Parliament votes to expand remit of European Medicines Agency

Moves to shore up the European Medicines Agency (EMA), making it better equipped to tackle COVID-19 and future pandemics are gathering momentum, with the European Parliament today voting through its agreed position, allowing negotiations with member states on what the reinforced agency should look like to begin.

“In short, [there should be] more transparency, more participation, more coordination and more prevention,” said MEP and rapporteur for the file, Nicolás González Casares.

Reforming EMA is a response to how the EU was found wanting by COVID-19, with limited central power to deal with problems including drug and medical devices shortages; the need to quickly approve and set up large scale clinical trials; and a lack of open channels through which to exchange data about the pandemic.

To avoid similar problems in future, it is proposed EMA will be responsible for a central database of stocks of medicines and medical devices, allowing it to monitor the position on the ground across Europe and move to head off shortages. “With the new database, we [will] provide the agency with a crucial tool to monitor medicines supply and prevent shortages at all times,” González told Science|Business.

The agency will also be given the power to take the initiative on clinical trials of medicines, vaccines and medical devices for health emergencies. In addition, EMA will be responsible for setting up and managing panels of experts to take a broad view of emergency response across Europe and to conduct an annual review of crisis preparedness.

Vaccine trials are central to Parliament’s proposal, with a demand for well-designed, large-scale clinical trials and sufficient public information about them.

“The pandemic has shown that the EU and its member states were not prepared to tackle a challenge of this magnitude. Agencies such as the EMA did not have an adequate mandate or sufficient resources. We are now strengthening the EMA's capacity to deal with future emergencies,” said González.

The European Commission proposed expanding EMA’s powers last November, as part of a package of measures to strengthen Europe’s preparedness for future pandemics. In its proposal, the European Commission cites cases where medical products that did not comply with EU regulations, were potentially unsafe, and in some instances counterfeit, got into supply chain.

As the pandemic took off, member states prevented exports of some devices and drugs, disrupting the single market - and in disregard of the need for solidarity.

The proposal to extend EMA’s power is controversial because it is seen as encroaching on member states’ rights to total control of their healthcare systems.

Cross-border cooperation on health may be a delicate subject, but heads of state did agree a joint position on expanding EMA’s remit at the EU Council meeting last month, giving the negotiating mandate to the Slovenian Council presidency which started on 1 July. Their demands include clearer financial and data protection rules and changes to the rules on how the emergency task force will advise on clinical trials for health emergency products.

Enabling large clinical trials

Setting up clinical trials was a very big hole in the EU response to the pandemic, prompting the then director general of EMA Guido Rasi to complain to the European Parliament about the lack of coordination in May 2020. At this point in the pandemic more than 260 COVID-19 clinical studies were listed as planned or running in EMA’s database, which Rasi complained were too small to provide the data EMA needed to decide if the products being tested were safe and effective.

One example of how this impacted treatment of COVID-19 patients is the steroid drug dexamethasone, which required a large randomised trial to show a benefit. EMA had to rely on data from a UK trial, showing mortality in patients who needed intensive care was reduced by a third, in deciding whether or not to recommend member states use dexamethasone. EMA did not complete this assessment until the middle of September, three months after the steroid had become standard of care in the UK for all patients admitted to hospital with confirmed COVID-19.

During the crisis, the powers of EMA were extended, to allow it to conduct rolling reviews of vaccines and treatments for COVID-19. That allowed it to approve four vaccines on an accelerated timetable. “Now we need to put these arrangements on a permanent footing,” EU health commissioner Stella Kyriakides told MEPs.

The medical devices industry has expressed uncertainty about the move to give EMA powers to monitor supply chains. Regulation of medical devices in Europe is entirely separate from EMA and the industry is concerned there will be no corporate representative on the steering group monitoring supplies of devices.

For its part, the pharma industry is all in favour of any moves that will speed up regulatory oversight, and would like to see what it views as “appropriate science and risk-based regulatory agilities and flexibilities”, which were introduced to support expedited development and review of COVID-19 vaccines and therapeutics, maintained in future.

The industry body Vaccines Europe, called for the emergency task force to be a permanent body, rather than being convened when crisis hits. As the proposal stands, the task force would be a useful tool to ensure a fast reaction to a crisis but is, “insufficient to improve EU preparedness for potential emergency situations caused by infectious pathogens,” Vaccines Europe said.