Shortages of masks, hydroalcoholic gel, reagents for screening tests, respiratory assistance equipment and anaesthetics in intensive care units… The COVID-19 epidemic has aggravated an issue that has been around for some time: the European Union has become dependent on medicines and medical equipment.
For 10 years, several health professionals, pharmacists, parliamentarians and patient associations have been sounding the alarm to convince public authorities of the need to promptly regain European pharmaceutical independence.
Unfortunately, it took a health crisis of this magnitude to raise awareness among Member States. This pandemic is ultimately a real-life stress test exercise. A test the European Union has sadly failed so far.
In the face of the health emergency, national egoisms are first to surface. State overstocks and export bans on medical products and equipment are attitudes that should be eliminated. Solidarity must come first.
After a few weeks of indecisiveness, the European Commission and the Member States realised that taking coordinated measures and actions was paramount against the virus.
Triggering the EU-RescUE reserve; using joint procurement procedures for medical equipment; speeding up procedures for placing medicinal product on the market; the Commission issuing recommendations to Member States; and, currently, reaching advance purchase agreements of vaccines, these emergency measures managed to temporarily mitigate the effects of our pharmaceutical dependence on several third countries.
Progress often emerges from crises. It is up to the European Union to demonstrate that it has grasped the scale of the challenge by adopting remedial innovative actions in the short, medium and long term.
We must now promote appropriate and sustainable responses. Adopting strong, diversified and complementary measures will hopefully shield us from ever experiencing such a state of tension.
Contrary to common belief, regaining our strategic sovereignty will not be achieved solely by bringing back medical equipment and medicines production to Europe.
There is of course an urgent need to relocate part of the production of essential products and medicines of major therapeutic interest to Europe. However, it is utopian to hope that the pharmaceutical industries will work towards that end without requiring some kind of compensation.
Whether it is through state aid or through the Important Projects of Common Interest Instrument (IPCII), the European Union will have to encourage companies to set up in or come back to Europe. In return for financial support, some guarantees will obviously be required. The aid granted will have to be conditional on full compliance by companies with the environmental and societal standards in force. And the European Union will have to make sure that their set-up or relocation does not result in higher prices for medicinal products.
Creating one or more non-profit pharmaceutical establishments in Europe could enable us to produce mature medicines that are constantly critical. These are old medicines that no longer have any real interest in terms of profitability for their producers.
These structures should, of course, be supported by the public authorities of the Member States. It will therefore be key to garner a strong political will in order to conduct the reflection on this proposal.
Beyond bringing back the health industry on European soil, we must explore various concrete ways of ensuring European pharmaceutical independence.
In the first version of its Multiannual Financial Programme dedicated to health, the European Commission referred to the creation of a sustainable stockpile of essential medicines. The initial budget of €9.4 billion considered by the Commission was a viable option. Unfortunately, the drastic budget cuts to the “EU4HEALTH” health programme, wanted by the Member States, seem to have blunted this too costly ambition. However, we should not give up on it.
The European Union could link marketing authorisations to industrial holders creating reserves of medicines of major therapeutic interest to meet the needs of people over a short period of time, for instance three months, which would not increase the risk of expiry due to storage.
It is finally towards a combination of the various pathways abovementioned that the European Commission seems to leaning in order to regain our health sovereignty.
In her State of the Union address, the President of the European Commission, Ursula von der Leyen, called for the creation of an advanced biomedical research and development agency at European level, modelled on the BARDA in the United States.
The aim of this new agency would be to strengthen our innovation capacity and preparedness for cross-border threats and emergencies. This European BARDA could enable us to build up strategic reserves of medical products.
However, it will require significant financial means, the US BARDA’s budget for 2020 being $1.6 billion. How are we to finance a European BARDA with a health programme trimmed down to €1.7 billion over 7 years? This is a question that the Commission and the Member States will soon have to answer in the negotiations with the European Parliament on the “EU4HEALTH” health programme.
Money remains the sinews of this war, so it seems. Despite a drastically reduced funding for health actions, we will have to regain our sovereignty over health products and stand ready to face yet another “stress test”.
This health crisis further reinforces the absolute necessity to build a Europe of Health, placing the protection of citizens as our top priority, even at the cost of questioning some of the prerogatives of the Member States to the benefit of a common and shared ambition.