Europe
When a pharmaceutical company has developed a new therapy and the European Medicines Agency (EMA) advises positively on its market authorization, a Health Technology Assessment (HTA) follows. To date, member states conduct this HTA separately. By January 2025, this will be done in a European context, when the European Union’s HTA regulation comes into force.
HTA is a form of policy research that examines the short- and long-term consequences of a health technology. HTA compares the new technology to existing alternatives. For drugs, this means looking at the therapeutic effect, possible side effects, impact on quality of life and the method of administration. In addition to medical aspects, also economic, social and ethical aspects of the new therapy are taken into account. As from 2025, the objective of this EU HTA is to improve and accelerate the availability of innovative health technologies to patients, ensuring efficient use of resources; and strengthening the quality of HTAs. The ultimate assessment of product value and the subsequent decisions on reimbursement and pricing of the new product remain within the competence of the individual member states.
If you want to read more about EU HTA, we refer you to this interesting article, published by the innovative medicine association (vereniging innovatieve geneesmiddelen, VIG) in the Netherlands.
Source: Vereniging Innovatieve Geneesmiddelen | Op weg naar de EU HTA in 2025