Drawing lessons from the Covid-19 pandemic, on Wednesday 11 November the European Commission presented a set of tools for better prevention of and response to future health crises. The new package allows the EU to declare a “public health emergency” without waiting for the World Health Organization. It also suggests increasing the teams, at European level, by around 100 people.
These proposals, which have been very well received by the main political groups in the European Parliament, revolve around a general communication, a draft regulation on cross-border health threats, a strengthening of the mandate of the European Centre for Disease Prevention and Control (ECDC) and an extension of the mandate of the European Medicines Agency (EMA) (see EUROPE 12599/18, 12592/5).
Strengthen existing tools
This new package clearly aims to avoid the mistakes of the past and to learn from the Covid-19, which has already infected a quarter of the European population.
“With today’s proposals we are preparing the first steps towards a European Health Union”, said Health Commissioner Stella Kyriakides at a press conference, stressing that this is about working within the limits of the Treaty. The question of competences will only be analysed later, in the framework of the Conference on the Future of Europe.
No revolution, therefore, but a strengthening of the existing tools. Thus, the Commission proposes to transform Decision 1082/2013/EU on serious cross-border health threats into a Regulation, in order to give it more weight. It also gives more weight to the Health Security Committee by allowing it to formally adopt guidelines or by inviting, for example, the Deputy Ministers of Health to meet in the Committee’s High Level Group.
It also strengthens the mandate of the ECDC and the EMA by allocating more staff to both bodies: 73 additional staff for the ECDC, 40 for the EMA and 21 for the Directorate-General for Health at the Commission. “This is an amount we estimate at around €605 million over the next seven years”, commented Commissioner Kyriakides.
For German MEP Peter Liese (EPP), the reinforcement of ECDC staff - now estimated at 290 - is particularly necessary. “The German Robert Koch Institute, for example, has twice as many staff as the ECDC and is only responsible for Germany”, he said by way of comparison.
For the EMA, there are also new competences in the field of medical devices.
Avoiding Covid-19 “fails”
The new package also aims to avoid the chaos and lack of preparation at the beginning of the year against the Covid pandemic.
It tightens up preparedness and response plans for cross-border threats, providing for a plan at European level and criteria and indicators for national plans (which will no longer have to be submitted every 3 years, but every year). It provides for full-scale testing exercises and an audit process for these national plans, which should also include a section on research sector readiness.
It also allows the EU to declare an emergency, in order to facilitate the development, manufacture, stockpiling and supply of critical products in the event of a crisis and the adoption of immediately applicable implementing acts by the Commission.
It also improves the EU’s common procurement agreement, which is considered too slow in times of crisis. To this end, it envisages extending participation to the European Free Trade Association (EFTA) Member States and EU candidate countries, as well as introducing an exclusivity clause (to mitigate the risk of internal competition for limited resources or parallel national routes).
Finally, it provides for a new network of EU reference laboratories allowing standardisation in diagnostics, serological tests, screening methods and the use and validation of certain tests.
Upcoming initiatives
While welcoming these initiatives, several political groups - such as Renew Europe and S&D - called for more to come.
This observation is shared by the European Patients’ Forum (EPF) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The first calls for looking beyond the pandemic and addressing older priorities, such as chronic disease. The second champions wider ambitions for the EMA, which “needs further strengthening to ensure that Europe has a regulatory framework that is stable but adaptable, fast, effective and globally competitive”.
In its general communication, the Commission notes its intention to present in 2021 an EU Health Emergency Response Authority (HERA) modelled on the US BARDA. “The mission of this authority will be to enable the EU and its Member States to rapidly deploy the most advanced medical and other measures in the event of a health emergency, covering the entire value chain from conception to distribution and use”, the document, which mentions a start date of 2023, stresses.
See package documents: General Communication: https://bit.ly/38Dj42e; Regulation on Health Threats: https://bit.ly/38NB4Hh; ECDC: https://bit.ly/3pfq3nE; EMA: https://bit.ly/38EBnUv (Original version in French by Sophie Petitjean)