Thursday, 13 August 2015

Progress at EMA for more public representation

Since one of the European Medicines Agency’s roles is to ensure that medicines are developed for the benefit of public health, it has been keen to involve patients and other stakeholders in its work wherever possible. Most of the Agency’s scientific evaluation work is carried out by its scientific committees, which have various tasks related to the development, assessment and supervision of medicines. The members of these committees are nominated by the Member States or the European Commission. 

Recently, there has been a new drive to feature more Civil Society involvement in the Agency’s work. The European Commission has launched a selection procedure to appoint representatives of the public to the Management Board of the EMA. The aim is to have two members representing patients’ organisations and one member representing doctors’ organisations. These Members will be appointed for a renewable period of three years. The deadline for expressions of interest to represent civil society at PRAC and CAT to be submitted to European Commission was set for 30 September 2015.

The main impact will on the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT). PRAC’s main role is to assess all aspects of the risk management of medicines for human use and it meets once a month. CAT’s responsibility is assessing the quality, safety and efficacy of advanced-therapy medicinal products (ATMPs) and following scientific developments in the field. The multidisciplinary nature of CAT’s work means it must draw upon experts from different scientific areas. Like PRAC, CAT meets once a month according to a published schedule. 

Since increased transparency is a stated objective for EMA, the further involvement of civil society members should be welcomed. Patient organisation representatives will want to ensure that patients’ needs are considered in discussions, while those representing healthcare-professional organisation will be focused on representing the views of health professionals. Civil society members will be expected to take an active role in discussions as well as the assessment of documents central to the work of the committees. 

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