Developments in the regulation of herbal medicinal
products
Regulation of herbal medicinal products is at a turning
point in Europe. Two issues are currently being addressed: the harmonisation
of regulation across EU member states and the development of a new directive
for products for “traditional use”. A key issue with this recently drafted
directive included the difficulty of capturing the essence of tradition
in a regulatory scheme, and whether or not harmonisation on this directive
was realistic, given the differing views among member states.
Opening the symposium, ESCOP chairman Professor
Fritz Kemper noted the “unprecedented” public and scientific interest
in herbal medicinal products (HMPs) and said that harmonisation of regulation
across EU member states was necessary. The co-operative welcomed the discussion
at the level of the European Parliament on new regulations for HMPs with
regard to “well-established” and “traditional use”. This could be “the
right key to the right lock”, he said.
Dr Paul Weissenberg, of the European Commission,
gave an overview of developments in the regulation of medicinal products.
First, he explained that it usually takes four to five years for new EU
legislation to come into force. New legislation needs, therefore, to be
relevant for at least five years, and those responsible for drawing up
legislation need to consider how the European environment will be in 10
years’ time.
In reviewing the pharmaceutical legislation, the
objectives were: to guarantee a high level of health protection for EU
citizens and to ensure that products were safe, innovative and available
to the consumer as soon as possible; to improve surveillance by strengthening
pharmacovigilance activities; to support the internal market; and to consider
the challenge of enlargement of the EU to 25 member states.
It was not necessary to start from scratch in designing
new legislation — there was already legislation in place, such as the
“well-established use” directive, a hurdle that many products had succeeded
in passing. However, the spirit of this directive was not always followed,
and this had led to the drafting of the “traditional use” directive (see
Panel).
The scope of the traditional use directive was still
controversial: was it only to apply to HMPs or to other products as well?
Several delegates at the meeting were concerned that Chinese and Ayurvedic
remedies would not be able to satisfy the condition of 15 years’ use in
Europe, and that the directive would effectively remove these products
from the market.
Professor Konstantin Keller, of the Federal Institute
for Drugs and Medical Devices, Germany, explained the “well-established
use” directive (99/83/EEC) and its application. He told the meeting that
the EU directive 65/65/EEC on harmonisation had included a reference to
well-established use. Companies were not required to submit data from
controlled trials if they could demonstrate, by detailed reference to
published scientific literature, that the constituent(s) of proprietary
medicinal products had well-established medicinal use with recognised
efficacy and an acceptable level of safety. However, directive 65/65 had
been interpreted differently by different member states. The newer directive
99/83 had tried to clarify what sort of evidence was required, for example,
post-marketing surveillance studies, epidemiological studies, studies
with other similar products.
There were several factors to consider: the time
over which a substance had been used; the level of exposure among the
population; the coherence of scientific assessments. For such a bibliographic
submission, a full dossier was required, and all evidence, both favourable
and unfavourable, had to be considered.
An important factor was that HMPs, such as tinctures,
teas, and different extracts, were complex biological mixtures produced
by different manufacturers and, consequently, were never identical. However,
they could be considered “sufficiently identical” if they met certain
criteria. Post-marketing experience with other manufacturers’ products
containing the same constituents was of particular importance, and applicants
should put a special emphasis on this issue.
Richard Woodfield, from the Medicines Control Agency,
said there was support for the “traditional use” directive because there
were weaknesses in the UK regulatory arrangements for herbal medicines
under other legislation.
Currently the UK measured up poorly with regard
to ensuring public access to a wide range of safe, high-quality herbal
medicines with appropriate information: licensed products gave too much
protection and not enough choice, whereas unlicensed products gave plenty
of choice but little protection. The traditional use directive, now in
its second draft, may apply to products beyond herbals and does not apply
to products which “can be” licensed under directive 65/65/EEC.
Mr Woodfield said that there was a strong view of
the need to recognise and respect the culture and traditions of ethnic
groups, such as Chinese and Ayurvedic remedies. Some of these remedies
were over 1,000 years old. Safety and quality were crucial, but ethnic
medicines should at least have an opportunity to apply for authorisation.
Dr Bernd Eberwein, of the German Medicines Manufacturers’
Association, said that the “traditional use” directive would not allow
manufacturers to make strong medical claims for their products (as efficacy
data were not required). However, the level of quality and safety required
would be comparable to that required for products licensed in the normal
way. He was concerned about the effects of another draft directive — on
food supplements — which had focussed initially on vitamins and minerals,
but which had been extended to include “other substances with a nutritional
and physiological function”, such as garlic, artichoke extract and co-enzyme
q10. In his view, this directive would have a negative influence on the
regulation of HMPs. What industry wanted was pragmatic consideration of
indications for traditional medicines, not licensing requirements for
HMPs that could not be fulfilled.
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