CHAPTER 5: REGULATION
Regulation of Herbal Products
5.86 In evidence we have received, the regulation
of herbal products has emerged as presenting particular challenges
for public health. We have heard evidence that the use of herbal
products makes up a significant proportion of the total consumption
of medicines and other health products in the United Kingdom.
The Pharmaceutical Society of Great Britain and the Proprietary
Association of Great Britain told us that, while the total size
of the market was difficult to estimate, in their view total annual
sales of herbal products were between £93 million (for the
retail sector) and up to £240 million per annum (including
direct sales, Internet sales and mail order), with signs of continuing
5.87 It was also evident that the regulation of these
products is not satisfactory. The Department of Health told us
the present regulatory arrangements for herbal
medicines have significant weaknesses. The regime for unlicensed
herbal remedies does not provide sufficient protection or information
for the public. At the same time, some of the regulatory hurdles
for licensed medicines may be unnecessarily demanding for relatively
benign herbal remedies" (P 108).
5.88 We heard evidence of the potential dangers that
arise from inadequate regulation in this area. The Committee on
Safety of Medicines (CSM), set up to provide advice to the Government's
MCA, told us that in their opinion "the regulation of unlicensed
herbal remedies is unsatisfactory and of considerable concern"
(p 247). Evidence about the adulteration of various Chinese products
with the toxic herb Aristolochia had led to sweeping restrictions
on these products by MCA.
5.89 The formal position relating to herbal products
was outlined for the European Union as a whole by the European
Agency for the Evaluation of Medicinal Products (EMEA) based in
London. The founding principles of medicines law, the basis formally
of all ensuing legislation across all Member States of the European
Union, are set out in European Council Directive 65/65/EEC. This
defined medicinal products as "any substance or combination
of substances, presented for treating or preventing disease in
human beings or animals; or which may be administered with a view
to making a medical diagnosis or to restoring, correcting or modifying
physiological functions in human beings or animals." These
definitions mean that any product that is supplied with therapeutic
intent, for example by having a claim on the label, is a medicinal
product and requires a licence (or marketing authorisation) in
each Member State.
5.90 The EMEA has established a formal Working Party
on Herbal Medicinal Products to advise it and the industry on
harmonising licensing procedures for herbal medicinal products
across the European Union. This has, among other activities, reviewed
the application of European Union regulations on the licensing
of herbal medicinal products, and considered the drafts of common
standards for herbal medicinal products across the European Union,
based on submissions to it of draft monographs by a scientific
network: the European Scientific Cooperative on Phytotherapy (ESCOP)
whose Chairman also gave evidence to us. It was clear to us from
the latter that the supply of herbal products in much of the European
Union is well integrated into conventional healthcare, with most
herbs being supplied by pharmacists and many recommended or prescribed
5.91 Especially in Germany, France, and the United
Kingdom, a large number of herbal medicinal products have obtained
marketing authorisations, under the terms of Directive 65/65/EEC.
However most of these have been on the basis of historical licences
of right awarded for products on the market when medicines legislation,
such as the Medicines Act 1968 in the United Kingdom, came into
force. We have heard that it has been extremely difficult for
manufacturers of herbal products to achieve marketing authorisations
for new products. As confirmed by the CSM, even a well-researched
herb like St. John's Wort, with strong evidence for efficacy in
depressive conditions, has not been licensed as a medicine in
the United Kingdom. This means that the majority of herbal products,
including almost all those originating from China, India and other
non-European cultures, are not licensed as medicines and are supplied
to the public without specific regulation. In the United Kingdom,
the terms of the Medicines Act 1968 allow exemptions from licensing
for a herbal remedy which is made up solely of the herb, and is
supplied without recommendations as to its use. Thus St. John's
Wort products are sold as remedies exempt from licensing, in spite
of growing evidence of potential interactions with conventional
medication. This exemption is not encountered elsewhere in the
European Union, but this anomaly may well be corrected by forthcoming
5.92 It was generally apparent from evidence submitted,
that as well as in the United Kingdom, there are significant inconsistencies
in the application of medicines legislation to herbal products
across the European Union. We heard further from the EMEA that
these notably applied to defining the borderline between a medicine
and a non-medicinal product such as a food or cosmetic: "
choice and decision as to on which side of the borderline [a product
lies] in principle is a decision for the Member State and the
competent authority of that Member State. Understandably this
leads to different decisions taken in different Member States.
This is part of the confusion of herbal products today" (Q
5.93 The difficulties faced by the public in identifying
products that are adequately regulated were clearly demonstrated
by the Proprietary Association of Great Britain (PAGB). They brought
before us examples of similar proprietary health products available
over the counter. Some were licensed as medicines by the MCA and
thus met rigorous pharmaceutical standards of quality, safety
and efficacy. Others, perhaps even produced by the same manufacturer,
had no such licence and were not required to meet such standards.
Only an inconspicuous licence number differentiated the two products.
In the words of the PAGB, the consumer has "no way of knowing
at all" (Q 1374) if a herbal or other natural product is
licensed or unlicensed, sold as foods, or as exempt products.
We recommend that the MCA find a mechanism that would allow members
of the public to identify health products that had met the stringent
requirements of licensing and to differentiate them from unregulated
competitors. This should be accompanied by strong enforcement
of the law in regard to products that might additionally confuse
the customer with claims and labelling that resemble those permitted
by marketing authorisations.
5.94 Particular concern was raised about the import
of herbal products from parts of the world where standards of
quality might be harder to assure. The public in the United Kingdom
consumes increasing quantities of herbal products from China,
India and other parts of Asia, and Africa. The case of Aristolochia
highlighted the difficulties in assuring quality where European
Union regulations and audit procedures did not apply. We have
also heard that herbal products from the USA are generally produced
as dietary supplements without the regulatory controls applied
to medicinal products.
5.95 In response to the increasing unease across
the European Union about the inadequate regulation of herbal products,
a working group was set up by the Pharmaceutical Committee of
the European Commission. This Committee is currently considering
draft proposals from the United Kingdom MCA for a new Directive
for the regulation of herbal medicinal products, that would allow
licensing of herbal medicines with evidence of traditional use,
in lieu of new clinical or other evidence of efficacy, provided
normal medicinal quality and safety standards are applied. We
understand that the formal draft of such a Directive will be published
around the time of our Report. We strongly recommend that the
Government should maintain their effective advocacy of such a
new regulatory framework for herbal medicines in the United Kingdom
and the rest of the European Union, and urge all parties to ensure
that new regulations adequately reflect the complexities of the
5.96 We were encouraged that there was consensus
that any new legislative framework for herbal medicinal products
would remain within the framework of 65/65/EEC and subsequent
medicines legislation, rather than in some less regulated environment.
In particular all witnesses agreed that there could be
no compromise with medicinal standards of quality for the regulation
of herbal products. As the CSM put it, regulation should be "
on the belief that good manufacturing practices are at the heart
of the matter and that this is accepted by the industry and adopted.
That the constituents, particularly, are authenticated carefully
and that proof of product quality with appropriate specifications
of both the raw materials and the finished products is available.
There should be adequate testing to restrict the level of potentially
hazardous constituents, and warnings about safe and correct use"
5.97 Amongst our witnesses there was some debate,
but no consensus, about the possibility of the United Kingdom
developing national mechanisms for regulating the supply of herbal
products if moves across the European Union were unsuccessful.
The Proprietary Association of Great Britain considered that residual
powers remained for effective regulation, without recourse to
primary legislation. We are concerned about the safety implications
of an unregulated herbal sector and we urge that all legislative
avenues be explored to ensure better control of this unregulated
sector in the interests of the public health.
5.98 We have also heard that many complementary practitioners
use herbal products as part of their professional activities.
The European Herbal Practitioners Association, which is
co-ordinating a move among the professions towards statutory regulation
for the herbal practitioner, told us that the major incentive
for this move was to protect their role in law as suppliers of
herbal medicinal products (Q 728). They also told us that they
were concerned that too rigorous an application of medicines licensing
requirement to their dispensing supplies could restrict their
practice to untenable levels. We support the view that any
new regulatory regime should respect the diversity of products
used by herbal practitioners and allow for simplified registration
of practitioner stocks. Nevertheless, any such regime must ensure
that levels of quality and assurance of safety are not compromised.