The European granting of marketing authorisations by a sole centralised
procedure would allow for a better harmonisation of evaluation, greater
transparency of decisions (conforming to the EU Regulation 1049/2001)
and therefore greater confidence of the public in medicines thus licensed
by the European Agency for the Evaluation of Medicines (EMEA). A unique
and transparent European agency, provided it is well staffed and efficient,
would challenge the American FDA and strengthen the image of medicines
approved in Europe.
True,
the non-harmonised and opaque procedure so called "by mutual
recognition" cannot be removed rapidly, but a progressive removal
over 5 years can be planned. It will necessitate an increase in
public funds for the European agency but will not put the small
and medium pharmaceutical companies in danger nor the national medicines
agencies.
Indeed,
all marketing applications do not require the same evaluation work.
Applications for generics do not require new evaluation on humans,
but at the most bio-equivalence studies. Applications for herbal
medicines do not involve further clinical evaluation if the plant
features on a list of plants authorised for traditional use and
offering safety guarantees. The same goes for homeopathic medicines.
And the requirements are also simplified for new presentations/formulations
of medicines existing already.
As
a result, drug companies could pay smaller fees for a centralised
authorisation depending on regulatory work, so as not to cause prejudice
to small and medium size companies.
The
national agencies currently involved in the mutual recognition procedure
would keep on working for exclusively national licensing. They could
devote more of their means to the setting up of active pharmacovigilance,
to a more systematic monitoring of numerous infractions to regulations
on pharmaceutical advertising, to more frequent inspections of pharmaceutical
facilities and supervision of clinical trials underway in the country.
Finally, a number of executives could be offered positions with
the European Agency.
If the Bayer product cerivastatin had been granted marketing approval
by a truly transparent centralised procedure done at the European
agency, and if national agencies had been in a position to better
monitor emerging side effects and control strictly the media hype
that led rapidly to a massive uptake of this poorly known statin,
then a serious crisis might have been avoided.
|