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Overview of Recent EU Regulations
Commission Regulation (EU) 2024/2730
This regulation establishes a fisheries closure for Mediterranean albacore in the Mediterranean Sea, specifically targeting vessels registered in Italy. It declares that the fishing quota allocated to Italy for this stock for 2024 has been exhausted, thereby prohibiting any fishing activities for Mediterranean albacore by Italian vessels after a specified date. This includes not only catching but also retaining, relocating, transhipping, or landing any fish from this stock post-exhaustion. The regulation aims to prevent overfishing and ensure the sustainability of the Mediterranean albacore stock. The provisions become effective immediately upon publication in the Official Journal of the European Union, mandating swift adherence across all Member States. An annex details the closure’s specifics, including the fish stock, geographical zone, and closing date for fishing activities.
Commission Implementing Regulation (EU) 2024/2699
This regulation sets forth detailed procedural rules for collaboration and information exchange between the Member State Coordination Group on Health Technology Assessment (HTA), the HTA secretariat, and the European Medicines Agency (EMA) regarding joint clinical assessments and scientific consultations. It mandates the EMA to provide the HTA secretariat with essential information on upcoming medicinal product submissions and medical devices likely to undergo assessments. The EMA is also required to inform the HTA secretariat about medical devices undergoing scientific opinion procedures, with quarterly reporting obligations. The regulation emphasizes secure information exchange through a dedicated IT platform, ensuring the confidentiality of shared information. It outlines measures for addressing breaches of confidentiality and establishes that the regulation will come into force twenty days after its publication and will be applicable from January 12, 2025.
Review of each of legal acts published today:
Commission Regulation (EU) 2024/2730 of 17 October 2024 establishing a fisheries closure for Mediterranean albacore in the Mediterranean Sea for vessels flying the flag of Italy
Commission Regulation (EU) 2024/2730 Overview
The Commission Regulation (EU) 2024/2730, adopted on 17 October 2024, establishes a fisheries closure for Mediterranean albacore in the Mediterranean Sea specifically for vessels flying the flag of Italy. The regulation is grounded in the Treaty on the Functioning of the European Union and is in accordance with the Council Regulation (EC) No 1224/2009, which sets out a control system to ensure compliance with the common fisheries policy.
Key Provisions
Article 1 – Quota Exhaustion
This article states that the fishing quota allocated to Italy for the Mediterranean albacore stock for the year 2024 is considered exhausted as of the date specified in the annex of the regulation. This indicates that Italian vessels have reached their limit for fishing this particular stock for the current year.
Article 2 – Prohibitions
Under this article, it is explicitly prohibited for vessels registered in Italy to engage in any fishing activities for the Mediterranean albacore stock after the specified date in the annex. The prohibition includes retaining on board, relocating, transhipping, or landing any fish from this stock caught after the quota exhaustion date. This measure aims to prevent overfishing and ensure the sustainability of the fish stock.
Article 3 – Entry into Force
The regulation comes into effect the day following its publication in the Official Journal of the European Union, making it immediately binding and applicable across all Member States. This ensures prompt enforcement of the fishing prohibitions to protect the Mediterranean albacore stock.
Annex Summary
The annex specifies the details of the closure, including the Member State (Italy), the fish stock (Mediterranean albacore), the species (Thunnus alalunga), the geographical zone (Mediterranean Sea), and the closing date for fishing activities (21 September 2024).
This regulation underscores the European Commission’s commitment to sustainable fisheries management in the Mediterranean Sea, emphasizing the need to adhere to established quotas to prevent depletion of marine resources.
Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices
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.[:]
