Glossary of terms*

An ATMP is a medicine for human use based on genes, cells, or tissue engineering. Unlike traditional medicines, which are typically made from chemical or biological substances, ATMPs are developed from living cells, genes, or engineered tissues and are designed to repair, replace, regenerate, or modify biological functions to treat disease.

A revised briefing package a developer resubmits after HTA assessors request clarifications on the briefing package, additional evidence, or narrow the scope of the questions asked during a Joint Scientific Consultation.

The assessment scope frames the research question by specifying the patient population, intervention, comparator, and outcomes for which the health technology developer submits clinical evidence. The assessment scope is prepared by the assessor and co-assessor of the JCA and reviewed by patients, carers, clinical experts, other relevant experts, and the Member States.

The assessor and co-assessor lead the Joint Clinical Assessment (JCA) or Joint Scientific Consultation (JSC) procedure. They are representatives of HTA bodies or equivalent organisations that are members of the relevant JCA or JSC Subgroup and always come from two different countries. They draft the JCA report or the JSC outcome document and seek contributions from patients, carers, and clinical experts at different stages of the process.

The document a health technology developer submits before a Joint Scientific Consultation, explaining its planned clinical development and posing specific questions for HTA bodies to answer.

Someone who supports a patient in daily life and, when the patient is unable to speak for themselves (for example, a young child or someone with a condition affecting cognitive ability), can share their perspective on the patient's behalf.

A healthcare professional invited to share their specialist medical knowledge in EU HTA assessments, based on their individual expertise rather than as a representative of any organisation.

Based in the Health Technology Assessment Unit within the Directorate-General for Health and Food Safety (DG SANTE) in the European Commission.

The HTA Coordination Group (HTACG) is the governing body responsible for overseeing the implementation of the EU HTA Regulation. It comprises representatives from Ministries of Health, HTA bodies or equivalent organisations from EU and EEA countries and oversees Joint Clinical Assessments (JCAs), Joint Scientific Consultations (JSCs), and the development of methodological guidance.

The HTA IT Platform is maintained by the European Commission. It provides a secure system for the exchange of information between the HTA Coordination Group and its subgroups, and with patients, carers, as well as clinical experts and other experts participating in the joint work.

A "health technology" refers to a medicinal product, a medical device, or medical and surgical procedures, as well as measures for disease prevention, diagnosis, or treatment used in healthcare.

Health Technology Assessment (HTA) is a multidisciplinary process for assessing the added value of a health technology compared to existing alternatives. HTA contributes to ensuring that patients receive effective, safe, and high-quality treatments, and helps countries decide which health technologies should be used and paid for, based on the best available evidence.

An HTD is the company (or other legal entity) responsible for developing a health technology: typically the pharmaceutical company or device manufacturer applying for, or holding, the marketing authorisation for a medicine, or the manufacturer of a medical device.

The deliverables of the Joint Clinical Assessment procedure, produced by the assessor and co-assessor, reviewed and validated by the JCA Subgroup, and endorsed by the HTA Coordination Group. These documents contain the assessors' analysis based on the health technology developer's submission, in line with the final assessment scope proposed by Member States.

Comprises representatives from HTA bodies or equivalent organisations from participating European countries who contribute to the production of Joint Clinical Assessments (JCAs).

The JSC Outcome Document is the final deliverable of the Joint Scientific Consultation procedure, summarising the advice given to the health technology developer on the evidence package to be submitted. This is a confidential document and will not be published.

Comprises representatives from HTA bodies or equivalent organisations from participating European countries who contribute to the production of Joint Scientific Consultations (JSCs).

Meetings for an exchange of views are integral components of the JSC procedure. Patients and carers, clinical experts, other relevant experts, the health technology developer, the European Commission, the assessor and co-assessor, and the JSC subgroup participate in these meetings to discuss the submitted briefing package and the developer's questions. Dedicated experts from the European Medicines Agency are also invited to these meetings for procedures in which both regulatory and HTA bodies are involved (i.e. 'parallel JSCs').

The scientific compilation and comparative analysis of the available clinical evidence on a health technology, compared with one or more other health technologies or existing procedures, based on an agreed assessment scope and limited to the clinical HTA domains: the health problem, the technology's characteristics, its relative clinical effectiveness, and its relative safety. The assessment includes a critical evaluation of the evidence but does not make judgments on the health technology's clinical added value, which are left to national HTA bodies.

A framework at EU level that enables health technology developers (HTDs) to obtain scientific consultation from HTA bodies (optionally in parallel with regulators such as the EMA) during the planning of their clinical development programme, on the evidence needed to support a future Joint Clinical Assessment (JCA).

The set of follow-up questions HTA assessors send to the developer after reviewing the briefing package, which the developer must answer in writing before the JSC meeting.

Someone with personal experience of living with a health condition or using a health technology, who contributes that first-hand perspective to EU HTA assessments as an individual and not on behalf of an organisation.