From Ashes, the European Health Union

[Written in the framework of the Master of Advanced Studies in European and International Governance (MEIG Programme) of the University of Geneva]

INTRODUCTION

Since December 2019, Covid-19 has dominated headlines, articles, and academic publications alike. It has caused a ripple reaction where the World has been forced to adapt and recognise the imperative of implementing appropriate governance structures to address pandemics and prioritise public health. Like a phoenix, the European Union has sought to rise from the ashes of Covid-19 with the determination to better itself in the area of public health by implementing the required governance frameworks and strategies. It is in this light that the European Health Union was born.

On 25 October 2020, Ursula Von de Leyen reverberated the clear message that the pandemic would not defeat the European Union, but will accelerate its efforts to achieve greater solidarity among member states in the area of public health: “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.”[1]

This article considers the elements of the European Health Union and fairly assesses whether it addresses the main weaknesses of the EU public health policy. In this regard, we consider the current strategies advanced by the European Health Union, in the light of the challenges and priorities identified in EU’s current public health policy. The article concludes with a reflection on the limitations of EU competence in the field of health and how the EU may explore a greater role in public health threats which have implications on matters falling within its exclusive competence, particularly the common commercial policy and internal market.

A. THE MAIN ELEMENTS OF THE EUROPEAN HEALTH UNION

On 11 November 2020, via European Commission Communication (COM(2020) 724 final) to the European Parliament, the plans for the establishment of the European Health Union were laid out.[2] The communication outlines the following 10 key strategic elements for the European Health Union:

i. Strengthening the EU Health Security Framework

This strategy envisions harnessing greater solidarity among EU member states to strengthen the EU health security framework. It seeks to build on initiatives such as the Coronavirus Response Investment Initiative (CRII) and the European Solidarity Fund as a basis for cohesion among member states in responding to major public health emergencies. The objective of this strategy is to ensure the continuity of the increased cooperation and coordination at the EU level to effectively address the ‘different interlocking damage caused by the pandemic in the health, economic and social sectors’.[3] By safeguarding public health, the European Health Union will likewise protect European economies and societies.

ii. Early Lessons from Covid-19 in Devising Proposals for the Way Forward

In reckoning with the shortcomings in the EU early response to Covid-19, the European Health Union seeks to ensure that this does not reoccur in future. Two of the major reforms proposed under this strategy is to strengthen the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). The emphasis is to ensure that these agencies are able to complement the strengthening of the EU health security framework by improving EU coordination and eliminating inconsistencies in the application of health measures across EU member states e.g. the use of masks, social distancing, testing strategies, and isolation/quarantine requirements.[4]

iii. Enforcing Coordinated Responses at the EU level

This strategy also emphasizes the need to strengthen the EU health security framework. It, however, targets strengthening the Health Security Committee directly. The Health Security Committee is a key body where EU member states consult each other in liaisons with the European Commission with a view to coordinating preparedness and response planning, national responses, and risk and crisis communication related to serious cross border threats to health. By strengthening the Health Security Committee, there is greater potential for effective coordination between member states in achieving a common EU level response and ensuring effective risk communication.[5] The objective of this strategy is to bridge the divide between technical discussions in European structures, such as the Health Security Committee, and the Ministries of Health in member states, in order to better inform decisions taken at national level so that they are in conformity with the EU’s vision and priorities.[6]

iv. Implementing Effective Medical Countermeasures

This strategy seeks to increase medical countermeasure stockpiles at EU and member state level and to strengthen EU supply chains for critical medical countermeasures.[7] It further envisions a refined coordinated and systematic EU level approach to support the development, production, procurement and purchase of necessary vaccines, therapeutics, diagnostics as well as personal protective equipment (PPE) and medical devices.[8] The strategy includes enhancing the EU’s Joint Procurement Agreement for medical countermeasures, refining the procurement process while mitigating the risk of internal competition for limited resources or parallel national tracks.[9] The strategy further seeks to better coordinate work at EU level and between member states in a manner that ensures the availability of medicinal products and medical devices, and facilitates the development of new treatment by inter alia formalising and reinforcing the current structure of the Steering Group on medicines.[10]

v. Improving Preparedness & Response Planning and Reporting

This strategy seeks to overcome the sub-optimality of the current national-level preparedness and response capacities and give greater clarity to an overall vision on the operationalisation of member state preparedness and response plans, as well as coherence with regards to their compatibility.[11] The strategy seeks to strengthen coordination mechanisms for preparedness, via the development of a binding EU health crisis/pandemic preparedness and response plan, with provisions for the EU and member states to adopt similar and interoperable plans at national and local levels.[12] A key element of this strategy is to reinforce the ECDC by establishing an integrated surveillance and monitoring system at the EU level, which will include research data and data on health systems capacity for diagnosis, prevention and treatment of specific communicable diseases, and patient safety.[13]

vi. Epidemiological Surveillance

This strategy seeks to bolster EU surveillance systems with capacities for detecting, monitoring and the surveying of emerging diseases and increasing frontline diagnostic testing capacity, in order to render readily available and accessible the relevant and necessary data required for the management of novel diseases.[14] This strategy has gained priority in light of the Covid-19 pandemic which has revealed inadequacies in EU surveillance of communicable diseases. The strategy prioritises up-to-date surveillance data to enable the monitoring of trends in the incidence of communicable diseases over time and across member states, and further allow for rapid detection and monitoring of cross border outbreaks.[15] It also seeks to harmonise interactions with other relevant agencies, including the European Food Safety Authority and the European Environment Agency, so that their responses and decisions are premised on the same set of data.[16]

vii. Laboratory Findings, Testing, and Contact Tracing

This strategy concerns the relationship between ECDC and member states, improving coordination in the sharing of data derived from national laboratory systems, including in achieving consolidated microbiological testing standards.[17] The objective is to integrate national laboratory systems into a coordinated ‘EU-wide system of reference laboratory networks for human pathogens’.[18] These ‘new EU networks’ will pursue uniformity under a single standard in addressing the challenge of diversity among member states in testing strategies and processes, under the broader objective of ensuring that improved capacity aptly responds to future serious cross-border health threats.[19] In this regard, the strategy identifies the need for: (1) a new network of EU reference laboratories to allow for alignment on diagnostics, serological testing, testing methods and use and validation of certain tests; and (2) a new network of member states services supporting transfusion, transplantation and medically assisted reproduction to allow for the continuous and rapid access to sero-epidemiological data.[20]

In addition, the strategy further prioritises reinforcing contact tracing across borders by its inclusion in the ‘EU health crisis/pandemic preparedness and response plan’, transitioning from a single view focus on contact tracing efforts within the boundaries of individual member states.[21] To achieve this, the strategy proposes that the ECDC be provided with an additional mandate to establish an automated system for contact tracing throughout the EU region, building on the technologies currently in use in member states.[22]

viii. Early Warning and Risk Assessment Capacity

This strategy broadens the scope of alerts under the EU’s Early Warning and Response System (EWRS) to include the needs for or shortages of medical countermeasures, as well as requests or offers for cross-border emergency assistance.[23] This strategy is advanced in direct response to the revelation during the Covid-19 outbreak of inadequacies in coordination among EU mechanisms, particularly with the strategic rescEU stockpile under the Union Civil Protection Mechanism (UCPM) and the Mobility Package under the framework of the Emergency Support Instrument (ESI).[24]

ix. International Cooperation and Coordination

This strategy seeks to strengthen partnerships with international stakeholders and partner countries.[25] The strategy seeks to confirm EU’s leading role in the global sphere of public health preparedness and response, with a two-pronged approach to addressing outbreaks at the source: (1) reinforced and targeted international cooperation; and (2) on the ground support to member states and third countries, in times of need.[26] To do this, the strategy envisions the reinforcement of the ECDC’s capacity to mobilise and deploy the EU Health Task Force to assist local response in member states and facilitate greater involvement in international response teams.[27]

x. Establish an EU Health Emergency Preparedness and Response Area

This strategy calls for the establishment of a dedicated European authority with the primary objective of enabling the EU and its member states to rapidly deploy the most advanced medical and other measures in the event of a health emergency.[28] The authority will strengthen the coordinated EU level action, harnessing greater preparedness and response capability for new and emerging cross-border threats to human health.[29] It will be specifically mandated to plan, co-ordinate and assemble ecosystems of public and private capabilities that jointly enable a rapid response when the need arises.[30]

DOES THE EUROPEAN HEALTH UNION ADDRESS THE MAIN WEAKNESSES OF THE EU PUBLIC HEALTH POLICY?

The current EU public health policy is set out in the EU4Health Programme 2021-2027.[31] The policy seeks to improve the EU’s preparedness and responsiveness to public health threats, as well as address the current Covid-19 pandemic. It further targets the following key health priorities and challenges in the EU region:

1. inequalities in health status among population groups, countries and regions, and access to affordable, preventive and curative health care of good quality;

2. burden from non-communicable diseases, including cancer, mental health, rare diseases and risks from health determinants;

3. uneven distribution of health care systems capacity, including health care workers;

4. obstacles to the wide uptake and best use of digital innovations as well their scaling up;

5. growing health burden from environmental degradation and pollution, in particular air, water and soil quality, and also from demographic changes.[32]

When measured against these priorities and challenges, the European Health Union is found wanting, as it does not mention any strategies towards addressing these weaknesses. There is no mention in European Commission Communication (COM(2020) 724 final) of strategies to address non-communicable diseases, inequalities in the health status among population groups, or the growing health burden from environmental degradation and pollution. Moreover, the strategies that are advanced to address the uneven distribution of health care systems and explore greater digital innovations are specifically confined to communicable diseases, particularly in the context of the current pandemic and possible future epidemiological outbreaks.

It is apparent that the European Health Union is heavily focussed on implementing the necessary frameworks to address communicable diseases, which is understandable in the light of the Covid-19 pandemic and its serious implications on core EU foundations and functions, including its adverse impact on the common commercial policy and the internal market, undermining the EU free movement of goods and persons. However, there is potential for the European Health Union to play an even greater role in addressing the main weaknesses of the EU's public health policy by contributing to and building on existing EU frameworks on public health.

The release of Europe’s Beating Cancer Plan on 3 February 2021, as a key pillar of the European Health Union, is a promising indication of its ability to play a greater role in addressing non-communicable diseases.[33] In this regard, the European Health Union may also consider further advancing the ambitions under the 2013 report of the Council of the European Union “Reflection process: Innovative approaches for chronic diseases in public health and healthcare systems”, many of which remain unrealised and a work in progress.

The European Heath Union may also play a role in strengthening or redefining the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases which was established in 2018. At present, the Steering Group appears to operate in an advisory capacity on best practices in the prevention and management of noncommunicable diseases according to a European Commission set criteria.[34] It may be promising to explore transforming the Steering Group into an authority within the European Health Union, providing it with greater mandate, capacity, and responsibility to ascertain the trade policies impacting public health. It may further perform an advisory role in regulating the trade of products with serious health implications.

In regard to other areas of weaknesses, the current strategies being advanced by the European Health Union for Covid-19 are still promising. If these same strategies are expanded beyond the confines of Covid-19 to apply more broadly and generally to EU public health and the healthcare system, they have great potential to address these underlying challenges and priorities. For example, the Pharmaceutical Strategy for Europe, although primarily concerned with ensuring the effective, fair and equitable distribution of Covid-19 vaccines, establishes a workable framework to address the concerns relating to the inequalities in health status and the uneven distribution of health care systems capacity.

Perhaps such an expansion will be explored by the European Health Union more comprehensively once the Covid-19 pandemic has been contained, allowing for greater attention to be paid to these other key challenges and priorities in the EU4Health Programme 2021-2027, especially since these have existed under and persisted since the former EU public health policy for the period 2014-2020.[35]

CONCLUSION

The call for a broader mandate for the European Health Union is made with full cognisance of the EU’s limitations in the field of public health. It is recognised that health is predominantly the competence of member states and that the EU’s role is complementary.[36] However, as demonstrated by the robust strategies envisioned for the European Health Union in response to Covid-19, that complementary competence has far greater reach if a clear connection can be established between the public health threat and matters which fall within the exclusive competence of the EU, particularly the common commercial policy and the internal market.

To truly address the weaknesses identified in the EU public health policy, which have persisted from former policies to the current, there needs to be greater effort in ascertaining the breadth of that complementary competence. This will necessarily require greater consideration of the impact that non-communicable diseases and a weak public health system have on the EU common commercial policy and the internal market, and vice versa. Establishing that link will provide the EU with a better defined and grounded legal basis to take action in areas of public health that demand their attention, in order to address them at an EU level.

However, for the purposes of this article, my conclusion is simply that the European Health Union does not holistically address the underlying weaknesses of the EU public health policy; although, it does establish solid foundations and demonstrates great potential to do just that.

[1] European Commission, ‘President von der Leyen at the World Health Summit’, 25 October 2020 (accessed 5/2/21). [2] European Commission Communication (COM(2020) 724 f It further envisions a refined, coordinated and systematic EU level approach to support the development, production, procurement and purchase of necessary vaccines, therapeutics, diagnostics as well as personal protective equipment (bid, p.9. [10] Ibid, p.10. [11] Ibid, p.12. [12] Ibid. [13] Ibid. [14] Ibid, p.14. [15] Ibid, pp.14-15. [16] Ibid, p.15. [17] Ibid, p.16. [18] Ibid. [19] Ibid. [20] Ibid. [21] Ibid, p.17. [22] Ibid. [23] Ibid, p.18. [24] Ibid. [25] Ibid, p.19. [26] Ibid. [27] Ibid. [28] Ibid, p.20-21. [29] Ibid. [30] Ibid. [31] European Commission, ‘EU4Health Programme’, 28 May 2020 (accessed 5/2/21). [32] Ibid, pp.1-2. [33] European Commission Communication 3.2.2021 COM(2021) 44 final, p.3. [34] European Commission Communication, ‘Criteria to Select Best Practices In Health Promotion And Disease Prevention And Management In Europe’, 2019 (accessed: 16/02/20). [35] European Commission Communication (COM(2011) 709 final), p.3 (accessed: 15/2/21). [36] Treaty on the Functioning of the European Union, Art. 168. ,