HTAR Implementation
The European Commission, Member States, and key stakeholders have been working to:
- Set up a joint framework for clinical assessment.
- Establish a common methodology and approach for clinical assessments and scientific consultations.
- Ensure that different Member States are applying the HTAR as intended through the mechanism of the EU.
- Provide Implementing Acts (See Figure 6?)
Implementing acts to be adopted by 2025
| Procedural rules for JCA medicinal products | Q4 2023 |
| Procedural rules for the prevention of conflict of interest | Q1 2024 |
| Cooperation by exchange of information with the EMA | Q1 2024 |
| Procedural rules for JSC medicinal products | Q2 2024 |
| Procedural rules for JSC medicinal devices and IVD medical devices | Q3 2024 |
| Procedural rules for JSC medicinal devices and IVD medical devices | Q4 2024 |
Figure 6 shows a list of Implementing acts to be adopted and their respective timelines.
Adapted from European Medicines Agency (EMA), In vitro diagnostics (IVD), Joint Clinical Assessments (JCA), Joint Scientific Consultations (JSC). Available at: PowerPoint Presentation (europa.eu)
Primary responsibility for implementing EU law lies with Member States. However, in areas where uniform conditions for implementation are needed such as health, the Commission (or exceptionally the Council) adopts so called ‘implementing acts’. The HTAR outline four domains where implementing acts must be drafted and adopted to ensure the new regulation is effectively conducted:
- Adoption of detailed procedural rules for Joint Clinical Assessments (Article 15).
- Adoption of detailed procedural rules for Joint Scientific Consultations (Article 20).
- General procedural rules for the participation of the Coordination Group, its subgroups, stakeholder organisations and patients, clinical experts and other relevant experts in JCA (Article 25).
- Rules for the format and templates of submission and report documents (Article 26).
It is important to remember that the HTAR does not present the actual implementing acts; they define specific areas of the Regulation that need implementing acts (i.e., articles that all Member States should implement following similar procedures to ensure efficient joint work).
🔗Referencing information from the European Commission's official website on decision-making processes available here: Implementing and delegated acts - Consilium (europa.eu):
An implementing act is a non-legislative act laying down detailed rules allowing the uniform implementation of legally binding Union acts. Implementing powers are conferred in many cases on the European Commission, while in duly justified specific cases and in the cases provided for in Articles 24 and 26 TEU, these powers are to be conferred on the Council.
Once the implementing acts for the four outlined areas are drafted, they still need to go through a formal examination procedure to be adopted and followed (Articles 33, 34).