eu dir

[Guest guest]

Dear All

Trudy has asked me to copy nimh response to EU dir below. Chris

Alison Daykin

Room 16 - 132

Market Towers

1 Nine Elms Lane

London

SW8 5NQ June 18th 2002

Dear Ms Daykin,

Comments on MLX 283: proposed Traditional Herbal Medicinal Products

amendments to 2001/83/EC

Benefits

As one of the professional associations belonging to the European Herbal

Practitioners Association (EHPA), the National Institute of Medical

Herbalists (NIMH) broadly supports these proposals and therefore endorses

the letter sent to Lord Hunt by the Chairman of the EHPA, McIntyre,

dated May 19th 2002. In particular NIMH endorses the introduction of full

labelling and package insert requirements which will promote for the

responsible self-use of herbal medicines. The combination of labelling which

gives indications based on traditional usage and appropriate warnings where

required on package inserts will enable the consumer to make informed

choices based on reasonable claims.

Improvements in quality throughout the supply chain, pharmacovigilance

procedures and systematic mechanisms for product recall are to be welcomed.

In particular, the full use of Latin binomials and adequate procedures for

identification of starting materials (referred to in 91/356 Annex 7

Manufacture of Herbal Products) will result in improved safety standards

throughout the industry. NIMH endorses the possible benefits of the proposed

regulatory regime (referred to as option 5) set out in Paragraph 14 of the

Partial Regulatory Assessment. This includes the greater transparency in the

regulatory framework and removal of current adverse incentives, in terms of

costs and marketing methods, for companies who comply with legal

requirements.

Application of Articles in 2001/83 “by analogy”

In Article 16g of the Directive amending 2001/83 and in its explanatory

preamble, there is a list of the Articles in 2001/83 which will apply “by

analogy” to traditional use registration. In that the Directive is proposed

as amendments to 2001/83 it is hard to see how the Articles could not but

apply. For example, do the other unlisted Articles apply or not? Paragraph 2

and 3 of Article 16g are unclear in that they refer to Articles 86-100 on

advertising and Articles 54-69 on labelling and additions to the relevant

Articles but yet these Articles are not included in the list of Articles

applying “by analogy”. Is there a legal definition of “by analogy”?

Included in the list in Article 16g is Article 3 of 2001/83 (the Directive

shall not apply to a medicinal product produced in a pharmacy according to a

medical prescription for an individual patient). However, Article 5 of

2001/83 is not included in the list. Article 5 states “A Member State may

in accordance with legislation in force and to fulfil special needs, exclude

from the provisions of this directive medicinal products supplied in

response to a bona fide unsolicited order, formulated in accordance with the

specifications of an authorized health professional and for use by his

individual patients on his direct personal responsibility”. This appears to

give Members States the power to draw up a list of authorized health

professionals who could be excluded from the provisions of 2001/83 and thus

from the Articles concerned with traditional Herbal Medicinal Products.

Your opinion may be that we continue to labour this point of the relevance

of the Directive to herbal practitioners as I have referred to it before in

our comments on these proposals. The relevance for us is that, although we

understand that the MCA does not perceive the Directive as applying to

herbal practitioners, we would like to be assured, as the Directive

incorporates herbal medicinal products into 2001/83, that no situation could

arise whereby the European Commission could indirectly limit the scope of

practice of herbal practitioners via the recommendations of the Committee

for Herbal Medicinal Products or any other Committee. If you refer to my

comments on MLX 282 (below), which is proposing changes in 2001/83, then my

opinion is that our concerns on this point are already justified. With this

in mind, we request that you seek the advice of the MCA legal department,

and reply in writing on the question of whether Article 5 applies to the

proposed Directive on traditional herbal medicinal products and whether

Members of NIMH or the other professional associations of the EHPA, could be

designated as authorized health professionals.

Although there is a transitional period so that regulatory procedures for

products currently on the market do not have to be in place until 2009,

there could be unforeseen delays in the changes to Section 12(1) of the

Medicines Act 1968 which would arise from the statutory self-regulation of

herbal practitioners. One would then be particularly concerned about the

usage of herbal medicines which are neither listed on Schedule III nor

licensed for use under the provisions of the amended Directive 2001/83.

MLX 282

In May 2002, NIMH submitted comments to the MCA on MLX 282 which amends

2001/83 and also amends 2309/93. I would like to bring to your attention

four proposed changes in particular. These are changes to Article 18.4 of

2309/93 which would give the Commission the power to act on its own

initiative to withdraw products from the market if an urgent safety issue

arose thus over-riding the powers of the licensing authorities of the

Members States; changes to Article 107 of 2001/83 (concerning requests to

Members States to adopt temporary measures to protect public health) and

changes to Articles 26,116,117 (concerning the concept of risk/benefit

balance). When taken together, in the light of our experience of the

difficulties in obtaining a full picture on the cases of hepatotoxicity

possibly associated with the use of Kava, and of the conflicting information

and opinions available about the safety of Kava, these three amendments

would move the control of medicines appreciably towards the European

Commission who may act hastily based on inadequate information and

consultation. We consider that we are potentially vulnerable as a profession

to such decisions as they will be taken in the context of a risk/benefit

balance appropriate to self-use of herbal medicines not in the context of

professional prescription of herbal medicines.

It is also proposed to amend Article 111 of 2001/83 to extend good

manufacturing practice (GMP) to cover active substances used as starting

materials ie including the procedures used abroad in manufacture or supply

of imported herbal ingredients. NIMH would agree with this amendment as it

enables the safety requirements to be implemented throughout the supply

chain. However, this will place burdens on importers of materials used by

all traditions in herbal medicine, and we would ask you to endeavour to

ensure, in accordance with paragraph 28 of the Regulatory Impact Assessment

(RIA), that the MCA seeks to ensure an adequate transition period.

Compliance costs

Consumer confidence in herbal medicines will tend to be increased by the

introduction of GMP. However, as licences will be approved, product by

product, the costs both financial and human, of introduction of GMP will

tend to reduce product ranges. This will result in the removal from sale of

products which have a good safety record but have small product runs. In the

wording of 2001/83, there are examples of phrases which rely for

interpretation on the judgement of the MCA but leave open the possibility of

onerous changes were that judgement to change. To give an example, Article

48 states that “the holder of a market authorization has permanently and

continuously at his disposal the services of at least one qualified person”

as defined in Article 49. If this is interpreted as being continuously

available as a consultant, the standard can be met. However, were it to be

interpreted as continuously on the premises, then the associated costs would

be very prejudicial to small companies. Many companies who are using

organically grown or fresh plant materials are small and the production of

high quality home-produced herbal medicines could decrease if the costs

associated with licensing are disproportionate to the potential eventual

income from the product. Such companies, who may currently be in Category 2

of Paragraph 22 of the Regulatory Impact Assessment, will also have to carry

higher costs/unit of production in upgrading facilities to obtain a

Manufacturers Licence. The Regulatory Impact Assessment carried out by the

European Commission claims that the proposals in this Directive will open up

wider markets in Europe for companies. This is likely to be the case for

pharmaceutical companies who have a natural products division. However, I am

not aware of any evidence to support this claim for small companies

manufacturing products using organic or cultivated plant materials for the

British market. Were levels of imports to increase, these same small British

companies will be adversely effected.

The RIA does not discuss fully the implications for wholesalers in the heath

food trade in meeting the requirements of a wholesalers license.

It is difficult for NIMH as a professional association to comment fully on

the implications of Article 81 “physico-chemical, biological or

microbiological testing” or the argument that these standards are

unrealistic. However, we would hope for a practical resolution of the points

in dispute.

Comments on innovations, non-European herbal traditions and non-herbal

ingredients

Our final proviso on the proposals is that they will reduce consumer choice,

in particular to the extent that it reduces the range of products with

non-herbal ingredients or ingredients from non-European countries. As was

argued at the Irish Medicines Board consultation day, the application of the

30-year rule and the association of the labelling with indications rather

than “health claims” (which are explicity banned in Article 90© of

2001/83) will stifle innovation in what is a changing and developing market.

This is of particular relevance to herbal practitioners in that valuable

improvements in the effectiveness of herbal practice have been associated

with the usage of medicinal plants which are imported and which are used for

“new” indications. An obvious example is the usage of Eleutherococcus

senticosus.

In conclusion, I would like to reiterate both our broad support for the

proposals and our concerns that they might have unforeseen implications for

herbal practitioners, and also to confirm that these comments may be made

freely available.

Yours sincerely,

Alison Denham MNIMH

Caton, MNIMH

chris@...