Health has become a “geostrategic weapon” that can bring a continent and beyond to its knees. These are the words of MEP Nathalie Colin-Oesterlé (EPP, France), who drafted a report on shortages of medicines (see EUROPE 12453/17). According to this newcomer to the European Parliament, who has a degree in notarial law, it is unthinkable to continue to address the issue of access to medicines as we did before the Covid-19 crisis, by relying on market forces and declaring that each State is sovereign.
Her report, which recommends more European solidarity, is still being translated. It was due to be put to a vote in the Committee on the Environment (ENVI) at the end of June and in plenary in July, in order to feed into the future European strategy on medicines (on the agenda of the college of Commissioners for the end of July). (Interview by Sophie Petitjean)
What does your own-initiative report address?
Nathalie Colin-Oesterlé - My report is entitled ‘Shortages of medicines in the EU: how to combat this emerging problem’. I admit that made me smile, because it is not an emerging problem at all, but it is true that the Covid-19 crisis has exacerbated it, both in terms of shortages of medicines and medical equipment.
These stock shortages and supply pressures, which mainly concern chemicals and low-cost products, have increased 20-fold between 2000 and 2018 and 12-fold since 2008. Anti-cancer medicines, antibiotics, vaccines, anaesthetics, treatments for high blood pressure, heart diseases and diseases of the nervous system are particularly at risk. This situation poses considerable risks to patient health and safety.
My report addresses these issues. I have pushed the boundaries a little, but at the same time it is incredibly obvious, given the current crisis, that no Member State can manage on its own.
And what solutions do you recommend?
The crisis has highlighted Europe's increasing dependence on non-Member States (mainly China and India). Today, 80% of the active ingredients are manufactured in China and India, where labour costs and environmental standards are less stringent, and 40% of finished medicines are imported. That is why we need to regain health sovereignty.
Of course, we are not going to be able to relocate everything overnight; we will have to target certain medicines, medicines which are of interest for health reasons and strategically [those for which a shortage will pose a significant and immediate risk and for which there is no alternative treatment, editor's note]. For these, I think that State Aid will have to be authorised, not only for research and innovation, but also fiscal measures and incentives for manufacturers to start producing in Europe again.
Will relocating to Europe lead to higher prices?
It's a real concern. In France, this is not the policy at all. In Germany, on the other hand, medicines are more expensive, which in turn encourages parallel exports (some suppliers will prefer to distribute their medicines in Germany rather than in France). The point of State Aid is to enable manufacturers to meet additional costs.
The CEO of Sanofi, Paul Hudson, calls for the creation of a European authority, such as the American BARDA (Biomedical Advanced Research and Development Authority), whose task is to intervene where the market fails in the event of a crisis. What do you think of that?
It’s certainly an idea. I myself advocate the creation of one or more non-profit European pharmaceutical establishment(s), financed by the European budget. These establishments would be responsible for producing certain medicines which are of interest for health reasons and strategically in critical situations (either because there is only one production line or because they are difficult to obtain) and medicines that no longer offer profitability to the laboratory. It is also necessary to proceed with the rescEU mechanism in order to have some sort of European emergency pharmacy, which would allow certain Member States to use this supply of medicines in the event of a shortage. This requires the development of health strategies at European level, with a common basket of prioritised medicines and vaccines with harmonised prices.
In the past, Member States have been relatively reluctant to pool their health resources. What makes you think it could be any different?
My role as rapporteur is to make an example of this crisis for the future and to push the boundaries. When we see that some Member States overstock on medicines, including between hospitals within a territory, we need a regulatory authority. This could be the role of the European Medicines Agency, which would have wider competences, including with respect to human resources, and which would be in direct contact both with the industry and with national agencies to regulate levels.
Are there other lessons to be learned from the crisis?
I also recommend the simplification of legislation, with flexibilities and regulatory measures in the event of crises and shortages to allow the circulation of medicines between Member States. In times of crisis, it is necessary to be able to accept different packaging formats so that they can circulate between Member States.
We must also focus on research and innovation by diversifying our resources, by moving towards biotechnologies, in order to become the continent of the future for medicines. This is essential for the future.