by Christina Merkou, Coordinator of the International Law Research Team
“We cannot wait for the end of the pandemic to repair and prepare for the future. We will build the foundations of a stronger European Health Union in which 27 countries work together to detect, prepare and respond collectively.”
Those were the exact words of the President of the European Commission, Ursula von der Leyer, at the World Health Summit, last October. Thus, it started the launch of new initiatives in the health sector, in November 2020. These reforms aim at creating a stronger collaboration between the member States so they could be better prepared and respond collectively to health crises, to ensure the availability of medical supplies and to improve the health care treatments for diseases like cancer (European Commission, 2021).
Health and EU
The EU’s involvement in health matters initially focused on medical research, medicine manufacturing and drug licencing among others. The first relevant legislation can actually be traced back in 1965, whilst the first health research programmes date back to 1978 (f.ex. on radiation risks) (European Parliament, 2020). After that first period of EU actions, in the ‘80s and mostly in the 90s, the Organisation adopted a more horizontal and interdisciplinary approach (European Parliament, 2020), since it followed the medical developments, and began taking action through the implementation of programmes on combating AIDS, HIV, and tobacco use (Seychell, M., Hackbar B., 2013; Hans Vollaard & Dorte Sindbjerg Martinsen, 2017).
The Maastricht Treaty, is actually the milestone on the EU’s involvement in health issues, since it’s the first one to explicitly set a goal of a high level of health protection in article 3, while also replacing former provisions on public health with article 12 9 (Treaty on the European Union, 1992). The next big evolution in that area, came with the Treaty on the Functioning of the EU (TFEU, 2009), which in article 4 proclaimed the EU’s shared competence with the member states on common safety concerns in public health matters, whereas in article 6 outlined its overall supplementary role on the protection and improvement of human health (Καλαβρός Γ.-Ε, Φ. Γεωργόπουλος, Θ.Γ., 2013). Additionally the TFEU’s article 168 on public health (former 152 TEC) proclaims the complementary EU’s role on national health policies (par.1), promotes the cooperation between member states in health matters (par.2), besides adopting measures to combat cross border health threats (par.5). However the legislative power -meaning the Commissions, Council, and Parliament- of the EU focuses only on certain public health issues, such as cross border health threats, veterinary and phytosanitary measures (Clemens, T.,Sørensen, K., Rosenkötter, N., Michelsen, K., Branda, H., 2017).
The EU’s policy on health related issues has -as it is already shown- primarily focused on public health policies concerning issues like AIDS, tobacco use, etc, and on the application of free movement in the internal market (Hans Vollaard & Dorte Sindbjerg Martinsen, 2017). However, the EU’s Court of Justice (CJEU) has also been instrumental in evolving the organisation’s role in healthcare. Specifically the CJEU developed a rich case law on patients rights across EU member states since 1998, which inspired the 2011 Directive. This development in patients rights could have been made years before, but was met with the objections by the Parliament as it is shown in the 2006 Services Directive which excluded healthcare (Hatzopoulos, V. and Hervey, T., 2013).
Τwo other factors that affected EU policies throughout the years were: cross-border public health crisis and the recent economic crisis. A pattern -that of the crisis and response- of the EU’s action can be traced back in 1997, when the BSE (Bovine Spongiform Encephalopathy) crisis led to the creation of the Directorate General for Food and Health Safety (Hans Vollaard & Dorte Sindbjerg Martinsen , 2017). Furthermore, the specialized European Centre for Disease Prevention and Control (ECDC, 2003) and the joint procurement mechanism for vaccines (EU Joint Procurement, 2009) were actually the results of SARS outbreak in 2003 and the swine flu epidemic in 2009 (Brooks, Geyer, 2020) that highlighted the need for a more proactive EU in the health sector. In addition, the recent financial and economic crisis with its promotion for healthcare reforms and austerity packages, marked a turn of the EU’s role in national healthcare systems (De la Porte and Natali, 2014; Martinsen and Vollaard, 2014, Vollaard et al, 2015).
It is obvious that the Organisation’s growing engagement with health matters needed to be supported by different structures and mechanisms that deal with health issues -and not only- that could provide their expertises while also promoting good practices and cooperation. The leading policy actor in the field, as referred to by academics, is the Directorate General SANTE of the Commission -formerly known as DG SANCO), with the evergrowing mandate, established in 1999 (Clemens, T.,Sørensen, K., Rosenkötter, N., Michelsen, K., Branda, H., 2017). In cross boundary health threats the role of the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the Health Security Committee is pivotal, since as a whole they create the EU’s mechanism of response . More specifically in 1995 EMA was established -with a limited scope – for the harmonisation of national medicine regulatory bodies. Since then, EMA not only has expanded its competencies, but also has created other specialized Committees (f.ex. Committee for Orphan Medicinal Products) to better respond to its growing role (EMA, 2021), while also being part of the european regulatory system for medicines. Accordingly, twelve years later, the ECDC was created and works in close collaboration with EMA. The ECDC is responsible for the analysis of surveillance data from the member states, on communicable diseases while also providing scientific advice (ECDC, 2021). Nevertheless the Commission has underlined that ECDC needs to become a real Health Agency, since it’s surveillance system is rather limited (European Commission, COM 724, 2020). Lastly Health Security Committee , which is responsible to coordinate national responses on an EU level (Brooks, Greyer, 2020), was formally established with the 2013 Decision, since until then it was an informal advisory group on health security.
The “New” State of Affairs ?
The pandemic crisis outbreak was the beginning for the resurface of old debates and the creation of new ones. In particular the possibility of a permanent system of EU joint procurement of medicines raised many questions since it concerns a very sensitive political matter (Baute S., De Ruijter A., 2021). Furthermore in the beginning there was the question -that was quickly abandoned- for the need of amendments in the Treaties in order to enhance the Organisation’s role on public health (Brooks and Greyer, 2020). Additionally the EU’s response to the pandemic, was and still is largely criticized, and not without reason. The vaccine debate, meaning the problematic negotiation process (Sipiczki A., Lanoo K., 2021), the slow response of the EU -since collective action was taken in phase two of the pandemic (Brooks and Greyer, 2020)- as well as the inadequacy of the pre-existing agencies (f.ex. ECDC, EMA) (Alemanno, 2020) were some of the deficiencies detected.
Despite the -legit- criticism (f.ex. Pacces and Weimar 2020; Renda and Castro 2020) the EU faced even early on in October 2020, a survey -Eurobarometer- among european citizens was published that measured the attitudes towards european action on the pandemic (European Parliament, Report, 2020). The findings of this survey showed that there is an agreement among citizens on the need to bestow more competences on the EU to deal with crises like the current one, while also maintaining that the public health sector should become a priority area for the EU budget (European Parliament, Report, 2020).
So it comes as no surprise that in November, the Agenda for the Health Union was launched with proposals, under the aforementioned Lisbon Treaty provision (namely art. 168, par. 5 of TFEU) for the first time as someone may add (Alemanno A., 2020). Its also noteworthy that the Communication mentions that these initiatives will help to the future realisation of the Charter of Fundamental Rights, article 35’s obligation on ensuring a high level of health protection. The Commision taking account the possibility of possible future outbreaks of communicable diseases sets as a main goal, a new stronger health security framework by focusing on key factors like building a more coordinated response and preparedness, medical countermeasures, epidemiological surveillance, to name some. Besides this the Communication’s legislative proposals attempts moreover to provide solutions to the changing health vulnerabilities and disease patterns created by the ageing of the european population (European Commission, COM 724, 2020).
The Communication of the Commission was accompanied by three legislative proposals in order to upgrade the already existing framework for cross border health threats (meaning the EU Directive of 2013) the mandate of ECDC, and EMA’s mandate (European Commission, COM 724,2020). It also must not go unnoticed that this entire Agenda is linked to the new proposal for the enhancement of the Union’s Civil Protection Mechanism. Besides these reforms, the Commission also proposed the establishment of a new Organisation, the Health Emergency Preparedness and Response Authority (HERA), envisaged as an EU“BARDA” (meaning the US Biomedical Advanced Research Authority), (European Commission, Public Consultation, 2021). At the same time the Commission decided to raise the funding for health research (Sipiczki A., Lanoo K., 2021), and redesigned the EU4 Health Programme. It is also noteworthy -especially given the backlash faced by the WHO on the topic- that the amended EU legal framework is more flexible concerning the issue of recognition of an emergency and without depending on WHO’s own declaration (European Commission, COM 724, 2020).
As aforementioned, the Communication attempts to enhance the role of already existing EU agencies since there were a lot of shortcomings in the way they dealt with the pandemic so far, due to their limited powers. More specifically concerning ECDC, the proposed Regulation focuses on better surveillance, engagement at a local level through Outbreak Assistance Teams, the creation of a Network of EU references laboratories (EU Commission, COM 726, 2020). The main goal of the proposal for EMA is to ensure shortages in medical equipment (medical products and devices) in the case of future crises, and promote the development of high quality medical products such as vaccines. (European Commission, COM 725, 2020). For that reason the establishment of two structures that will help EMA’s work -a permanent EU Executive Steering Group on shortages of medicines and a new EU Executive Steering Group on medical devices- is necessary. Another important initiative is the Commission’s proposal for a permanent EMA emergency Task Force (formerly ad hoc COVID-19 EMA pandemic Task Force), acknowledging the need for a rapid implementation of research results (European Commission, COM 724, 2020).
The EU’s Pharmaceutical Strategy (November 2020), also plays a vital role in preventing medicine shortages, and is complementary to the proposed EMA mandate. The Strategy is based on a four pillar system that aims not only to create a regulatory framework but also to support and promote research and innovation of the EU’s related industry (European Commission, COM 761, 2020). The main challenges that the Strategy aims to address with legislative and non legislative actions (f.ex.proposal for a European Data Space) are: medicines affordability, crisis preparedness and response mechanisms, the promotion of a high level of quality, efficacy and safety standards worldwide, with the support of the EU’s industry. In particular the European Health Data Space legislative of the Strategy aims to address the states concerns over sharing patients data (Sipiczki A., Lanoo K., 2021).
Lastly, “Europe’s Beating Cancer Plan”, that has been promoted by the Commission, is the most recent one in a line of EU’s programmes on cancer since 1986 (Albreht,T., 2021), and follows the four pillar logic of the Pharmaceutical Strategy, and will be supported by additional actions spanning across other policy areas (f.ex.employment). This new Plan identifies key action areas for the future ten flagship EU initiatives by supporting actions, namely on : a. prevention by addressing risk factors, early detention (improving access, quality, etc), diagnosis and treatment and lastly improving the quality of life for former patients and their families (European Commission, COM(2021) 44, 2021).
This pandemic crisis has outlined a persistent question; should the EU’s role on public health be enhanced, and is subsidiarity the right choice? (De Rujiter, A. 2019) The expansion of the EU’s role in health issues has been long and hard since it tries to align different states’ approaches on public health. In addition, it can be argued that there is a structural problem since EU’s health policy (as a whole) is rather weak (Greer, S.L., 2021) and its fragmented -across treaties and policies- nature creates different dynamics. There is a lot of scepticism on the Commission’s plan for a Health Union, by the member states but also by academics for different reasons. One of the biggest questions of this crisis has been, whether a Treaty revision was in order, but that was quickly dismissed, since art. 168 provision is quite flexible as it has been supported (Guy M., 2020). There is also the legit criticism that there is a more economic approach on the matter, even in light of the Commission’s proposals (Alemanno A., 2020)., taken by the EU, as it can be shown by budget surveillance that affects health policies (Volaard H, Martinse, D.S, 2017). It’s also true that the Organisation adopted a crisis and response approach instead of taking initiatives in a non pressing time. Despite that, and despite using the “old recipe” of amending older regulations and relying on existing agencies, this time the approach aims to better prepare the Organisation for a future crisis, by addressing some persistent issues. Joint procurement Agreements, medical countermeasures, the shortcomings of the already existing structures like the scarsed meetings of the Health Security Committee, were addressed by the Commission’s communication. Of course it remains to be seen whether these initiatives of the Commission will be endorsed by the Parliament, since all of them are rather politically sensitive issues and whether they will be effective in the future.
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