Session (CTI)

Issue Joint Scientific Consultations (JSCs) are designed to facilitate early dialogue between health technology developers (HTDs), HTA bodies, regulators, patients and healthcare professionals. By enabling discussion on evidence generation plans early on, JSCs aim to support more informed decision-making and contribute to the generation of evidence relevant to multiple stakeholders. The first parallel JSC procedures involving both HTA bodies and regulators have now been completed. The experience gained raises a number of important questions. How useful was the advice provided through parallel consultations? To what extent did the process influence evidence generation strategies and development plans? How were patient and clinical perspectives integrated into the discussions? What operational, methodological or procedural challenges were encountered by participants? Most importantly, what lessons can be drawn to strengthen future JSC procedures? For the first time, stakeholders directly involved in parallel JSCs can move beyond expectations and discuss real-world experience. This Issue Panel will explore what has been learned from the first procedures and how the JSC framework should evolve to maximise its value for all participants. Overview The moderator will introduce the role of JSCs within the EU HTA framework and the objectives of parallel consultations involving HTA bodies and medicines regulators. Industry representative will share their practical experience, highlighting both the value generated by the process and the challenges encountered when translating advice into evidence generation strategies. Representatives from HTA bodies will reflect on the strengths of the process, key lessons learned and opportunities for future improvement. Patient organisations involved will discuss the contribution of patient and clinical expertise to early evidence planning. The panel will conclude with an interactive discussion among speakers and audience members on how the JSC framework can continue to evolve as experience accumulates, ensuring that it delivers meaningful value for developers, decision-makers, healthcare professionals and patients.