Towards a regulation of HTA in Europe: the proposal from the European Commission

KEYWORDS:

• Health Technology Assessment
• HTA
• Europe
• European commission
• regulation

1. Background

Health Technology Assessment (HTA), defined as the systematic evaluation of the properties and effects of a health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision making regarding health technologies [1], is nowadays well-known across many regions of the world [2,3] due to its capacity of providing valuable elements for decision-making at different levels. At European level, the investment into the development of shared methodological frameworks for HTA and the transfer of its outputs to local contexts has been of great magnitude, from the many projects funded by the European Union Framework Programme 7 (FP7) [4] to the extensive EUnetHTA collaboration, started in 2006 and being currently ongoing with its third Joint Action (JA3), which is supposed to end in 2020 [5].

Recently, opening the consultation phases during 2016, the European Commission engaged in an extensive process to reach the final goal of a European HTA activity regulated at central level. This work was initiated to strengthen the cooperation on HTA between Member States beyond 2020, in response to the calls coming from the Members States, the European Parliament, and other interested parties. On January 2018, a legislative proposal was adopted by the European Commission and sent to the European Parliament and the Council with the aim of adoption by 2019 [6]. After such adoption, 3 years will be necessary to start the application of the new regulation and this will be followed by another three years of transitional period for the Member States. Even if the process ahead is still quite long, and changes may occur, it is worthwhile to look at five key-elements of the proposal: the creation of a Member State Coordination Group on HTA, the production of joint clinical assessments, the provision of joint scientific consultations, the program on emerging health technologies, and the support to voluntary cooperation among Member States [7].

2. Key-elements of the proposal for a regulation on HTA

2.1. Coordination Group on HTA

Led by Member States, the Coordination Group will have the role of defining an annual HTA work program, managing the whole cooperation process among subgroups of experts and HTA bodies nominated by Member States and appointed to produce the joint assessments, and approve the final joint reports that will be then published by the Commission.

2.2. Joint clinical assessments

Joint clinical assessments of pharmaceuticals will be limited to medicinal products undergoing the central marketing authorization procedure, new active substances, and existing products for which the marketing authorization is extended to a new therapeutic indication. For non-pharmaceutical technologies, the joint clinical assessments will be limited to certain classes of medical devices and in vitro diagnostics (IVD) for which the relevant expert panels (established in accordance with European Regulations 2017/745 and 2017/746) have given their opinions or views and which have been selected by the Coordination Group according to a set of pre-defined criteria, such as unmet medical need, potential impact on patients, public health, or healthcare systems, significant cross-border dimension, Union-wide added value (e.g. relevance to a large number of Member States), and available resources. The joint clinical assessments will cover the domains typically based on global evidence (e.g. clinical effectiveness, safety) while the assessment of those elements that are often more sensitive to national/regional contexts (e.g. economic, ethical, organizational) will not be included and can be carried out by Member States independently.

2.3. Joint scientific consultations

Joint scientific consultations, also known as ‘early dialogues,’ will be produced by the Coordination Group in response to a request of advice from a health technology developer. In particular, the advice will be related to the data and evidence likely to be required as part of a (potential) future joint clinical assessment. However, even if the approval by the Coordination Group will be necessary, the final output of this activity will not be published but reserved to the health technology developer and will not be binding at any level.

2.4. Emerging health technologies

Emerging health technologies will be matter of study within the annual work program of the Coordination Group. The aim is to perform horizon scanning activities to guarantee that those technologies expected to have a major impact on patients, public health, or healthcare systems are identified at early stages. Part of the activities will be the full consultation with all relevant interest groups such as technology developers, patient organizations, clinical experts, the European Medicine Agency (EMA), and the Medical Devices Coordination Group (established by the European Regulation 2017/745).

2.5. Voluntary cooperation

Voluntary cooperation among Member States will be supported by the European Commission and will be related to the non-clinical assessment of health technologies (e.g. economic, ethical, organizational aspects), the collaborative assessment on medical devices, the assessment of those health technologies that are not medicinal products nor medical devices, and those activities linked to evidence generation to support HTA.

3. Considerations

On the paper, it seems that the European Commission’s proposal for a regulation of HTA may hit the target assuring, from one hand, the central coordination of the HTA activities and, from the other, leaving to Member States the room for further analyses aimed to explore highly context-dependent aspects. At a first glance, this may be translate in a reduction of duplication in the assessment activities, a well-known phenomenon that, for example in the case of medical devices, can count from 7 to 22 reports on the same technology over a time-span of 13.5 years [8]. Of course, at the very bottom, there should be a robust base of trust and shared methodology that allow the Member States to build on each other’s conclusions. The processes and deliverables foreseen by the proposal are clearly rooted into the extensive work performed along the years within the largest project around this topic, EUnetHTA. With a total budget of 20 million Euro and 81 organizations consisting of national, regional, and not-for-profit agencies from 29 countries involved [9], it is hard to argue that relevant elements have been left outside. However, the story is being written right now. Details, rules, and processes have to be clearly defined and willingness from the side of Member States will be a major element for the success of the proposal.

Declaration of interest

The author is a consultant at Agenas which is involved in EUnetHTA. The present paper solely represents the personal point of view of the author. No writing assistance or funds were received for the production of this manuscript.

Reviewer disclosures

One peer reviewer is affiliated with the Ludwig Boltzmann Institut fur Health Technology Assessment which is involved in EUnetHTA. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.