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Commission Implementing Regulation (EU) 2024/2699 Overview
Article 1: Subject Matter
This Regulation establishes detailed procedural rules for cooperation between the Member State Coordination Group on Health Technology Assessment (the Coordination Group), the Commission acting as the HTA secretariat, and the European Medicines Agency (EMA). The cooperation encompasses:
- Planning and forecasting of joint clinical assessments and joint scientific consultations.
- Identification of patients, clinical experts, and other relevant experts for participation.
- Exchange of information on horizontal scientific and technical matters related to joint activities.
- Security measures for sharing and protecting confidential information exchanged between the EMA and the HTA secretariat, and subsequently with the Coordination Group and its subgroups.
Article 2: Information Exchange Related to Planning and Forecast
By April 30 each year, the EMA must provide the HTA secretariat with:
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Medicinal Products:
- Upcoming submissions of initial marketing authorization applications, including details such as the active substance name, developer name, therapeutic indication summary, eligibility basis for centralised procedure, priority scheme eligibility, and expected submission dates covering the current and following year.
- Information on variations to existing marketing authorizations for new therapeutic indications planned by holders.
- Estimated number of advice procedures under Article 57(1)(n) of Regulation (EC) No 726/2004.
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Medical Devices and In Vitro Diagnostic Medical Devices:
- Number of ongoing and finalized advice procedures initiated by manufacturers, including device type, intended purpose, medical indications, contraindications, target populations, and development phase.
- Estimated number of future advice requests from manufacturers.
Additionally, the EMA must provide updates relevant to the preparation of reports on emerging health technologies.
Article 3: Information Exchange Related to Selection of Medical Devices for Joint Clinical Assessment
The EMA is required to provide the HTA secretariat with information on:
- All medical devices for which expert panels under Regulation (EU) 2017/745 have provided or intend to provide scientific opinions, including device name and type, manufacturer, notified body, expert panel decisions, and available scientific opinions.
- All in vitro diagnostic medical devices under similar expert panel evaluations, including device name and type, manufacturer, notified body, and available expert panel views.
This information must be submitted no later than 15 days after the end of each quarter, starting from January 1, 2024.
Article 4: Information Exchange with the Coordination Group and Its Subgroups
Upon receiving information from the EMA:
- The HTA secretariat must provide the relevant information to the EHT Subgroup or the Coordination Group for analysis and preparation of reports on emerging health technologies and the annual work programme.
- The EHT Subgroup may consult the EMA through the HTA secretariat while preparing these reports.
- Information related to the selection of medical devices for joint assessments must be provided to the Coordination Group or its relevant subgroups for recommendation purposes.
Article 5: Information Exchange on Identification of Individual Experts
The EMA must provide the HTA secretariat with information on potential experts, including names, contact details, and areas of expertise, upon request. The Regulation ensures:
- Recording whether an expert is engaged in evaluations related to the same medicinal product or device within different procedures.
- Protection of personal data in compliance with Regulation (EU) 2018/1725, including measures like pseudonymisation and access controls.
- Retention of personal data for up to three years for experts not selected for joint work.
Article 6: Information Exchange on Horizontal Scientific and Technical Matters
The Coordination Group and its subgroups are tasked with exchanging scientific and technical information with the EMA on issues that affect joint clinical assessments and consultations, excluding the assessment of specific health technologies. The coordination may involve the HTA stakeholder network to enhance decision-making and knowledge sharing.
Article 7: Secure Exchange of Information
Information between the HTA secretariat and the EMA must be exchanged through the HTA IT platform, a secure system designed for this purpose. The exchange is governed by technical specifications that ensure effective technical and security measures for interfacing, access, and data processing.
Article 8: Protection of Confidential Information
Information received from the EMA must be used exclusively for joint assessments and consultations. The EMA must indicate the protection level of shared information, and the HTA secretariat must maintain at least an equivalent level of protection when sharing with the Coordination Group and its subgroups. Members must implement technical and organizational measures to safeguard confidentiality, limiting access to authorized individuals and reporting any breaches immediately.
Article 9: Failure to Respect Professional Secrecy
If a representative or individual expert breaches professional secrecy:
- The Commission will notify the individual and request clarification within 14 days.
- Failure to provide clarification may result in exclusion from joint work until the issue is resolved.
- If intentional or grossly negligent, exclusion can last up to two years.
- The HTA secretariat is responsible for informing relevant parties and enforcing the Commission’s decisions.
Article 10: Entry into Force
This Regulation enters into force 20 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.[:]
