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Here's a new conundrum for drug developers to solve: what to do with ownership of COVID vaccine candidates that have been abandoned despite promising trial results…
The question arises from Sanofi's decision this week to drop its mRNA product—and from the immediate call from Médecins Sans Frontières for the transfer of the technology and know-how to the World Health Organization-led mRNA vaccine hub in South Africa.
Sanofi's decision to drop further clinical development of the vaccine, which it acquired when it took over Translate Bio in August, prompted the suggestion from MSF, which has been a leading advocate of technology transfer to widen global access to COVID vaccines. As MSF argues, such a move is overdue. Since the set-up of the WHO hub was announced in April, it has still yet to receive any technology transfers, and is now resorting to attempting to develop its own mRNA COVID-19 vaccine candidate from scratch—"a lengthy, unnecessarily duplicative process," says MSF. Any mRNA know-how shared "could save time and help the hub’s efforts towards developing a safe and effective mRNA vaccine for low- and middle-income countries."
So far, most of the international pharmaceutical sector—with strong backing from the European Commission and from many governments with a domestic pharmaceutical industry—has stood firm against weakening of its grip on title to its discoveries and the related know-how. The confrontation has taken place most conspicuously over intellectual property rights, played out in the high-profile debates at the World Trade Organization over patent waivers on COVID vaccines.
A proposal from India and South Africa to address inequities in access to critical COVID vaccine commodities, by providing a waiver under the international trade treaty provisions known as TRIPS, is still deadlocked a year after it was submitted, despite being co-sponsored by 63 WTO member states and being supported by more than 100, as well as by the World Health Organization and leading scientific, medical, and political leaders. The European Parliament has also approved a resolution “calling for support for proactive, constructive, and text-based negotiations for a temporary waiver of the WTO TRIPS Agreement, aiming to enhance global access to affordable COVID19-related medical products and to address global production constraints and supply shortages”.
The industry argument has consistently focused on the need for strong IP rights to maintain the incentive for innovation. According to the main European drug lobby, EFPIA, "Intellectual property has acted as the much-needed catalyst to develop COVID-19 vaccines, treatments and diagnostics," and "we agree with the Commission that the broad waiver proposed by a number of WTO members is not the right response to the pandemic." EFPIA and its member companies "do not believe the use of TRIPS flexibilities can address the concerns raised, as those concerns can only be addressed by removing the real obstacles to distribution, such as trade barriers, movement of raw materials to existing facilities, and sharing of excess doses." Similar messages have come from the global IFPMA and the US PhRMA.
But the arguments against forced transfer of rights on products developed or under development might not serve with the same force in the case of a candidate vaccine no longer under development – and even more so when the candidate has, on the developer's own admission, shown positive Phase I/II study interim results that "confirm the potential", with high seroconversion across the three dosages tested and comparable tolerability to other unmodified mRNA vaccines. "Sanofi as a global pharmaceutical actor should assist the hub in getting access to key starting materials for mRNA vaccine development and production. If successful, the hub would then assist multiple able manufacturers in low- and middle-income countries to start production of COVID-19 and other mRNA-based vaccines for the current and future pandemics," says MSF.
“It’s unconscionable for Sanofi to let a promising vaccine candidate gather dust on its shelves simply because it won’t be lucrative for them, when they have an opportunity to put this research to lifesaving use by transferring their know-how to the WHO mRNA vaccine hub in South Africa," said Alain Alsalhani, Vaccines and Special Projects Pharmacist at MSF’s Access Campaign.
And just to demonstrate the complexity of influence and decision-making in this contentious field, this week the European Parliament's legal affairs committee adopted a report that insists that "stronger intellectual property rights are needed to help EU businesses recover from the pandemic." That's one of the powerful committees of the same parliament that voted just months ago in favor of the TRIPS waiver. And the parliament is one of the three principal legislative bodies of the EU—alongside the European Commission that is highly cautious about weakening IP rights.
So, answers please, on a postcard…