Implementation of the European health technology assessment legislation (EU HTAR)
The National Health Care Institute is preparing for new European health technology assessment legislation which is going to be effective from 2025 onwards. This assessment is referred to as Health Technology Assessment (HTA). The abbreviation for the new legislation is EU HTAR and the new rules will have an effect on the work of the National Health Care Institute.
What does the EU HTAR imply?
The European Union adopted the new EU HTAR legislation (regulation 2021/2282) on 15 December 2021 and it is going to be effective from 2025 onwards. EU member states are currently preparing for this and the aim is for them to cooperate more when assessing medicinal products and medical devices. It will save medicine producers a great deal of time and costs if they can submit documents in a more central fashion at EU level, instead of in all countries individually. EU member states are going to continue to be allowed to decide unilaterally which medicines they do or do not reimburse. The cooperation is to be limited to assessments of the effect of a medicine or medical device and will not cover economic, ethical and organisational aspects. Those aspects will be dealt with by countries at national level.
Phased introduction from 2025 onwards
The new legislation is to be introduced in phases. The legislation covering medicines for cancer and advanced therapy medicinal products (ATMPs) will become applicable from 2025 onwards. These are medicines which are used in advanced treatments, such as cell and gene therapy. The legislation for orphan medicinal products will become applicable from 2028 onwards. These medicines are used for rare, often serious, diseases. Legislation for all other medicines and for certain medical devices will come into effect from 2030 onwards.
Preparations by the National Health Care Institute
Although 2025 is some way off, the National Health Care Institute has already started preparing for the introduction of the EU HTAR. We are analysing the consequences of the new legislation for our current processes relating to medicinal products and medical devices. We are also finding out about the method of working we are going to have to use from 2025 onwards. We are going to discuss the results with relevant stakeholders. In addition, we are preparing for larger-scale cooperation at European level.
EU HTAR Information Day 2024
The 2024 EU HTAR Information Day took place on January 30. The aim of the event 'EU HTAR, from Theory to Practice' was to inform stakeholders about the EU HTAR, engage in discussions together, and discuss its opportunities and challenges. An essential objective of the regulation is to encourage collaboration among member states of the European Union in the evaluation of pharmaceuticals and medical devices. These member states include the Netherlands, Belgium, Luxembourg, Austria and Ireland, which are all part of the Beneluxa Initiative. Preparations for implementing this new system are currently being made, both in the Netherlands and in Europe.
A variety of topics was discussed during the panel sessions:
- The EU regulation on Health Technology Assessment - what’s in it and why it matters.
- The national perspective - Expectations, opportunities, and the challenges ahead.
- Ensuring engagement and cooperation in joint clinical assessments.
- Ensuring engagement and cooperation joint scientific consultations.
The EU HTAR Information Day was recorded. You can watch the videos on the website of the event.
Further information
If you have any questions about the preparations for the EU HTAR, you can send an e-mail to:
Laura Snyders
E-mail: lsnyders@zinl.nl
Schedule
| Process phase | Date |
|---|---|
| File start date | June 2022 |
| File end date | 1 January 2030 |
Parties involved
- Association Innovative medicinal products (Vereniging Innovatieve Geneesmiddelen, VIG)
- Association of Dutch Healthcare Insurers (Zorgverzekeraars Nederland, ZN)