Key insights from the new draft regulation on the communication with the European Medicines Agency

The new Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) initiatives, which are part of the European-wide Health Technology Assessment (HTA) reform, support the cooperation between EU countries to clinically assess new health technologies. The aim is to find the balance between efficient resource use and prevention of duplication of efforts by health services, while respecting national competences.

New EU HTA regulation implementing act defines information exchange with EMA for joint clinical assessments (JCA) and joint scientific consultations (JSC)

This initiative details the collaboration between the HTA Coordination Group (HTACG), European Commission (acting as secretariat of the HTACG) and EMA to define the rules of exchange of information necessary for EU-level assessments of new health technologies. This includes the exchange of information for:

1. Planning and forecasting JCA and JSCs
2. Identification of patients, clinical experts and other relevant experts to be involved in JCA and JSC
3. General scientific and technical matters related to JCA and JSC
4. Security of sharing and protection of confidential information exchanged between the EMA, the HTA secretariat, Coordination Group or its subgroups and their members

The draft implementing regulation feedback period started on 26th June 2024 and was open until 24th July 2024. The Commission adoption is planned for the second quarter of 2024.

Information exchange related to the planning and forecast of the JCA and JSC for medicinal products (pharma, drugs, biotech)

EMA is set to provide the HTA secretariat with the following information concerning medicinal products:

1. Information on upcoming marketing authorisation submissions: (i) the INN; (ii) the name of the health technology developer; (iii) the therapeutic indication summary; (iv) the eligibility basis for the centralised procedure provided; (v) the eligibility for a priority (PRIME) scheme; (vi) the expected submission date of the application for marketing authorisation
2. Information, where available, about the planned marketing authorisation extensions to new therapeutic indication
3. Estimated number of advice procedures for undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products

Information exchange related to the planning and forecast of the JCA for medical devices

EMA is set to provide the HTA secretariat with the following information concerning medical devices likely to be the subject of JCA:

1. Number of ongoing advice procedures and information on medical devices subject to the advice (where available): (i) the name of the manufacturer; (ii) the name of the device; (iii) the type of device; (iv) the intended purpose; (v) the target population; (vi) the development phase of the device
2. Estimated number of future requests for advice by manufacturers from the expert panels and information on medical devices subject to the future advice

Information exchange related to the selection of medical devices and in vitro diagnostic medical devices for JCA

The EMA is set to provide the HTA secretariat with:

1. Information on all medical devices for which the expert panel has provided/will provide a scientific opinion: (i) the name and type of the device; (ii) the name of the manufacturer; (iii) the name of notified body; (iv) the expert panel decision regarding the intention to provide a scientific opinion; (v) where available, the scientific opinion of the expert panel
2. Information on all in vitro diagnostic medical devices for which the expert panel has provided or has been asked to provide its views: (i) the name and type of the in vitro diagnostic medical device; (ii) the name of the manufacturer; (iii) the name of notified body; (iv) where available, the views of the expert panel

Information exchange with the Emerging Health Technologies (EHT) Subgroup and the Coordination Group

Once the HTA secretariat receives the above information from the EMA, it will make that information available to the EHT Subgroup and/or the Coordination Group for further analysis (to prepare the emerging health technologies reports, the recommendations, and to prepare and amend the annual work programme of the Coordination Group).

Information exchange related to the identification of individual experts in the context of JCA and JSC

If requested and available, EMA will 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 JCA or JSC, while ensuring protection of personal information.

Secure exchange of information and protection of confidential information

The HTA secretariat and the EMA will exchange the information through a secure IT platform (referred to in Article 30 of Regulation (EU) 2021/2282). The information received from the EMA within the context of JCA and JSC shall be used exclusively for the purposes of planning and conducting the JCA and JSC. The members of the Coordination Group or its subgroups will implement necessary and appropriate technical and organisational measures to ensure and protect within their organisation the confidentiality of the information received from the EMA within the context of JCA and JSC.

Stay updated

Until all details on the process are unveiled, significant uncertainty persists and concerns of a duplication of HTA processes on EU and member state level. Our expert consultants are closely tracking all EU HTA related news and changes relevant to our pharma, biotech and medtech clients. For more detailed insights and updates, visit the JSC blog regularly.

Source: Consult the full draft regulation