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In brief

The highly awaited common Regulation on Health Technology Assessment (hereinafter, the Regulation) will soon become a reality. After a long process which began early 2018 and back and forth discussions between EU Parliament and EU Council, the EU Council finally gave its final go-ahead for the adoption of the Regulation on 9 November 2021. The Regulation now needs to be adopted by the European Parliament and published in the EU Official Journal. It will begin to apply 3 years after its entry into force (allowing Member States to adapt their national procedures in accordance with the Regulation and to put in place at EU level the appropriate framework for the conduct of joint clinical assessments).

Health Technology Assessment (HTA) is a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing health technologies. This multidisciplinary process evaluates the medical, social, economic and ethical issues related to the use of a health technology. Health technologies encompass medicines, medical devices, in vitro diagnostic medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.

HTA results are of great value since they are used as a criterion to determine the allocation of health care resources, such as pricing or reimbursement levels for health technologies.

HTAs have been introduced in a number of EU countries and for more than 20 years, a voluntary cooperation between HTA agencies from 28 EU countries has been set up to address the challenges of transferring assessment results between Member States. However, this voluntary cooperation did not have the desired effect since the use of the results of the joint action remained very limited.

Health technology developers are then being confronted with multiple and divergent requests for data and must carry out burdensome assessments by Member States with divergences between processes and methodologies of assessment.

Therefore, the new Regulation contemplates to create a permanent cooperation – embodied in a Coordination Group composed of representatives from national HTA authorities and agencies – to move towards a common and harmonized assessment of health technologies. The Regulation sets out 4 main principles to harmonize the HTA across the EU: joint clinical assessments, joint scientific consultations, identification of emerging health technologies and voluntary cooperation in other potential areas (e.g. on surgical procedures).

After the Regulation comes into force, health technology developers will submit only once, at EU level, any information, data, analyses and other evidence required for the contemplated joint clinical assessment. This will definitely save them time and money by avoiding unnecessary repetition of similar administrative procedures in different Member States, and it will also avoid discrepancies between Member States individual assessments.

Focusing on France, it is interesting to note that the French National Authority for Health (HAS) will play a prominent role in this new EU cooperation, notably with the current president of HAS holding the vice-presidency of the heads of agencies group, which brings together the heads of national HTA agencies.

From the industry perspective, concerns have been expressed on the overall added value of the contemplated framework in accelerating access to needed medical technologies. The upcoming implementation of the new framework will reveal if the Regulation’s stated goals are met.


Julie Yeni practices in the Pharmaceutical and Healthcare Industries Practice Group of Baker McKenzie in Paris.


Caroline Arrighi-Savoie is an Associate in Baker McKenzie Paris office.

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