Spain: European Council and Parliament reach informal agreement on joint clinical assessment of health technologies at EU level
The legislative path to strengthen cooperation at EU level on clinical health technology assessments (HTAs) has taken another step forward, more than three years after the Commission adopted its proposal for a regulation on joint HTAs. On June 22, 2021, the Council of the EU and the European Parliament finally sealed a provisional agreement and a common position on the text of the future regulation.
It is worth recalling the scope and obligations contained in the 2018 proposal for a regulation on HTA. The regulation aims to avoid fragmentation between Member States and duplication of efforts by national HTA agencies, while providing health technology developers with greater predictability in terms of market access.
To achieve this, the initial project focused on harmonizing clinical aspects of HTA (with regard to the quality and effectiveness of the technologies evaluated) by introducing two mechanisms at EU level: evaluations joint clinics and joint scientific consultations. Joint clinical evaluations are limited to centrally authorized drugs and certain medical devices (those with greater impact). Once the joint report is published, Article 8 of the Commission proposal provides that it will be used at national level and that no further clinical evaluation can be carried out.
The final regulation has not yet been officially approved by the two EU lawmakers and is due to enter into force. Therefore, there is no document published and we are not aware of the amendments introduced as a result of the trilogue negotiations. However, it seems that the European Parliament has compromised on the binding nature of joint clinical evaluation reports. National ministers had Reservations regarding the mandatory use of joint clinical evaluations and the impact this could have on national P&R decisions.
Some media have reported that consideration of joint clinical evaluations will finally be ensured by annexing them to national evaluations and forcing member states to disclose their use in national HTAs. For EFPIA, the European Trade Association of Pharmaceutical Companies, such a compromise can lead to “an unpredictable system in which member states decide on a case-by-case basis whether and how to commit to using jointly conducted clinical evaluations”.
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