In the short to medium term, there is a concrete willingness to follow up on the lessons learned from the pandemic crisis, by strengthening European preparedness and a common response to present and future health emergencies. In the long term, the explicit ambition to undertake the path towards a European Health Union, without proposing an extension of the (reduced) EU competences in health matters defined in the Treaties. In between, the usual distance separating, on the one hand, the Commission’s aspirations laid out in comprehensive strategies and, on the other hand, the reality of limited EU powers and an inadequate common budget to achieve them.
The package of health initiatives presented on 11 November by the European Commission – a political communication and three legislative proposals – firstly aims to consolidate the regulatory framework for preparing and responding to health crises by strengthening the role of the involved agencies. In the EU executive’s intentions, it also outlines the first building-blocks of the future Health Union, announced last September by President Ursula von der Leyen in her first SOTEU speech.
The Health Union’s project is the content of the strategic communication adopted. The Commission’s thinking necessarily stems from the experience of the current pandemic crisis, which clearly demonstrates the need for greater coordination and cooperation between Member States and European institutions. The EU must, therefore, equip itself with adequate instruments to adequately prevent, manage and prepare for health crises. In the Commission’s conclusion, only a stronger Health Union with related social and economic benefits can be equal to this task.
However, the EU executive quickly points out that these first proposals “are in line with the provisions of the current Treaty”, as they will require the greatest commitment by the Member States “while respecting national competences in health matters”. The proposal to discuss the revision of the competences set out in the constitutional texts will be (perhaps) postponed to the Conference on the Future of Europe, but risks only remaining on paper. This is because it remains unlikely that the Conference can seriously debate and adopt binding conclusions on the reform of the Treaties, and because of the historic opposition of Member States to sovereignty transfers in the health sector.
Where legislative initiatives are concerned, the first aims to reform legislation on serious cross-border health threats in order to establish a stronger regulatory framework enabling the Commission and EU agencies to provide a better coordination in situations of crisis. Among other things, the EU executive proposes to strengthen crisis preparedness by authorising the formulation of a set of recommendations that should lead to elaborate uniform national prevention plans. As well, to strengthen surveillance, the Commission foresees establishing an integrated and enhanced monitoring system at European level, and promoting the use of “artificial intelligence and other advanced technological tools”.
Member States should be required to step up communication of health system indicators (availability of hospital beds, intensive care units, etc.). The most innovative element of the proposed legislation, however, is the possibility for the Union to declare an emergency situation at European level and, thus, move to a greater coordination so that the medical material needed for the crisis can be developed, stored and supplied immediately.
Strengthening the general regulatory framework means extending the mandates of the European agencies closely involved in fighting health crises – the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). The Commission proposes that the ECDC’s mandate should be reinforced so that it can better support the Commission and the Member States and not merely issue technical guidance without being able to provide, for example, any analysis of the data collected, as happened during the current pandemic. The new ECDC should, among other things, make stronger recommendations on measures to combat disease outbreaks and suggest risk management options to Member States. It should also intensify analysis and modelling to support individual countries in controlling outbreaks, collecting and processing more data and ensuring real-time epidemiological surveillance, and ensure capacity to mobilise and dispatch continental health task forces to support local response in individual countries.
The main objective of strengthening the European Medicines Agency’s mandate is to make the exceptional measures put in place during the Covid-19 pandemic permanent. The new EMA will, therefore, need to provide structural monitoring and risk mitigation actions for possible shortages of essential medicines and medical devices, provide a faster approval of medicines to treat or prevent diseases that may cause public health emergencies, speed up the process of scientific advice on trial protocols and carry out regular analyses of data collected from clinical trials and other studies
The communication also gives more details on the future European Agency for Advanced Biomedical Research and Development, recently announced by von der Leyen with a reference to the US BARDA model. In the course of the pandemic crisis, as has been repeatedly highlighted in recent months, Europe did not have access to the necessary medical supplies. The vulnerability of its own supply chains has emerged, being a theme repeatedly referred to in European executive documents as the cornerstone of the Union’s possible industrial strategic autonomy. There was also a lack of a coordinated and systematic approach to support the development, production and purchase of the necessary material. The new agency should help to remedy these structural shortcomings, especially in relation to development in the biomedical field. For example, with an analysis of emerging biomedical technologies that could find concrete application in crisis situations. However, in order to clearly understand the role and functions of the new agency, we will have to follow the usual Brussels legislative timetable with the Commission only presenting the proposal for its establishment in the fourth quarter of 2021.
How will all of this be financed? The issue remains once again the sore point of the Commission’s entire strategy, alongside that of constitutional powers. Most of the planned actions will have to be funded by the new EU4Health Programme, foreseen in the next Multiannual Financial Framework 2021-27. Here, von der Leyen should especially thank the MEPs, who managed to increase the budget to €5.1 billion during the negotiations with the Council (but still only 0.3% of the entire Recovery Plan package). The Commission’s original proposal, which had suggested to provide EU4Health with €9.4 billion, had actually been completely jeopardised by the July agreement among Member States, which had heavily cut the budget to €1.7 billion. This indicates, if nothing else, a lack of willingness on the part of the countries to transfer their competencies in health matters to the European level.
The path of the coming months is already mapped out. The three legislative proposals presented will obviously have to follow the legislative process and be discussed in Parliament and in the Council. However, the Commission is preparing to relaunch health policies in the coming weeks and to outline the two priorities that will be at the heart of the European health agenda in the coming years – the Pharmaceutical Strategy, scheduled for 24 November, and the Plan against Cancer, scheduled for 9 December. The two themes are at the centre of the I-Com Health Symposium “Designing the future European Health Union? Scaling-up ambitions, powering resilience“ (18 November).
