Functioning of the agency

We applaud:
• the Commission accepted that the time allocated for administrative procedures relating to marketing authorisation be shortened, which might result (see drug evaluation section below) in more time being available for the scientific assessment (amendments 30, 32 and 33, articles 9-3, 10-1-1 and 10-2-2bis);

• the Commission accepted that representatives of patients, physicians and health insurance organisations come on the EMEA management board (amendments 116 and 117, articles 58-1 and 2).

We regret:
• the Commission rejected the principle of patient representation on the EMEA Advisory Board (amendment 119, article 59-1);

• the Commission rejected the part of amendment 91 (article 51-1-2-j) concerning the independent financing of the medicinal products database, considering that "it cannot be excluded that pharmaceutical firms do not contribute financially to the development of this data base";

• the Commission rejected an amendment aimed at ensuring public funding of the Agency's core tasks (amendment 152, recital 17b). The Commission considered that "the fees [paid by companies] should serve to pay for the services carried out for industry: the Community contribution should serve to finance the tasks of a public nature required of the Agency by the legislators (…)". This last argument sums up the logic of the Enterprise Directorate, i.e. that marketing authorisation is a service rendered to drug companies and not a task performed in the public interest;

• the Commission accepted the principle that rapporteurs for marketing applications submitted to the Agency should seek the opinion of patient organisations; however, whereas EU parliamentarians wanted to make this obligatory, the Commission proposed it should be optional (amendment 105, article 55-1-1);

• the European Parliament also recommended that presidents of EMEA scientific committees be required to participate in meetings of the EMEA management board (amendment 118, article 58-3). In contrast, the Commission made such participation optional;

• the Commission accepted that the EU marketing authorisation committee (CPMP) should comprise only one representative of each Member State (currently two), who would be appointed from a list of five persons proposed by the Member State (amendment 102, article 54-1-2). However, this means that the CPMP may end up being composed solely of administrative representatives of national medicines agencies, while a system with two representatives from each Member State would allow there to be one administrator and one scientist working together.

©La revue Prescrire 15 January 2003