Health as a fundamental value. Towards an inclusive and equitable pharmaceutical strategy for the EU
Dr Aurélie Mahalatchimy and Dr Éloïse Gennet
20 October 2021
The Covid-19 pandemic has highlighted many loopholes in how innovative pharmaceutical products are created, evaluated, produced and distributed in EU countries. One of the most visible issue brought into the spotlight has been and still is the gruelling lack of health equity, be it between EU citizens or between EU countries. Although the European Union has demonstrated unprecedented solidarity in response to the crisis, the new Pharmaceutical Strategy for Europe may be the opportunity to address some of these loopholes and strive for even more ambitious standards of equity of access to therapies.
While the EU’s pharmaceutical strategy has mainly been built on pursuing internal market objectives due to historical politico-legal reasons, a successful proposal for an EU Health Policy Platform 2021 Thematic network offers a contrast by promoting an inclusive and equitable European pharmaceutical strategy in reaffirming health as a fundamental value.
We will work on this proposal with interested health stakeholders of the EU Health Policy Platform through exploring:
- the evolution of the role of the European Commission and Directorate General for Health and Food Safety,
- Patient-centered approaches and inclusive research & development strategies, and
- Solidarity, trust and equitable access to pharmaceuticals.
Dr Aurélie Mahalatchimy and Dr Éloïse Gennet (UMR 7318 DICE CERIC, CNRS- Aix-Marseille University, France) on behalf of the European Association for Health Law (EAHL) Interest Group on Supranational Biolaw, join us to discuss the development of the Thematic Network proposal and ongoing work on this.
EU law, common values and public health
Professor Markus Frischhut (MCI Innsbruck)
3 November 2021
EU integration has started at an economic level (coal and steel) in order to safeguard peace, and has later on expanded to human rights and the political level. The Lisbon Treaty has turned the EU into a Community or Union of values. Likewise, since the 1990s, we can identify an increasing reference in EU law to non-legal concepts such as ethics (and morality).
The EU’s common values enshrined in Article 2 TEU are sometimes well defined (e.g. non-discrimination), sometimes rather broad and undetermined (e.g. pluralism, tolerance). Sometimes we seem to have a clear understanding of a value like ‘solidarity’, but struggle to apply it various fields, such as migration, or the current pandemic.
Solidarity is a good example of a ‘concept’, which can be qualified both as a ‘value’ and as a ‘principle at the same time. Principles tend to be more concrete, can have legal addressees and can lead to legal consequences. This approach of values that are more abstract, as well as more concrete principles can be found in the 2006 Health Values document of the Health Ministers, which provides more clarification in one specific field.
Finally, in December 2020 the ECJ has established animal welfare as the first value outside Article 2 TEU, and for the first time addressing animals and not humans. As the Charter has been referred to as a ‘living instrument’, we can discuss, if and how health should be seen as a value (cf. presentation of Aurélie Mahalatchimy and Éloïse Gennet 20 October – recording now available).
- Frischhut, M., & Werner-Felmayer, G. (2020). A European perspective on medical ethics. Medicine, 48(10), 634–636.
- Frischhut, M. (2020). EU Values and Ethical Principles for AI and Robotics with Special Consideration of the Health Sector. In M. Hengstschläger & Austrian Council for Research and Technology Development (Eds.), Digital Transformation and Ethics (pp. 244–274). Ecowin Verlag.
- Frischhut, M. (2019). The Ethical Spirit of EU Law. Springer International Publishing. (Open Access)
- Frischhut, M. (2022, forthcoming). The Ethical Spirit of EU Values. Springer International Publishing. | N.B. Will be published open access as well.
Book Presentation – Health Politics in Europe: A Handbook by Immergut, E., Anderson, K., Devitt and Popic, T., Oxford University Press, 2021
Dr Tamara Popic (Queen Mary University of London)
Dr Karen Anderson (University College Dublin)
Dr Camilla Devitt (Trinity College Dublin)
Health Politics in Europe: A Handbook is a major new reference work, which provides historical background and up-to-date information and analysis on health politics and health systems throughout Europe.
In particular, it captures developments that have taken place since the end of the Cold War, a turning point for many European health systems, with most post-communist transition countries privatizing their state-run health systems, and many Western European health systems experimenting with new public management and other market-oriented health reforms.
Following three introductory, stage-setting chapters, the handbook offers country cases divided into seven regional sections, each of which begins with a short regional outlook chapter that highlights the region’s common characteristics and divergent paths taken by the separate countries, including comparative data on health system financing, healthcare access, and the political salience of health.
The event will offer the overview of the book and presentation of two main chapters on Ireland and the Netherlands.
Dr Elisabet Ruiz Cairó (Geneva)
How can we strengthen the promotion of public health in EU external relations?
Article 168 (3) TFEU requires the European Union to cooperate with third countries and international organisations in the sphere of public health, and the COVID-19 pandemic has highlighted the importance of bold international cooperation in this field. The European Union plays an increasingly significant role as a global health actor and it has successfully promoted public health in a number of areas. The participation of the Union in the negotiation of the Framework Convention on Tobacco Control and its Protocol provides a useful illustration in this regard. However, the role of the European Union as a global health actor is challenged by two main constrains. Internally, the Union’s role in global health is limited by the principle of conferral. The European Union essentially has support powers in public health under Article 168 TFEU. To circumvent this limit, it acts on the basis of alternative legal bases, notably the internal market and the environmental policy. This approach leads to a fragmented legislative activity, under which some public health concerns are extensively regulated whereas others are not. Externally, the Union’s role in global health is limited by the rules of international organisations and agreements, which do not systematically accept regional organisations as parties. The European Union thus holds a variety of statuses in health-related international organisations and agreements, ranging from full member to observer with several possibilities in between. The above-mentioned limitations hinder the development of a consistent and comprehensive external public health action. Public health is essentially approached on a case-by-case basis, which damages the role of the Union as a global actor. It is thus necessary to explore measures that could enhance the EU external public health action.
The following proposals may contribute to that goal:
1. Enhancing EU public health competences under Article 168 TFEU. Although unlikely in the current circumstances, previous public health crises have led to a strengthening of this provision.
2. Strengthening the status of the European Union in health-related international organisations and agreements. The future negotiation of an International Pandemic Treaty could contribute to this goal.
3. Clarifying the relationship between public health and EU principles and objectives. This proposal could be implemented through an inclusion of public health among the objectives of the EU external action (Article 21 TEU) and the definition of some guiding principles for all EU public health actions.
4. Reinforcing the linkages between the different provisions related to public health matters in the Treaties, notably Articles 9 and 168 TFEU and Article 35 of the Charter.
Although EU public health is increasingly relevant and the role of the Union in global health is emerging as an essential feature of this policy, a stronger and more comprehensive action still needs to be built. The COVID-19 pandemic provides the perfect opportunity to bring some fundamental changes to this area and a significant evolution is expected in the coming years.
For more information on this topic, see E. RUIZ CAIRÓ, The Promotion of Public Health in EU External Relations (Series in European Law No 35, Schulthess, Zürich 2021), 508 p.
EU health policy in the aftermath of Covid-19:
Neofunctionalism and crisis-driven integration
Dr Eleanor Brooks (Edinburgh)
The EU has responded to the COVID-19 pandemic with greater integration. Member states have substantially increased their investment in existing health policy tools such as civil protection and financing for health initiatives. There has been innovation in EU law, where a process of redefining public health began, and in strategies for vaccines and pharmaceuticals, where the EU took on a direct and significant role in medicines procurement for the first time. We use a detailed analysis of developments in health policy during the pandemic to further understand the dynamics of this integration, and in particular to understand what has driven EU member states to pursue closer cooperation in health. These decisions reflect a long-term pattern of health policy development, wherein public health crises have led to a gradual increase in EU health responsibilities. Although the strict provisions on subsidiarity confine integration to the area of public health and preclude a bigger EU role in health care, the pressures created by COVID-19 seem set to, once again, test the strength of the subsidiarity principle. We argue that, as neofunctionalism might predict, member states solved problems born of integration with more integration: preserving the internal market, insuring against disasters, preventing border closures and enhancing EU power in vaccine development and procurement.
Lex-Atlas Covid-19: The European Union
The EU itself (as opposed to its Member States) has limited competence in public health. There is no ‘EU health system’. All matters pertaining to health systems organisation and financing fall within Member State competence. Some aspects of public health regulation are harmonised at EU level, but in general the hallmark of EU action in the public health domain is coordination and persuasion. EU action flows from the principle of subsidiarity, according to which governance should take place at the lowest level commensurate with the issue concerned. As communicable diseases do not respect state boundaries, on the one hand this should mean that a pandemic response should be coordinated at EU level (or indeed at World Health Organisation (WHO) level). On the other hand, public health responses are also dependent on health system capacity, indicating that a subsidiarity-respecting EU pandemic response should take place at national or even sub-national level. In practice, responses to pandemics remain nationally driven, even among those EU Member States most committed to the European Union’s institutions.
The EU has been very active in response to Covid-19, especially using soft law mechanisms. In the EU’s self-assessment, it has also been effective, but it would probably be fairer to say that the EU’s record may be considered mixed. In the early phases of the pandemic, the governments of the EU Member States, in general, did not seek to coordinate their actions through the EU’s institutions. Initial humanitarian assistance to Italy, Spain, and France did not come from the EU. But some aspects of the EU’s response, such as its repatriation of EU citizens from Wuhan and joint procurement of Personal Protective Equipment (PPE) in February 2020, its vaccine rollout (and export of vaccines to elsewhere in the world) in February/March 2021, or the EU’s mutually recognised ‘digital certificate’ of vaccination/negative test/Covid-19 recovery applicable since 1 July 2021, suggest that the EU is an important site of Covid-19 governance for its 27 Member States and their citizens and residents.
Dr Silvia Capíková (Comenius University Bratislava)
Rule of law as a unifying framework for anti-pandemic response? Case of Slovakia.
COVID-19 pandemic evoked an urgent need for transformation of political representatives into public health leaders overnight. Due to the pandemic, law became an increasingly visible tool of public health, with a myriad of measures passed to enable disease control by various public authorities. Rule of law conceptual framework enables better understanding of problems related to the legal response to the COVID-19 pandemic, with national regulation in Slovakia as a case study to examine how the existing legal framework of a democratic country responded to the need to control the spreading of an unknown, lethal contagious disease.
The combination of legitimate interests of various subjects was very challenging and restrictions had polarized society – in particular the part of the population who did not feel directly at risk from COVID-19 demonstrated its feeling of oppression and distrust, fed by disinformation. Existing rule of law normative and institutional framework served as a safeguard against some disproportionate effects of anti-pandemic measures in Slovakia.
The application of the rule of law doctrine is linked to the human rights value base it is intended to protect, which is inextricably linked to the EU value base. (A “checklist” of empirical indicators had been developed by the Venice Commission in 2016.) Besides need to coordinate to control the pandemic, there is also vital need to control the “infodemic” on the EU level to preserve values and functioning of our common European house.
For more information on this topic, see:
Silvia CAPÍKOVÁ, Eduard BURDA & Mária NOVÁKOVÁ (2021). Measures Introduced in the Slovak Republic in Response to the Public Health Crisis Caused by the COVID-19 Pandemic. Medicine, Law & Society, 14(2). Print ISSN 2463-7955 Available from: https://doi.org/10.18690/mls.14.2.321-350.2021
Silvia CAPÍKOVÁ & Mária NOVÁKOVÁ (2020). Challenging COVID-19 Times – Possibilities and limitations of law in regulation of health behavior of individuals. Pp.13 – 32. in Iwona Florek, Andrea Koroncziová, Jose Luis Zamora Manzano (Eds.). Crisis as a Challenge for Human Rights. Bratislava: Comenius University in Bratislava. 480p. ISBN 978-80-7160-551-5 Available from: https://www.flaw.uniba.sk/fileadmin/praf/Veda/Zborniky/Crisis_as_a_challenge_for_human_rights.pdf