Article 5 · Commission Implementing Regulation (EU) 2024/2699

Contents

Article 5Information exchange related to the identification of individual experts in the context of joint clinical assessments and joint scientific consultations#

1.On request and where that information is available, the European Medicines Agency shall provide the HTA secretariat with information on potentially suitable individual experts for its consideration to be proposed to the relevant subgroup as a patient, clinical expert or other relevant expert in a joint clinical assessment or joint scientific consultation. Personal data that may be provided are limited to names, contact details and areas of expertise of individual experts.

2.The summary minutes of the meeting of the Coordination Group and its subgroups as well as joint clinical assessment reports or joint scientific consultation outcome documents shall record whether an individual expert was engaged in the context of the evaluation of the same medicinal product or comparator medicinal product during the centralised procedure or the same medical device or in vitro diagnostic medical device or comparator device during the procedures pursuant to Article 54 of Regulation (EU) 2017/745 and Article 48(6) of Regulation (EU) 2017/746. Personal data of patients involved in joint clinical assessments and joint scientific consultations shall not be published.

3.The processing of personal data referred to in paragraph 1 shall be based on Article 5(1), point (a), of Regulation (EU) 2018/1725, and Article 10(2), point (i), thereof for data concerning health. The Commission shall be controller of the processing of the personal data received from the European Medicines Agency. The Commission shall take specific safeguards for the data processed in the context of Article 10(2), point (i), of Regulation (EU) 2018/1725, such as pseudonymisation, prevention of unauthorised access, prevention of unauthorised reading, copying, modification or deletion of personal data, as well as organisational measures ensuring that personnel authorised to process data have access only to data covered by their access authorisation, and that it is possible to verify and establish what data have been accessed, by which member of the personnel and at what time.

4.The Commission shall keep the personal data of individual experts not selected to take part in a joint clinical assessment or a joint scientific consultation only for as long as necessary in order to ensure the relevant in-depth specialised expertise in the joint work and no longer than 3 years after the date on which the European Medicines Agency provided the HTA secretariat with this data.