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

• CELEX: Implementing Regulation (EU) 2024/2699
• Articles: 10

Article 1 Subject matter

This Regulation lays down detailed procedural rules concerning cooperation, in the form of exchange of information, of the Member State Coordination Group on Health Technology Assessment (‘Coordination Group’), with the facilitation of the secretariat of the Coordination Group (‘the HTA secretariat’), with the European Medicines Agency on the joint clinical assessment and joint scientific consultation referred to in Articles 7 to 21 of Regulation (EU) 2021/2282 as regards:

(a)

planning and forecast of the joint clinical assessments and joint scientific consultations;

(b)

identification of patients, clinical experts and other relevant experts (‘individual experts’) to be involved in joint clinical assessments and joint scientific consultations;

(c)

horizontal scientific and technical matters related to joint clinical assessment and joint scientific consultation;

(d)

security of sharing and protection of confidential information exchanged between the European Medicines Agency and the HTA secretariat and then shared by the HTA secretariat with the Coordination Group or its subgroups and their members within the context of joint clinical assessment and joint scientific consultation.

Article 2 Information exchange related to the planning and forecast of the joint clinical assessments and joint scientific consultations

1.   At the latest by 30 April each year, the European Medicines Agency shall provide the HTA secretariat with the following information concerning medicinal products:

(a)

information on upcoming submissions of initial applications for marketing authorisation for medicinal products;

(b)

information, where available, about the variations to the terms of existing marketing authorisations which correspond to a new therapeutic indication planned by marketing authorisation holders;

(c)

estimated number of advice procedures for undertakings pursuant to Article 57(1), point (n), of Regulation (EC) No 726/2004.

The information referred to in the first subparagraph, point (a), shall cover the period of the current year and at least the following year and include the following elements, where available:

(i)

the international non-proprietary name for the active substance;

(ii)

the name of the health technology developer;

(iii)

the therapeutic indication summary;

(iv)

the eligibility basis for the centralised procedure provided for in Regulation (EC) No 726/2004;

(v)

the eligibility for a priority (PRIME) scheme;

(vi)

the expected submission date of the application for marketing authorisation.

2.   At the latest by 30 April each year, the European Medicines Agency shall provide the HTA secretariat with the following information concerning medical devices likely to be the subject of joint clinical assessment:

(a)

number of ongoing and finalised advice procedures initiated by manufacturers in accordance with Article 61(2) of Regulation (EU) 2017/745 and information on medical devices subject to the advice for the period of last 12 months;

(b)

where available estimated number of future requests for advice by manufacturers from the expert panels pursuant to Article 61(2) of Regulation (EU) 2017/745 and information on medical devices subject to the future advice.

The information referred to in the first subparagraph shall include the following elements, where available:

(i)

the type of device;

(ii)

the intended purpose, including any medical indication(s), contraindication(s) and target population(s);

(iii)

the development phase of the device.

3.   The European Medicines Agency shall provide the HTA secretariat with available updates of the information referred to in paragraphs 1 and 2, identified together with the EHT Subgroup as relevant for the preparation of the report on emerging health technologies referred to in Article 22 of Regulation (EU) 2021/2282.

Article 3 Information exchange related to the selection of medical devices and in vitro diagnostic medical devices for joint clinical assessment

1.   The European Medicines Agency shall provide the HTA secretariat with:

(a)

information on all medical devices for which the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745 have provided or have decided to provide a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation;

(b)

information on all in vitro diagnostic medical devices for which the expert panel has provided or has been asked to provide its views in the framework of the procedure pursuant to Article 48(6) of Regulation (EU) 2017/746.

The information referred to in the first subparagraph, point (a), shall include the following elements:

(i)

the name and type of the device;

(ii)

the name of the manufacturer;

(iii)

the name of the notified body;

(iv)

the expert panel decision regarding the intention to provide a scientific opinion referred to in Section 5.1, point (c), of Annex IX to Regulation (EU) 2017/745;

(v)

where available, the scientific opinion of the expert panel.

The information referred to in the first subparagraph, point (b), shall include the following elements:

(i)

the name and type of the in vitro diagnostic medical device;

(ii)

the name of the manufacturer;

(iii)

the name of the notified body;

(iv)

where available, the views of the expert panel.

2.   The European Medicines Agency shall provide the information referred to in paragraph 1 no later than 15 days after the end of each quarter, pertaining to that quarter. For the first reporting period, the European Medicines Agency shall provide the information referred to in paragraph 1 covering the period from 1 January 2024.

Article 4 Information exchange with the Coordination Group and its EHT Subgroup and JCA Subgroup

1.   Once the HTA secretariat receives the information from the European Medicines Agency pursuant to Article 2, it shall make that information available as appropriate to the EHT Subgroup or to the Coordination Group, or both, for further analysis in the preparation of the reports on emerging health technologies referred to in Article 22 of Regulation (EU) 2021/2282 and for the preparation and amendment of the annual work programme of the Coordination Group.

The EHT Subgroup may, via the HTA secretariat, consult the European Medicines Agency in the context of preparing the reports on emerging health technologies referred to in Article 22 of Regulation (EU) 2021/2282.

2.   Once the HTA secretariat receives the information from the European Medicines Agency pursuant to Article 3, it shall make that information available for further analysis in the preparation of the recommendation referred to in Article 7(4) of Regulation (EU) 2021/2282 to the following:

(a)

the Coordination Group;

(b)

the EHT Subgroup or the JCA Subgroup, based on the decision of the Coordination Group; or

(c)

the Coordination Group and the EHT Subgroup or the JCA Subgroup, based on the decision of the Coordination Group.

Article 5 Information 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.

Article 6 Information exchange on horizontal scientific and technical matters related to joint clinical assessment and joint scientific consultation

1.   The Coordination Group and its subgroups shall ensure an 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. These exchanges shall occur via the HTA secretariat and shall not relate to the assessment of individual health technologies.

2.   The Coordination Group may involve the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282 (‘the HTA stakeholder network’) in the exchange of information referred to in paragraph 1.

Article 7 Secure exchange of information

1.   The HTA secretariat and the European Medicines Agency shall exchange the information within the context of joint clinical assessment and joint scientific consultation as appropriate through the IT platform referred to in Article 30 of Regulation (EU) 2021/2282, 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’).

2.   The exchange of information through the HTA IT platform shall be based on its technical specifications containing provisions on effective technical and security measures for interfacing, access to information and data processing.

Article 8 Protection of confidential information

1.   The information received from the European Medicines Agency within the context of joint clinical assessment and joint scientific consultation shall be used exclusively for the purposes of planning and conducting the joint clinical assessments and joint scientific consultations referred to in Articles 7-21 of Regulation (EU) 2021/2282.

2.   The European Medicines Agency shall clearly indicate the level of protection that it attributes to the information shared with the HTA secretariat within the context of joint clinical assessment and joint scientific consultation. Before providing the information received from the European Medicines Agency to the Coordination Group and to its relevant subgroups, the HTA secretariat shall attribute to this information at least an equivalent level of protection.

3.   The members of the Coordination Group or its subgroups shall implement necessary and appropriate technical and organisational measures to ensure and protect within their organisation the confidentiality of the information received from the European Medicines Agency within the context of joint clinical assessment and joint scientific consultation. In particular, the members of the Coordination Group or its subgroups shall ensure that only their representatives appointed to the Coordination Group or its subgroups and other individuals bound by the professional secrecy obligations who have a ‘need-to-know’ may access this information.

4.   The members of the Coordination Group or its subgroups shall immediately report to the HTA secretariat any breach or suspected breach of protection of the information received from the European Medicines Agency within the context of joint clinical assessment and joint scientific consultation.

Article 9 Failure to respect the obligations of professional secrecy

1.   If the Commission becomes aware that a representative of the member of the Coordination Group or its subgroups or an individual expert failed to respect the obligations of professional secrecy as laid down by Article 339 of the Treaty on the Functioning of the European Union and Article 5(6) of Regulation (EU) 2021/2282, as well as by the Commission’s rules on security regarding the protection of EU classified information and sensitive non-classified information, as laid down in Commission Decisions (EU, Euratom) 2015/443  ( 7 ) and (EU, Euratom) 2015/444  ( 8 ) , it shall inform the representative or individual expert in writing and request a clarification of the situation. The representative or the individual expert shall provide the requested clarification within 14 days from the day of the notification of the request.

2.   If the representative or the individual expert does not provide the requested clarification within the period referred to in paragraph 1, the Commission may decide to exclude the representative or the individual expert from participation in the joint work until the clarification is provided and assessed by the Commission.

3.   If the requested clarification is provided, the Commission may exclude the representative or the individual expert from the joint work for a period up to 2 years, if the representative or the individual expert failed to respect the obligations of professional secrecy intentionally or by gross negligence.

4.   The HTA secretariat shall inform the representative, the individual expert and, as appropriate, the member of the Coordination Group or its subgroup, the Coordination Group or its subgroups of the decisions of the Commission referred to in paragraph 3 and shall ensure the enforcement of the measures imposed in those decisions.

Article 10 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 12 January 2025.