Last week Myeloma Patients Europe (MPE) provided feedback, as part of a public consultation, on the new European Medicines Agency (EMA) policy on the handling of competing interests of scientific committees’ members and experts.

The new policy increases restrictions for the participation of experts, including patient experts, in the EMA procedures assessing specific medical products. The measures are designed to safeguard the impartiality of experts by, for example, excluding from participation experts who have clear commercial and financial interests in the products assessed. But the measures also place limitations on, and potentially exclude, experts involved in advisory committees for companies or research organisations.

By engaging with companies or research organisations, either on product-specific or general issues, patients provide vital information about patients’ needs and expectations. This information can ultimately lead to the development of better targeted therapies, better designed clinical trials and better adherence to treatments. Furthermore, rare diseases, like myeloma, have a small pool of patient experts available who are not only knowledgeable about the disease and can represent their community, but are also knowledgeable about regulatory processes. As a result, they are invited to be a part of a variety of advisory committees. MPE believes that limiting or excluding such experts from EMA procedures could lead to the loss of the best available expertise.

The new EMA policy on conflicts of interest acknowledges the need for a nuanced and balanced approach to ensure that experts are free from conflicts of interest and that the best possible expertise is included. While MPE agrees with the need to achieve this balance, we recommend a proportionate approach to assessing direct and indirect interests and adding more nuance to some of the provisions of this policy, to ensure the inclusion of patients from rare diseases with the best expertise.

Click here to read more about the new EMA Policy.