a White Paper,Forthcoming Legislation on the
Safety, Quality and Description of Drugs and Med-
icines(Cmnd 3393), was published in September
1967, and the Medicines Act, based on these pro-
posals, received the Royal Assent in October 1968.
The Act is a comprehensive measure replacing
most of the previous legislation on the control of
medicines for human use and for veterinary use.
The first provisions laid down in the Act, regarding
licensing of medicinal products and other aspects
of control, came into effect on 1 September 1971.
The Act was administered by the health and agri-
culture ministers of the United Kingdom, acting
together or in some cases separately, as the health
ministers or the agriculture ministers in respect of
human and veterinary medicines, respectively.
The Medicines Commission was appointed by
ministers to give them advice generally relating to
the execution of the Act. A number of expert
committees with specific advisory functions were
appointed by ministers after considering the
recommendations of the Commission, as proposed
in Section 4 of the Medicines Act.
Under the Medicines Act (1968), the Licensing
Authority consists of the Secretaries of State for
Health and Social Services, the Secretary of State
for Agriculture and the Secretaries of State for
Wales, Scotland and Northern Ireland. The Medi-
cine Act (1968) was implemented to operate from
September 1971. The day-to-day administration of
the Act for human medicines was conducted by the
Medicines Division of the Department of Health
and Society Security (DHSS) and was managed
jointly by an under-secretary and the professional
head of the Division, who held the rank of Senior
Principal Medical Officer.
In 1988, the DHSS was split into two depart-
ments, the Department of Health (DoH) and the
Department of Social Security (DSS). Following
the Evans–Cunliffe report, from April 1989, the
Medicines Division of the DoH became the Med-
icines ControlAgency (MCA)underadirector,and
was expected to self-fund its operation from fees
commensurate with the services provided. The UK
MCA in 1997 had 458 staff, of whom 150 approxi-
mately worked in licensing, 130 in post-licensing,
including pharmacovigilance, 75 in licensing
inspection of manufacture and enforcement, and
28 on theBritish Pharmacopoeiaand the United
Kingdom contribution to theEuropean Pharmaco-
poeia. This has now increased to 600 staff in 2002.
On 12 September 2002, the then Health Minis-
ter, Lord Philip Hunt, announced that the MCA
would merge with the Medical Devices Agency
(MDA) with effect from 1 April 2003. The merged
agencies would be known as the Medicines and
Healthcare Products Regulatory Agency (MHRA).
The Licensing Authority is advised by expert
committees, appointed by ministers, as advised by
the Medicines Commission under Section 4 of the
Medicines Act. These advisory committees consist
of independent experts, such as hospital clinicians,
general practitioners, pharmacists and clinical
pharmacologists, not the staff of the DoH, and
are appointed by ministers on the advice of the
Medicines Commission. Since 1971, the relevant
advisory committees have been the Committee on
Safety of Medicines (CSM); the Committee on
Review of Medicines (CRM), which was set up
in 1975 and disestablished on 31 December 1994;
the Committee on Dental and Surgical Materials
(CDSM) was established in 1975 and disestab-
lished on 31 March 1992; theBritish Pharmaco-
poeia Commission (BPC) and the Veterinary
Products Committee, which is administered
through the Ministry of Agriculture, Food and
Fisheries (MAFF). There are proposals out for
consultation which suggest the merger of the Med-
icines Commission with the Committee on Safety
of Medicines, implementation of such a proposal
would require Primary Legislation to change the
Medicines Act 1968.The licensing of new medicines
The United Kingdom joined the European Com-
munity (EC) in 1973, but the data requirements for
granting MAs has, as the implementation of the
Medicines Act (1968), been in accordance with
EC Directive 65/65and the subsequentDirective
75/318, which elaborated on the requirements
for preclinical testing, pharmaceutical quality and
manufacture. Both these Directives and the
Medicines Act (1968) envisaged that MAs issued
on the basis of these requirements would be valid
for five years and subject to review and/or renewal.426 CH33 THE DEVELOPMENT OF HUMAN MEDICINES CONTROL IN EUROPE