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Commission Implementing Regulation (EU) 2024/2699
Article 1: Subject Matter
Establishes detailed procedural rules for cooperation and information exchange between the Member State Coordination Group on Health Technology Assessment (Coordination Group), the HTA secretariat, and the European Medicines Agency (EMA) regarding joint clinical assessments and joint scientific consultations. The cooperation covers:
- Planning and forecasting of joint clinical assessments and consultations.
- Identification of patients, clinical experts, and other relevant experts.
- Horizontal scientific and technical matters.
- Security and protection of shared confidential information.
Article 2: Information Exchange for Planning and Forecasting
Mandates the EMA to provide the HTA secretariat by April 30 each year with:
- Details on upcoming submissions of initial marketing authorisation applications for medicinal products, including aspects like non-proprietary names, developer names, therapeutic indications, eligibility criteria, PRIME scheme eligibility, and expected submission dates.
- Information on medical devices likely to undergo joint clinical assessments, including device type, intended purpose, contraindications, target populations, and development phases.
Additionally, the EMA must supply updates relevant for reports on emerging health technologies.
Article 3: Selection of Medical Devices for Joint Clinical Assessment
Requires the EMA to provide the HTA secretariat with information on medical and in vitro diagnostic devices undergoing scientific opinion procedures. This includes device names, types, manufacturers, notified bodies, and expert panel decisions or opinions. Reports must be submitted quarterly by the 15th day after each quarter’s end, starting from January 1, 2024.
Article 4: Information Exchange with Coordination Group and Subgroups
Upon receiving information from the EMA, the HTA secretariat must distribute it to the EHT Subgroup or Coordination Group as appropriate for the preparation of annual work programmes and reports on emerging health technologies. The EHT Subgroup may also consult the EMA when preparing these reports.
Article 5: Identification of Individual Experts
Provides that the EMA shall supply the HTA secretariat with information on potential experts, including names, contact details, and areas of expertise, upon request. Meeting minutes and assessment reports must note any expert’s engagement in related evaluations. Personal data processing is governed under Regulation (EU) 2018/1725, with the Commission acting as the data controller. Data retention for non-selected experts is capped at three years.
Article 6: Exchange of Horizontal Scientific and Technical Information
Ensures that the Coordination Group and its subgroups exchange information with the EMA on scientific and technical issues related to joint assessments and consultations. These exchanges should be facilitated by the HTA secretariat and exclude individual health technology assessments. The Coordination Group may involve the HTA stakeholder network in these exchanges.
Article 7: Secure Information Exchange
Mandates that the HTA secretariat and the EMA use the HTA IT platform, a secure information exchange system, for all joint clinical assessments and scientific consultations. The platform must adhere to strict technical and security specifications to ensure data protection and interoperability.
Article 8: Protection of Confidential Information
Specifies that information from the EMA is to be used solely for joint assessments and consultations. The EMA must denote the level of protection for shared information, and the HTA secretariat must assign at least equivalent protection levels before sharing with the Coordination Group or its subgroups. Members must implement technical and organizational measures to maintain confidentiality and report any breaches immediately.
Article 9: Failure to Respect Professional Secrecy Obligations
Outlines procedures if a Coordination Group member or expert breaches professional secrecy, including notifications, requests for clarification, potential exclusion from joint work for up to two years, and enforcement of measures by the HTA secretariat.
Article 10: Entry into Force
States that the Regulation comes into force twenty days after its publication in the Official Journal of the European Union and applies from January 12, 2025. It is binding and directly applicable in all Member States.[:]
