If, a little over a year ago we had asked EU citizens what the acronyms EMA or ECDC stand for, very few would have known the answer. Now, however, they are familiar to millions of Europeans. Somehow, we have discovered the importance of having strong European institutions in the field of healthcare.
The European Medicines Agency, based in Amsterdam, is one of the EU’s largest agencies. It employs a significant number of professionals and is a benchmark for knowledge in its field. Its main work focuses on the scientific evaluation, supervision, and monitoring of the safety of medicines for human and veterinary use.
One procedure fundamental to the workings of the EMA is that of centralised authorisation: medicines recommended by the Agency and approved through a single procedure by the European Commission can be marketed throughout the EU and EEA.
That is the procedure (via an accelerated route) that the four vaccines currently authorised for prevention of SARS-CoV-2 passed. As such, the EMA has been in the spotlight over the last few months because of a key issue: consulting on and evaluating the approval of vaccines that will be used to fight the biggest pandemic in 100 years; that is threatening a common area that is home to over 450 million people.
This is a complex task, and one that is not free from controversy. It is one in which the EMA has worked hard within the scope of its mandate and within a legal framework, the existing framework, and which has revealed its weak points.
“Faced with global threats, we need common European responses; that’s one of the clear lessons of the past year”
One of the lessons learnt from this pandemic is that we must reinforce European coordination in healthcare and move to a so-called ‘Health Union’. Faced with global threats, we need common European responses; that’s one of the clear lessons of the past year.
Hence the proposal to increase the Agency’s role in a health crisis; we cannot go on improvising ad hoc responses when faced with emergencies, whether they are pandemics - such as the one we are experiencing currently - or indeed any other kind.
Under the new regulation, the EU will be equipped with the right institutional framework to face emergencies without improvisation, with a clear mandate, and will be provided with legal cover for European institutions playing a more active role.
Clearly, another lesson to be learnt from this pandemic is that Europe needs to play a bigger part in healthcare. We all recall the multiplicity of national responses at the outset: the border closures, the refusal to help in response to requests for healthcare materials.
This cannot happen again. Europe must establish a prevention and response for dealing with such emergencies. In the EMA’s case, such a structure implies an institutional framework defined in collaboration with the governing bodies on the matter of medicines and healthcare products. It would also involve the task force, specifying who does what and when, coordinating the response, and avoiding unilateral, short-term action.
It requires a framework for monitoring and controlling the medicines supply chain with obligations imposed on each actor. It will mean defining lists of critical medicines and healthcare products for each emergency and, for the first time, a common definition of a medicine shortage. All of the above are badly needed and so often requested by the European Parliament.
Yet responding to these emergencies involves preparing for, and - to the fullest extent possible - acting to prevent shortages. The Pharmaceutical Strategy for Europe has already put forward several initiatives that will be implemented over the coming years and should help provide a global response.
“One of the lessons learnt from this pandemic is that we must reinforce European coordination in healthcare and move to a so-called ‘Health Union’”
However, this Regulation is a useful instrument that can and should provide transparency in the supply chain as well as for better monitoring of that chain to prevent shortages that could prove critical in the context of a health emergency.
Therefore, we must seize this moment, of rebuilding our economies and our exhausted health systems, to provide fresh momentum and new tools. These should allow us to know which stocks we have, where they are and who manages them, and allow us to cross-reference the data at national and European levels to find solutions.
We must also take advantage of this data to make forecasts and anticipate potential problems. It is more than likely that, if a Regulation with these features had come into force before the current pandemic, then issues such as shortages or the approval of new treatments would have been dealt with much more quickly. Therefore, let us not delay its approval.