Expectations of the Council Presidency and new rapporteur.

Health Technology Assessment (HTA) is a way for national systems to efficiently distribute limited resources towards effective health services.

The objectives of three Joint Action projects run by the European Network for Health Technology Assessment (EUnetHTA) have been to promote scientific exchange, develop a method for joint HTA procedures and produce the first joint HTA reports.

Under EU law, it will be difficult to continue funding EUnetHTA after the current five-year financial framework expires in 2020. On 31 January 2018, the European Commission therefore submitted a proposal for a Regulation on clinical evaluation of health technologies to the European Parliament and the Council (see article Oct 2018).

Associations demand more involvement

The European Commission has justified its proposal by the fact that, despite having EUnetHTA, the positive effects of a professional network, cooperation in further developing clinical evaluation methods and joint HTA procedures have only been done voluntarily and on a project-by-project basis, meaning they have not reached their full potential. With the help of the Regulation on health technology assessment, the European Commission wants to achieve EU-wide harmonisation of existing national HTA procedures.

Article 8 of the proposal prohibits Member States in the future from carrying out clinical assessments of technologies for which a joint HTA assessment is planned or are already on the List of Assessed Health Technologies (‘List’ as per Article 7). The use of the joint HTA assessment is mandatory for these technologies, as is notification of the outcome of a national assessment based on a joint HTA assessment.

The German Health Insurance Funds generally welcomes the proposed consolidation of cooperation between the HTA authorities. However, the German Health Insurance Funds strongly rejects the proposal with regard to the ban on Member States carrying out their own clinical HTAs. One of the decisive factors is that, due to existing differences in national health systems, there may be clear differences regarding which therapies are considered as standard and thus as the basis for comparison. An assessment against a comparator that is unsuitable in the specific environment is useless. It is counterproductive and unnecessary to impose an obligation and prohibit supplementary assessments.

The European associations (ESIP, AIM, BEUC) welcome the proposal for a joint HTA methodology at European level. However, they emphasise that a uniform procedure must not jeopardise the quality and safety of healthcare and they are calling for more involvement of national decision-makers in the development of the assessment procedure.

In a joint statement, the pharmaceutical industry has welcomed the proposal and reiterated the need for a debate on joint methodology.

New rapporteur appointed

The GKV-Spitzenverband supports the proposal with regard to the European Commission’s intention to further develop assessment procedures at European level. However, there must be a clear distinction between ‘assessment’ at European level and ‘appraisal’ at national level. It must also be possible to carry out supplementary assessments on the basis of national specificities.

The European Parliament adopted a common position in October 2018, with the aim of creating more binding European HTA cooperation while at the same time taking into account the needs of national health systems and thus allowing more freedom in the use of joint assessment reports.

This line continues to be supported by the newly appointed rapporteur for the HTA dossier in the European Parliament, Tiemo Wölken (S&D, DE), and by Peter Liese (EPP, DE), coordinator and group spokesman for the Health Committee of the European Parliament.

The European Commission and the Council have not yet taken a position on the issue.

What next?

Finland will continue the dossier during its Presidency. The main elements of the upcoming negotiations will be the legal process, the legally binding nature of the proposal and how health technologies will be included in the ‘List’. It is still unclear which priorities the upcoming Croatian Council Presidency will set with regard to the dossier.