Expert contributions are critical to health technology assessment (HTA), particularly in rare diseases, which often lack sufficient evidence or guidelines causing heterogenous practice. The EU Commission established a regulation for conflict-of-interest (CoI) management in Joint Clinical Assessment (JCA) and other joint HTA work. In rare diseases, where expertise is usually limited, strict CoI provisions may jeopardize representative expert participation, risking ill-informed assessments.
Authors: Julia Tokarska, Remon Helmy, Paul Craddy, Karl-Johan Myren, Simu Thomas
Objectives & Methods:
To compare CoI management provisions in the EU Commission Implementing Regulation (EU) 2024/2745 with those of the HTA bodies in Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Spain, and Sweden, highlighting potential implications for expert (clinician/patient) involvement in orphan medicinal product (OMP) JCA.
The provisions were extracted and mapped from each corresponding website. The following domains were compared wherever possible: interests assessed (e.g., employment, consultancy), look-back period, threshold for financial interests, action triggered by identified CoI, and exceptional participation rules.
Results:
The Implementing Regulation sets explicit definitions that trigger exclusion from assessments, including manufacturer-sponsored trial investigator roles, consultancy, or payments ≥€1,000 within the prior 3 years. Contrarily, the investigated HTA bodies generally rely on committee-led, case-by-case assessments to determine appropriate actions (e.g., exclusion, restricted involvement, or participation with disclosed CoI), without pre-defined financial thresholds or exclusion triggers.
The JCA allows conflicted experts to participate in “exceptional cases, e.g. rare diseases” when no conflict-free expert is available but leaves judgment to the assessors. Conversely, well elaborated provisions using pre-defined criteria exist in France, Italy, Sweden and the Netherlands.
Conclusions:
The JCA framework establishes a strong basis for CoI management. However, its exclusionary approach may limit rare disease expert participation. As rare-disease expertise is itself rare and its practice can be heterogenous, seeking expert opinion should be more inclusionary to reflect the clinical practice in the EU, applying CoI management best practices in the member states.