The boundaries between medicines and other products are
becoming increasingly blurred, presenting new challenges to
When we think of medicines, products such as paracetamol,
antibiotics or anti-cancer drugs probably spring to mind. But
medicines encompass many different things, such as vaccines and
barium meals, and increasing numbers of borderline products also
claim health benefits.
The regulatory bodies charged with overseeing and granting
licences to new medicines must assess many different products:
- Under the Medicines Act, a medicine is defined as "any
substance or combination of substances which may be administered to
human beings or animals with a view to making a diagnosis or to
restoring, correcting or modifying physiological functions in human
beings or animals".
- Appliances, instruments and devices are classed not as
medicines but as medical devices. They also come under the Act. The
range of products is very wide, from syringes and dressings to
surgical instruments, hospital beds and walking frames – even
condoms and contact lenses.
The term 'medicine' encompasses many different types of
The boundaries between medicines and other products are becoming
increasingly blurred, especially because the legislation covers
marketing claims made for products such as 'fighting' or
'protecting against' a disease.
Products such as disinfectants or cosmetics are not normally
regarded as medicines and so do not require a license in the UK.
Similarly, food supplements containing additives such as vitamins
or minerals generally come under food safety and labelling
But if any of these contains a pharmacologically active
substance or makes medicinal claims (for example, claiming to lower
cholesterol or calm anxiety), it may require a licence before it
can be released onto the market.
Herbal remedies are classified as medicines. As public interest
in complementary medicine has led to increased demand and an influx
of new remedies from many countries and medical traditions, their
regulation has come increasingly under the spotlight in Europe. A
few traditional medicines, such as the herb kava-kava used in
medicines and food supplements to combat anxiety, have been banned
following Yellow Card alerts on serious adverse reactions.
Herbal medicines present a problem for licensing as the system
is designed to assess chemical entities not whole plants (such as
garlic or St John's Wort). A EU Directive (Directive on Traditional
Herbal Medicinal Products 2002) waived the requirement for
traditional herbal medicines to undergo double blind clinical
trials, if they can be shown to have been in safe continuous use
for 30 years in the EU.