Safety, Quality, Efficacy: Regulating Medicines in the UK

SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK
products derived from biotechnology, and optional
for other high technology or innovative products.
Experts from one member state are nominated to
carry out the assessment, and those of other member
states have the opportunity to contribute to the final
decision, which is then binding on all member states.
1.19 The Agency plans to introduce in 2002-03 a new
'national rules' scheme for products that did not meet
the eligibility criteria of the original registration scheme.
At this early stage the Agency is not able to estimate how
many applications might be made to the new scheme.
part one
! the mutual recognition procedure, which begins with
the company filing an application dossier with the
regulatory agency of a member state of their choice.
This "reference member state" carries out an
assessment and may grant a national marketing
authorisation. It then shares the assessment with other
"concerned member states", who may comment on or
object to the authorisation proposed for their own
territory. Any unresolved objections are subject to
arbitration by the European Committee on Proprietary
Medicinal Products (known as CPMP). Once this is
complete, a national marketing authorisation in each
concerned member state is granted.
1.16 In 2000, the European Commission began a process of
consultation on wide ranging changes to the regulatory
system, partly in response to the likely expansion of the
European Union. Among other changes, the proposals
envisaged further development of the centralised
procedure so that all new pharmaceutical products
would be required to go through that route. Member
States and the European Parliament are still discussing
these proposals.
The Agency is required to regulate an
increasing range of products as a result
of EU Directives
1.17 The European Union regulatory environment works
alongside the UK's national regulatory environment, and
EU Directives must be transposed into UK law. Three
European Directives have recently had an impact on the
range of products the Agency is expected to regulate.
(a) Homoeopathic medicines
1.18 EU Directives in 1992 and 2001 set out requirements for
each national regulatory authority to implement a
simplified registration scheme for homoeopathic
medicines. The Agency implemented a scheme in 1994
that required any homoeopathic products developed
since then and intended for sale on the UK market to be
registered. So far, 356 homoeopathic medicines have
been registered with the scheme. The Agency has found
no evidence of significant safety risks from the
approximately 3,000 older homoeopathic products that
received licences "of right" as they were already on the
market when the 1968 Medicines Act was passed.
However, some have been withdrawn from the market
because of problems complying with the evolving EU
quality standards.
(b) Herbal medicines
1.20 There is no estimate of the number of herbal medicines
sold in the UK. A 1999 market research report 2
estimated that the value of herbal medicine sales in the
UK was some £50 million a year and growing. Some
500 herbal medicines are licensed but an unknown
number of others are exempt from licensing under the
Medicines Act 1968, and can be sold as over-thecounter
products as long as they make no claims on the
packaging or in the form of a brand name, and are
entirely herbal. Or, under the 'herbalists exemption',
they can be sold in personal consultations between
herbalist and patient. Some herbal medicines have been
banned or their availability restricted on safety grounds.
1.21 An EU Directive is currently being negotiated and the
Agency has consulted herbals manufacturers and other
interested groups on its proposed requirements for a
simplified compulsory registration scheme. This would
cover any product that has been used as a traditional
remedy and would be intended to protect patients by
bringing these products within the regulatory framework,
allowing them to make limited efficacy claims.
(c) Clinical trials of medicines
1.22 Clinical trials are currently regulated on a voluntary
basis, and the Agency carries out inspections where
requested. From 1st May 2004 an EU Directive will
require, for the first time in the UK, formal authorisation
of Healthy Volunteer studies carried out for the purpose
of assessing clinical efficacy and safety. This will involve
inspection of sites involved in clinical trials work and
audit of the investigational medicinal products used in
clinical trials. The benefits of this include better
administration of clinical trials and safer use of
medicines under development.
The Agency faces increased competition
within Europe
1.23 The Agency already faces competitive threats from other
European regulators who can also bid for a share of the
reducing volume of new active substance licensing
work under the EU mutual recognition arrangements.
More centralisation of licensing work and the expansion
of the European Union are likely to mean less work to
share between more regulators in both the centralised
and mutual recognition streams.
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2 Mintel Marketing Intelligence, 1999.