What is the Joint Scientific Consultation process?
| Site: | EUPATI Open Classroom |
| Course: | EU Health Technology Assessment Regulation (HTAR) |
| Book: | What is the Joint Scientific Consultation process? |
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| Date: | Friday, 18 October 2024, 10:37 AM |
Section Overview
- What is the Joint Scientific Consultation process?
- Step 0. The Coordination Group sets time periods for requests
- Step 1. Requests for joint scientific consultations
- Step 2. Coordination group selects health technologies for JSC
- Step 3. Preparation of the Joint Scientific Consultation report
- Step 4. Approval of the joint scientific consultation outcome document
What is the Joint Scientific Consultation process?
Joint Scientific Consultation should occur after a health technology’s early developmental stage but before the health technology is on the market and has undergone a Joint Clinical Assessment (Recital 46).
Medicinal Products
JSC for medicinal products may occur in parallel and have synchronised timing with scientific advice from the European Medicines Agency (EMA) on the conduct of the various tests and trials necessary to demonstrate the quality, safety, and efficacy of a medicinal product (Article 16(5)).
JSC for medical devices may occur in parallel with the consultation of expert panels consisting of advisors appointed by the European Commission based on relevant expertise with the aim of reviewing a health technology developer’s clinical development strategy and proposals for clinical investigation (Article 16(5)).
Figure 3 provides an overview of the steps involved in a Joint Scientific Consultation.
Figure 3: Overview of Joint Scientific Consultation procedure. Wolf See
Step 0. The Coordination Group sets time periods for requests
The Coordination Group designates when requests can be submitted and the planned number of JSCs per period and publishes this information on the IT platform.
Step 1. Requests for joint scientific consultations
For health technologies that are likely to be the subject of joint clinical assessment according to Article 7(1) and where the clinical studies and clinical investigations are still in the planning stage (Article 16(2)), health technology developers may request a joint scientific consultation (Article 17 (1)).
JSCs can be requested for new health technologies or when an existing health technology is being developed for a new indication.
HTDs of medicinal products interested in a parallel scientific advice from the EMA must request this at the same time as applying for a JSC.
HTDs will also benefit from patient and clinical expert contributions, who will be involved in the parallel consultation process and their opinion will be reflected in the final result documents.
The objective of this parallel process is to allow medicine developers to obtain feedback from regulators and HTA bodies in Member States on their development plans to support decision-making and to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies at the same time.
The parallel processes will result in two documents, one scientific advice letter from EMA and one Joint Scientific Consultation outcome document from the JSC subgroup, which are both not binding. However, experience shows that it is advantageous to follow the advice and recommendations given.
Medical Devices
Similarly, health technology developers of medical devices – interested in parallel consultation with an expert panel – may request this parallel consultation when submitting the JSC request (Article 17(2)).
Step 2. Coordination group selects health technologies for JSC
Joint Scientific Consultations requests are managed by the Coordination Group.
At the end of each request period, should the number of eligible requests exceed the planned number of consultations, the Coordination Group will select requests based on potential need and impact of the medicinal product or medical device. The Coordination Group informs HTDs of acceptance or refusal. (Article 17(3,4)).
Step 3. Preparation of the Joint Scientific Consultation report
Once accepted, each JSC becomes the responsibility of a subgroup designated by the Coordination Group (Article 18(1)).
This subgroup appoints an assessor and co-assessor from different Member States, based on relevant scientific expertise. Their role is to review documentation provided by the health technology developer and prepare a draft Joint Scientific Consultation report (Article 18(2-4)).
Other members of the designated subgroup may provide comments on the draft document and provide additional recommendations specific to their Member State (Article 18(5)). The subgroup will also ensure that patients, clinical experts and other relevant experts are given an opportunity to provide input during the preparation of the draft outcome document via a meeting between the health technology developer and patients, clinical experts, other relevant experts, and – if applicable – representatives of the European Medicines Agency or the expert panel involved in carrying out parallel consultations (Article 18(5-8)).
The assessor, assisted by the co-assessor, will consider all comments, finalise the draft joint scientific consultation report. This draft will then be submitted the Coordination Group for approval (Article 18(9-10).
Step 4. Approval of the joint scientific consultation outcome document
The Coordination Group must approve the finalised draft joint scientific consultation report, after which the Commission will send the approved document back to the health technology developer (Article 19(1-2)).
The CG is expected to include anonymised, aggregated, non-confidential summary information on each JSC in its annual reports and on the publicly accessible webpage of the IT platform (Article 19(3)).