Addressing medicine shortages: the symbol of the creation of a Europe of Health

By Nathalie Colin-Oesterlé, MEP (EPP Group - France), Vice-President BECA Commission & Member of the ENVI Committee

The shortages of medicines and medical equipment are not a new concern. However, the COVID-19 health crisis, with the sudden and rising global demand for these products, has shed light on a phenomenon that healthcare workers and some patients know all too well.

Stock-outs and supply tensions have increased twenty-fold between 2000 and 2018, posing considerable risks to patient safety and undermining the health systems of the Member States.

The COVID-19 health crisis also brought to light the EU’s increasing dependency on third countries, chief among which are China and India.

We have discovered, albeit a little late, that public health has become a geostrategic weapon that can bring a continent to its knees.

While health is the responsibility of each Member State, it befalls on the European Union, in accordance with Article 168 of the Treaty on the Functioning of the EU, to coordinate and complement national measures, to take action to ensure a high quality health policy for European citizens, to protect citizens against health hazards, to improve surveillance and preparedness against epidemics and bioterrorism, and to strengthen the capacity to address new health challenges, including those arising from climate change.

Closer cooperation and improved consultation are therefore essential to strengthen European efficiency and responsiveness. This cooperation has finally begun to take shape and must absolutely be made permanent, the fight against medicine shortages being one of the catalysts.

This fight must be based on three pillars: regaining health sovereignty by securing supplies; strengthening European action to better coordinate and complement health policies in Member States; and developing cooperation between Member States. This was in fact the sole purpose of my work as the author of the own-initiative report on medicine shortages adopted by an overwhelming majority in the European Parliament on 17 September 2020. I am delighted that these ideas have been placed at the core of the European Commission’s proposals for the implementation of its pharmaceutical strategy and the recast of the legal framework on serious cross-border health threats, as well as the revision of the European Medicines Agency and the European Centre for Disease Prevention and Control regulations.

First of all, it is crucial that the RescUE system be made permanent in order to turn it into a European emergency pharmacy for medicines of health and strategic interest, i.e., those for which a stock shortage would bring about a vital and immediate risk for patients suffering from a serious pathology, if there is no therapeutic alternative recommended by the authorities. The goal is to develop a few health strategies with a common basket of priority medicines and vaccines.

At the same time,

It is essential to rethink tendering procedures by granting security of supply as much importance as price, by having suppliers set up multiple production sites to limit uncertainties or by awarding tenders to several winners.

We must also strengthen and ensure greater transparency in the distribution chain and better information for all the players concerned, through centralised information. It is crucial to counter the effects of “overstocking”, particularly at Member State level.

One point that is particularly dear to my heart, and which the crisis has highlighted, is the issue of European production and the relocation of certain industries. I am therefore pleased that this key point in my report has been widely taken up at European level, particularly in the strategy put in place by the European Commission to encourage manufacturers to produce within the European Union, including by allowing national public aid, to guarantee our security and independence.

The last couple of months have shown us that the issue of development, access and distribution of treatments is fundamental to guaranteeing appropriate medical care to all European citizens. The COVID-19 crisis has laid bare our shortcomings and, above all, our naivety when negotiating contracts with companies and our international partners. This must not be repeated, and we must not wait for the next crisis before taking the appropriate steps. We are aware of some of our needs, and as developing production chains cannot be done overnight, we must lay the foundations today to secure our independence. To this end, knowing our current capacities is essential, as well as strengthening them if necessary and helping develop new ones. We also need to identify the weaknesses in our health systems so that we can address them. And finally, we need to promote, especially in times of crisis, the development of partnerships between companies to boost production, as it is currently the case with the production of COVID-19 vaccines.

The European continent must become the continent of the future through the promotion of research and innovation. Increasing the budget of Horizon Europe, Europe’s research and innovation framework programme, is excellent news, as was the development of a new European agency, the European Health Emergency Preparedness and Response Authority.

This agency will strive to improve the EU’s preparedness and response to serious cross-border health threats by promoting the prompt availability and dissemination of, and access to the necessary countermeasures. However, if we really want to create our European “BARDA”, we must bestow upon it the means to do so.

Finally, in my report I also suggested creating one or more non-profit European pharmaceutical establishments capable of producing medicines of health and strategic interest in critical situations, or no longer profitable for pharmaceutical companies. The aim is not to compete with laboratories and industrial players but to compensate for the lack of production. It is regrettable that at present this proposal, despite benefitting from the support of Parliament, has not been taken up, even though I believe it could guarantee access to medicines for every citizen.

Together, we must devise solutions to ensure the establishment of a real European health policy, one that would meet the needs of the patients.