On 13 December 2021, the European Parliament endorsed the agreement with the EU Council on Health Technology Assessments (HTA).
In its press release, the European Parliament stated that no proposals or amendments were tabled to reject the Council position on the recommendation for second reading on the file. As such, with the vote on amendments for the recommendations no longer being required, the regulation on HTA was adopted by the MEPs.
This is relevant for the in silico community because the HTA allows Member States to pool their expertise and coordinate health technology assessments under one harmonised assessment. Not only should this improve access to health technologies – such as computer modelling and simulation – it is also an opportunity to ensure that in silico evidence is accepted as evidence for the single, harmonised assessment.
The Regulation will apply from January 2025; implementation work will start in the upcoming months.