The Connected Universe (2016)

Apollo 18

Parliament gives green light on Health Technology Assessment

On the 3rd of October, the European Parliament voted on the report on Health Technology Assessment (HTA), under the leadership of S&D MEP Soledad Cabézon Ruiz, with a majority of MEPs approving the European Commission’s proposal (576 in favour, 56 against) which vows to introduce a joint clinical assessment of health technologies at EU level. The plenary backed an amendment from the European People’s Party that would change the threshold for decisions in the Coordination Group from a two-thirds majority to a qualified majority.

The proposal covers new medicines and certain medical devices, and would provide the basis for permanent EU-level cooperation in four areas: joint clinical assessments; joint scientific consultations; identification of emerging health technologies; and voluntary cooperation on other aspects of HTA.

All in one, HTA is a research-based tool that focuses specifically on the added therapeutic value of a health technology in comparison with other health technologies. Yet, there are challenges to tackle. Due to the large heterogeneity of the methodologies used across practices and Member States, it is very difficult to obtain a consolidated opinion from a HTA. On the other hand, a number of advantages is unparalleled, such as faster and more efficient drug development, tackling rare diseases and allowing to answer multiple research questions in parallel.

How does the Commission envisage HTA implementation?

Overall, the cooperation would be Member State driven, with the Commission hosting a secretariat to provide administrative, scientific and IT support. Participation in the joint clinical assessments and use of the joint clinical assessment reports at Member State level would become mandatory after six years: following the regulation’s entry into force, the Commission proposes a three-year period for adopting tertiary legislation and another three year (transitional) period to allow Member States to fully adapt to the new system.

Next steps?

We now wish to call upon EU policymakers to initiate trilogue inter-institutional negotiations without delay, in view of reaching a final agreement ahead of the European elections in 2019. In the case of no position adopted before the upcoming elections, next May, a new parliamentary position may have to be developed and adopted.

Additionally, the reluctance of a number of Member States may come as a hurdle too. Countries like Germany, France, Poland and Czech Republic can block the proposal in the Council of the EU, compromising reached amendments.