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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
The latest initiative against COVID, the European Health Emergency Preparedness and Response Authority, is taking shape with intentions of revealing the vulnerabilities in global supply chains and more.
The European Union is still beating itself up for its failings in countering COVID, and the latest initiative to emerge in its bid to remedy the deficiencies is destined to make some early changes to the rules on medicines marketing, and to bring in some longer-term changes to clinical development too. The project, known as HERA–a classic EU non-abbreviation, this time for the European Health Emergency Preparedness and Response Authority–is now taking shape, with multiple objectives that will overall, according to the European Commission proposal, be a systematic response to “revealed vulnerabilities in global supply chains, and insufficient oversight of manufacturing capacities and research priorities in the EU.”
EU leaders have been calling for urgent action, ranging from better epidemiological data to mobilizing research funds, and for regulatory flexibilities to accelerate the development of vaccines and therapies, as well as more joint procurement programs for critical supplies. They have openly acknowledged their admiration for the example shown by the US Biomedical Advanced Research and Development Authority in accelerating the development of countermeasures and boosting manufacturing capacities when needed.
So HERA is going to come into being, as a complement to the European Centre for Disease Prevention and Control and the European Medicines Agency. And in the meantime, a series of immediate actions “will test a number of solutions that could serve as a blueprint”–looking particularly at emerging biological threats to human health and antimicrobial resistance. One of these is the ‘HERA incubator’, presented as a concept in mid-February. This will provide new money for genomic testing, more agile approval procedures, and pressure for industry to boost production capacity. Sourcing vaccines from beyond the EU and support for transfer of technology are also entertained as options.
One of the first changes likely to take effect will be faster regulatory processing of vaccines adapted to tackle COVID variants. Based on current EU procedures for approving annual influenza vaccines, it will permit release on a smaller set of additional data submitted to the European Medicines Agency on a rolling basis, with early guidance for developers on data requirements. Central to this approach is a “new category of emergency authorization of vaccines at EU level with shared liability among member states.” The real novelty is the sharing of liability. At present, member states can give national-level emergency approvals on the basis of only limited data–as Hungary has done for the Russian Sputnik vaccine–but each country that chooses this route must cover any liabilities that arise from the product’s use. By giving such approvals formal EU status, the liability would be borne by all member states–which would, it is calculated, allow more rapid EU-wide response. To further ease supply, certification of new or repurposed manufacturing sites for vaccines will be pushed through faster, with early involvement of regulatory authorities.
Early responses to the EU thinking have been broadly favorable from stakeholders directly involved in drug development or regulation. The European affairs department of the French government has lent its support to the project, and the Danish government gave its backing, although with a warning against uncertainties arising from overlapping tasks–a view echoed by the German Medicines Manufacturers’ Association, BAH.
Johnson & Johnson rapidly welcomed the proposal, urging large-scale investments in research and development for new vaccines, therapeutics, diagnostics and devices. “HERA should be equipped to collaborate throughout the entire process for the discovery, development, production, and deployment of effective countermeasures for future health crises, including pre-clinical and clinical development, manufacturing scale-up and validation, regulatory interactions and submissions, procurement and potential stockpiling,” it said. GSK said it was ready to cooperate, via its network of 14 manufacturing and four R&D facilities across the EU, and applauded the concept of a streamlined approach to development. It recommended funding HERA to carry out R&D and clinical development projects with appropriate research, industry and regulatory experts on its staff. EUCOPE, the lobby for Europe’s smaller research-based drug firms, threw its weight behind closer coordination and cooperation, particularly for greater regulatory flexibility, and for the development and manufacturing of specialized medicines and vaccines that are not viable without financial securities and regulatory collaboration.
In a detailed response, the main European drug industry association, EFPIA–together with its specialist Vaccines Europe section–endorsed the need for “a robust, resilient and agile ecosystem to anticipate and effectively manage pandemics and their consequences,” and welcomed the ambition to create HERA. “What is needed most for effective emergency preparedness and response is a system that is connected, responsive and collaborative, as innovation and opportunities to address health threats may come from unexpected areas,” it said. HERA could be both a central actor and a systems designer, working with health authorities and the private sector, it suggested. That will need “clear structures to address the existing gaps in supporting late-stage development and manufacturing.” But it warns of the risk that such a complex structure “implies hurdles, which might reduce the speed of decision-making,” so tools will be required “to eliminate redundant bureaucratic procedures and guarantee the necessary flexibility and speed to act.” At the same time, the new authority should have strong ties with international agencies such as WHO or BARDA, to avoid unnecessary competition and overlaps.
The process of creating this new agency is not going to run rapidly, since the EU has its own lengthy consultative and legislative machinery that must be satisfied. But just at the end of February, EU leaders gave a renewed jolt to the reflections, devoting an entire day of one of their summit meetings to beefing up Europe’s response to COVID. EU Council President Charles Michel’s invitation letter to the heads of state and government of the 27 member countries was unambiguous about the urgency: the situation “remains challenging due to the emergence of new variants,” but “our priority continues to be to speed up vaccinations across the EU.” Central to the discussions, he insisted, would be the issues around “accelerating the authorization process of vaccines, as well as their production and delivery,” and “solutions to bring manufacturers across supply chains together in order to scale-up production in the EU.”
It won’t be the first time that EU leaders have been asked to act rapidly on an issue of crucial importance for Europe and its citizens–and their record has not always been perfect in coming up with the required responses. But this is the first time they have been asked to move fast against the background of a mounting toll of death and disease that their actions could prove to be literally vital in arresting.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium