The COVID-19 epidemic has exacerbated a situation that predates the current crisis: the European Union has ceased to be self-suffcient as regards medical supplies and drugs. As a result, European patients are suffering, on a very regular basis, from the shortage of drugs and medical materials. Unfortunately, it has needed a pandemic to raise awareness of this issue among the Member States.
Yet it is often from crises that progress is born. It is up to the European Union and the Member States to show that they have come to grips with the challenge. To remedy it, they need to adopt innovative measures in the short, medium and longterm.
“European patients are suffering, on a very regular basis, from the shortage of drugs and medical materials. Unfortunately, it has needed a pandemic to raise awareness of this issue among the Member States”
Currently, owing to the pressing need for vaccines, the Commission has just launched the HERA incubator, which will be the cornerstone of the future European authority of preparation for and reaction to healthcare emergencies. This will enable us to accelerate the approval of vaccines, to facilitate the homologation of new manufacturing sites and to sustain the massive production of adapted or new vaccines. This is only a prelude to Europe’s drug reinforcement campaign, the implementation of which will require the adoption of robust European legislation and recourse to innovative instruments.
While reviewing the mandate of the European Medicines Agency (EMA), we must enable it to anticipate, monitor and manage the shortages of medicines. In addition, it should be able to create a joint platform with the European Centre for Disease Prevention and Control (ECDC) in order to monitor the efficacy and safety of vaccines and medicines.
Within the framework of the Pharmaceutical Strategy, the review of regulations governing access to drugs should enable us to confront shortages, both in times of crisis and in periods of calm. In order to sustain the innovation and the accessibility of medicines in Europe, incentives matching guarantees of supply by companies need to be put in place. In a parallel manner, the European Union will need to encourage the setting up of coalitions of Member States for the pricing of drugs, the processing of payments and policies of joint purchases. European negotiation for the joint purchase of vaccines is a first, and one which will demonstrate that this is feasible.
Without negotiation on a Union-wide scale, few Member States would have been able to aspire to a diversified portfolio of vaccines. Yet it will be necessary to do much more in order to restore our pharmaceutical independence. In the medium term, we will need to convince the major companies to set up their businesses in, or to return to, European territory. However, it would be naive to think that they will do so without suitable financial incentive. That could be possible through State Aid or via the instrument for Important Projects of Common European interest (IPCEI). No pathway should be excluded.
“Without negotiation on a Union-wide scale, few Member States would have been able to aspire to a diversified portfolio of vaccines”
However, the process of making our territory a more attractive place to do business must not in any way be to the detriment of the environmental and social standards to which European citizens are deeply and understandably attached. The creation in Europe of one or several pharmaceutical establishments pursuing a non-profit objective could, in addition, enable us to produce established medicines in an ongoing critical situation.
These are the ones that are no longer presenting real opportunity in terms of profitability for the major companies. In the longer term, the creation of HERA, a European Authority for the preparation of, and reaction to, health emergencies - in other words a type of European BARDA - is a welcome piece of news. As of 2023, HERA will be able to reinforce the preparation and the response of the EU to cross-border health threats, whilst enabling the swift availability, access and distribution of the necessary countermeasures.
So, the options are all on the table. And we will go as far as the political will of the Member States will allow. It will be in their interest and that of their citizens. This health crisis has shown the absolute necessity of building “Health Europe”. Questioning certain prerogatives of the Member States may well not go down well, but we must consider the long-term benefits of a common ambition enabling us to assert our strategic independence and ensure the protection of citizens’ most precious possession - their health.