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European Parliament adopts Health Technology Assessment Regulation

  • 08/10/2018
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On 3 October 2018, the European Parliament adopted with a large majority the proposed Regulation on Health Technology Assessment (“HTA”) (the “Regulation” - see also our  article of 1 February 2018).

The initiative on HTA cooperation at the European level had generally been well received in January 2018 when the European Commission first issued its proposal. However, several Member States (such as Germany) questioned the Regulation’s compatibility with the subsidiarity principle and objected to the mandatory uptake of the joint HTA reports and to the oversight to be exercised by the European Commission. National and regional HTA agencies also voiced concerns  over the increased workload that would be caused for them and flagged the need for more robust guarantees to avoid publication and reporting bias by health technology developers.

The amended Regulation as adopted by the European Parliament has given rise to a new flurry of criticism. In particular, patients, together with some left-leaning parties, regret that they were not given a concrete role in the decision-making process along with scientific experts, despite a proposed amendment to that effect. Instead, these stakeholders are only given the right to submit written comments. Similarly, healthcare professionals are as yet not included in the HTA process.

For its part, MedTech Europe raised concerns regarding the inclusion of specific medical devices in the scope of the Regulation at a time when that industry is already spending substantial resources on compliance with the new EU Medical Devices Regulations. MedTech Europe also advocates allowing Member States with similar needs to conduct voluntary joint HTA.

The European Parliament accommodated a major wish of a group of Member States by changing the threshold for the Coordination Group’s decisions from a two-thirds to a qualified majority. That Coordination group, composed of representatives from Member States’ HTA authorities and bodies, is the body entrusted with overseeing joint clinical assessments and other joint work under the Regulation. In addition, national and regional HTA agencies would be entitled to carry out their own additional clinical assessments which they consider necessary to complete the HTA or the overall pricing and reimbursement process on condition that these assessments are “justified, necessary and proportionate”, do not duplicate work carried out at Union level and do not unduly delay patient access to those technologies. However, this attempt to placate certain Member States seems at odds with the harmonisation purpose of the Regulation, which industry (e.g. EFPIA) has been quick to point out.

It remains to be seen how the Regulation will fare before the Council. It seems unlikely at this stage that the legislative process will be completed before the European Parliament elections in May 2019.

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