Joint Scientific Consultations

What is a Joint Scientific Consultation (JSC)?

For medicines, the Joint Scientific Consultation (JSC) focuses on planning clinical trials before the product is authorised in the EU. The goal is to help developers align their trial designs with what HTA bodies will later need to assess the medicine’s value for patients and healthcare systems. For medical devices and diagnostic tests, JSCs can help plan both pre-market and post-market studies. These may involve clinical investigations or performance studies depending on the device type and its risk level. The production activities take place through the HTA IT Platform.

What to expect when being involved in a JSC?

For joint scientific consultations, patients, carers, as well as clinical experts and other relevant experts take part in two phases: reviewing the briefing package and participating in the meeting for an exchange of views.

First Phase

In the first phase, you will be expected to review the information sent by the health technology developer. This documentation, known as the briefing package, is a document where the developer explains how they intend to proceed with the development of their product (including the population, treatment or testing goals, comparators, outcomes, and study design), and asks questions to the assessor and co-assessor to verify whether the data generated will be suitable for future assessments.

Your role in this phase:

• Review the briefing package and focus on what matters from a patient’s, carer’s, or clinical expert’s perspective.
• Highlight whether the population, outcomes, or comparisons reflect real patient needs.
• Raise any concerns (e.g. measuring quality of life, reporting disease symptoms).

Second Phase

In the later phase of a joint scientific consultation, you will be asked to share your input in written format via questionnaire or verbally via interview, and to join a virtual meeting with the health technology developer, the assessors, the JSC Subgroup, and other experts. In this meeting, the data development plans will be discussed, and patients, carers, as well as clinical experts and other relevant experts may provide their views directly to the health technology developers. If the joint scientific consultation takes place in parallel with the European Medicines Agency’s (EMA) scientific advice/expert panel consultation, the experts selected in accordance with the relevant EMA rules, as well as EMA staff providing secretarial support, will also participate in the virtual discussion meeting.

Your role in this phase:

• Share your perspective on key patient-relevant topics.
• Answer questions about patient needs, daily impact, or treatment expectations.
• Help others understand the real-life experience of the disease and what matters most to patients

The advice provided to the health technology developers is not legally binding, but it reflects current scientific standards and helps developers design better studies. You should expect your involvement to take up one and a half working days in total for a JSC. Your input helps to ensure that patients’ needs and clinical practice realities are reflected in the EU HTA processes.

Important: Participation is confidential. BCCH and the European Commission HTA Secretariat will support you throughout the process.