COVID-19 Catalyzing Changes in European Medicines Regulation

It isn’t that Europe has given up on fighting COVID-19. It just hasn’t been managing very well to bring down infections, hospitalizations, and deaths, despite the valiant efforts of researchers and companies and regulators to develop and deliver treatments and vaccines. So—with the remarkable exception of the UK, whose appalling mortality rate is at least partly compensated for by a rapid vaccination campaign—Europe doesn’t have a very good tale to tell its citizens.

The poor current performance isn’t why the European Union is increasingly turning its focus to the future. All the constant EU talk of what’s coming up next is in fact a recognition of its failings, rather than a diversion or smokescreen to disguise its errors. The shift toward next week, next month, next year is inspired by a genuine ambition to fill those massive gaps in its healthcare capacities exposed so cruelly by COVID over the last year or so.

That is why the EU has been announcing initiatives and plans and proposals on an almost weekly basis since mid-2020. And alongside the strategies for economic recovery, the principal emphasis has been on health, and particularly on medicines. A vaccines strategy, a European health union, a pharmaceutical strategy, a European health data space, a new agency—modeled on the US BARDA—to bring together pharma companies, health authorities, and scientists to devise responses to virus mutations.

The most recent of these ideas is to boost the powers of the European Medicines Agency (EMA), and a proposal is just starting its progress through the EU’s legislative machinery. It takes the form of a draft regulation “on a reinforced role for the [EMA] in crisis preparedness and management for medicinal products and medical devices.”

“The unprecedented experience of the pandemic has demonstrated that the Union’s ability to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development is currently limited,” the proposal concedes right up front, recounting the shortages experienced of products and data, and the ad hoc solutions deployed in response. For the EU to “become efficient and predictable,” and to put adequate new structures in place, legally-enforced change is necessary, it concludes. So it envisions a new framework for making preparations and for responding to public health emergencies that will allow the EU “to react quickly, efficiently, and in a coordinated manner.”

The new responsibilities of EMA will be to “monitor and mitigate potential and actual shortages of critical medicines,” and to advise on products that could treat, prevent, or diagnose, whether they are in R&D, used under national compassionate use, or already authorized for a different indication and to be repurposed.

The new duties will include gathering data on medicines and devices considered the most likely to be impacted by a health emergency. The agency will have to “ensure timely development of high quality, safe, and efficacious medicinal products with a particular focus on addressing a given public health emergency.” And there will be new procedures to ease one of the big challenges that drug firms have been facing as they try to develop new treatments: Europe’s Byzantine clinical trials rules. The EU’s survey of problems encountered over recent months reveals that in particular, “developers indicated a lack of harmonization on aspects related to clinical trials, stemming mainly from the fact that each trial needs to be authorized separately in each member state,” the text of the draft law explains. A passage in the new law will aim to overcome this: “By facilitating the development of medicines which have the potential to treat, prevent, or diagnose a disease causing a public health crisis, the proposal will support the implementation of the current legislation on clinical trials. The agency and member states can use opinions and recommendations on such medicines in regulatory procedures leading to their authorization for use within the EU.”

Overall, the new arrangements amount to a mea culpa, and a bid to remove obstacles. Looking back over the last year, the EU says: “An uncoordinated approach to the development of medicines which have the potential to treat, prevent, or diagnose diseases causing public health emergencies can cause delays in their development during periods where time is of the essence. In addition, regulators’ access to EU-wide health data is limited and scattered across different partners leading to complex and slow analysis, undermining the optimal time window for certain interventions.”

The candor of the EU analysis is unusual. But so too is the situation. And so too is the planned response.

Reflector is Pharm Exec’s correspondent in Brussels