the unanticipated challenges in scaling up production of vaccines, the dynamics on the conversation on voluntary sharing approaches may begin to change globally. (See below, the EU is planning on making its own voluntary pool, to ensure faster access to vaccines, albeit for its own citizens only)

BEST-LAID PLANS

In a letter sent in March 2020, President of Costa Rica, Carlos Alvarado, WHO to “undertake an effort to pool rights to technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic.” The letter called for a voluntary mechanism where those who own intellectual property (IP) and data and know-how relevant to the development and manufacture of diagnostic tests, devices, medicines, or vaccines would contribute knowledge and pool in their information on a shared platform.

Later in May 2020, the WHO launched the Solidarity Call to Action “to realize equitable global access to COVID-19 health technologies through pooling of knowledge, intellectual property and data.” Only 40 countries have so far responded to this call. Vaccine manufacturing powerhouse India has not signed up, neither have the big economies in the EU. The US has also not joined the initiative.

WHAT THE C-TAP SET OUT TO DO:

The C-TAP mechanism envisions that research funders must “take action to promote innovation, remove barriers, and facilitate open sharing of knowledge, IP and data necessary for COVID-19 detection, prevention, treatment and response through measures to ensure availability, affordability and assured-quality of the concerned products.” It pushes for provisions in funding agreements to ensure accessibility and affordability of resulting health products globally including through non-exclusive voluntary licensing and other means to expand access by sharing know-how and other data. It seeks all research outcomes to be published open licenses. It also encourages open and collaborative approaches in pre-competitive drug discovery.

Further, the C-TAP lays out how research organizations could work with the various partners in order to facilitate voluntary sharing approaches. It suggests research organizations to voluntarily license, technologies developed to the Medicines Patent Pool (MPP) or by voluntary non-enforcement of IP rights.

It also suggests that research organizations must share knowledge to enable worldwide production, distribution and use of such technologies through mechanisms such as the Technology Access Partnership (TAP) hosted by the UN Technology Bank or the Open COVID Pledge Initiative hosted by Creative Commons.

Further, sharing of viral genome sequences can be facilitated through mechanisms, such as the Global Initiative on Sharing All Influenza Data (GISAID), it says.  It also asks participants to “place in the WHO Global Observatory on Health Research and Development, relevant information and analyses on COVID-19 research and development activities.”

HOW WILL THE C-TAP RUN?

The C-TAP, housed in the WHO secretariat has since set out an operational plan laying out how it might work in practice.

WHO has said that the operational parts of C-TAP “will be built around existing institutions which will constitute the engine room” of the initiative.

These include:

-          the UN Technology Access Partnership focusing on technology transfer to, and local production of, personal protective equipment (PPE), medical devices such as ventilators and other oxygen-related technologies and diagnostics and testing materials/components in LMICs.

-          the Medicines Patent Pool (MPP) whose mandate was expanded in March 2020 to include any health technology that could contribute to the global response to COVID-19. C-TAP seeks to leverage MPP’s expertise in negotiating voluntary licenses and apply it to COVID-19 medical products.

-          In addition the Open COVID Pledge (OCP), the Global Initiative on Sharing All Influenza Data (GISAID), the WHO Global Observatory on Health R&D are also part of this mechanism.

The WHO C-TAP DATABASE

In a concept paper released in October 2020, WHO has said, “the WHO C-TAP database will be at the core of C-TAP operations, being the repository for data and know-how on key Covid-19 health technologies to be part of C-TAP and for the submission of Member States pledges to support C-TAP. The WHO C-TAP database will act as a coordination platform and be connected to other data-sharing platforms and databases where Covid-19 related health technology information is already available.”

WHO acknowledges that there is a need is to identify an operating model that is attractive to the funders and holders of IP, knowledge, data and technology. “Some of the incentives for participation by funders and owners of knowledge may be commercial,” the paper says. (It is understood that taxation or regulatory incentives at the national level have been suggested.)

According to plans, WHO seeks to “establish a prioritization process” to identify the products, technologies and “pooled assets” that the C-TAP should initially focus. Top WHO officials have often stated that the C-TAP has a medium- to long-term role to build capacities for future epidemics.

C-TAP GOVERNANCE

The WHO sees itself playing a leadership role in mobilizing key actors including member states, funders and the strategic partners in industry, research institutes and academia and civil society. It also seeks to work with other UN agencies even as it provides a strategic role in setting standards and guidance for C-TAP.

A Technical Advisory Group of experts and a Steering Committee (also composed of other partners) are bodies expected to advise and govern the C-TAP.

Sources familiar with the setting up of the mechanism said that the C-TAP has so far been under-funded and lacks sufficient support even inside WHO.

According to WHO, while the C-TAP Secretariat is a very small team, it has received funding from Unitaid and other sources to initiate the work. A spokesperson pointed out that C-TAP works through its implementing partners that have their own budgets allocated.

SO WHAT IS HOLDING C-TAP BACK?  

ACT A Vs C-TAP

Internally questions have been raised as to what C-TAP will add to the efforts of the ACT Accelerator, for example. “Some senior officials at WHO did not see the need for two different mechanisms,” a source who spoke on the condition of anonymity, told Geneva Health Files. Although, the ACT A and the C-TAP have different approaches.

One IP expert said, “while ACT A perpetuates the status quo in terms of protecting intellectual property even in the response to the pandemic, the C-TAP challenges it by suggesting voluntary approaches that will contribute to faster equitable access to medical products for the pandemic.”

WHO points out that while the ACT-A is principally about funding the development of the new tools necessary to fight COVID-19, the C-TAP has the overall objective of promoting open science.  It sees these two initiatives as complimentary to each other.

“Sharing knowledge of all kinds which is normally only available to funders, originators or technology holders, or confidentially held by regulators will facilitate accelerated innovation and the scale-up of manufacturing globally. It will facilitate more affordable access to new tools, through nonexclusive and public-health driven licensing accompanied by enhanced arrangements for technology transfer. In particular, it will support technology transfer to boost local production of relevant products in LMICs through the Medicines Patent Pool and the Technology Access Partnership,” WHO says.  

“As complementary initiatives, the linkages and mutual benefits between the two should be made more explicit and further promoted, for example, the data, know-how and IP associated with technologies prioritized for development and subsequent manufacture under ACT-A could be made available for sharing within C-TAP mechanisms, WHO adds.

However, ACT A partners including CEPI and Gavi which steer the COVAX Facility, have not engaged with the C-TAP, sources say. Queries sent to Gavi for this story were unanswered when this edition went to print.

Ellen ‘t Hoen, Director, Medicines Law & Policy, former head of the Medicines Patent Pool, “I think it's always difficult to take on issues related to intellectual property. There's always a nervousness around such an issue. The ACT A, the COVAX Facility, have some very important and influential backers behind it. So that plays a role. But I'm quite optimistic and I think WHO has been vocal and clear about it. There is organizational commitment to it. It is not going to be easy.  But it is good that it is a UN agency being in the lead because it is quite a tall order.”

A WHO spokesperson clarified that “The ACT-A Therapeutic pillar is prioritizing some key products and C-TAP is using this information to engage in discussions with relevant companies to promote voluntary licensing or technology transfer.” In the context of vaccines, “In order to facilitate the matching among owners of such IP or knowledge and potential manufacturers of key health products, C-TAP is working in collaboration with different partners to do mapping of manufacturing capacities. (e.g. with CEPI and UNICEF for vaccines).”

THE ROLE OF THE MEDICINES PATENT POOL

The MPP has a near central role for the functioning of the C-TAP given that the voluntary approach is the bedrock of the initiative. After all, timely voluntary licenses can accelerate affordable access by diversifying and working with manufacturers in different countries.

The mandate of the MPP was officially expanded by its board to work on the response to COVID-19. In March 2020, the MPP Board authorised the temporary expansion of MPP’s remit to include any health technology where licensing could improve access for low- and middle-income countries. The temporary expansion remains in force.

According to the MPP, as many as 21 companies representing a large portion of the world’s generic pharmaceutical manufacturers have pledged to work together via MPP, towards providing access to hundreds of millions of doses of new COVID-19 interventions for low- and middle-income countries including for small molecules and biologics.

However, a source mentioned that it is understood that the MPP may have some reservations on being at the center of C-TAP. “By engaging with the C-TAP, it puts the MPP in a somewhat difficult position, since it has to work closely with the pharma industry in order to negotiate voluntary licensing for therapeutics,” the source said. In addition, the MPP was not set up for technology transfer and has not worked on voluntary licensing for vaccines (MPP has worked on voluntary licensing for HIV antiretroviral treatments), the source pointed out.

One source said, “the industry has been wary of C-TAP, since it is also backed by influential access to medicines advocates”. To be sure, the C-TAP has been supported by a wide range of civil society groups and other stakeholders.

In response to queries from Geneva Health Files, the MPP said, “MPP is a part of the C-TAP and lends its services and expertise to the group. It is our expertise in negotiating and managing licenses that brings this unique skill that could contribute to facilitating rapid global access. We have efficiently delivered more than 15 billion doses of HIV and hepatitis C treatments to people in LMICs.”

MPP said that in response to the pandemic, it has approached originators on priority candidates to tackle COVID-19, led discussions with possible generic manufacturers in the event effective treatments and technologies become available.  

However, top officials also concede that there has not been much interest from IP holders to engage, in the context of COVID-19 medical products.

On whether MPP had relevant experience in working with products such as vaccines, a spokesperson of the MPP said in a detailed statement, “We have undertaken exploratory work on biological medical products even before COVID-19 pandemic began, and we found that MPP could have a role in improving access, especially in low- and middle-income countries.  However, biologics have unique challenges such as complexity, cost, and time to develop products…. But we remain ready to support WHO and others in the field of vaccines, if MPP’s licensing expertise can contribute to facilitating access.”

The MPP believes that its lessons of working in HIV and hepatitis C over the last 10 years can be applied to the pandemic. “Each of these precious lessons goes beyond the identity of disease and type of health innovation, and can thus be easily translated to COVID-19,” MPP said in a statement.

WHAT WILL IT TAKE TO GET THE C-TAP GOING?

Experts say that the C-TAP will need high-level backers for it to take off. A source pointed out that when the Medicines Patent Pool was launched, it received its first licence from the United States National Institutes of Health (NIH) for patents related to a HIV medicine. “It was an important signal, back then” the source said.

(Reportedly, Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, has expressed support for the C-TAP)

Getting the UK, or the major economies in the EU, will be important for C-TAP, the source added. (While the UK has flagged the C-TAP at WTO’s TRIPS waiver discussions, how it intends to support C-TAP is less clear)

Supporters of the initiative such as ‘t Hoen, say, “WHO cannot do this alone. It will need support from the member states who have wasted an opportunity by spending billions on the research and development of the vaccines without regulating who at the end of the game will have a say over the know-how, the intellectual property and the technology that is developed.” C-TAP also needs support from the entities that own that know-how or have that know-how and the IP, she adds.  

“It was of course difficult to get the C-TAP off the ground when the vaccines weren't really there. That is always the case with a public policy proposal to solve a problem that hasn't occurred yet. It's very difficult. Even though we all knew a year ago what was going to happen. But now we are here. There are all kinds of problems and almost every Parliament on the planet is discussing how we are going to solve this,” ‘t Hoen told Geneva Health Files.

To be sure, governments worldwide are under pressure to make vaccines available. The European Union has been considering voluntary approaches in the backdrop of variants of SARS-CoV-2 and production glitches.  

Earlier this week, the European Commission said, “The Commission will foster the creation, if need be, of a voluntary dedicated licensing mechanism, which would allow technology owners to retain a continued control over their rights whilst guaranteeing that technology, know-how and data are effectively shared with a wider group of manufacturers. The Commission will support the pre-production cooperation between undertakings for building-up manufacturing capacities.”

So how much leeway does WHO really have in terms of pushing the C-TAP concretely instead cajoling countries and companies to sign up to the mechanism in editorials and press briefings?

Some experts believe that Tedros must play hard ball with the industry in order to decisively address production shortages of medical products during the pandemic.

K M Gopakumar, Legal Advisor to Third World Network said, "WHO must ask regulatory agencies to share the dossiers to promote non-originator production of biotherapeutics and vaccines. WHO should invoke public interest in the time of a health emergency and use the information available with it to develop an abbreviated pathway for COVID-19 vaccines.”  

“By bringing about regulatory reforms, WHO can change the dynamics between regulators and originator companies.  

If industry is refusing to adopt the voluntary approach to sharing knowledge, WHO must use its constitutional powers. At a minimum, WHO can independently convene a working group under C-TAP, for mRNA vaccines, for example, and get relevant experts to engage in knowledge sharing, so that non-originator manufacturers can benefit,” Gopakumar told Geneva Health Files.

THE PUSH FOR THE C-TAP FROM WTO?

Some believe that the political discussions on intellectual property such as on the TRIPS Waiver proposal at WTO may well push initiatives such as C-TAP into action. Faced with the prospect of compulsory licensing, it may nudge the industry to adopt voluntary approaches, some believe.

Experts believe that while the TRIPS waiver proposal in theory, can expedite response to the pandemic by suspending a range of protection from intellectual property to trade secrets, it may not eventually be able to actually force technology transfer. Moreover, it is not entirely clear whether the waiver proposal will facilitate production of vaccines, while it may be more useful for other kinds of technologies necessary to effectively address the pandemic.

We will still need a mechanism such as the C-TAP to facilitate technology transfer to ease access to medical products, one expert said.

“You also have to recognize that this is building a ship while it's sailing out of the harbor. The transfer of technology is not something new, neither is the transfer of vaccine technology. But you will need to pull the right experts in,” ‘t Hoen, who was MPP’s first executive director said.

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2. Next Week’s Agenda

Global Vaccine and Immunization Research Forum : 22-25 February

WHO Member States Virtual Informal Consultation: Strengthening WHO Preparedness for and Response to Health Emergencies (organized by the European Union)

Meeting of the WTO TRIPS Council: The TRIPS Waiver discussion: 23 February

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