EFA has responded to the European Medicine Agency’s (EMA) public consultation on the draft policy on handling of competing interests of scientific committee members and experts, the so-called ‘Policy 0044’. EFA calls for more understanding of existing patient collaboration with the pharmaceutical industry, to continue with their involvement in EMA processes.
EFA supports EMA’s intention of introducing a transparent, robust, and balanced framework for assessing competing expert interests, to improve impartiality and independence in assessing medicines. We also agree with the policy’s distinction between interests and competing interests when assessing expert patients and healthcare professionals experts.
Patient collaboration with industry
EFA is concerned that the policy’s additional restrictions and exclusions related to interests and involvement of patients on certain activities with the pharmaceutical industry may risk excluding patients from participating as experts in EMA processes. This concern is down to two reasons; patient associations must rely much on corporate funding sources, mainly pharmaceutical industry in absence of other funds. Second, patient involvement is also required to advise healthcare companies to be more patient-centred, and crucially, to develop their products which are intended to address the needs of real patients.
Patient involvement in EMA decision-making
EFA discouraged the exclusion of experts based on their involvement in scientific advisory groups and activities such as meeting attendance, involvement in the scientific assessment and guidance development, as this would hugely impact patient representatives, whose expertise in the patient perspective of medicinal product is essential in its assessment.
EFA warned EMA’s strict conflict of interest approach for collaboration between patient associations and pharmaceutical companies in (research) projects may simplify categorisation and improve transparency, but can adversely impact patient participation in EMA activities. EFA urges EMA not to consider patient experts, patients' organizations and caregivers as pharmaceutical companies. Patients are human experts, and patient testimonials should be recognised by EMA as an essential resource in all stages of its processes.
After all, there is a fine balance between trust, mistrust, perceived and real conflict of interest (CoI) which EMA needs to strike. EFA suggests EMA should weight its policy between the objective of inclusivity and exclusivity, and to embrace expertise.
Recognition of patient investment in EMA processes
Patients often participate in their patient associations on a voluntary basis and EMA processes require large time and cost investment from patients. EFA expressed its concern that grants or other funding paid by a company to patient experts are seen as conflict of interest. Patients should not be asked to provide their expertise free of charge to pharmaceutical companies and institutions aimed at improving their quality of life. Very often, the nature of these activities is similar, such as consultancy on patient needs, product development/evaluation, clinical trials, quality of life insights, and other activities also required by EMA. In any case, these activities are covered by the relevant Codes of Ethics, guaranteeing the independence of the expert patient.
Next steps
EFA is member of the EMA Patients and Consumers Working Party since 2013, and a long-standing collaborator on scientific, informative and communicative processes of the agency.
EMA is expected to adopt the final policy by the end of 2024.
EFA’s response to the EMA consultation on handling competing interests can be found here. We deeply thanks our members organisations Associazione Respiriamo Insieme, Longfonds, VCME, Food Allergy Italia and AEPNAA for their invaluable input to develop our position.
For more information on patient experts involvement in EU regulatory processes, you can read EFA’s recent submission to the European Commission consultation on the conflict of interest of experts involved in EU Health Technology Assessment procedures.