EU-based pharmaceutical innovators are expressing concerns over the limited availability of joint scientific consultation (JSC) advice meetings to discuss trial designs and evidence generation plans. This shortage could pose challenges to the timely and effective execution of Joint Clinical Assessments (JCAs) for cancer therapies and cell and gene therapies, under the incoming EU Health Technology Assessment (HTA) Regulation.
The HTA Regulation, set to be implemented on January 12, 2025, aims to harmonize the assessment of health technologies across member states, with JCAs playing a pivotal role in evaluating the relative clinical effectiveness of new treatments. However, the scarcity of advisory meetings threatens to impede the process, according to some stakeholders. In 2025, the HTA Coordination Group has only planned for around 5 to 7 JSC meetings.
Industry associations, including the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Alliance for Regenerative Medicine, the European Confederation of Pharmaceutical Entrepreneurs, EuropaBio, and Vaccines Europe, have jointly voiced their concerns. They emphasize that without sufficient opportunities for early dialogue on trial designs and evidence generation, the quality and timeliness of JCAs could be compromised, adversely affecting the introduction of new treatments. A statement from EFPIA says, “JSCs have to be prioritised and properly resourced: the number of planned JSCs is less than a third of the number of JCAs expected for 2025. This does not reflect the realities of product development where there are more products at the development stage than those that are submitted for a Marketing Authorisation. The forecasted number of slots for advice meetings will not be sufficient to meet the expected high demand, as all companies launching their products in Europe will need to adjust to the new assessment framework when planning their studies.”
EU institutions and member states are being urged to address the issue by increasing the number of available advice meetings and increasing collaboration between regulatory bodies and the pharmaceutical industry to ensure that the objectives of the EU HTA Regulation are met to facilitate patient access to new medicines.
This is not the first time that industry associations have spoken out against the regulation. Speaking to TMM in May 2024, Herbert Altmann and Lung-I Cheng of US-based drug wholesale company and CRO Cencora urged stakeholders to prepare early for the regulatory changes: “Developers should initiate their internal market access planning for JCA at least 10 months before expected filing with EMA. This timeline allows ample preparation for meeting JCA dossier requirements and developing high-quality package evidence. Ideally, alignment on internal processes should occur prior to designing phase III clinical trials.”
It is an extremely complex process to harmonize any new industrial regulations across the bloc, and the additional complexities of clinical trial design and implementation will require some extremely careful navigation. If you have an opinion on this topic, feel free to share it with me: rob.coker@conexiant.com
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