herbs and occasional substitution of toxic for safe species; illegal inclusion of
prescription-only drugs or heavy metals in some ‘herbal’ medicines; microbial
contamination; and discovery of problematic herb–drug interactions.
However, this situation is about to change.
For these various reasons a reform of the 1968 herbal provisions was
undertaken. The UK law relating to the sale and supply of over-the-counter
herbal remedies (Section 6.2 of the Act) has now been replaced by the Euro-
pean Directive on Traditional Herbal Medicinal Products of the European
Parliament (2004/24/EC) and of the Council of 31 March 2004 amendment
(available at http://tinyurl.com/2w9nfw)..) This establishes a registration
scheme for industrially produced over-the-counter herbal medicines, under
which manufacturers have to demonstrate safety and quality, but not efficacy.
Quality is guided by European good manufacturing practice, and safety is
protected by requiring evidence of at least 30 years of safe use, of which at
least 15 years must be within the European Community. There is a lead-in
time to allow manufacturers and suppliers to make the necessary adjustments,
but after 2011 any over-the-counter herbal product that is not registered
under this scheme will be illegal. This lead time is, however, only for products
that were on the market before April 2004. All new herbal medicinal products
must have a traditional use registration before being placed on the UK market.
Further advice on the Traditional Herbal Medicines Registration Scheme is
available at the UK Medicines and Healthcare products Regulatory Agency
(MHRA) site at http://tinyurl.com/2ls8wm. By 3rd September 2009 a total of
88 THMR applications had been received by the MHRA of which 45 had
been granted.
The European Directive leaves intact the UK exemption for herbal reme-
dies made up by practitioners after a personal consultation, i.e. the exemp-
tion created by Section 6.1 of the 1968 Act. Such medicines will not have to
be licensed and, because they are not industrially produced, will not have to
be registered under the European Directive. There are, however, concerns
about the quality and safety of herbal medicines supplied by this route. This
is the context of the proposals for reform of Section 6.1 of the 1968 Act,
published as a consultation document by the MHRA in March 2004,
known as MLX 299 (available at http://tinyurl.com/3ctap2)..)
The issue is how to strengthen the public’s protection while preserving
their access to herbal medicines. This consultation document looked at a
number of possible changes, including those discussed below:
- The statutory regulation (SR) of the herbal medicine profession
provides the main mechanism, in a number of ways. First, members of
the statutory register can be tied, through a codes of practice, to
suppliers that have been audited and demonstrated satisfactory
standards of quality assurance. The Register of Chinese Herbal
Traditional Chinese medicine | 159