Timeline of the Implementation of the EU HTAR

The HTAR entered into force in January 2022 and applies across the EU from January 2025 onwards. The HTAR implementation period is dedicated to:

• Establishing the Member State Coordination Group on HTA (Article 3(1)); subgroups dedicated to Joint Scientific Consultation, Joint Clinical Assessment, Horizon Scanning, and methodological/procedural guidance (Article 3(7)); and the Stakeholder Network (Article 29).
• Ensuring that Member States are applying the HTAR as intended through the mechanism of the implementing acts (Article 34).

The European Commission has an implementation rolling plan with a list of key activities that the Commission has carried out or intends to carry out in preparation for the implementation of HTAR. 

🔗Access the European Commission's website to find more information about this plan 

The date of HTAR application  (January 2025) marks the commencement of the preparation of reports on emerging health technologies expected to have a major impact on patients, public health or healthcare systems (Article 22); and of joint scientific consultations (Section 2). The rolling out of Joint Clinical Assessments of medicinal products takes place in three phases as per Article 7(2):

• As of January 2025: JCAs commence of eligible medicinal products with new active substances indicated for cancer treatment or medicinal products which are regulated as advanced therapy medicinal products.
• As of January 2028: JCAs commence of eligible orphan medicinal products.
• As of January 2030: JCAs commence of remaining categories of eligible medicinal products.

Additionally, as of January 2025, the European Commission shall adopt decisions at least once every two years selecting medical devices and in vitro diagnostic medical devices for JCA based on one or more of the following criteria:

• unmet medical needs,
• first-in-class status,
• potential impact on patients, public health or healthcare systems,
• incorporation of Artificial Intelligence (AI) machine learning or algorithms,
• significant cross-border relevance, and
• major EU-wide added value.

The Commission seeks recommendations from the Coordination Group in this process (Article 7(4)). 

Following the date of application, a further two-year period is granted for Member States to fully adapt to the application of this Regulation, and particularly the consideration of joint work in their national HTA processes, including the way joint clinical assessment reports are considered when conducting national HTAs. Member States shall report to the Commission on the application of HTAR no later than January 2027, (Article 31 (2)).

An evaluation of the HTAR will take place 3 years after the Joint Clinical Assessment comes into effect. The Commission shall present a report to the European Parliament and to the Council on the application of HTAR no later than January 2028, (Article 31(1)).

Figure 8 presents an overarching timeline for the implementation and roll-out of HTAR.

HTAR IMPLEMENTATION PHASE

PHASED ROLL-OUT

Figure 8. Timeline of HTAR Implementation and Roll-Out.