Joint Clinical Assessment of Health Technologies (cepInput)


The European Commission wants to introduce joint clinical assessments of medicinal products and medical devices at EU level. A cepInput continues the monitoring of the legislative procedure, for which a cepPolicyBrief has already been published in 2018. While the Commission Proposal is supported by Parliament, the Council is divided on this issue.


The joint clinical assessment faces a dilemma: On the one hand, it would strengthen the internal market and provide significant gains in efficiency as well as a reduction in bureaucracy costs. Its introduction would therefore be appropriate. On the other hand, the EU lacks the legislative competence to introduce it. Parliament's call to allow Member States to carry out a "complementary assessment" aims to bridge this gap. The fewer Member States that use such a right, the greater the economic benefits of the joint clinical assessment. From cep's point of view, this is the way to go forward. If no agreement can be reached in the Council with this approach, a second compromise proposal would be that Member States will be given the freedom to decide whether or not to opt for a joint clinical assessment. This would completely safeguard the Member States' area of responsibility.