Megatrend: unified HTA across the EU space?

EU Regulation on HTA: coming into force as of 13th December 2021


Talks around the European Union of an HTA process kept everyone busy at least since 2018 and in reality for more than a decade. The Regulation entered in force at the end 20 days after its publication in the Official Journal of the EU and thus started to create legal effects across all Member States with immediate effect.


The European Commission welcomed this Regulation and underlined that it would lead to more readily available health technologies across the Union:


Regulation on Health Technology Assessment (HTA), a deliverable of the EU Pharmaceutical Strategy, has been adopted.


The new rules will allow vital and innovative health technologies - such as innovative medicines, certain medical devices, medical equipment and prevention and treatment methods - to be more widely available.


The Regulation will also ensure the efficient use of resources, strengthen the quality of HTA across the EU, and save national HTA bodies and industry from duplicating their efforts, reassure business and ensure the long-term sustainability of EU HTA cooperation.


However, there is a caveat which is worth pointing out: the Regulation provides for a delayed application of three years, during which the Commission will set up a co-ordination group as well as a stakeholder network but will also co-ordinate the necessary executive measures and delegated act.


Finally, the question of a methodology for joint HTA work -required by the Regulation- will also probably require time, efforts and lengthy discussions.


Click here for more information available on the website of the European Commission.


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