Probably a large part of the European or Spanish citizenship was unaware of the existence of the European Medicines Agency (EMA) before the pandemic caused by SARS Cov-2 and, however, in the last year its evaluations and recommendations have crept into the daily conversations and have generated enormous anticipation. The clearest example is the vaccines against COVID-19.
The EMA, located in Amsterdam (after the failed opportunity of Barcelona) after its transfer due to Brexit, is one of the large European agencies, whose fundamental function, in short, is to evaluate and advise for the marketing authorization of medicines. The EMA is one of the largest European agencies both in terms of personnel and budget, but despite this, like many other health institutions or the governments themselves, it was not fully prepared to face a crisis like the one we are still experiencing.
The EU experienced moments of lack of coordination and confusion at the beginning of the pandemic, since it surprised us without a true European health policy. Fortunately, we realized that this was not a situation to respond to in 27 different ways, so that through the creation of ad hoc structures, a coordinated response was emerging that has allowed successes such as the vaccination campaign and progress in the design of a new European health policy, the “Health EU”, which the European institutions have put in place to advance in a coordinated manner in the face of common health challenges and threats without undermining the health competencies of the states.
Within this new approach, the reinforcement of the EMA for crisis situations will be the first legislative proposal of the “Health EU” approved by the European Parliament, taking good note of what happened during this crisis and the relevant role that for hundreds out of millions of Europeans and Europeans has played, and continues to play, this institution.
This proposal, on which I have had the honor of working as rapporteur for the European Parliament over the last few months, advances in several crucial aspects for the future of European health policies, such as, for example, improving coordination with member states and greater transparency of agency deliberations in crisis situations. A transparency that is also reinforced in terms of the publication of clinical trials of new drugs or vaccines, since this lack of information in some cases has led to complaints from institutions and civil society that are now being addressed. For this reason, we also incorporate the representatives of patients and health professionals with a more active role.
On the other hand, we have incorporated into the new regulation the “one health” approach, which confirms the evidence that human health, animal health and that of our environment are connected, as this pandemic and other previous health crises. In this sense, a link is also established for consultation with the veterinary drugs committee in cases of zoonoses.
But if there is a crucial element in the proposal, it is the implementation of solutions to advance in the fight against an endemic problem in the field of health in the EU: the shortage of drugs. The European Parliament has insisted through different resolutions on the urgency of putting measures to combat them on the table as it is increasingly common for patients not to receive the medicines that their doctor prescribes. It is a multi-causal problem (industrial, commercial, logistic, etc.) but, of course, if we want to advance in its solution, the first thing we need is to monitor the operation of the supply chain to know its scope in detail and be able to act. For this, we have proposed a European Database on the Supply of Medicines that reports on existing stocks, supply, demand and neglected demands at the level of each member state and that the EMA can visualize at the European level, detecting and even advancing the appearance of shortages.
Likewise, and as what we are looking for is a real impact on improving the functioning of supply chains, we have envisaged a sanctions regime that encourages compliance with the obligations provided for pharmaceutical companies and manufacturers of medical devices and penalizes non-compliance.
Finally, we strengthen the coordinating role of the EMA also in the field of managing the supply of medical products and devices (protective equipment, apparatus, consumables …) in crisis situations, since, as we saw at the beginning of the pandemic, their scarcity it can lead to extremely serious healthcare stresses for both healthcare professionals and patients.
In short, the path to the Health Union began months ago but, without a doubt, it is urgent to move forward firmly if we want to offer citizens greater security in this field. This proposal to strengthen the EMA is a crucial first step to build the ambitious Health Union focused on the needs of the citizens that Europe needs. Let’s go ahead.