Glossary of Terms
Pri obravnavi posameznih izrazov so uporabljene naslednje opredelitve:
The assessor and co-assessor are employees of HTA bodies or equivalent organisations operating in EU Member States, as well as Norway and Iceland. The assessor and co-assessor always come from two different member states. They work together to produce a Joint Clinical Assessment (JCA) report or a Joint Scientific Consultation (JSC) outcome document. They will ask for the contribution from patients, carers, and clinical experts at different stages of the production process.
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 finalised by the JCA Subgroup after the review by patients, carers, clinical experts, other relevant experts, and the Member States.
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 Brussels Centre for Collaboration in Health (BCCH) is a non-profit organisation established under Belgian law by the National Institute for Health and Disability Insurance (RIZIV-INAMI). BCCH provides administrative and project management support for the implementation of joint activities by European Health Technology Assessment (HTA) bodies under the EU HTA Regulation. It coordinates the involvement of patients and experts through a dedicated hub. BCCH supports collaboration across Europe by offering operational and logistical assistance to the HTA Framework Contract Consortium (HTA FCC), which enables Member States to carry out Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs).
Based in the Health Technology Assessment Unit within the Directorate-General for Health and Food Safety (DG SANTE) in the European Commission.
Comprises representatives from HTA bodies or equivalent organisations, represented by selected employees (civil servants) delegated by Member States to produce Joint Clinical Assessments.
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, represented by selected employees (civil servants) delegated by Member States to produce Joint Scientific Consultations.
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.
An organisation (typically a privately held company) developing a medicinal product, medical device, diagnostic, preventive, or surgical procedure.
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.