BAKGRUNN (fra kommisjonsforordningen)

(1) Regulation (EU) 2021/2282 lays down a support framework and procedures for cooperation between Member States on certain health technologies and establishes the Member State Coordination Group on Health Technology Assessment (‘the Coordination Group’). 

(2) The Commission is to lay down rules for the implementation of Regulation (EU) 2021/2282 as regards the cooperation, in the form of exchange of information, of the Coordination Group and the Commission acting as secretariat of the Coordination Group (‘the HTA secretariat’) with the European Medicines Agency and with the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council relevant for the joint work referred to in Articles 7 to 21 of Regulation (EU) 2021/2282. Pursuant to Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council, the European Medicines Agency is acting as secretariat for those expert panels. Therefore, the cooperation with the expert panels provided for in this Implementing Regulation should be conducted via the European Medicines Agency.

(3) The exchange of information should include the exchange of information for the planning and forecast of the joint clinical assessments and joint scientific consultations. The exchange of that information is necessary for establishing and amending the annual work programme to be adopted by the Coordination Group that is to set out the planned number and type of joint clinical assessments and their updates and the planned number of joint scientific consultations. Pursuant to Article 6(3), points (a) and (b), of Regulation (EU) 2021/2282, in the preparation or amendments of the annual work programme, the Coordination Group is to take into account the reports on emerging health technologies referred to in Article 22 of Regulation (EU) 2021/2282 and information from the European Medicines Agency on the status of submitted and upcoming marketing authorisation applications for medicinal products referred to in Article 7 thereof. Pursuant to Article 22(2), point (b), of Regulation (EU) 2021/2282, the relevant sources for the preparation of the reports on emerging health technologies are to include information by the European Medicines Agency in relation to upcoming submissions of applications for marketing authorisation for medicinal products referred to in Article 7(1) thereof. The Commission should therefore set deadlines to ensure that the relevant information is provided by the European Medicines Agency to the HTA secretariat in a timely manner for the preparation of the reports on emerging health technologies and the work programme. The Coordination Group should, via the HTA secretariat, receive from the European Medicines Agency other available information related to the forecast of the joint clinical assessments and joint scientific consultations necessary for the preparation of the reports on emerging health technologies in accordance with Article 22 of Regulation (EU) 2021/2282. The Commission should therefore specify which information and within which deadlines should be submitted by the European Medicines Agency. 

(4) Under Article 7(4) of Regulation (EU) 2021/2282, the Commission, after seeking a recommendation from the Coordination Group, is to adopt a decision, by means of an implementing act and at least every two years, selecting the medical devices and in vitro diagnostic medical devices referred to in Article 7(1), points (c) and (d), of Regulation (EU) 2021/2282 for joint clinical assessment. For the purposes of such selection, it is necessary to ensure that the HTA secretariat regularly receives from the European Medicines Agency the list of those medical devices and in vitro diagnostic medical devices. 

(5) In order to ensure the preparation of the reports on emerging health technologies referred to in Article 22 of Regulation (EU) 2021/2282, the preparation of the annual work programme of the Coordination Group, its adoption and the adoption of its amendments and to enable the Coordination Group to provide the recommendation referred to in Article 7(4) of Regulation (EU) 2021/2282, the HTA secretariat should share the information provided by the European Medicines Agency related to the planning and forecast of the joint clinical assessments and joint scientific consultations, as well as the information on the medical devices and in vitro diagnostic medical devices referred to in Article 7(1), points (c) and (d), of Regulation (EU) 2021/2282 as appropriate with the Coordination Group and/or its relevant subgroups established by the Coordination Group on 28 November 2022 pursuant to Article 3(7), point (k), of Regulation (EU) 2021/2282, that is the subgroup on the identification of emerging health technologies (‘the EHT Subgroup’) or the subgoup on joint clinical assessments (‘the JCA Subgroup’). 

(6) The information on upcoming marketing authorisation applications, as well as certain other available information related to the planning and forecast of the joint clinical assessments and joint scientific consultations, is based, inter alia, on the information shared by health technology developers with the European Medicines Agency on a voluntary basis and it may contain commercially confidential data. In addition to the requirements of Article 5(6) and Article 30(3), point (m), of Regulation (EU) 2021/2282, appropriate and specific measures to protect adequately this and other confidential information received by the HTA secretariat from the European Medicines Agency within the context of joint clinical assessment and joint scientific consultation should be set out in this Implementing Regulation. This is necessary in order to ensure that such information is protected not only at the level of the Coordination Group or its subgroups, but also at the level of their members, including where the access to that information is given to other individuals who might be involved in joint clinical assessment and joint scientific consultation by the members of the Coordination Group and its subgroups. Moreover, in order to safeguard the appropriate protection of confidential information shared by the European Medicines Agency within the context of joint clinical assessment and joint scientific consultation, it is appropriate to specify the purposes for which the information received from the European Medicines Agency may be used and set out the rules on how the level of protection is attributed. Without prejudice to any legal or criminal proceedings by the competent national authorities of the Member States in accordance with their laws and regulations and to contractual remedies, in case of breaches or failure to respect the obligations of professional secrecy, appropriate measures should be taken. 

(7) Regulation (EU) 2021/2282 provides for the involvement of patients, clinical experts and other relevant experts (‘individual experts’) having expertise in the therapeutic area concerned in joint clinical assessments and joint scientific consultations. Similarly, individual patients and healthcare professionals having expertise in the therapeutic area concerned are being engaged by the European Medicines Agency in the context of the evaluation of medicinal products. Joint clinical assessments and joint scientific consultations under Regulation (EU) 2021/2282 are conducted on the health technologies that are subject to the centralised procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council, the clinical evaluation consultation procedure pursuant to Article 54 of Regulation (EU) 2017/745 and the performance evaluation consultation procedure pursuant to Article 48(6) of Regulation (EU) 2017/746 of the European Parliament and of the Council. Under Regulation (EU) 2021/2282, the joint clinical assessments are to be conducted in parallel with the centralised procedure and in close cooperation with the European Medicines Agency and joint scientific consultations may be conducted in parallel with the preparation of scientific advice pursuant to Article 57(1), point (n), of Regulation (EC) No 726/2004 and with the consultation with an expert panel pursuant to Article 61(2) of Regulation (EU) 2017/745 and in close cooperation with the European Medicines Agency. Therefore, the HTA secretariat and the European Medicines Agency should cooperate to identify individual experts to be engaged in the respective procedures. 

(8) The specific rights and responsibilities of the individual experts are different during the assessments of health technologies performed by the Coordination Group and the evaluation of medicinal products and consultation procedures on medical devices and in vitro diagnostic medical devices performed by the European Medicines Agency and the expert panels. Therefore, an individual expert should not be prevented from being engaged in the context of the evaluation of health technologies during the centralised procedure or during the procedures pursuant to Article 54 of Regulation (EU) 2017/745 and Article 48(6) of Regulation (EU) 2017/746, on the one hand, and in a joint clinical assessment or joint scientific consultation of the same health technology, on the other hand. However, the transparency of such engagement should be ensured. 

(9) The cooperation between the HTA secretariat and the European Medicines Agency on the identification of individual experts should include the exchange of personal data, namely the names, contact details and areas of expertise of individual experts. Such processing is necessary within the meaning of Article 5(1), point (a), and Article 10(2), point (i), of Regulation (EU) 2018/1725 of the European Parliament and of the Council6 for the performance by the Commission of its tasks laid down in Article 28 of Regulation (EU) 2021/2282. This Implementing Regulation should determine that the Commission is the controller within the meaning of Article 3, point 8, of Regulation (EU) 2018/1725 for the processing of the personal data received from the European Medicines Agency. In order to ensure the relevant in-depth specialized expertise in the joint work, for example, in the event where the selected individual experts step down from their roles and responsibilities, it is appropriate to provide for a retention period of personal data of individual experts not selected to take part in a joint clinical assessment or a joint scientific consultation. 

(10) The identity of the patient may reveal the patient’s health status in relation to the subject-matter of the joint clinical assessment or the joint scientific consultation. Therefore, that type of data should be considered a special category of personal data under Article 10 of Regulation (EU) 2018/1725, and the processing of such data should be made conditional on the fulfilment of the criteria laid down in Article 10(2), point (i), of that Regulation, including the set-up of suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy. Personal data of patients involved in joint clinical assessments and joint scientific consultations should not be published. 

(11) In order to allow for a more informative decision making and for exchange of information and pooling of knowledge, the Coordination Group, with the facilitation of the HTA secretariat, should ensure appropriate exchange of information with the European Medicines Agency on horizontal issues of scientific or technical nature related to joint clinical assessment and joint scientific consultation, such as methodological issues following international standards of evidence-based medicine. In order to preserve the separation of the respective remits of the Coordination Group and the European Medicines Agency, these exchanges should not relate to the assessment of individual health technologies. The Coordination Group should also be able to involve in this exchange of information the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282 (‘the HTA stakeholder network’). 

(12) Under Article 30(1) of Regulation (EU) 2021/2282, the Commission is to set up and maintain an IT platform consisting of a secure system for the exchange of information on the joint work, including the exchange of information with the European Medicines Agency (‘the HTA IT platform’). The Commission and the European Medicines Agency will be working towards the interoperability of the HTA IT platform and the IT systems of the European Medicines Agency, which will however not be in place by the date of application of Regulation (EU) 2021/2282, that is 12 January 2025. It is therefore necessary to specify that the HTA secretariat and the European Medicines Agency should exchange the information within the context of joint clinical assessment and joint scientific consultation as appropriate through the HTA IT platform. 

(13) As Regulation (EU) 2021/2282 applies with effect from 12 January 2025, this Regulation should also apply from that date. 

(14) The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725 and delivered an opinion on 27 August 2024. 

(15) The measures provided for in this Regulation are in accordance with the opinion of the Committee on Health Technology Assessment,