Health Technology Assessment and Health Care Reimbursement in the European Union: Permissive Dissensus and the Limits of Harmonization through the Backdoor

Abstract

Member states have consistently limited the European Union's competences in the area of health care reimbursement. Despite these efforts, there has been a slow but steady tendency toward harmonization of a key tool in reimbursement decision-making: health technology assessment (HTA), a multidisciplinary evaluation of “value for money” of medicines, devices, diagnostics, and interventions, which provides expert advice for reimbursement decisions. This article examines the origins of this paradoxical appetite for harmonization as well as of the dissensus that has, at the moment, somewhat stalled further integration in HTA. It finds that the prointegration neofunctionalist “permissive dissensus” is still present in decision making on HTA but potentially offset by dissensus or outright opposition from key actors, including member states and the medical device industry. These actors are able to decipher the potential consequences of highly technical issues, such as HTA, for national systems of social protection. Despite that, they have little interest in politicizing the issue, potentially opening the door to integrative policy solutions in the future.

Networked Health Cooperation in the European Union: Horizontal or Hierarchical?

“…On the other hand, they insisted on a member state-led EAN, where national experts in joint actions become responsible for HTAs and the role of the Commission was toned down. An independent HTA was long dropped as an unrealistic idea (Löblová, 2021). This demonstrates EANs as important building blocks in the emerging institutional architecture of an EU health policy.…”

“…By doing so, national regulators that have developed a certain regulatory tradition steer the network and are able to push their preferences and approaches towards convergence on a European level. This may explain why some of the more experienced HTA regulators, such as Germany, France and Spain, insisted on maintaining a member state-led network, as opposed to transferring their powers to a more central Commission (Löblová, 2021).…”

“…To pool resources and further develop health technology cooperation, the Commission has pushed for mandatory take‐up of joint assessments. The idea of an independent EU HTA agency was dropped as unrealistic (Löblová, 2021, p. 127) and instead the Commission worked for a permanent and powerful European Administrative Network on HTA. Anticipating the end of Joint Action 3 in late 2020, the Commission developed a proposal for a regulation on health technology assessment in January 2018, including mandatory joint HTAs.…”

“…In a joint letter, a potential blocking Council minority consisting of Bulgaria, the Czech Republic, France, Germany and Spain took position against mandatory uptake of joint clinical assessments and too strong a role for the Commission (Löblová, 2021). The European Parliament was, on the other hand, in favour of the proposal from early on (Löblová, 2021). However, in line with the more general push for a European health policy in the midst of COVID-19, the Council changed position.…”

EU health solidarity in times of crisis: explaining public preferences towards EU risk pooling for medicines

“…Organizing the availability of medicines at the EU level would probably also involve more central EU expertise as to the efficacy of different modes of use and prescription. At the EU level, this discussion is also at stake in the context of 'health technology assessments' (Löblová, 2021;Vreman et al, 2020). In this regard, the determination of reimbursement for medicines through the national baskets of care is an important biomedical, ethical and political debate that may evoke more or less public support and social legitimacy.…”