Life Sciences Horizons Brochure 2025 - Flipbook - Page 101
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2025 Horizons Life Sciences and Health Care
EU Health Technology Assessment takes effect for ATMPs, oncology medicines
Pricing and reimbursement are not harmonized in
the EU; instead they are regulated on a country-bycountry basis. Regulation (EU) 2021/2282, which took
force in January 2022, introduced rules on the health
technology assessment (HTA), introducing EU-wide
collaboration. HTA is a scientific, evidence-based
process that allows competent authorities to
determine the relative effectiveness of new or existing
health technologies, prior to making decisions on
pricing and reimbursement. The Regulation became
applicable in mid-January 2025.
The rules apply to medicinal products, medical devices, in vitro
diagnostic medical devices, and medical procedures, as well as
measures for disease prevention, diagnosis, or treatment. The
relative effectiveness is measured on the basis of clinical and
non-clinical aspects, although the Regulation focuses on
clinical aspects:
The Member State Coordination Group on HTA (“Coordination
Group”), as introduced in the Regulation, will help oversee “joint
clinical assessments” (JCA): a mechanism that ensures that any
information, data, analyses, and other evidence required for an
HTA is submitted only once at the EU level by the health
technology developer.
the identification of a health problem and current health
technology,
The JCA only applies to certain health technologies, including
medicinal products for which an application for a centralized
marketing authorization is submitted to the European Medicines
Agency, but with step-wise implementation timelines. First, as of
12 January 2025, oncology medicinal products with a new active
substance as well as advanced therapy medicinal products
(ATMPs), including cell and gene therapies, are subject to JCA.
As of 2028, orphan medicinal products will be subject to JCA.
As of 2030, the HTA Regulation’s full scope will apply.
the examination of the technical characteristics of the health
technology under assessment,
its relative safety, and
its relative clinical effectiveness.
The Regulation aims to enhance the coordination of the HTA in
order to avoid multiple assessments of the same product with
diverging outcomes in the EU member states. The outcome of the
HTA shall be used to support the EU member states’ budgetary
decisions. This includes decisions on pricing and reimbursement;
however conclusions on the added value for health systems of
health technologies remain under the EU member states’
sole discretion.
Hein van den Bos
Partner
Amsterdam
Samantha van Dijk
Junior Associate
Amsterdam
