4 Authorisation of traditional herbal
medicinal products
| (24453)
8532/03
COM(03) 161
| Amended draft Directive amending Directive 2001/83/EC as regards traditional herbal medicinal products.
|
| Legal base | Article 95 EC; co-decision; qualified majority voting
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| Document originated | 9 April 2003
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| Deposited in Parliament | 24 April 2003
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| Department | Health |
| Basis of consideration | EM of 9 May 2003
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| Previous Committee Report | None, but see footnote 30
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Not cleared; further information awaited
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Background
4.1 Under Community legislation, no medicinal product may be placed
on the market without an authorisation granted either by the Commission
under Regulation 2093/93[28]
or, in the case of human medicines, by a Member State under the
decentralised (mutual recognition) procedure in Directive 2001/83.[29]
The latter specifies the information which must be supplied in
support of an application for authorisation, including the results
of pharmaceutical and clinical trials carried out to establish
quality, safety and efficacy. However, the Directive makes an
exception to the need to present particulars relating to safety
and efficacy in the case of products where it can be demonstrated
by detailed references to published scientific literature that
there is a well-established medicinal use.
4.2 current proposalAccording to the Commission, this framework
is suitable for certain traditional herbal medicinal products,
but, for many which have been used for a long period, sufficient
published literature to demonstrate a well-established use is
not available. Since the Commission believes it would be difficult
to justify withholding an authorisation where the traditional
use of the product allows sound conclusions to be drawn on its
safety and efficacy, it proposed in January 2002 that a special
procedure should apply, permitting the registration, and hence
marketing, of such products without the need for particulars and
documents on tests and trials on safety and efficacy.[30]
The products to which this would apply would be identified in
a positive list, subject to their meeting certain conditions,
including:
· the need for
safety to be demonstrated through bibliographic data and an expert
report;
· the normal
requirement for proof of efficacy being replaced by a requirement
to demonstrate a history of 30 years use in the Community (though
evidence for up to 15 of the 30 years can relate to use outside
the Community);
· the use of
agreed medical indications, but limited to those adapted for traditional
herbal products for use without the advice or intervention of
a doctor;
· the need for
labelling to include a clear statement that product efficacy is
not proven, as well as other information for the safe use of the
product.
It was also proposed that there should be a subsequent
review of the operation of the Directive, with a view to a possible
extension of traditional use registrations to other categories
of traditional medicinal products, for example those containing
non-herbal ingredients, such as minerals.
4.3 Governments viewAs we noted in our Report of
10 April 2002, the Government considered that this proposal would
rectify a number of the widely acknowledged weaknesses in the
current regulatory arrangements for herbal medicines in the UK,
including the fact that the majority of them may be placed on
the market as unlicensed herbal remedies without meeting
specific safety or quality requirements. Because of this, the
Government had advocated European legislation to regulate these
medicines, and believed that the Commissions proposals were in
line with its own thinking, subject to clarification of a number
of detailed points. The UK also welcomed the proposal for a subsequent
review of the extension of the Directives scope, since it considered
there were a number of genuinely traditional medicines which might
contain non-herbal active ingredients.
4.4 The Government also provided us with a partial
Regulatory Impact Assessment, identifying the potential benefits
and compliance costs, though it pointed out that these were likely
to vary widely according to specific circumstances. However,
one cost in particular, albeit unquantified at this stage, would
be the registration fee charged by the Medicines Control Agency,
which would need to recover the substantial compliance costs it
would face.
4.5 In commenting on the Governments general support
for this proposal, we noted that it related to more general proposals[31]
on the authorisation of human (and veterinary) medicines which
we had recommended on 20 March 2002 for debate in European Standing
Committee C. We therefore recommended that this document should
be debated at the same time. That debate took place on 18 June
2002.
The current document
4.6 The present document is an amended proposal which
the Commission has produced to incorporate some of the amendments
suggested by the European Parliament at its first reading on 21
November 2002. The most important of these would:
· extend the
proposal to allow herbs to be combined with vitamins and minerals,
where there is evidence that this is safe, and where the action
of the nutrient is ancillary to the herb itself: however, due
to the risks arising with animal products, medicines combining
herbs with biological material would continue to require a full
authorisation;
· allow the proposed
Committee for Herbal Medicinal Products discretion in individual
cases to lower the requirement (see paragraph 4.2 above) that
a product must have been in use within the Community for a minimum
of 15 years;
· provide greater
harmonisation in terms of mutual recognitions granted in other
Member States;
· specify that
there should be a review of the scope of the measure no later
than three years after it enters into force.
4.7 In her Explanatory Memorandum of 9 May 2003,
the Parliament Under-Secretary of State at the Department of Health
(Ms Hazel Blears) says that the proposal has received broad support
from Member States, including the UK. She also indicates that
the Government favours these latest amendments, though it will
wish to discuss with the herbal sector the implication of greater
mutual recognition, where she sees the advantages for companies
seeking to market in other Member States having to be balanced
against possible limitations on national flexibility.
4.8 The Minister has also provided with her Explanatory
Memorandum a revised Regulatory Impact Assessment, but, although
this analyses the implications of the proposal in great detail,
it has again proved difficult to quantify these. She adds that
there is much work still to be undertaken, and that further versions
of the Assessment will be issued as necessary.
Conclusion
4.9 We have noted the present position, including
the broad support which the UK has given to the various amendments
adopted by the Commission. However, notwithstanding the debate
held on the original proposal, we would be interested before taking
a view on the present document to see any further Regulatory Impact
Assessment, particularly if this is able to quantify the effects
of the proposal more clearly than has been possible hitherto.
In the meantime, we are keeping this document under scrutiny.
28 OJ No. L.214, 24.8.93, p.1. Back
29
OJ No. L.311, 28.11.01, p.67. Back
30
(23244) 6240/02; see HC 152-xxiii (2001-02), paragraph 4 (10 April
2002). Back
31
(22867) 13361/01 and (23022)14591/01; see HC 152-xxii (2001-02),
paragraph 3 (20 March 2002). Back
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