Europe opens first submission period for joint scientific consultations under HTA regulation

European Commission officially marks opening of the first request submission period for joint scientific consultations (JSCs) under the new Health Technology Assessment Regulation (HTAR), marking a significant milestone in the implementation of the HTAR, which came into effect on January 12, 2025.

JSCs provide a structured mechanism for health technology developers (HTDs) to engage with regulators and obtain guidance on the evidence requirements for future joint clinical assessments (JCAs) and national HTA submissions. Through early dialogue on clinical study design and data expectations, the process aims to align evidence generation with assessment needs, potentially reducing regulatory uncertainty and expediting market access.

Conducted by the JSC Subgroup (JSC SG) within the Health Technology Assessment Coordination Group (HTACG), the consultation process involves assessors from multiple Member States. JSCs are available for both new medicinal products and existing treatments with new indications and can be pursued in parallel with scientific advice from the European Medicines Agency (EMA). The HTACG plans to initiate 5–7 JSCs for medicinal products and 1–3 for medical devices across two submission periods in 2025: February–March and June.

The current request submission period runs from February 3 to March 3, 2025, with available consultation slots scheduled as follows:

• June 2–5, 2025 (Briefing document due by May 5, 2025)
• July 7–10, 2025 (Briefing document due by June 2, 2025)
• September 1–4, 2025 (Briefing document due by July 7, 2025)

With only ten consultation slots available for JSCs in 2025, competition is expected to be fierce, as Ruairi O'Donnell (EU HTA Lead, Cencora) explained to The Evidence Base:

"With slots at such a premium, applicants need to carefully address the selection criteria to have the best chance of success. If not successful first time round, they can apply again or investigate other ways of getting advice on their evidence plans. A lack of JSC does not mean the end of the road - only the beginning!"

HTDs must present a well-substantiated and compelling case to secure a place in the process. Industry groups have raised concerns that the limited availability of JSCs could hinder the rollout of JCAs and delay patient access to innovative treatments across the EU. To be eligible, a health technology must meet two conditions: it must be likely to undergo a JCA and the relevant clinical studies and have clinical studies or investigations still in the planning stage. While eligibility is broad, selection criteria will determine which applications receive priority.

HTDs must justify their selection for JSCs based on key criteria:

• Unmet medical need: Applies when no satisfactory diagnostic, preventive, or treatment option exists, or when a new medicinal product offers a major therapeutic advantage. As explained in the selection guidance, the definition is under debate, and HTDs must substantiate claims with epidemiological and clinical data.
• First-in-class status: Granted if no alternative with the same mechanism of action is authorized in Europe. If the first product of its kind is not yet approved, another with the same mechanism may qualify. Products already approved in a different therapeutic area may still be eligible.
• Potential impact on patients, public health, or healthcare systems: Evaluates improvements in survival, morbidity, quality of life, and safety. Public health impact includes addressing health threats and economic burdens, while healthcare system impact considers improved care organization or potential negative effects due to complex administration.
• Significant cross-border dimension: Applies to medicinal products relevant to EU decision-making and affecting most Member States.
• Major union-wide added value: Requires clinical studies to demonstrate benefits over EU-recommended alternatives and reflect the European patient population.
• Union clinical research priorities: Considers whether the product aligns with EU-funded research programs, such as EU4Health Programme or Europe’s Beating Cancer Plan.

If the number of eligible requests exceeds the available JSC slots, Member State assessors will prioritize applications based on individual assessments of these criteria.