Go to content

European collaboration for EU HTAR

From 12 January 2025, the National Health Care Institute will use European legislation for the evaluation of medicines and medical devices. This Act is called EU HTAR and should lead to a more efficient process, ensuring the right care can be delivered to the right patient more quickly. The EU HTAR rules will have an effect on the work of the National Health Care Institute.

The EU HTAR: collaborating to evaluate care

From 2025, all the countries of the European Union will collaborate to evaluate medicinal products and medical devices, making sure that the right treatment can reach the right patient more quickly. The countries will use these evaluations in their decisions on insured care. In the Netherlands, we continue to decide for ourselves what care we ensure from the basic health care package.

The collaboration is limited to reporting results on the effectiveness and safety of a medicinal product or medical device compared to usual care. The European reports do not contain statements about the value of interventions. The reports are used as input for the national assessments, especially on the effectiveness of care. Economic, ethical and organisational factors do not play a role here. Countries will deal with those aspects completely at a national level. The National Health Care Institute consults the relevant parties at the start of the European reports. The national assessment process starts when the European report is final and the marketing authorisation holder applies for reimbursement in the Netherlands. This process also includes the consultation phases that are already a fixed part of the national assessment process. 

Phased introduction from 2025 onwards

The EU HTAR will start in 2025, but several types of care will be introduced step by step. The schedule is as follows. 

  • From 2025 onwards, the Act applies to medicinal products for cancer and ATMPs, which stands for advanced therapy medicinal products. 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. 
  • The Act will come into effect from 2030 onwards for all other medicinal products. 

When the EU HTAR Act will come into effect for medical devices has yet to be determined.

The National Health Care Institute and the EU HTAR

At a European level, the Coordination Group and 4 sub-groups are continuing to work on the EU HTAR. Together, they are working on joint clinical evaluation reports, scientific consultation and the mapping of emerging technologies and procedural guidelines. The National Health Care Institute is represented in the Coordination Group and in the subgroups. The 4 subgroups are:

  1. Joint Clinical Assessments (JCA);
  2. Joint Scientific Consultations (JSC); 
  3. Identification of Emerging Health Technologies (EHT); 
  4. Development of Methodological and Procedural Guidelines (MPG).

Further information

If you have any questions about EU HTAR, please send an e-mail to:

Anne Willemsen
E-mail: awillemsen@zinl.nl