Press Release - Safety, Quality, Efficacy: Regulating Medicines
in the UK
16 January 2003
The Medicines Control Agency (MCA) has a good track record,
nationally and internationally, in protecting public health and in
ensuring that medicines are in general safe, of good quality and
effective if used properly. But, according to a National Audit
Office report, it needs to do more to improve the quality of
information and advice provided to the public and make sure that
messages about suspected adverse reactions to drugs get through to
clinicians and others.
Head of the National Audit Office Sir John Bourn today reported
to Parliament on the work of the MCA, the body responsible for
regulating medicines in the UK. He concludes that the system for
monitoring the safety of licensed medicines is leading edge. A
rigorous inspection regime for medicines development and
distribution ensures that they are also generally of high
quality.
But better reporting by clinicians of adverse reactions to drugs
is needed. The Agency has made reporting of suspected adverse
reactions to drugs easier and open to a wider group of health
professionals and later this year – through NHS Direct – patients
and consumers. Even so, under the voluntary scheme clinicians
report only a quarter or fewer of such suspected reactions. The
Agency does not routinely measure the effectiveness of its safety
warnings but has developed a strategy to improve the management and
communication of risks which it is now looking to implement.
Patient information leaflets enclosed with medicines are often
found by the public to be unhelpful and confusing. Many consumers
read only part of the information provided and around one in ten
never read the leaflet at all. The Agency is pressing the case in
Europe for more user-friendly information and is working with
others to reduce medication errors attributed to confusing
packaging and labelling.
There are also some risks to the public from unregulated
medicines, including those bought over the internet. The MCA has
recognised that illegal sales of prescription medicines over the
internet are growing and is addressing the problem. The majority of
herbal medicines on sale in the UK are unlicensed, although
European legislation to regulate them is currently being discussed.
Just like conventional medicines, they can have side effects and
interact adversely with other medicines. The Agency has taken
regulatory action to protect public health when specific problems
with such products have arisen, but risks need to be communicated
to the public better.
The MCA is due to merge with the Medical Devices Agency (MDA) in
April 2003, and there are some key issues ahead. Pharmaceutical
licensing and regulation in Europe are becoming increasingly
centralised and the new Agency will need to focus on continuing to
protect UK public health, while maintaining its existing strong
position to influence developments in Europe.
The MCA must provide a service to industry while observing its
overriding aim of protecting public health. While there are
safeguards in place to prevent any conflict of interest, some
stakeholders are concerned that there is the potential for such
conflicts, especially as the Agency is fully funded by industry
fees. The Department of Health is to clarify the MCA’s objectives
when it merges with the MDA.
According to today’s report, the MCA should consider whether its
public profile enables it effectively to provide information which
will contribute to the safe and effective use of medicines and in
what ways this profile can be strengthened. It should build on its
existing regional networks, and work with others, such as hospital
and community pharmacists and consultants, to disseminate key
information on medicines safety more effectively to both health
professionals, including GPs, and the public.
The Agency should also build on actions already taken to ensure
that the Drug Alert distribution system for recall of defective
medicines across the UK reaches all appropriate health
professionals, especially in the light of widened prescribing
powers and recent changes in the structures of the NHS.
Sir John Bourn said today:
"The Medicines Control Agency has a good record and its
work is highly respected around the world and forms a model in many
countries. But it needs to do more to communicate directly with
health professionals and the public and improve the effectiveness
of its safety messages. The Agency, and its successor after merger
with the Medical Devices Agency, must build on its strong position
to maintain an influential position in the European regulatory
environment."
Notes for Editors
- Well over a billion prescriptions and over the counter
medications are dispensed or bought in the UK each year. The
Medicines Control Agency is responsible for the licensing,
regulation and surveillance of medicines manufacture, supply,
promotion and provision. It is an Executive Agency of the
Department of Health.
- Not all medicines on sale in the UK are licensed by the MCA.
Some are licensed through a centralised European procedure or
through mutual recognition of licences granted originally by other
EU member states. Some medicines, including as the majority of
herbal medicines, traditional medicines and homoeopathics, are not
currently licensed.
- The National Audit Office also published a management report on
the Agency and booklet of international comparisons on medicines
regulation which are available at www.nao.org.uk
- Press notices and reports are available from the date of
publication on the NAO website at http://www.nao.org.uk/ Hard copies can
be obtained from The Stationery Office on 0845 702 3474.
- The Comptroller and Auditor General, Sir John Bourn, is the
head of the National Audit Office employing some 750 staff. He and
the NAO are totally independent of Government. He certifies the
accounts of all Government departments and a wide range of other
public sector bodies; and he has statutory authority to report to
Parliament on the economy, efficiency and effectiveness with which
departments and other bodies have used their resources.
Press Notice 02/03
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