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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
Parliament's health committee is answering calls for a firmer grip on policies affecting the well-being of its 450 million citizens.
The European Parliament's health committee is hammering home some of the lessons from the COVID pandemic, which demonstrated so clearly that Europe, both at EU level and among its 27 member countries, "was not ready to deal with public health emergencies." In an April 15 debate, MEPs restated—yet again—the need for changes to the way the EU operates in terms of health policy. Not the first such demand, but the latest in what is becoming a tidal wave of calls for a firmer grip on policies affecting the well-being of its 450 million citizens.
"Despite having experienced previous threats, health structures were not geared towards this possibility," said Spanish socialist Nicolas González Casares, who is leading the parliament's examination of EU plans for upgrading the role of the European Medicines Agency in the wake of the devastation wrought by the pandemic. He attributed the inadequacy to budget cuts that have "diminished the adaptive capacities of our health systems," and pointed to the desperate attempts to cope over the last year as the European Commission and EMA "have had to act by setting up ad hoc structures to achieve a better and more coordinated response."
He told his fellow MEPs that "there is a need for the Union to equip itself with an appropriate institutional framework to deal with emergencies such as the one we are experiencing, without having to improvise, with a clear mandate, and by providing a legal framework for EU institutions to play a more active role." And first up is the proposal for a strengthened mandate of EMA. However, the principal objective of his plea is not to arrange for faster authorization of new medicines to tackle pandemics, not to offer incentives to innovate. Instead, this proposal is limited to bolting additional tasks onto EMA in relation to the specific issue of drug supplies. His draft recommendation is designed to avert the sort of penury in medicines that have hit health services since the crisis began, and he urges developing an institutional framework that defines who does what at any given moment, provides for monitoring and controlling the medicines supply chain, and an agreed definition of drug shortages. He wants to see steering groups set up to overview the production and supply chain for medicines and medical devices. He spoke at length on the need to coordinate and share the knowledge among the member states, the EU institutions and the pharmaceutical industry, and on the merits of creating a European medicines supply database.
"Had a regulation of this nature been in force before the pandemic, some issues such as shortages or the approval of new treatments would probably have been dealt with more deftly during the pandemic," remarked González Casares. He may be right. But readers of ACT will be relieved to be reassured that the EU response to COVID goes further than merely turning EMA into a pill-counting institution. As González Casares acknowledges in the document, he presented to the health committee, there are other EU initiatives underway of a more strategic nature. Another of these was debated and voted through by the committee on April 16: a new procedure to accelerate the EU-wide approval of vaccines adapted to COVID variants. This takes the form of a rapidly-created legal provision to ease the passage of vital new medicines through the EMA's authorization system. It will provide a simplified procedure for vaccines that have already received EU authorization but which are being adapted to be effective against variants of the virus.
Their vote—which now needs to be endorsed by the parliament as a whole at a future plenary session—comes after the release of an EMA reflection paper in February, and discussions in recent weeks with senior members of EMA, including Marco Cavaleri, head of its office on biological health threats and vaccine strategy. They received assurances on the criteria and operation of the new mechanism—including requirements that variant vaccines must be based on already approved/in use vaccines, and justification for the relevance of the variants included, based on disease surveillance and characterization of strains circulating at the time of selecting the variants. The efficacy of a monovalent or a multivalent variant vaccine against the variant strains may be inferred from provision of immunogenicity data after primary vaccination with the variant vaccine; and after a single dose of the variant vaccine when given to subjects who previously received primary vaccination with the parent vaccine. And as soon as a global forum is established to support SARS-CoV-2 strain selection for vaccines (such as has been discussed at the World Health Organization), the recommendations made should be consulted when selecting the variant strains.
This may prove a more effective measure to bring the pandemic under control—but it also underlines the growing conviction among many Europeans—and their politicians—that there is a need for more Europe in the field of health, and for progress towards a health union to match the EU's other major achievements such as its monetary union that created the Euro and its customs union that permits free trade across the internal borders between its member states.