Description
Position Paper
September 2020
Aim: This position paper aims to emphasize the importance of obtaining patient input in the development of medicines and of reflecting this input in the regulatory and HTA decision making process. EuropaBio recognises the huge benefits that patient engagement in drug development can bring to patients’ care and quality of life, as well as to the entire healthcare system. Among other aspects, patient involvement helps to improve protocol research questions, understand appropriate comparators, and identify patient relevant endpoints. The efforts made by Regulators and HTA bodies in Europe to consult with patients when discussing medicinal products are much appreciated and fully supported. EuropaBio would like to advocate that patient engagement and the patient’s voice is also more consistently and transparently reflected in regulatory/HTA assessment and decision-making processes which should be supported by appropriate guidance. EuropaBio is sharing this position paper with the European Medicines Agency (EMA) to advocate a European guidance framework on patient engagement that allows sufficient flexibility but enables alignment on cornerstone requirements with key stakeholders and draft FDA guidance, as well as considering the outcome of initiatives, such as the IMI PREFER project.
