E UROPEAN S OCIAL AND H EALTH P OLICY A PPROACH

The overview of the EU’s developing structure over the years shows that the Union as a legal personality expanded its influence over quasi all policy areas, however, the social policy remains a policy field widely governed by soft law and negative integration at the most. The economic leitmotiv which guided the Member States of the EU combined with the fear of losing sovereignty and voters’ trust allowed for little concessions in social policy. The significant high cost the implementation of positive integration - social policies represents another complication for the European Union and is proven by the fact that little amount of the budget is actually allocated to the principle DGs driving EU social policy (EMPL, SANTE). ⁴⁹ The “negative-integration” character of the EU’s social policy can thereof not only be explained by the

49 Anderson, Social Policy in the European Union, 30.

complex policymaking procedure, national electoral politics and lacking exclusive competences, but also by a financial constraint. Continuously, in order to fully comprehend the reasons and motivations for this deterrence of implementing social policies, we must also examine the European understanding of social policy and health policy accordingly. As previously mentioned, European social policy is non-conventional for it rather regulating than employing social policy.

The social policy objectives laid down in the TFEU in Article 151 refer to “promoting employment, improving working and living conditions, equal treatment of workers, adequate social protection according to need, social dialogue, developing human resources aimed at achieving a high and sustainable level of employment as well as combating exclusion”. ⁵⁰ This understanding of Social Policy keeps in line with the general aforementioned definition but pays special attention to the exact fields this policy comprises. However, particular attention must be paid to these mentioned fields.

According to Article 151 of the TFEU, the social policy of the European Union revolves around the social needs related to the employment realm. Yet, Article 9 of the same Treaty includes “a high level of education, training and protection of human health” as social requirements to comply and respect the Charter of Fundamental rights. ⁵¹ The EU aims to protect human health by:

Figure 1: EU's Health Strategy

50 EUR-Lex - Access to European Law, ‘Glossary of Summaries - EUR-Lex’, 2021, https://eur-lex.europa.eu/summary/glossary.html.

51 EUR-Lex - Access to European Law.

• “Prevent[ing] illness/disease by promoting healthier lifestyles;

• Facilitat[ing] access to better and safer healthcare;

• Contribut[ing] to innovative, efficient and sustainable health systems;

• Deal[ing] with cross-border threats;

• Keep[ing] people healthy throughout their lifetimes;

• Harness[ing] new technologies and practices”.

Source: (EUR-Lex - Access to European Law 2021).

As a response to the COVID-19 pandemic, the Commission adopted the EU4Health programme which adds (1) preparing for health crises in terms of medical supply, sufficient health staff and experts and increased surveillance, (2) strengthening health systems to withhold short- and long-term health crises, and (3) reforming the pharmaceutical market by making medicines and medical devises available and affordable to the health goals pursued by the EU. ⁵² As to the competences, the EU has only shared and not exclusive competences in nine policy areas associated to social policy including health and safety of workers and public health ⁵³ (view box 1.1).

The legislative basis of the European Union does not provide for any exclusive competences to initiate public health policies. Mossialos et al. trace the development of the European social policy without any exclusive competences back to the ‘spill-over’ effect. Mossialos thus investigates the reasons for the establishment of minimum standards in occupational health and safety. The author concludes that the fear of possible social and ecological dumping and the goal to create a “level playing field” were economically motivated and hereinafter created European social policies. ⁵⁴

Ergo, European policymaking is not solely restricted to direct policy making. As Duncan puts forward in his paper “Health policy in the European Union: how it’s made and how to influence it”, various policy areas are used for the implementation of European health policy or even unintentionally influence the latter. ⁵⁵ In order to achieve the social policy objectives of the TFEU, the executive bodies of the EU resorted to both hard and soft law. As regarding ‘hard’

law, the EU follows a rather regulatory and harmonizing approach for instance by expanding qualified majority voting to occupational health and safety with the Single European Act ⁵⁶ and

52 EUR-Lex - Access to European Law.

53 EUR-Lex - Access to European Law.

54 Elias Mossialos and Martin McKee, EU Law and the Social Character of Health Care, Work & Society, no. 38 (Brussels; New York: P.I.E.-Peter Lang, 2002).

55 B. Duncan, ‘Health Policy in the European Union: How It’s Made and How to Influence It’, BMJ 324, no. 7344 (27 April 2002): 1027–30, https://doi.org/10.1136/bmj.324.7344.1027.

56 Anderson, Social Policy in the European Union, 61.

setting minimum standards. For the implementation of ‘soft’ law, the EU resorts to the Open method of coordination introduced by the Lisbon Treaty, which is mostly applied – due to its non-binding nature – for highly discussed and complex policy fields such as social policy. The OMC operates by using peer pressure for prompting non-compliant member states to implementation. For instance, Anderson mentions the use of the OMC for the promotion of pension reforms in the member states. ⁵⁷ However, additionally to these examples of direct hard and soft social policy legislations, the European executive bodies pursued indirect and unintentional social policy making. Hence, the recently ratified and discussed trade agreements include human rights clauses, common safety standards and pharmaceutical clauses. ⁵⁸ Finally, the European definition of social policy and (public) health policy is rather enigmatic and technical and vague at the same time. Instead of defining the social realm comprehensively including the goals, objectives and influencing tools, the European understanding of both terms refer to a set of superficial goals without providing the corresponding tools and instruments.

The superficiality of the goals is even more complicated combined with the shared competences the EU upholds.

A recently published study by the Policy Department for Economic, Scientific and Quality of Life Policies, Directorate-General for Internal Policies (2019) drafted a proper definition of public health policy:

“[…] the aim of public health is to create the enabling conditions to promote health, understood as a state of complete physical, social and mental well-being. Public health policy therefore covers, but also goes beyond issues concerning health systems and healthcare delivery.

Central to the practice of public health is the recognition that health and well-being is shaped by multiple social, economic, political, environmental and biological determinants. […]

57 Anderson, 93.

58 Duncan, ‘Health Policy in the European Union’.

The most prominent determinants are highlighted below:

• Social, or socio-economic, determinants of health

• Environmental determinants of health

• Health system determinants of health

• Commercial determinants of health

• Individual determinants of health” ⁵⁹

This interpretation of public health policy delivers much more clarity on the European policy approach by addressing the field from a technical and comprehensive point of view, acknowledging the cross-sectoral and interlinked character of public health policy to other policy areas. However, even though the effects of “the conditions in which people are born, grow, live, work and age” (social, or socio-economic determinant) on human health are indisputably unquestionably, to meet the purpose and the envisaged length of this paper, the analysis will only take health system determinants into account. According to Pushkarev et al.

health system determinants describe “the health impacts of different approaches to organising, resourcing and operating health systems.” The evaluation of an effective health system, as stated by the authors, is based on the capability of delivering “quality services to all people, when and where they need them without causing financial hardship.” ⁶⁰

Hereinafter, we can deduce, that the European approach to social policy and (public) health policy is based on a complex and intricate treaty collection which instituted in the 50s and continuously amended and completed – politically and structurally, i.e., Treaty of Rome, Maastricht Treaty, Treaty of Amsterdam, Lisbon Treaty. Although the EU started off as an economic merger aiming to maintain peace in the region, developed into a political union with supranational features influencing quasi every policy area – whether indirectly, directly or unintentionally. The European health policy has evolved over the years from a market enabler, located at the margin of the EU’s zone of interest, into a predominant policy field.

59 Nikolai Pushkarev, Fiona Godfrey, and Sascha Marschang, ‘EU Public Health Policies. State of Play, Current and Future Challenges’, ed. European Parliament and Policy Department for Economic, Scientific and Quality of Life Policies Directorate-General for Internal Policies, September 2019, 52.

60 Pushkarev, Godfrey, and Marschang, 12.

The following chapter will crucially focus on the technicalities of the implementation approach of the European public health policy and define its strong and weak characteristics.

2. European (public) health policy – futile or crucial?

Research on the European health policy attempt is extensive, consistent and contradictory. For starters, most scholars agree that the structural framework of the European Union does not provide for a European health policy and that it principally ought not to be considered a genuine Community policy based on the lack of exclusive competences. However, the same scholars continue stating that the executive bodies have developed a moderate yet complicated and incomplete health policy. ⁶¹ Nevertheless, the evaluations of the success of this said policy differ drastically from each other. After a thorough analysis of “[t]he theoretical basis and historical evolution of health policy in the European Union” (2002), Mossialos and McKee conclude that

“[…] there is no all-encompassing strategic health policy and there is a need for a new Community health policy. It must be one that has at its foundation a new and comprehensive Treaty-based definition of health policy and the EU’s role therein […].”⁶²

While the terminology of an efficient health policy applied in this paper agrees with Mossialos and McKee on the grounds that European health policy lacks in clarity and strategy, the subsequent conclusion favouring the dissolution of the current framework and the establishment of a new health policy - on one hand – dismisses the developments achieved hitherto, and – on the other hand – deducts a drastic quick-fix to the problem by resorting to a new policy instead of improving the existing system. Other scholars, such as Anderson, identify European health policy to be coherent from the beginnings on, although with room left for improvement.

Accordingly, Anderson judges, among other things, the decision to include human health and life as a substantial factor for trade policies within the Treaty of Rome (Art. 36 EEC/TFEU) to be the beginning of a coherent European health policy. ⁶³ On a similar note, Lamping uses

61 Mossialos and McKee, EU Law and the Social Character of Health Care; Anderson, Social Policy in the European Union; Steffen, Health Governance in Europe; Duncan, ‘Health Policy in the European Union’; Scott L. Greer, ‘The Three Faces of European Union Health Policy: Policy, Markets, and Austerity’, Policy and Society 33, no. 1 (March 2014): 13–24, https://doi.org/10.1016/j.polsoc.2014.03.001.

62 Mossialos and McKee, EU Law and the Social Character of Health Care.

63 Anderson, Social Policy in the European Union, 172.

Art. 3, TFEU – setting health policy as a Community objective – as supporting argument. ⁶⁴ As regards health policy as a Community objective, Greer pursues this reasoning even further, based on Art. 168 (TFEU), stating that the determination of health policy as a Community objective as well as the mere existence of the Article would sufficiently demonstrate the EUs involvement and the possible influence of health policy on other policy fields. ⁶⁵ To all intents and purposes, article 168 of the TFEU provides the EU with a significant set of loopholes by introducing the all-Union-policy-approach. Thereof, Art. 168 obliges the EU to ensure “a high level of human health protection […] I the definition and implementation of all Union policies and activities.”⁶⁶ Thus, even though the EU merely shares competences with the Member States, Art. 168 enables the executive bodies to invoke the Health in all Policies (HIAP) approach to all other policies and thereby indirectly expanding the influence of the EU health policy.

Additionally, the EU is thenceforth admissible to set harmonising standards for “organs and substances of human origin, blood and blood derivatives pharmaceuticals, and measures in the veterinary and phytosanitary field.” ⁶⁷

Nevertheless, Mossialos and McKee make a valid point when arguing that the lack of a straightforward Treaty-basis intensifies the complexity of grasping the legal basis for health policy.

Thus, in order to get a comprehensive understanding of the state of play, the next part will briefly summarise the available treaty basis currently in force addressing health policy issues.

64 Steffen, Health Governance in Europe, 20.

65 Greer, ‘The Three Faces of European Union Health Policy’, 15.

66 European Union, ‘The Treaty of the European Union and the Treaty on the Functioning of the European Union’

(1958), https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:C:2016:202:FULL&from=EN.

67 Bart Vanhercke, Slavina Spasova, and Boris Fronteddu, Social Policy in the European Union: State of Play 2020, 2021.

2.1. European Treaties – incidental or intended?

Figure 2: Treaty-basis on health policy

Article Content

Article 35, FCHR

• “Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices.”

Article 56, TFEU Freedom to provide services

• “[…] restrictions on freedom to provide services within the Union shall be prohibited in respect of nationals of Member States who are established in a Member State other than that of the person for whom the services are intended.”

• Case C158/96 Kohll: The ECJ ruling states that an exclusion of the public health sector, “as a sector of economic activity and from the point of view of freedom to provide services, from the

• “The Commission, in its proposals […] concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection […]”

Art. 114, TFEU Single Market

• The functioning of the internal market shall be considerate to a high level of health, safety, environmental protection and consumer protection;

• The Commission shall, on demand of a Member State, regarding a specific problem on public health, given the occurrence of prior harmonisation measures, examine the necessity of proposing appropriate measures to the Council, e.g., Tobacco Products Directive (2014/40EU) and alcohol-related harm.

Art. 153, TFEU Social Policy

• The Union shall carry out actions, support or complement the actions of the Member States to the improvement in particular of

the working environment to protect workers’ health and safety (OMC);

• The EP and the Council may adopt soft law as well as minimum requirements for gradual implementation respectful of the functioning of the internal market.

Art. 168, TFEU Protection of Public Health

• HIAP: The Union policies and activities must respect a high level of human health protection when defining and implementing all Union policies and activities;

• Political direction of complementary Union activities to Member States ought to pursue the “improv[ement] of public health, preventi[on] of mental illness and diseases, and obviati[on of]

sources of danger to physical and mental health;

• Union’s action shall be limited to encouragement for cooperation between Member States aiming at improving cross-border health services and can – if need be – support those actions. For the promotion of Member States coordination, the Commission may resort to any useful initiative e.g., aiming to establishing guidelines and indicators, exchanging best practices and preparing monitoring and evaluation procedures” (OMC).

Source: (Pushkarev, Godfrey, and Marschang 2019; European Union 1958)

This outline demonstrates, once again, the weakness of the legal framework of European PHP.

The European executive bodies are primarily restricted to implement soft law and make use of the OMC. Article 114 presents however the possibility for the EU to disguise a health policy as an internal market problem, and thus, implementing hard law.

In the following part, ongoing and drafted health policy acts will be scrutinised based on the applied treaty-basis, the competence, and finally, against the backdrop of the state of health

assimilated to the quality of life. A published summarising catalogue of EU legislation in the field of Public Health, accessible on EUR-Lex⁶⁸, will be used as database.

2.2. Case study comparison

(1) Patient’s rights cross-border healthcare

As defined in the Charter of Fundamental rights, EU citizens have “the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices.” ⁶⁹ After the ECJ ruling on Case C-158/96 Kohll in 1998, EU citizens may seek healthcare outside of their domestic nation state.

The administrative framework for the legislative transposition into EU law is provided by Directive 2011/24/EU on patients’ rights in cross-border healthcare. The directive defines requirements and obligations of the Member States as well as of the patients.⁷⁰

Hereinafter, the only provision enabling the Member State of the patient to refuse cross-border healthcare must be based on the capability of the Member State to deliver the necessary healthcare within the respective medical time limit. ⁷¹

The directive states as its objective an increase in cooperation between national healthcare systems. A study published by the European Commission in 2017 evaluates the European cross-border cooperation on the basis of seven case studies.⁷² Their findings demonstrate that a strengthened cross-border cooperation on health improves the quality of healthcare provisions and enhances management of shortages and failings owing to mutual enrichment. However, the

68 EUR-Lex - Access to European Law, ‘Public Health’, accessed 10 December 2021, https://eur-lex.europa.eu/summary/chapter/29.html?expand=2905%2C290501%2C290502%2C2906%2C290601%2C2906 02%2C2907%2C290701%2C290703%2C290704%2C290707%2C2908%2C290801%2C2909%2C290901%2C 290902%2C290903%2C290904%2C290905%2C2910%2C2911%2C291103%2C2912%2C291201%2C291202

%2C291203%2C2913%2C291301%2C291302%2C2999.

69 Official Journal of the European Communities, ‘Charter of Fundamental Rights of the European Union’, C 364/1

§ (2000).

70 EUR-Lex - Access to European Law, ‘Healthcare in Other EU Countries - Patients’ Rights’, n.d., https://ec.europa.eu/health/cross_border_care/overview_en.

71 EUR-Lex - Access to European Law.

72 European Commission. Directorate General for Regional Policy., European Cross-Border Cooperation on Health: Theory and Practice. (LU: Publications Office, 2017), https://data.europa.eu/doi/10.2776/271537.

same study highlights, on the one hand, the complex procedures necessary for a successful and effective cooperation as regards administrative issues, such as health insurance entities, health professions, financing, and on the other hand, the primary pre-requisite of individual involvement, support and cooperation.⁷³

Yet, the general concept of the directive and the selected case studies of the study differ from each other, as the directive applies to individual patients seeking healthcare outside of their nation state’s territory, whereas the case studies represent cooperation of public entities.

Consequently, since the main objective of the Directive was an increase in cooperation among Member States’ national healthcare systems, the execution of these case-studies presents a favourable outcome.

For the legal basis of the directive, the executive bodies identified the aim to foster cross-border cooperation in the healthcare sector as an objective to strengthen the internal market of the EU.

Furthermore, the ruling of the ECJ appeals to Article 114 and identifies the provision of healthcare services as “a sector of economic activity.” Additionally, the directive transposes the EU’s commitment to ensure “a high level of human health protection” (Art. 168, TFEU) into

Furthermore, the ruling of the ECJ appeals to Article 114 and identifies the provision of healthcare services as “a sector of economic activity.” Additionally, the directive transposes the EU’s commitment to ensure “a high level of human health protection” (Art. 168, TFEU) into

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