Medicine has provided a good model for such an arrangement through
its Approved Suppliers scheme. Under SR an arrangement of this kind
can be extended to all registered practitioners. As it will be illegal to
practise under the title of herbalist or Chinese medicine practitioner
without membership of the register, the public will have stronger
assurance about the quality of Section 6.1 products than at present.
Second, some more potent items in the materia medica can be
restricted to use by registered practitioners. Third, SR provides a
possible route for preserving access to so-called patent medicines (see
below).
- At present practitioners have access to a wide range of Chinese
medicine ‘patents’. These are unlicensed medicines that would be
considered industrially produced and thus, once the European directive
is in force, would have to be registered under that scheme in order to
remain legal. However, it seems likely that most of these patents would
be considered unsuitable for registration under the European directive,
because even if they met the tough quality assurance standards, most
would not be suitable for over-the-counter use. On the other hand,
they are industrially produced, so they could not be supplied under the
normal Section 6.1 conditions. One way in which access might be
preserved is through the so-called ‘Specials’ regimen, a provision in
European medicines law that allows authorised health professionalsto
commission a third party (who would have to possess a manufacturer’s
license) to make up medicines according to a particular specification.
As registered herbalists would be authorised health professionals, it
would in principle be possible for herbalists to commission a range of
products for the exclusive use of practitioners on the statutory register.
This possibility was put forward by the MHRA. - For acupuncturists to be able to commission specials they would also
need to be designated ‘authorised healthcare professionals’ and able to
demonstrate that they operate on a comparable level to herbalists in
terms of the public’s protection. Under the new specials regimen, it is
the practitioner who would be responsible for the formulation of any
herbal patent medicine. Suppliers would not be able to advertise their
products but would be able to advertise that they are able to provide a
service. - The current licensing exemptions apply only to plant remedies. The
1968 legislation was brought in when very little non-European herbal
medicine was practised in the UK, and the question of non-plant
ingredients did not arise. However, the use of CHM, in which mineral
and animal ingredients play an important role, has grown rapidly in
the UK since then. Although there have been no prosecutions to date
arising specifically from the use of non-plant ingredients – hence the
160 | Traditional medicine