The lack of medicinal products and medical devices, of which the general public has been so aware of over the past few months, is nothing new. The COVID-19 health crisis and the sudden and greatly increased global demand for medicines has merely shone a public light on a phenomenon that healthcare professionals and some patients were already well aware of.
Unfortunately, this situation is at risk of creating headlines again, as we enter flu season and are hit in full force by the second wave of COVID-19. The disruption and pressures affecting supply were multiplied twenty times between 2000 and 2018, resulting in considerable risks to patient safety and weakening the healthcare system in the Member States.
The COVID-19 health crisis has also highlighted the increasing dependence of the European Union on third countries, mainly China and India. We are discovering, slightly too late, that public health has become a geostrategic issue, one that is capable of bringing a continent to its knees.
“The COVID-19 health crisis has also highlighted the increasing dependence of the European Union on third countries, mainly China and India. We are discovering, slightly too late, that public health has become a geostrategic issue, one that is capable of bringing a continent to its knees”
While healthcare falls under the competence of each Member State, it is the duty of the European Union, according to Article 168 of the Treaty on the Functioning of the EU, to coordinate and supplement the national actions, to act to guarantee European citizens a high quality healthcare policy, to protect citizens against threats to health, to improve monitoring and preparation for epidemics and bioterrorism and to strengthen the ability to face new health issues such as climate change.
More cooperation and dialogue are therefore essential for strengthening European effectiveness and reactivity. This cooperation should be structured and ongoing and the fight against medicinal product shortages should be one of the catalysts for this. This fight should be based on three pillars: delivering health sovereignty by securing provisions, strengthening European actions to better coordinate and supplement the health policies of Member States and developing cooperation between the latter.
This was the whole purpose of my work as the rapporteur of an own-initiative report on medicinal product shortages adopted by a very large majority in the European Parliament on 17 September. In this report, we propose short-term, medium-term and long-term approaches aimed at remedying the shortages that occur during pandemics.
First of all, it is essential to continue with the RescUE system, which aims to create a European emergency pharmacy for medicinal products deemed as having a health and strategic interest. In other words, those for which any disruption would result in an immediate life-threatening situation for patients suffering from a serious illness, and where there are no therapeutic alternatives recommended by the authorities.
The objective was to develop healthcare strategies with a common basket of priority medicinal products and vaccines. At the same time, it is essential that we rethink tendering procedures and make security of supply as much of a priority criteria as the price, by asking suppliers to guarantee multiple production sites to expand contingencies and by awarding tenders to several bidders.
We also need to strengthen and guarantee better transparency in the distribution chain and better information for all of the actors involved by centralising information. It is essential that we tackle the effects of “overstocking”, particularly at Member State level. My report also proposes making the European Medicines Agency the regulatory authority for issues of real-time stock control, together with national agencies, to anticipate stock pressures and regulate them.
One point that is especially close to my heart and that the crisis has emphasised is the issue of European production and the relocation of some industries. This is a key point in the report. It is vital that we encourage manufacturers to produce within the European Union, including authorising national public aid, to guarantee our security and our independence.
“One point that is especially close to my heart and that the crisis has emphasised is the issue of European production and the relocation of some industries. This is a key point in the report. It is vital that we encourage manufacturers to produce within the European Union”
In order to both respond to the needs of patients, and fight against shortages, I wanted to put forward the idea of creating one or more European non-profit pharmaceutical establishments. These should be capable of producing medicinal products, of a health and strategic interest, during critical situations or periods in which this is no longer profitable for pharmaceutical companies. I am glad that my colleagues supported this.
The purpose of this was not to compete with laboratories and manufacturers but rather to compensate for any lack of production. The report is just a first step in the EU4Health COVID-19 response framework programme negotiations that are currently ongoing and also in the implementation of the pharmaceutical and industrial strategy.
We owe it to ourselves to collectively achieve solutions that guarantee the implementation of a real European health policy across the continent, one that better responds to patient needs.