Launch of legislative procedure on Health Technology Assessment

The Committee on Industry, Research and Energy (ITRE) has appointed Lieve Wierinck (ALDE, Belgium) as rapporteur for opinion. Ms. Wierinck has been extremely involved in health-related dossiers since she joined the European Parliament in 2016 following Philippe De Backer’s appointment as Belgian national minister. She will be in charge of preparing the Committee’s opinion on the Commission proposal. This opinion will consist of amendments to the proposal accompanied by short justifications and will be taken into account when drafting the Parliament’s position on the proposal.

The Commission proposal establishes a requirement for mandatory use of the joint clinical assessment reports and no repetition of the assessment in Member States' overall HTA processes. Member States will continue to carry out non-clinical assessments (i.e. on economic, organisational, ethical domains) and will draw conclusions on the overall added value of the assessed health technology based on the joint clinical assessment report and their own non-clinical assessment.

The proposed mandatory cooperation model is based on a four-pillar approach:

• Joint clinical assessments – where EU added value is considered to be strongest.
• Joint scientific consultations – this will allow a developer in the development phase of a health technology to seek the advice of HTA authorities and bodies on the data and evidence likely to be required as part of a potential future joint clinical assessment.
• Horizon scanning – an annual study will be carried out on the identification of emerging health technologies.
• Voluntary cooperation – although the proposal provides for mandatory cooperation on joint clinical assessments, it also provides for the possibility for Member States to continue to cooperate on a voluntary basis at Union-level.

Background

The proposal takes the form of a Regulation.Regulations are legal acts that apply automatically and uniformly to all EU Member States as soon as they enter into force, without needing to be transposed into national law.

The proposal will follow the so-called “ordinary legislative procedure”. This means that both Council and Parliament will work on their opinion on the proposal and draft a report. The two institutions (“co-legislators”) will then need to agree on a common position.

For more information, the full Commission proposal is available here.