The
European Medicines Evaluation Agency (EMEA) was created by a European
Regulation in 1993, and has been in force since 1995. The EMEA's role
is to co-ordinate scientific resources provided by Member States,
with a view to the evaluation and surveillance of medicines. It comprises
consultative bodies, mainly the Committee for Proprietary Medicinal
Products (CPMP) and working groups made up of experts. The European
Commission grants centralised marketing authorisations for the European
market taking into account the opinions of the CPMP.
Perhaps
because the European Commission did not include the Health and Consumer
Protection Directorate-General (SANCO) in 1993, the EMEA became attached
to what is known today as the Enterprise Directorate-General. This
attachment seems now illogical and risky: is responsible for maintaining
and boosting industrial enterprises, not monitoring health and consumer
protection, which is the role carried out by SANCO. From the Enterprise
Directorate-General's point of view, the role of the EMEA is to favour
easy and rapid marketing of new medicines, so as not to hinder medicines
development and competitiveness of EU pharmaceutical firms. This vision
relegates public health concerns to a position of secondary importance.
A
member of the CPMP publicly deplored the attachment of the EMEA to
the Enterprise Directorate-General, noting, "If the concerns
for public health were paramount, the approval of new medicines by
the EMEA would depend on their benefit to patients and would only
be approved for precise clinical uses and after thorough evaluation".
Other CPMP experts joined him in demanding that the EMEA be attached
to the Health and Consumer Protection Directorate-General. |