regulatory bodies to carry out the functions out-
lined in it, including the following:
(a) The Licensing Authority, which decides
whether licences for medical products should
be granted.
(b) The Medicines Commission and the Commit-
tee on the Safety of Medicines, which are
examples of independent bodies set up under
the Act to advise the Licensing Authority.
As well as domestic legislation, there is extensive
European legislation governing member states.
The European Community has over the years
established measures to harmonize the regulation
of medicines throughout Europe. In 2001, all Eur-
opean Community Directives adopted between
1965 and 1999 on the regulation of medicines
were consolidated into a ‘Community Code’. At
the time, the Code could not incorporate the new
Clinical Trials Directive harmonizing EU controls
on the approval and conduct of clinical trials (i.e.
Directive 2001/20/EC). The Community Code has,
however, since been amended to take into account
the Directive’s ethics.
It was through this series of, now codified,
Directives that a Europe-wide Committee for Pro-
prietary Medicinal Products was created, now
known as the Committee for Medicinal Products
for Human Use (CHMP). Its role is significant. In
conjunction with the European Medicines Agency
(EMEA) established in February 1995, which it
advises, it is responsible for overseeing the proce-
dures established for the regulatory harmonization
of pharmaceutical products throughout Europe,
namely:
The ‘centralised procedure’, which involves one
application made to the EMEA. This has been
mandatory for biotechnology products since
January 1995, and has been extended to further
categories since then.
The ‘mutual recognition’ procedure (or the
‘decentralised procedure’), which is in essence
a national registration recognised by the other
member states.
In the centralised procedure, it is the CHMP which
initially decides if the new product should be
authorized and gives its ‘opinion’ to the EMEA.
Also, through the mutual recognition procedure, it
is the CHMP which resolves any disputes. Thus,
thereare twowaysinwhichadrugmaybegranteda
licenseintheUnitedKingdom;viatheEMEA(beit
through the centralized or mutual recognition
procedure) or through its own MHRA.
The above procedures were reevaluated in 2001
as required in the originating legislation. The Eur-
opean Commission concluded that the main struc-
tures should remain but more flexibility was
needed in pharmaceutical legislation. Issues con-
sidered were the need to provide European citizens
with the highest level of healthcare, the need for an
increase in the availability of innovative medicinal
products and the then imminent enlargement of the
EU. The findings of the Commission plus the inter-
vening introduction of the ‘Community Code’
prompted the replacement of Regulation 2309/93
by Regulation 726/2004. The new regulation was
drawn up to improve the previous version taking
into account practical experience and to update all
references to Directives since codified. The regula-
tion also sets out the EMEA’s other tasks such as
coordinating existing resources for the evaluation,
supervision and pharmacovigilance of medicinal
products.
One of the new developments of the European
legislation above is the introduction of financial
penalties for failure to comply with obligations
and the ‘naming and shaming’ of offending com-
panies. The United Kingdom, Medicines Act
(1968) places responsibility on the applicant for a
licence, which in most cases is a company, not on
an individual within the company. The legal
responsibility is thus that of the company (and
those in positions of leadership and authority) to
comply with the various regulations under the Act.
Under certain circumstances, the regulatory
authority (i.e. the government) may be sued if it
was allegedly somehow at fault in granting or fail-
ing to withdraw a licence for the product that
supposedly caused harm.
In the United States, pharmaceutical products
are the most heavily regulated of all consumer
products. The Food and Drug Administration46.6 THE LEGAL FRAMEWORK FOR REGULATING PHARMACEUTICAL PRODUCTS 599