Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards traditional herbal medicinal products"
Date: 2002-09-18
Institutions: European Economic and Social Committee
Subjects: approximation of laws, consumer information, legal code, medicinal product, pharmaceutical legislation, public health, single market

14.3.2003

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Official Journal of the European Union

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Opinion of the Economic and Social Committee on the ‘Proposal for a Directive of the European
Parliament and of the Council amending Directive 2001/83/EC as regards traditional herbal
medicinal products’

(2003/C 61/02)

On 22 February 2002, the Council decided to consult the Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing
the Committee’s work on the subject, adopted its opinion on 11 September 2002. The rapporteur was
Mr Braghin.

At its 393rd Plenary Session (meeting of 18 September 2002), the Economic and Social Committee
adopted the following opinion with 124 votes in favour and two abstentions.

1.

Introduction

1.1.
The proposal for a directive specifically concerns herbal
medicinal products that have been well-established over time
(defined as ‘traditional’), not the use of substances or herbal
preparations which do not come under the definition of a
medicinal product contained in Directive 2001/83/EC (1), i.e.
substances or preparations that do not have ‘properties for
treating or preventing disease in human beings’ or for ‘restor-
ing, correcting or modifying physiological functions’ (2).

The market for herbal substances and preparations
1.2.
(plants, parts of plants, algae, fungi, lichen and related prep-
arations obtained from various methods of treating herbal
substances) has grown rapidly, and in some Member States it
is not yet subject to satisfactory regulations. Furthermore,
there is an increasing supply of non-traditional substances on
the market in Europe, often associated with the spread of
alternative therapies from other cultures.

1.3.
Several factors have contributed to this development:
the perception that ‘natural’ substances present fewer health
risks, dissatisfaction with certain mainstream medical treat-
ments for minor illnesses, the availability of such substances
in alternative outlets (herbalists, health shops, mail order
businesses — especially over the internet — etc.) and the rising

trend for patients to opt for self-treatment. The public is
particularly attracted by the suggestion that such products can
improve their health or physical appearance. These products
are advertised in all forms of media, but especially in publi-
cations targeting groups of the population particularly sensitive
to such forms of advertising, as well as in retail outlets with
the use of apparently scientific leaflets. Often, however, there
is no evidence to support the claims made, which are often
based upon a supposed result of combining substances rather
than on scientific studies. In addition, consumers do not always
follow the recommendations for dosage in the erroneous
conviction that herbal products do not present any health
risks.

1.4.
The use of herbal substances and preparations should
be regulated as soon as possible to avoid public health risks
(resulting from substandard preparation techniques; chemical,
physical or biological contamination of raw materials; possible
traces of undesired plant material; or interaction with food or
other medicinal products, of which consumers are often
unaware) and also to avoid unfair competition practices and
unwarranted barriers to the free market.

( 1) Directive 2001/83/EC (OJ L 311, 28.11.2001) lays down the
new Community code on medicinal products for human use,
incorporating into one text the previous directives on medicinal
products, which are hence repealed. On 26 January 2001 the
Commission presented the Proposal
the
European Parliament and the Council amending the above
Directive, regarding both medicinal products for human use and
veterinary medicinal products (COM(2001) 404 final).

for a Directive of

( 2) Proposed amendment of Article 1 of Directive 2001/83/EC

contained in COM(2001) 404 final.

1.5.
The legal and practical status of such products varies
significantly from one Member State to another. More compre-
hensive action is needed at Community level
to deliver
increased public health protection and to ensure the free and
undistorted supply of these products within the EU. This
would also aim to close legislative loopholes and remove the
in the field of dietetic products, food
various ‘grey areas’

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supplements, herbal products and herbal medicinal products
as well as to regulate or at least harmonise the use of claims
to boost health or well-being, which sometimes mislead
consumers or even amount to outright deceptive and fraudu-
lent practice on the part of manufacturers.

2.4.
Under this proposal, the mutual recognition procedure
cannot be applied to registrations of traditional herbal med-
icinal products, but Member States are invited to take due
account of authorisations or registrations of certain products.
To further facilitate such applications, a list of herbal sub-
stances fulfilling the conditions of eligibility is also to be drawn
up.

1.6.
The EESC therefore welcomes the Commission pro-
posal which seeks to harmonise the market for traditional
herbal medicinal products and close a loophole in existing
legislation. Nevertheless, it calls on the Commission to speed
up the tabling of proposals to regulate the whole sector of
herbal substances.

2. Gist of the Commission proposal

2.1.
The proposal for a directive aims to amend Directive
2001/83/EC (1) as regards traditional herbal medicinal prod-
ucts, the legal and practical situation of which varies signifi-
cantly between Member States. The proposal provides for a
special registration procedure which does not require particu-
lars and documents regarding tests and trials on safety
and efficacy, unlike the above-mentioned directive. Sufficient
published scientific literature is not available for many such
medicinal products, and new tests and trials cannot be justified
since the traditional use of the medicinal product is of such a
nature as to allow sound conclusions on its safety and efficacy.

2.2.
The main objective of the draft directive is to establish
a harmonised legislative framework for traditional herbal
medicinal products, introducing those provisions considered
indispensable to attain a sufficient degree of harmonisation
while ensuring the utmost protection of public health and
respecting the principles of proportionality and subsidiarity.

2.3.
The proposal covers those traditional herbal medicinal
products which are not eligible for authorisation under the
simplified or normal registration procedure. It lays down the
conditions to be fulfilled for a product to be authorised,
concerning indications, ways the product can be administered,
specified strength, and minimum period of traditional use. It
also confirms the need for adequate documentation of results
of physico-chemical, biological or micro-biological tests and
quality of the medicinal product (the same criteria required by
Directive 2001/83/EC). The conditions under which regis-
tration is to be refused are also laid down.

( 1) Directive 2001/83/EC, (OJ L 311, 28.11.2001) lays down the
new Community code on medicinal products for human use,
incorporating into one text the previous directives on medicinal
products, which are hence repealed.

2.5.
The proposal contains the obligation to include in the
the package leaflet and in any advertising the
labelling,
information that the product is a traditional herbal medicinal
product and that its efficacy has not been clinically proven.

2.6.
A new Committee for Herbal Medicinal Products is to
be set up within the European Agency for the Evaluation of
Medicinal Products. The committee’s tasks will relate to the
scientific issues with regard to herbal medicinal products and
herbal substances, and it should work in close cooperation
with the Committee for Proprietary Medicinal Products. It has
the specific task of establishing Community herbal mono-
graphs (to be used as a basis for any application for registration
under the new provisions) and of drawing up a list of
herbal substances which can be considered traditional herbal
medicinal products.

3. Comments

3.1. Harmonisation and the internal market

3.1.1.
The EESC endorses the need for action to progress-
ively harmonise the regulatory framework for traditional
herbal medicinal products and first and foremost guarantee
public health and safety. The aim is to remove the grey area
surrounding traditional, well-established medicinal products
and to some extent predating the first EC directive on medicinal
products.

3.1.2.
The specific inclusion of traditional herbal medicinal
products in the recent consolidated legislation on medicinal
products for human use (1) certainly encourages greater protec-
tion of public health and safety as it
imposes minimum
quality standards for manufacturers, harmonised and coherent
systems for pharmacovigilance — and therefore more efficient
data collection on potential negative side-effects — and lastly
harmonised procedures by national authorities in classifying
corresponding products which are not considered medicinal
products across the board.

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3.1.3.
The EESC considers the proposal to be appropriate
and timely in that it will also apply to candidate countries,
some of which have specific therapeutic traditions involving
herbal medicinal products. The EESC invites the Commission
to consider the case for transitional agreements in this
specific field and to identify particular aspects that should be
incorporated into the acquis communautaire.

3.2.2.
The EESC considers this aspect particularly important
in order to differentiate between preparations obtained from
the same plant in cases where some of these preparations are
classified as medicinal products while others are not, because
the concentration and dosage of the active ingredient does not
give rise to a therapeutic effect that would warrant their
classification as a medicinal product.

3.1.4.
The EESC endorses the need to keep traditional
herbal medicinal products on the market which, despite their
long tradition, do not fulfil the regulatory criteria laid down in
existing legislation and welcomes the fact that by effectively
incorporating these products into Directive 2001/83/EC, they
will be subject to the same conditions guaranteeing the safety
and quality of all medicinal products for human use.

The EESC considers, however, that the proposal does
3.1.5.
not resolve all the difficulties encountered which render the
internal market for such products excessively fragmented and
lacking in common or at least harmonised regulations. The
EESC advocates taking a more decisive course of action to
encourage the marketing of such products in countries other
than those where they were originally marketed and/or
registered, provided they fulfil the minimum criteria as laid
down in the proposal.

3.1.6.
The EESC also considers that the real state of the
market has not been adequately gauged. In practice, essentially
corresponding products are classified in some Member States
as medicinal products and in others as foodstuffs. The EESC
recommends applying the precautionary principle to unclear
cases, thereby classifying them as traditional herbal medicinal
products throughout the European Union, in order to guaran-
tee a greater level of control on the quality and safety of such
products.

3.2. Definitions

The definition of a ‘herbal medicinal product’ does
3.2.1.
not appear sufficient to redress the current discrepancies
between Member States. Firstly, it refers to ‘active ingredients’
as if these were easily identifiable and distinguishable, when
in fact all such medicinal products contain several active
ingredients. The effect of each ingredient cannot always be
readily identified or defined with precision, nor often can the
cumulative effect of such ingredients be proven. Secondly,
‘herbal preparations’ are rather loosely and generically defined,
without highlighting the properties necessary and sufficient
for their authorisation, and thus for comparing medicinal
products obtained from the same plant.

The definition of

‘herbal substances’ and ‘herbal
3.2.3.
preparations’ as referred to in new points 31 and 32 respect-
ively is inconsistent with the definition of herbal substances
laid down in Article 1(3) of Directive 2001/83/EC.

3.2.4.
Another shortcoming is the absence of any statement
specifying whether the term ‘traditional herbal medicinal
products’ can also apply to products containing not only
one or more herbal substances or herbal preparations or a
combination of them, but also non-herbal
ingredients, for
example vitamins, minerals or mineral substances.

The words ‘also in combination with non-herbal
3.2.5.
ingredients’
the end of
should therefore be added at
Article 1(30). The EESC considers that, in order to avoid the
persistence of an extensive grey area in the pharmaceuticals
market, such products should be included in the definition of
traditional herbal medicinal products if the main pharmaco-
logical action derives from herbal substances or herbal prep-
arations contained in them.

The EESC considers the concept of ‘corresponding
3.2.6.
(Article 16c(2)), referring to products
medicinal products’
containing the same active ingredients and an equivalent
strength, to be inadequately defined and in any case difficult
to apply, unless it is specified whether this refers to substances
derived from the same plant.

In this context, it is useful to refer to monographs
3.2.7.
contained in existing and officially recognised Pharmacopoeia
to define products containing herbal substances with proper-
ties listed therein as corresponding products. A reference to
such Pharmacopoeia is thus advisable here.

As the conditions guaranteeing full safety of use are
3.2.8.
laid down in the monograph itself, the EESC considers that the
following phrase in recital 11 should be deleted: ‘unless there

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are major objections of public health’. This has led to significant
discrepancies in application and abuse.

all operators in the sector is established within a reasonable
timescale.

3.3.

Period of use and other procedural aspects

The requirement to show medicinal use throughout
3.3.1.
a period of thirty years seems excessive. Well-established use
for twice the amount of time needed for simplified registration,
i.e. a twenty-year period, could be considered sufficient to
guarantee a good level of safety of use. However, the EESC
welcomes the provision that the thirty-year period may be
completed by a period of well-established use in territories
outside the Community of at least the same duration as use
within the EU, since this enriches the European medicinal
arsenal with plants from other territories.

3.3.2.
Transitional measures for products of well-estab-
lished use in candidate countries should be introduced upon
accession of these countries into the EU, so as to encourage
the use of their traditional herbal medicinal products while
ensuring that these meet Community standards of quality and
safety.

3.3.3.
Article 16e lists the conditions which would warrant
refusal of the application for registration. The EESC rec-
ommends that if a product is refused for being potentially
harmful under normal conditions of use, immediate measures
should be in place to withdraw it and corresponding products
from the market in other Member States, appropriate and
reasoned measures should be taken to inform the public of the
decision to refuse registration, and there should be an arbi-
tration procedure to deal with disagreements between national
authorities.

3.4.

The Committee for Herbal Medicinal Products

The EESC endorses the proposal to set up a Com-
3.4.1.
mittee for Herbal Medicinal Products under the European
Agency for the Evaluation of Medicinal Products, with two
main tasks: drawing up a list of herbal substances with the
information needed to guarantee the safe use of such substan-
ces, and establishing Community monographs to be used as a
basis for all applications for registration.

3.4.3.
The EESC urges the above committee, when drawing
up Community monographs, to take into account material
contained in existing official Pharmacopoeia, which are the
result of centuries of work. This should lead to the creation of
a database of medicinal herbal products and the safe use
thereof, especially regarding pharmacological interactions and
contraindications.

According to the EESC,

in order to attain the
3.4.4.
objectives laid down concerning health protection and the free
movement of herbal medicinal products, the new committee
should have the task of assessing existing documentation on
products and pharmacovigliance results in particular concern-
ing interaction between foodstuffs and medicinal products —
as well as playing an arbitration role in the case of disagreement
between national authorities.

3.4.5.
The responsibilities of the above committee should
also be further clarified concerning the assessment of all
medicinal products derived from herbal substances (not only
traditional products), the possibility of issuing a prior scientific
opinion on request, the binding nature of its opinions as well
as the lists and monographs that it must provide as an
institution.

Decisions made by the above committee (addition to
3.4.6.
or deletion from the list of herbal substance, monographs
drawn up) are to become binding on registration holders
without having previously been the subject of a Community
decision to make them binding in EU territory. The EESC
points out that this is inconsistent with the general regulatory
framework, as it creates a risk that the work of the Committee
for Herbal Medicinal Products will be considered as a non-
binding scientific opinion and will be thwarted by non-
recognition on the part of national authorities, who retain the
final say in decisions on the authorisation and registration of
medicinal products.

3.5. Classification and labelling

3.4.2.
However, the EESC calls for deadlines to be set for
the completion of such work in order that the framework for

Article 16a(a) should be simplified as follows: ‘indi-
3.5.1.
cations consolidated by use, therefore may be sold without a
medical prescription’.

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3.5.2.
As traditional herbal medicinal products are sold
without a medical prescription, it is essential that the user
package leaflet is clear, simple, readable and comprehensive in
listing warnings, known contraindications and interactions in
order to serve as a guide for the correct use of the product.
The EESC believes that the Committee for Herbal Medicinal
Products should also take these aspects into consideration
when drawing up monographs.

3.5.3.
In addition, the EESC emphasises the importance of
including a specific reference in the Directive that labelling
must contain an exact definition of the product (e.g. if it is a
medicinal product in powder form or made from a dry or
liquid plant extract, how it is standardised, etc.) since the
different methods of preparation can change the bio-avail-
ability of active ingredients.

The user package leaflet and the packaging must clear-
3.5.4.
ly state that the user should consult a doctor or a pharmacist or
seek professional advice from a qualified herbalist if symptoms
persist. The EESC considers that Article 16g(b) should be sup-
plemented with the above-mentioned details to give the patient
a clearer course of action to follow.

3.5.5.
The labelling provisions appear unsuitable for this
type of product, since they refer to ‘a specified indication’ in
the singular, whereas the products usually have several specific
indications. In addition the phrase ‘the efficacy of the product
has not been clinically proven’ could provoke unjustifiable
concern amongst consumers over the safety of the product,
and subsequently shift demand towards herbal products with
even less documentation and control.

3.5.6.
Article 16g(2)(a) on labelling and the user package
leaflet should be amended as follows: ‘the product is a herbal
medicinal product for traditional use in specified indications
and that the efficacy of the product is based exclusively on
long-term use and experience’.

3.5.7.
The EESC calls for the following sentence to be added
to the second paragraph of Article 16h(3): ‘If appropriate, the
registration holder may however refer to other monographs
from official Pharmacopoeia, publications and supporting
data’.

Brussels, 18 September 2002.

The President

of the Economic and Social Committee

Göke FRERICHS