On 11 March 2008 the EU Commission issued a proposal for drafting a legislative
initiative for combating medicine counterfeits - see also
News from 9 April 2008.
The proposal also comprised a more comprehensive control of the so-called supply
chain for finished products as well as for APIs. In addition, it is planned to
conduct GMP inspections at API manufacturers in Europe and outside the EU
The now published comments from the various groups showed how important the
issue is for both authorities and industry. Altogether 100 stakeholders sent
their comments, among them associations, individual pharmaceutical
manufacturers, retailers and also patient groups.
The comments demonstrate the different groups' interests and how difficult it
will be for the EU Commission to consider all of them. Medicinal product safety
is not always the centre of attention. However, most organisations basically
welcome the EU Commission's initiative. But there's also frequent criticism,
that already existing programmes such as the
WHO IMPACT Programme
FDA Initiatives have to be better coordinated to really find a solution to
the problem of counterfeits.
Especially labelling systems (so-called trace and track processes) generated
comprehensive comments. The European Federation of Pharmaceutical Industries and
Associations (EFPIA) emphasises in its comment that harmonisation is absolutely
necessary, because several countries already established labelling systems.
However, these systems are neither synchronised nor compatible.
On behalf of the European Compliance Academy (ECA)