Entre la experiencia y la independencia: lecciones y retos en la gestión de conflictos de interés

Joan Carles Bailach and Claudia Gonzalo

CUADERNOS DE DERECHO FARMACÉUTICO Nº 91 OCTOBER-DECEMBER 2024

This article analyzes the recent rulings by the Court of Justice of the European Union in the Aplidin
® and Hopveus® cases, which have highlighted the importance of properly managing conflicts of interest in the evaluation of medicinal products. These rulings have prompted the European Commission to review and tighten impartiality criteria in evaluation procedures, especially regarding the involvement of experts with potential conflicts of interest. The management of conflicts of interest may also affect the evaluation of health technologies, both at the European level and within the new Spanish framework. In both cases, it is necessary to manage conflicts of interest in a balanced manner, particularly in rare disease areas where the number of conflict-free experts is limited. The search for a balance between impartiality and scientific quality is the key element underlying all the regulatory reforms currently being implemented in this field.

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