2. EUROPEAN (PUBLIC) HEALTH POLICY – FUTILE OR CRUCIAL?
2.2. C ASE 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 EU law thereby.
The cross-border healthcare directive supports and promotes cooperation between Member States and sets the administrative framework accordingly. Case studies demonstrate individuals’ ambition and voluntariness and the recent allocation and distribution of patients suffering from COVID-19 throughout the whole EU emphasizes the indispensability of this directive to the European health policy. However, the occasional involvements of the European executive bodies remain clearly marginal. Notwithstanding the weak treaty-basis, the European Commission could further exploit the advantages of mutual enrichment by launching best practice exchanges and monitoring procedures for the creation of a database of common and distinctive features as well as identification of strengths and weaknesses.
As regarding the objectives aiming at protecting human health set by the EU’s Health Strategy, the directive under examination aims to meet the objectives: (2) facilitating access to better and
73 European Commission. Directorate General for Regional Policy.
safer healthcare, (3) contributing to innovative, efficient and sustainable health systems, (4) dealing with cross border threats and (6) harnessing new technologies and practices.
(1.1) European health insurance card (EHIC)
The cross-border healthcare directive seeks to ensure that the EU citizen’s rights to access healthcare with reimbursement for the costs will be respected throughout the entirety of the Union.74 The implementation thus states that a European citizen must be provided with healthcare services outside of his/her country and that the national insurance must cover the expenses. In order to facilitate the manoeuvre for citizens temporarily based outside of their country of residence, in 2011 the Council made provisions for the establishment of a European health insurance card designed for a facilitated reimbursement procedures of received healthcare services.
Whilst the EHIC does not represent a direct influence on the quality of the European health policy besides facilitating access, it is an illustration of integrating the EU’ leitmotif of growing into an ever-closer Union into health policy.
Nevertheless, after having introduced the electronic health card as the only valid proof of entitlement to claim benefits from health insurance firms, the German Bundestag has brought about the electronic patient record (ePA) of January 2021. The ePA stores all medical files and records of a patient. 75 While the transposition of national law to EU law of such a complex undertaking would entail several questions regarding particularly data regulations, the EHIC could be a forerunner in terms of health and digital policy if integrating the possibility to digitalise one’s medical records into the EHIC, similarly to the ePA.
(2) Tobacco regulations
European actions against tobacco consumption count among the most significant health policy acts. As part of the Union’s actions in the fight against cancer, the reduction of tobacco consumption was identified as a major goal. By those means, the EU has been taken legal
74 EUR-Lex - Access to European Law, ‘Healthcare in Other EU Countries - Patients’ Rights’.
75 Federal Ministry of Health, ‘Elektronische Patientenakte’, accessed 10 December 2021, https://www.bundesgesundheitsministerium.de/elektronische-patientenakte.html.
actions to reduce tobacco consumption since 2002. Three main problematics – (a) tobacco advertising and sponsorship, (b) tobacco smoke exposure, and (c) tobacco manufacturing, presentation and sale – have been identified and addressed under the aegis of directives and council recommendations.
Before examining the single legislations, particular attention will be paid to the Treaty-basis applied here. In total, four major recommendations and directives have addressed tobacco regulations:
(1) 2002: Council recommendation on preventing smoking and on initiatives to improve tobacco control;
(2) 2003: Tobacco advertising and sponsoring directive 82003/33/EC);
(3) 2009: Council recommendation on smoke free environments; and (4) 2014: Tobacco products directive.76
While the Council recommendations are non-binding and offer an insight to the intended binding legislations of the future, the directives are part of the secondary legislation, and thus of a binding character. As determined earlier, the European Union does not have exclusive competences in health policy – per se. However, Art. 95 (3), TFEU, the three executive bodies, Commission, Parliament and Council, shall pay a high level of protection to health safety while drafting proposals for the establishment and implementation of the Internal Market. Article 114 of the TFEU further tasks the Commission to “examine the necessity of proposing appropriate measures to the Council” regarding a specific problem on public health. 77 Theses treaty provisions form the legal basis for both directives seeking to regulate tobacco consumption.
Thus, the directive states that Member States legislation’ should seek “to protect public health by regulating the promotion of tobacco, an addictive product responsible for over half a million deaths in the Community annually […].” 78
76 European Commission, ‘Public Health, Overview, Tobacco’, Text, Public Health - European Commission, 25 November 2016, https://ec.europa.eu/health/tobacco/overview_en.
77 European Union, The Treaty of the European Union and the Treaty on the Functioning of the European Union.
78
Contrarily to the other policy measures, the tobacco regulation can be categorized as secondary legislation or Direct health policy making, as identified by Duncan (2002). 79 Whereas the recommendations refer to primary and non-binding regulations.
The first Council recommendation urges the Member States to implement measures discouraging (young) people to smoke and proposes a set of legislations to implement. These include – among other things – an endorsement to reduce tobacco advertising and promotional activities. 80 The directive, published one year later, hereinafter regulates the advertisement and promotion in the printed media, on radio and in information society services and sponsoring of the latter throughout the EU. 81 2009, the Council drafted another recommendation on smoke free environments and tasks the Commission to “reduce the attractiveness and addictiveness of tobacco products. The tobacco products directive was passed five years after the recommendation and establishes a clear set of rules regarding manufacture, presentation and sale of tobacco products. As such, it requires a 65% coverage of health warnings on packages, bans flavours and slim packages, establishes safety and quality rules for electronic cigarettes and tasks manufacturers to submit reports on ingredients.
A comparison of two published Eurobarometer – (a) Survey on Tobacco – Analytical report (2009), and (b) Attitudes of Europeans towards tobacco and electronic cigarettes (2020) – show, that the amount of occasional and daily smokers has reduced by 8%, from 31% to 23%.
Furthermore, according to the survey, all Member States implemented policy measures creating smoke-free environments. 82
Provisions of the Member States Relating to the Advertising and Sponsorship of Tobacco Products’, 2003/33/EC
§ (2003).
79 Duncan, ‘Health Policy in the European Union’.
80 Official Journal of the European Communities, ‘Council Recommendation on the Prevention of Smoking and on Initiatives to Improve Tobacco Control’, 12 2002.
81 European Commission, ‘Public Health, Overview, Tobacco’.
82 European Commission.
The tobacco case study used the interlinked character of health policy and internal market policy in order to combat a major health scourge. A similar approach, as taken for tobacco regulations, could be applied to combat childhood obesity.
(2.1) Childhood obesity
The European Commission launched policy measures tackling childhood obesity in 2014 with the EU Action Plan on Childhood Obesity 20014-2020. 83 This Action Plan concludes that a healthy lifestyle including physical activity would ultimately lead to “better health and quality of life of EU citizens and the sustainability of the health systems […].”84
Within the Action Plan, the European Commission recognizes that the labelling of foods could have a positive effect in convincing consumers to choose healthy options. 85 Six Member States (France, Belgium, Spain, Luxembourg, Germany, and the Netherlands) chose to implement a nutritional-rating label dubbed Nutri-Score. According to the NGO foodwatch.org, the Commission discusses a binding policy measure obligating Member States to implement nutritional-rating labels. 86
The legal provisions serving as scope for the legislation could be similar to the tobacco case study. Obesity has proven to be a major health scourge and possible to lead to significant socio-economic consequences, and hitherto, the EU could not detect any positive outcomes of the recent policy initiatives. 87
83 EUR-Lex - Access to European Law, ‘Tackling the Epidemic of Childhood Obesity’, 11 2017, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=legissum%3A4304070.
84 EUR-Lex - Access to European Law.
85 Official Journal of the European Communities, ‘Council Conclusions to Contribute towards Halting the Rise in Childhood Overweight and Obesity’, 2017/C 205/3 § (2017).
86 ‘WHO: EU-Wide Introduction of Nutri-Score Necessary’, accessed 10 December 2021,
https://www.foodwatch.org/en/news/2021/who-eu-wide-introduction-of-nutri-score-necessary/?cookieLevel=not-set.
87 Official Journal of the European Communities, Council Conclusions to contribute towards halting the rise in Childhood Overweight and Obesity.
For Art. 95 (3), Art. 114 to be applicable when combatting obesity, the responsible executive bodies must agree on obesity being a specific problem of public health stemming from ignorance. Food labelling as well as educative measures (as proposed by the Action Plan) could improve the situation and thus assist people battling obesity. The multitude of social difficulties being caused by obesity might additionally be decreased.
This measure would greatly contribute to the objectives fixed in the EU4Health Strategy.
Therefore, a decrease of (childhood) obesity would not only promote a healthier lifestyle but would also relieve the health care system in general.
(3) Pharmaceutical strategy
The pharmaceutical strategy published in November 2020, respects the wholesome character of health policy by noting that
“Good health is central to wellbeing and depends on a multitude of factors including healthy lifestyles and fair and equitable access to healthcare, a central pillar of the European way of life.” 88
Furthermore, the pharmaceutical strategy acts supportively to the European Green Deal, the Zero Pollution ambition for a toxic free environment, the European Pillar of Social Rights and the strategic frameworks on achieving a Union of Equality and many more. 89 This comprehensive approach reflects the definition of social policy applied in this paper.
To those means, the strategy is divided into 4 pillars and 15 subgroups aiming at “creating a future proof regulatory framework and at supporting industry in promoting research and technologies that actually reach patients in order to fulfil their therapeutic need while addressing market failures.” 90 The pillars are as followed:
88 European Commission, ‘Pharmaceutical Strategy for Europe - 2020’, 11 2020, https://ec.europa.eu/health/sites/default/files/human-use/docs/pharma-strategy_report_en.pdf.
89 European Commission, 6.
90 Vincent DRAGUET, ‘A Pharmaceutical Strategy for Europe’, Text, Public Health - European Commission, 3 March 2020, https://ec.europa.eu/health/human-use/strategy_en.
• “access to affordable medicines for patients, and addressing unmet medical needs;
• supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines;
• enhancing crisis preparedness and response mechanisms
• ensuring a strong EU voice in the world.” 91
The strategy is said to be patient-centred and (a) to sustainably ensure affordable access to medicines, (b) to increase innovation in the pharmaceutical industry, (c) to strengthen the EU’s defence strategy for combatting forthcoming pandemics, and (d) to increase the EU’s global competitiveness in the pharmaceutical market. 92
(4) Health technology assessments
In 2018, Portugal used its Presidency of the Council of the EU to promote negotiations on a legislative proposal for health technology assessments (HTA).
“HTA is a research-based tool to support decision-making in healthcare. HTA assess the added value of new or existing health technologies – medicines, medical devices […] and diagnostic tools, surgical procedures, as well as measures for disease prevention, diagnosis or treatment – compared with other health technologies. […]
The proposed regulation on HTA aims to strengthen EU-level cooperation among Member States for assessing health technologies. According to the Commission, it would not only make innovative health tools reach patients faster, but also boost innovation and improve competitiveness of the European health sector. Building on existing EU cooperation on HTA, including the HTA network and the EUnetHTA joint action, the proposal would provide the basis for a permanent, sustainable cooperation,” 93
91 DRAGUET.
92 Clara Bauer-Babef, ‘MEPs Call for the EU Pharma Strategy to Address Medicine Shortages’, www.euractiv.com, 14 October 2021, https://www.euractiv.com/section/health-consumers/news/meps-call-for-the-eu-pharma-strategy-to-address-medicine-shortages/.
93 European Parliament, ‘Legislative Train Schedule’.
Based on the proposal’s motivation to increase the European health sector’s competitiveness and to further health technology research, the responsible section is Single Market, Production and Consumption. Continuously, the treaty-basis applied as legal justification are both Article 168 and 114 (TFEU). The proposal, when applied, would make use of the Open Method of Coordination.
As regards the EU strategy, HTAs respond to two strategic objectives: contributing to innovative, efficient and sustainable health systems and harnessing new technologies and practices.