The Europeanization of Health Care Coverage Decisions: EU-Regulation, Policy Learning and Cooperation in Decision-Making

Abstract

The paper presents two cases of Europeanization in health policy – an area that has so far been viewed as hardly affected by European integration. We show that even in the less likely case of coverage decision-making, some traces of Europeanization can be found. This is possible because the Commission has a strong interest in further integration in this field and all other relevant actors have motives to at least engage in cooperation. Our first case deals with the EU’s transparency directive and shows that this has forced member states to establish formal decision-making procedures, but did not result in a harmonization of decision-making processes and institutions, which is why the Commission has fostered cooperation and networking. The second case looks at the Europeanization of health technology assessment, demonstrating how cooperation and policy learning take place and how the Commission has successfully promoted the emergence of a new policy field.

Keywords:

• Europeanization
• policy convergence
• health care reimbursement
• health technology assessment

Acknowledgements

We thank the VolkswagenStiftung for funding research this article is based on and two anonymous reviewers for helpful comments and suggestions on a previous version of this paper.

Notes

1. Which medical services and goods are actually available in a public health care system depends on various factors such as, for example, the health care budget, the organization of service provision or the reimbursement scheme. We concentrate here on direct interventions to define the public health care benefit basket.

2. There exist various different forms of price regulations (e.g. reference price systems, value based pricing). For an overview see Mrazek and Mossialos (2004).

3. We owe the following counter arguments to an anonymous referee.

4. If pricing and coverage decision is taken within one administrative procedure, the timeframe is extended up to 180 days (see Art. 6 No. 1 Transparency Directive).

5. Table 1 presents data for European OECD-member countries, excluding Greece because of data problems.

6. Hungary has a social insurance system that is strongly regulated by the state. The OEP which is in charge of reimbursement decisions is controlled by the state, which is why it has been classified here as public health administration.

7. In the Czech Republic SUKL decision-making seems to be a more bureaucratic process where stakeholders as well as independent experts are consulted but not otherwise involved in decision-making.

8. The Pharmaceutical Forum is a successor to the High Level Group on Innovation and Provision of Medicines, called in brieft ‘G-10 Initiative’. For a description of the EC’s previous engagement in the area of pricing and reimbursement see Permanand (2006, 162ff.).

9. Network of Competent Authorities for Pricing and Reimbursement of Pharmaceuticals.

10. See: http://ppri.oebig.at.

11. PPRI project leaders have also been heavily involved in advising the Working Group on Pricing of the Pharmaceutical Forum (Vogler, Espin, and Habl 2009).

12. HTA is also used to inform the development of guidelines, inform treatment decisions on the individual level or to initiate public health strategies,. In general, HTA can be applied: first, to all interventions supplied by the health system (e.g. medical services, drugs, diagnostics, etc.), second, to interventions into the health care system (e.g. organization of service delivery, financing of the system, etc.) and third, to health interventions outside the health care system (e.g. environmental policies that aim at healthy living conditions) (Velasco Garrido, Zentner, & Busse 2008). We will focus here on the former and restrict our analysis to HTA as a basis of reimbursement decision-making.

13. Communication of the Commission: Follow-up to the high level reflection process on patient mobility and health care developments in the European Union, from 20April 2004, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2004:0301:FIN:EN:PDF (accessed 18 July2011).

14. See www.eunethta.eu.

15. The partner organizations must be nominated by the national ministry of health. Besides the European partners, EUnetHTA involves five partners from Australia, Canada, Israel and the US as well as nine international organizations.

16. Directive of the European Parliament and of the Council on the application of patients' rights in cross-border health care (2011/24/EU).

17. The legal text is formulated in rather general terms and does not name EUnetHTA, but the description it gives of the designated network exactly fits EUnetHTA. In a communication preparing the Patients’ Rights Directive, the Commission explicitly refers to EUnetHTA (European Commission 2008b).