WHO donors seek a new tech transfer hub under ACT-A, C-TAP sidelined
Newsletter Edition #40 [The Friday Deep Dives]
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1. Story of the week
DONORS WANT A TECH TRANSFER HUB TO PUSH FOR BILATERAL DEALS, WHO C-TAP AT RISK
A new technology transfer hub to facilitate bilateral licensing arrangements, is being proposed by France and powerful private groups, to be under established in the ACT Accelerator, away from the C-TAP.
For a world grappling with acute shortages of vaccines - the panacea to fight the pandemic and to restore the economy - technology transfer has come to emerge as a key to unlock idle manufacturing capacities which can be repurposed to churn out vaccines for an endless global queue of susceptible populations under the threat of SARS-CoV-2 and its variants. One year into the pandemic and more than 2.6 million deaths later, there is no global mechanism yet to ensure or kick start technology transfer in a way that meets this urgent demand.
The steps towards technology transfer have come by way of solutions including Costa Rica’s proposal for a COVID-19 Technology Access Pool that has met with insufficient support since its inception; the TRIPS Waiver proposal from South Africa and India that aims to alleviate production concerns by suspending IP obligations in international trade rules for the duration of the pandemic.
What is however, increasingly cited as a preferred path by both the private sector and the new DG of the WTO, for example, is bilateral licensing arrangements. For all the woes facing the company, AstraZeneca’s model of licensing its vaccines to be produced by manufacturers in a few different countries has become a favorite example for technology transfer among international policymakers.
It is this model, which is non-transparent and mostly subject to bilateral contractual negotiations, that is seen to be taking centerstage in this crucial discussion on how technology transfer be made possible during this stage of the pandemic that has seen a 10% increase of new reported cases in recent days.
A new ‘Covid Vaccine Capacity Connector’ that seeks to formalize bilateral arrangements for tech transfer, is now being proposed.
THE FORCES BEHIND THE PROPOSED TECH TRANSFER HUB
Sources have brought to our attention that discussions are under way to institute a ‘COVID Vaccine Capacity Connector’ under the aegis of the ACT Accelerator that is expected to “house” a technology transfer hub. It is understood that the efforts are being driven by France, other actors in the ACT Accelerator including the Bill & Melinda Gates Foundation, CEPI among others. Sources said that these plans are still under discussion. A concept paper on the proposal, seen by Geneva Health Files lays out how such a hub would function, including timelines on transferring technology and establishing a hub by the end of this year.
There is a concerted effort for such an initiative to be away from the COVID-19 Technology Access Pool, a WHO initiative first spearheaded by Costa Rica in early 2020. Sources say that the proponents of such a hub are not in favor of pooling in know-how to facilitate technology transfer, a fundamental idea underlying the C-TAP.
By instituting a tech transfer hub under the ACT-A, WHO member states will not be involved in the way this process will be run, critics fear. (Similar to concerns on how the COVAX Facility is being governed, away from member states’ oversight.)
With minimal support and few takers so far, the C-TAP initiative has beleaguered even though there is a greater imperative for such a mechanism now more than ever before. By locating any formal technology transfer mechanism, outside of the C-TAP, may be a body blow to the initiative that seeks to promote open licensing to spur tech transfer and knowledge sharing.
Such plans that appear to seek tight controls on the means of production and the terms of engagement show how much is at stake for interests that protect intellectual property and the access to knowledge.
Sources familiar with the developments also say, that such an initiative is meant to also prepare for future pandemics. This means that whatever structures are put in place to facilitate technology transfer now, will likely continue in the future perpetuating the lack of transparency in such deals. “There is a risk that such bilateral arrangements between manufacturers will become a standard for the future”, the source said.
Already, there have been clear demands to make the ACT Accelerator, a permanent feature in the global health post-pandemic architecture. Alongside his fervent calls for the C-TAP mechanism, DG Tedros has lent support to continuing with the ACT Accelerator [ACT-A] super structure, conceived, funded and run by powerful actors including public private partnerships, foundations, donor countries and the private sector. (We have reported on the complex state of play behind the C-TAP. Read it here.)
“The C-TAP initiative, is a middle path, between the all-encompassing TRIPS Waiver on the one hand, and the secret bilateral deals between manufacturers, on the other. Yet, it is not preferred by the private sector and other powerful groups,” a source who did not want to be identified told us.
Recent months have seen a flurry of reports critical of the approach adopted by the Gates Foundation, an outsized donor of WHO, that has been keen on “letting intellectual property rights determine who gets access to critical technologies”. These efforts to secure tech transfer deals in a bilateral manner, is very much in line with earlier strategies adopted by the Gates Foundation including during the pandemic.
We were also asked to read these developments, in conjunction with discussions at the WTO, including on a potential “Third Way” suggested by DG Ngozi Okonjo-Iweala and the Ottawa proposal on trade and health at the WTO. (Also see WTO doc WT/GC/230 Enhancing The Role Of The World Trade Organization In The Global Effort Toward The Production And Distribution Of Covid-19 Vaccines And Other Medical Products)
Sources pointed to a recent WHO press briefing, which apparently indicated towards such a technology transfer hub. At the meeting, Tedros Adhanom Ghebreyesus, WHO DG said, “The volume of doses being distributed through COVAX is still relatively small. One of our main priorities now is to increase the ambition of COVAX to help all countries end the pandemic… This means urgent action to ramp up production. Next week, WHO and our COVAX partners will meet with partners from governments and the industry to identify bottlenecks in production and discuss how to solve them.”
These efforts towards a tech transfer hub under the ACT-A ran parallel to the vaccine manufacturing summit that which brought together industry experts, CEPI and the IFPMA. The recent summit also highlighted how WHO has been sidelined in these discussions on addressing production shortages of vaccines for the pandemic.
As The Geneva Observer reported, although the WHO was a co-sponsor to the Global C19 Vaccine Supply Chain & Manufacturing Summit, “it did not take a lead role in the event which was attended by more than 100 of the biggest players in the field. Instead, CEPI (the Coalition for Epidemic Preparedness Innovations) and industry players were the driving force behind the event. WHO Chief Tedros Adhanom Ghebreyesus was invited but did not attend, informed sources said.”
As we have noted earlier, WHO has been increasingly critical and clear about its position on bilateral deals and its unequivocal support for the TRIPS waiver proposal at the WTO. This has upset donor countries and the private sector, who are opposed to the waiver.
At the briefing, Tedros also said, that one of the ways of ramping up production is bilateral technology transfer, through voluntary licensing from a company that owns the patents on a vaccine to another company who can produce them. He cited, AstraZeneca, which has transferred the technology for its vaccine to SKBio in the Republic of Korea and the Serum Institute of India, which is producing AstraZeneca vaccines for COVAX. “The main disadvantage of this approach is the lack of transparency,” Tedros had said.
Former WHO top official Marie-Paul Kieny, current chairperson of the board at the Medicines Patent Pool, also spoke at the briefing in early March. She is also heads the French Scientific Committee on COVID-19 Vaccines, under President Emmanuel Macron.
At the briefing, the former WHO Assistant Director-General for Health Systems and Innovation, spoke of her legacy in creating the Pandemic Influenza Framework. Kieny, a highly respected scientist and policy maker, is also Director of Research at the Paris-based International Institutional Cooperation, INSERM. She has spoken about her efforts at WHO on a technology transfer project for influenza vaccines in the developing world “in collaboration with donors, academics, a dozen countries, and industrial partners” that helped address the global supply of influenza vaccines.
Sources point out that the role of the MPP is not clear in the context of the tech transfer hub. “It seems that MPP has been reduced to only matching or connecting parties, although its principal activity is to promote patent pooling and transparent, non-exclusive licenses,” the source said. Remember that the MPP is also a key implementing partner under the principles of the Solidarity Call to Action and C-TAP, although a somewhat reluctant partner as some have pointed out. (See our recent story on C-TAP dynamics.)
WHAT DOES THE PLAN FOR A TECH TRANSFER HUB LOOK LIKE?
It is understood that the Gates Foundation, CEPI and partners are proposing a ‘Covid Vaccine Capacity Connector’ under the ACT-A that will have a technology transfer hub.
According to a draft seen by Geneva Health Files, the plans detail how such a vaccine capacity connector would work, what its goals will be and how it would solve the problem of constrained capacities.
In order to meet the demand for vaccines, the proposal recognizes “an urgent need to increase the global supply of Covid vaccines” to immunize populations, adapt vaccines for emerging strains. “In addition, it is critical to increase the ability of all regions to respond to pandemic threats without being dependent on restricted global supply chains,” the proposal notes. It also appears that the proposal seeks to make a distinction between kinds of vaccine technologies that will be useful in the future.
“…To alleviate immediate COVID-19 vaccine supply limitations, and longer-term aspirations of countries of all level of income to strengthen their health security through local capacity to produce critical vaccines, WHO with its partners proposes to establish a Covid Vaccine Capacity Connector in the context of ACT-A,” the proposal says. Despite this language, in reality, sources say that this is being driven by private groups, effectively using WHO’s “name”, that would increase buy in among member states for such a proposal.
It lists out three strategies including unblocking bottle necks between production and fill-finish; promoting bilateral Covid vaccine technology transfer to increase production; promoting multilateral technology transfer and local production through technology transfer hubs.
On fill and finish capacities, the proposal recognizes that “vaccine manufacturers have typically limited filling line capacity” and that generic drug manufacturers have large excess sterile filling capacity. Examples cited in the proposal are Moderna filling at Recipharm, Catalent and Curevac at Fareva.
The proposal sets outs tasks for the MPP variously from identifying fill-finish capacity that meet Good Manufacture Practices, to assessing the total supply of bulk vaccine or antigen to be formulated. It seeks WHO to map “opportunity costs including impact of stopping filling of other vaccines or drugs if facilities used to fill Covid vaccines”
On bilateral technology transfer, the proposal envisages a rapid process where no additional clinical trials will be needed “if originator retains market authorization”. It also acknowledges that in this case the recipient of the technology will be bound by contract which may limit production of other vaccines that could impact sustainability. (The example cited is J&J collaboration with Merck)
“Smaller manufacturers/biotechs in covid vaccine clinical development with promising products could transfer technology to drug manufacturers in LMICs,” the draft says.
On bilateral tech transfer, the proposal says,
“Existing manufacturers have already established a number of bilateral technology transfer agreements, and many of the vaccines registered in at least one country are already being produced or are in preparation for production in other countries. While this is enabling an increase in the global supply, global supply still falls far short of demand.
On the other side, there are a few vaccines in the late-development pipeline that are anticipated to demonstrate efficacy within the next few months, and several of these are from entities with limited in-house manufacturing capacity. It will therefore be critical to facilitate emergence of partnerships to enable production of these vaccines at large scale.”
On the multilateral technology hub, it has been proposed to “establish the process and provide access to necessary know-how and licenses to enable LMIC manufacturers to acquire the technology” in order to increase Covid-19 vaccine supply and facilitate preparedness for future epidemics and pandemics, according to the draft.
Such a multilateral tech hub could be “independent of multinational vaccine manufacturers. Ideally suited to enabling LMIC manufacturers acquire independent manufacturing for national health security,” the draft says.
Under such a multilateral arrangement, each manufacturer may have to conduct large clinical trials, the proposal notes. The WHO-led GAP programme for pandemic influenza capacity, is cited as an example for this kind of a multilateral tech transfer.
“A few technologies seem amenable such as mRNA technology– IP not barrier in LMICs, know-how available in academia and biotech,” the proposal notes.
On multilateral tech transfer, the proposal seems to build on WHO’s experience in enabling manufacturers in LMICs to obtain the know-how and technology necessary to produce pandemic- and seasonal- influenza vaccines. The proposal seeks to “establish one or more technology transfer hubs to enable any LMIC vaccine manufacturer that is interested to acquire the know-how and any necessary licenses to be able to manufacture a Covid vaccine and, as appropriate, use the technology for other pandemic or routine vaccine production.”
The technologies for transfer will be determined by factors including “Intellectual property freedom or availability of licenses under suitable terms, availability of experts with know-how who are free to share the know-how, capital investment required at country-level, ready availability of reagents etc.”
Image Source: Draft paper on COVID Vaccine Capacity Connector
THE PROBLEM WITH BILATERAL ARRANGEMENTS FOR TECH TRANSFER
One legal expert familiar with technology transfer discussions, asked “What kind of technology transfer are they talking about? For whom? We have seen in the past year that voluntary licensing approaches have largely failed to spur the production we need to meet the demand of vaccines for the pandemic. Only a fraction of the demand was met in 2020. So why are such secretive approaches being pushed?”
The recent vaccine summit showed that of the projected demand for more than 9 billion doses of vaccine needed in 2021, less than 500 million doses have thus far been produced.
The expert pointed to the Supply and License Agreement between Novavax-Serum Institute of India, which forbids SII to reverse engineer vaccine components. (See provision 2.6 on Restrictions on Use, in the agreement that has been published in the database on COVID-19 contracts by Knowledge Ecology International.)
There have been calls for companies such as J&J, for example to share technology, intellectual property, and know-how with WHO.
Sources also said that there has been resistance among leading vaccine manufacturers to map manufacturing capacities in the developing world. It is understood that “countries have been urging companies to share vaccine know-how”, as AP reported recently. (Also, see this CEPI document from June 2020 that had initial projections on manufacturing capacity.)
WHAT IS AT STAKE?
At this critical phase of the pandemic, instead of bolstering shared approaches such as the C-TAP to boost production of vaccines, the initiative is at a real risk of being hollowed out, even before it begins operations. WHO got 40 countries on board for C-TAP.
The tech transfer debate is being decisively seized and shaped by those who want to set the terms and conditions under which knowledge can be transferred. “The money is with ACT Accelerator, not WHO’s C-TAP, so naturally these efforts will be controlled by those who pay,” the source said.
WHO’s partners including CEPI, that has invested more than $1 billion in COVID-19 vaccines, and intends to raise $3.5 billion to invest in vaccines for future pandemics, is essentially against the idea of pooling of patents, sources said.
“Most of the major actors in the ACT Accelerator, are not in favor of C-TAP,” the source said.
“What will be the terms in these bilateral agreements in such a tech transfer hub? It is possible, we will never come to know,” a source said.
Questions have been raised why there has been so little transparency on the way, for example, CEPI and Gavi have structured COVAX contracts with manufacturers. While the pressure on the European Commission has been consistently building up with Members of European Parliament waiving redacted contracts, there has been no such ostensible pressure on international global health agencies during this pandemic, barring calls from civil society groups.
The problem with C-TAP, is that it is a voluntary arrangement, a source conceded. To be sure, this was highlighted right at the beginning, when some critics called WHO to out in place mandatory measures to share technology and know-how.
“Ultimately, member states have to step up and fight to support the C-TAP and keep this in the WHO.” If tech transfer needs to be administered within a multilateral framework to ensure transparency and equity, countries have to come together for this, the source said.
(This story was updated after publication to add the following link to a WTO document.)
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2. Wrap this week
In case you missed it, these EU-wide discussions will inevitably have a ripple effect in Geneva, both at WHO and WTO.
Ursula von der Leyen at the European Commission briefing this week speaking on using Article 122, of the European Union legislation that allow for emergency measures to regulate essential goods if “severe difficulties arise” in securing supplies.
The European Medicines Agency briefing on the conclusion of the review of the AstraZeneca vaccine and blood clots
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