EMEA Paper Reviews Patient and Consumer Involvement in Agency Activities

December 31, 2009
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency recently released a reflection paper regarding the involvement of patients and consumers in the agency's activities.

The European Medicines Agency (EMEA) recently released a reflection paper regarding the involvement of patients and consumers in the agency’s activities. The agency issued a similar report in March 2008 to the EMEA Management Board and agreed to work with patient and consumer organizations in a more structured manner. The reflection paper proposes actions to further carry out this engagement.

The reflection paper notes that some of the current framework of interaction has been implemented (such as patient participation in scientific committees for orphan medicinal products and for pediatrics) but also notes areas that need more structure such as a procedure to systematically assess the need to involve patients in the Committee for Medicinal Products for Human Use (CHMP). The areas in which patient and consumer involvement have not increased generally are those areas that lack a legal basis for supporting patient interaction.

“The added value of patients and consumers in the scientific process of benefit/risk evaluation is [that] they enrich regulatory outcomes by complementing them with the views of those directly affected by regulatory decisions,” according to the paper’s executive summary. In addition, patients’ and consumers’ contributions build trust in the regulatory process because they foster higher levels of transparency.

The paper also discusses the compensation of patients and consumers who participate in agency activities. Currently, such work is done on a voluntary basis. Patients and consumers participating in an EMEA questionnaire confirmed their interest in remaining active in agency activities, including at the CHMP level, according to the paper.

Ultimately, the paper asks EMEA Management Board to revise “the framework of interaction between the agency and patients’ and consumers’ organizations” so that the legal basis for patient involvement is extended, and to “provide financial support to experts and delegates in need of it under certain conditions.”