Opinion of the Economic and Social Committee on:the Proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products,the Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, andthe Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
Date: 2002-09-18
Institutions: European Economic and Social Committee
Subjects: European Medicines Agency, drug surveillance, market approval, medicinal product, pharmaceutical legislation, single market, veterinary drug

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II

(Preparatory Acts)

ECONOMIC AND SOCIAL COMMITTEE

393rd PLENARY SESSION, 18 AND 19 SEPTEMBER 2002

Opinion of the Economic and Social Committee on:

— the ‘Proposal for a Regulation of the European Parliament and of the Council laying down
Community procedures for the authorisation and supervision of medicinal products for
human and veterinary use and establishing a European Agency for the Evaluation of
Medicinal Products’,

— the ‘Proposal for a Directive of the European Parliament and of the Council amending
Directive 2001/83/EC on the Community code relating to medicinal products for human
use’, and

— the ‘Proposal for a Directive of the European Parliament and of the Council amending
Directive 2001/82/EC on the Community code relating to veterinary medicinal products’

(2003/C 61/01)

On 7 January 2002 the Council decided to consult the Economic and Social Committee, under Articles 95
and 152(4)(b) of the Treaty establishing the European Community, on the above-mentioned proposals.

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 Fuchs.

At its 393rd Plenary Session (meeting of 18 September 2002) the Committee adopted the following
opinion by 112 votes to two with three abstentions.

0. Summary of the opinion

The Committee welcomes in principle the Commission pro-
posals for revising and developing EU legislation with regard
to medicinal products for human and veterinary use. It attaches
great importance to the point that the protection of human
and animal health must take precedence over all other areas of
regulation.

The Committee

— supports the Commission in its efforts to enhance the
safety of medicinal products by improving patient and
consumer information about such products and to
improve pharacovigilance by involving health pro-
fessionals and patients as partners in the reporting of the
risks associated with medicinal products;

— welcomes the Commission’s efforts to promote new
developments in the field of medicinal products and

make them available as soon as possible for patient
therapy. However, data protection must be guaranteed
and competition between the manufacturers of generic
medicinal products must not be hampered unduly;

— thinks that a balanced relationship must be maintained
between the various authorisation systems (centralised
authorisation, authorisation with mutual recognition and
national authorisation) and that in principle applicants
must be entitled to choose between the various systems;

— considers that it is necessary to improve and extend the
supply of veterinary medicinal products and that a
programme is required to promote the development of
medicinal products for treating rare animal diseases;

— recommends that a clear distinction be drawn between
medicinal products and other products such as medical
devices,
foodstuffs (including food supplements) and
cosmetics;

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— welcomes the Commission’s intention to extend the rules
on good manufacturing practice to starting materials and
especially active substances;

market. Regulation (EEC) No. 2309/93 is to be recast and the
two recently adopted directives on Community codes for
human and veterinary medicinal products are to be amended.

— considers that it is necessary to harmonise the rules for
the prescription of medicinal products in the Member
States;

— proposes that the Commission accede to the European
anti-doping convention as the Community’s contribution
to the fight against drugs in international sport.

1. Background

1.1.
A Community procedure for the authorisation and
supervision of medicinal products was introduced for the first
time on 1 January 1995 on the basis of Regulation (EEC)
No. 2309/93 (1). The European Agency for the Evaluation of
Medicinal Products (hereinafter called the Agency) took up its
work at the same time.

1.2.
The Commission — acting on the basis of Article 71
of the aforementioned Regulation — has drawn up a report
on the operation of Community procedures for authorising
the placing of medicinal products on the market, which is now
to serve as the basis for the further development of the
legislation governing medicinal products.

European Parliament and Council Directive 2001/83/
1.3.
EC (2) consolidated — for reasons of clarity — the various
directives on the approximation of legislative and administrat-
ive provisions for proprietary medicinal products adopted in
the wake of Council Directive 65/65/EEC of 26 January
1965 (3). The wording of the text was also adapted as a result
of the consolidation exercise.

For the same reason, and with the same objective in
1.4.
mind, various directives on the approximation of legislative
and administrative provisions for veterinary medicinal prod-
ucts adopted in the wake of Directive 81/851/EEC (4) were
brought together in Directive 2001/82/EC (2) on the Com-
munity code relating to veterinary medicinal products.

2. Gist of the Commission proposals

2.1. Gist of the proposed regulation on medicinal products for

human use

2.1.1.
The proposal states that the centralised procedure
for the authorisation of medicinal products is to be extended
beyond the present framework to all new substances appearing
on the Community market.

2.1.2.
amended (one representative per Member State)
account of EU enlargement.

The composition of the Scientific Committee is to be
to take

The centralised procedure itself is not to be changed
2.1.3.
substantially. One change concerns the appeal procedure for
applicants who contest the scientific opinion of the committee.
The purpose of this is to make it possible to clear up problems
with the assessment of authorisation data at expert level,
tighten up the formal authorisation procedure as a result and
avoid legal disputes in the courts. The Commission is thus
responding to the repeated criticism of the amount of time it
takes for decisions to be reached.

2.1.4.
The Commission proposes
renewal of marketing authorisations be abolished.

that

the five-yearly

2.2. Gist of the proposed regulation on medicinal products for

veterinary use

1.5.
The Commission has now presented three proposals
for the further development of Community legislation on the
basis of its report on the operation of Community procedures
for authorising the placing of medicinal products on the

A large proportion of the amendments with regard
2.2.1.
to procedural matters have been aligned on the amendments
for medicinal products for human use. Important changes
have also been made to the scope and the general terminology.

( 1) OJ L 214, 24.8.1993.
( 2) OJ L 311, 28.11.2001.
( 3) OJ P 22, 9.2.1965, as most recently amended in OJ L 229,

15.8.1986.

( 4) OJ L 317, 6.11.1981, as most recently amended in OJ L 87,

2.4.1992.

2.2.1.1.
For example, the definition of a veterinary med-
icinal product has been amended in order to ensure that the
directive applies to preparations that must meet quality, safety
and efficacy requirements, and new definitions have been
added in order to harmonise and simplify conditions in the
field of medicinal products.

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2.2.2.
It is proposed that the application of the centralised
procedure be adapted to the specific context in which certain
veterinary medicinal products are used. This applies in particu-
lar to the regional occurrence of certain infectious diseases.

It is vital in the field of veterinary medicine to make
2.2.3.
it easier to use non-veterinary products, e.g. human medicines,
if no approved veterinary products are available for a specific
animal species or disease.

2.3.

Provisions on the Agency and general provisions

2.3.1.
administrative and scientific structures to the new tasks.

The amendments concern the adaptation of the

2.3.2.
The Commission proposes that the scientific advice
provided for companies during the research and development
of new medicinal products be strengthened and systematically
developed in order to:

— stimulate pharmaceutical research in Europe;

— allow European patients to benefit earlier from more

effective medicinal products; and

— promote the burgeoning of small and medium-sized

enterprises.

2.3.3.
The Commission proposes that the Agency partici-
pate in the compassionate use programme at Community
level.

2.3.4.
The Commission proposes that the Agency partici-
pate in international scientific cooperation. The Agency is to
increase and develop its technical and scientific support for
the Member States and the Commission.

2.3.5.
The aim of a further proposal is to prevent or solve
potential conflicts between the scientific opinions of the
Agency and those of other scientific bodies in the Community.

2.3.6.
The Commission thinks that the changes made to
the Agency and the planned enlargement of the Community
make it necessary to change the structure of the Agency’s
committees and the composition of the Management Board
and to set up an Advisory Board.

2.3.7.
Finally it is proposed that the 1993 Regulation’s
general provisions be amended and new provisions be intro-
duced in order to create the requisite legal certainty and
guarantee the Agency’s proper functioning.

2.4. Gist of the proposed directive on medicinal products for human

use

2.4.1.
The definition of medicinal product is to be adapted
to take account of new therapies and their particular method
of application. Other necessary adaptations are to be made.

2.4.2.
A definition of generic medicinal product and its
reference medicinal product is to be introduced, the adminis-
trative protection of data is to be improved and the harmonis-
ation of existing reference medicinal products is to be facili-
tated.

2.4.3.
The proposal states that any medicinal product not
compulsorily subject to the centralised procedure is to be
covered by the decentralised or mutual recognition procedure
on condition that it is intended for the markets in more than
one Member State. The procedures are to be simplified as a
result of the criticism that has been expressed.

2.4.4.
The inspection and surveillance of medicinal prod-
ucts’ manufacture and quality assurance is to be improved. The
provisions regarding compliance with good manufacturing
practice are to be extended to starting materials, and especially
active substances used as starting materials.

2.4.5.
Pharmacovigilance is to be improved by making
greater use of electronic information technologies, and the
exchange of data between all parties involved in the trade in
medicinal products and the authorities is to be made easier.

Patient information is to be improved. By way of
2.4.6.
experiment, information about a limited number of prescrip-
tion medicinal products is to be authorised.

2.5. Gist of the proposed directive on veterinary medicinal products

2.5.1.
proposed directive on medicinal products for human use.

Definitions are to be adapted by analogy with the

2.5.2.
The aim of the proposal is to improve the supply of
medicinal products for animals and to solve the special
problems associated with the lack of availability of veterinary
medicinal products, with due regard to health and consumer
protection.

3. Aims

The general aim of

the Commission proposals is
3.1.
to develop further the Community’s legislation governing
medicinal products for human and veterinary use on the basis
of

— the report on the operation of Community procedures
for authorising the placing of medicinal products on the
market,

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— the experience acquired between 1995 and 2000, and

— an analysis of the comments made by all the parties
concerned (competent authorities from the Member
States, doctors’ and pharmacists’ organisations, patient
and consumer associations and associations representing
the pharmaceutical industry).

The Commission thinks that

3.2.
the
Community’s legislation must be guided by the following
objectives:

the revision of

3.2.1.
To guarantee a high level of health protection for the
people of Europe, particularly by providing patients, as swiftly
as possible, with innovative and reliable products and through
increased market surveillance thanks to a strengthening of
monitoring and pharmacovigilance procedures. In the case of
veterinary medicinal products,
to improve animal health,
particularly by increasing the number of medicinal products
available.

— the promotion of the development of new and better
medicinal products as the sine qua non for therapeutic
progress;

— the rapid availability of new medicinal products;

— effective and equivalent authorisation systems and pro-

cedures;

— effective risk monitoring with the aid of a comprehensive

pharmacovigilance system.

The changes proposed by the Commission will be of

4.3.
great importance and consequence in future for

— the supply of safe medicinal products to EU citizens;

— the extension of the provisions to the new Member States;

3.2.2.
To complete the internal market in pharmaceutical
products taking account of the implications of globalisation,
and to establish a regulatory and legislative framework that
favours the competitiveness of the European pharmaceuticals
sector.

— the functioning of the common market in medicinal

products;

— competition worldwide and especially with the US and

Japanese markets.

3.2.3.
the European Union.

To meet the challenges of the future enlargement of

3.2.4.
To rationalise and simplify the system as far as
possible, thus improving its overall consistency and visibility,
and the transparency of procedures and decision-making.

The Committee is well aware of the complexity of the
4.4.
subject-matter. This applies in particular to the difficulty of
finding balanced solutions wherever a number of legitimate
interests are at stake. These interests concern:

— the protection of patient and consumer health;

3.3.
The purpose of the Community provisions concerning
the placing on the market of medicinal products for human
and veterinary use is to guarantee a high level of public health
protection and to enable the rules of the internal market to
operate effectively. No medicinal product may be placed on
the market unless its quality, safety and efficacy have been
previously demonstrated. These guarantees must be maintai-
ned when it is actually placed on the market.

— the healing professions;

— pharmaceutical research;

— the pharmaceutical industry;

— trade in medicinal products.

4. General comments

4.1.
The Committee attaches great importance to the point
that the protection of human and animal health must take
precedence over all other areas of regulation. It welcomes in
principle
revising and
developing EU legislation with regard to medicinal products
for human and veterinary use.

the Commission proposals

for

4.5.
The proposals for recasting the EC Regulation and
amending the recently consolidated directives on medicinal
products for human and veterinary use have been closely
coordinated in terms of substance and form and together
constitute a self-contained and transparent body of rules and
regulations.

4.6.

Safety of medicinal products

4.2.
The Committee has carefully examined the Com-
mission proposals and decided to focus on the following
points in its opinion:

— the safety of medicinal products for patients and con-
sumers, including the provision of comprehensible objec-
tive information on such products;

4.6.1.
The Committee welcomes the Commission’s efforts
to make information about medicinal products more trans-
parent, especially at a time when there is a growing desire on
the part of patients to be involved in decisions about their
health. They receive information from a variety of sources —
both written and oral — and therefore need to be advised by

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doctors and pharmacists about the benefits and risks. Doctors,
veterinarians and pharmacists are called on to advise con-
sumers and patients about the benefits and risks of medicinal
products.

There is therefore no reason why members of the
4.6.1.1.
medical and pharmaceutical professions — or even lay persons
— should not be provided on request with the texts checked
and approved by the relevant authority which serve as
information for users or professionals or as the official
assessment reports.

the proposed directive does not provide the necessary guaran-
tees to ensure complete, objective and comparative infor-
mation in the best interest of the patient. Self-regulation of the
industry and the establishment of guidelines do not seem to
provide strong enough guarantees to prevent information
becoming advertising in face of weakness in the implemen-
tation of the control mechanism.

4.7.

Promoting the development of innovative medicinal products

These texts, which have been officially checked and
4.6.2.
approved by the authorising authorities, are already available
on the Internet in some cases and may be regarded by patients
as being of a more objective and therefore reliable standard
than information from other sources. Being able to receive
objective, balanced and comparative information is very
important because in some Member States medicinal products
can already be ordered on the Internet. Also needed are studies
into how to make information about medicinal products more
intelligible for the lay person and, above all, to make it easier
to read and understand.

The Committee welcomes in principle all the efforts
4.7.1.
made by the Commission to promote the development of new
active principles in medicinal products. These represent a vital
prerequisite for therapeutic progress — including the treatment
of rare diseases. In order to make such medicinal products
available as soon as possible for use in treatment, the provision
of advice to applicants prior to authorisation by the authorising
authority and the abridgement of testing and administrative
procedures are very important for the authorisation process.
The Committee would point out that speeding up the substan-
tive testing procedure must not undermine the safety of
medicinal products.

4.6.3.
The Committee attaches great importance to a clear
de facto and de jure distinction between information that is
vetted by the relevant authority about medicinal products —
such as instructions for use, package leaflets and assessment
reports — and commercial advertising material. It supports
the Commission in its efforts to continue to ban public
advertising of prescription medicinal products. Even in the case
of those illnesses where information on certain prescription
medicinal products is authorised under strict conditions in the
interest of patients, such information must be objective and
balanced and may not claim any benefits for the product that
go beyond those set out in the official product information.

4.6.4.
The Committee assumes that patients also need
additional information about certain medicinal products in
cases where these are prescription-only or available without
prescription. The Committee is aware that the packaging insert
leaflets (PILs) for all medicines are public documents and that
several medicines agencies publish them on their websites. In
addition the EMEA publishes on its website both PILs and a
Summary of Products Characteristics (AmPC) of the medicines
authorised via the centralised procedure. The Committee
believes that it is necessary to increase the visibility and
accessibility of this authorised and objective information to
patients.

4.7.2.
The Committee attaches great importance to the
protection of the data setting out the findings of the tests for
developing new medicinal products or extending the fields of
application of existing products.

4.7.2.1.
Given the high development costs, it is necessary
to provide various incentives — not only of a financial nature
— to induce the pharmaceutical industry to develop innovative
medicines, research new therapeutic indications and carry out
new studies into the therapeutic doses for known medicinal
products. This applies in particular to their use with certain
categories of patients such as children and the elderly.

4.7.2.2.
The Committee would point to the need for the
industry to make package leaflets more patient-friendly. These
instructions for use should be tested on patients to see whether
they find them clear, intelligible and easy to understand.

4.7.3.
The Committee accordingly welcomes the Com-
mission’s efforts to extend data protection and in particular
approves the extension of the protection to data which support
new therapeutic indications for known preparations. However,
it would like the period of protection to be extended from one
to two years in such cases.

4.6.4.1.
The Committee supports the principle expressed
by the Commission to increase the availability of information
especially in relation to prescription-only medicines. However,
it believes that the Commission’s proposal in Article 88(2) of

In this context no distinction should be made between the
various authorisation systems in the Member States with
regard to the duration of the data protection.

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4.7.4.
The Committee supports the Commission’s proposal
that, in order to improve competition for manufacturers of
generic medicinal products, it be made easier to draw up
authorisation data before the expiry of the data protection
period.

— to improve public awareness of the need to use medicinal
products sensibly involving patients groups and health
professionals.

4.8. Authorisation of medicinal products

4.8.1.
In the Committee’s view the division of tasks between
the central Agency and Member States’ authorities has proved
on the whole to be a success. Responsibilities must be clearly
allocated in this context (transparency).

In accordance with the rules on subsidiarity, only
4.8.2.
those tasks should be performed centrally which, by their very
nature, are better performed by the Agency for all the Member
States using a uniform procedure.

4.8.3.
Centralised authorisation should be restricted in
essence to medicinal products which have already been
authorised by the Agency hitherto under existing laws. Appli-
cants wishing to put medicinal products containing new
substances on the market should be able to choose between
centralised and decentralised authorisation. The decentralised
mutual recognition procedure should be simplified, thereby
making it more attractive.

4.8.4.
National data banks should be networked. It should
be the responsibility of the Agency to coordinate the assess-
ment and upkeep of data — including data on pharmacovigil-
ance.

4.8.5.
coordinated by the Agency.

Individual Member States’ safety decisions should be

4.8.6.
National authorities for medicinal products — with
their expertise — should continue to exist and operate in
order, in particular,

4.8.7.
The Committee thinks that an appropriate division of
labour based on specialisation between the national authorities
responsible for medicinal products is both possible and
desirable.

4.9.

Pharmacovigilance

4.9.1.
The Committee welcomes the Commission’s inten-
tion to improve pharmacovigilance through the use of modern
information technologies. All parties handling medicinal prod-
ucts (doctors, veterinarians, pharmacists) should play an active
part in providing advice about, and collecting information on,
the risks associated with medicinal products and form part of
the information network. Patients, too, should be involved as
partners in the reporting of such risks.

4.9.2.
The Committee welcomes the Commission’s decision
to exclude provisions from the proposals which primarily
concern the cost of medicinal products and reimbursement by
social security schemes. Such provisions would be out of place
in this context. Nevertheless it is recognised that variations in
costs for medicinal products and their reimbursement have a
pervasive influence on the common market in medicinal
products and competition. The Committee would therefore
encourage the Commission to continue its efforts to improve
the single market in medicinal products in the interest of
patients.

— to guarantee the safety of medicinal products at national

5. Specific comments

level;

— to collate and assess the risks associated with medicinal

products and to coordinate national measures;

— to facilitate national authorisations;

— to promote the mutual recognition of authorisations;

— to monitor trade in medicinal products;

— to observe the distinctive features of national prescribing

habits and the market in medicinal products;

— to advise the government in the particular Member State;

— to provide the Agency with expert support

in the

performance of its tasks;

The definition of ‘medicinal product’ given in the
5.1.
proposal for a directive on medicinal products for human use
seems to be very general and could be interpreted and applied
differently in individual Member States. The Commission has
attempted to provide a definition that takes account of new
therapeutic methods. It should be made clear, the Committee
thinks, that plant-based products which claim to deal with
certain indications should be regarded as medicinal products.
The definition is intended to make it possible to distinguish
more easily between medicinal and other products, especially
medical devices, foodstuffs (including food supplements) and
cosmetics, since the legal consequences of being classified in a
particular category are considerable. Given the cross-border
trade in such products between Member States, the national
differences in classification according to legal categories should
be kept to a minimum in order to guarantee legal certainty for
both consumers and businessmen.

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5.2.
The Commission proposal states that the marketing
authorisation for a medicinal product does not need to be
checked after five years and therefore it is not necessary to
apply for an extension of the authorisation. Improvements in
pharmacovigilance are the main reason given for this.

shortage of medicinal products which are authorised for
special indications or where there is a regional need for the
supply of medicinal products (e.g. special vaccines, emergency
medicines).

5.2.1.
The Committee thinks that this proposal goes too
far. The Committee broadly agrees with the Commission that
it is not necessary to apply for an extension after five years,
since adaptations to the state-of-the-art can be made at any
time during that period by modifying the authorisation data.
Nonetheless, this possibility should as a rule apply only to
specific changes with regard to the quality or safety of the
that this proposal
medicinal product. There is no doubt
would simplify the administrative formalities. However, the
Committee thinks that a comprehensive check should be made
after a longer period of time on the authorisation of the data
and their adaptation to the state-of-the-art in terms of quality,
efficacy and safety. It therefore considers that conducting such
checks every ten years is an acceptable compromise.

5.3.
The Committee does not agree that the marketing
authorisation should be revoked if it is not used within two
years of being granted. Such a measure would seem to make
sense in terms of market transparency, but experience with
such provisions has shown that it is difficult to prove the facts
and hardly possible to implement measures.

5.4.
The Committee welcomes the proposals regarding
compassionate use so that patients can be treated with
innovative medicinal products which are still being clinically
tested or have been clinically tested but are still awaiting
authorisation. However, it is absolutely necessary to stop a
situation arising where the supply of unauthorised medicinal
products cannot be checked. Therefore, this provision should
be confined to absolutely necessary cases. The Committee
would point out in this connection that the treatment of
patients with medicinal products that have not yet been
authorised requires arrangements to be made for having the
costs reimbursed by social security systems.

The Committee welcomes the extension to active
5.5.
substances of the rules governing proper manufacture and
quality controls. This will improve the quality of medicinal
products. Member States have recognised the need for this for
many years, and the European Pharmacopoeia already contains
such a requirement.

5.7.
The Committee considers that the Commission’s pro-
posal asking for prescription only status for officinal prep-
arations for animals (Article 67(iv)(d) proposal to amend
Directive 2001/82/EC) is confusing. Officinal preparations are
by definition prepared in a pharmacy according to a prescrip-
tion as indicated in the relevant pharmacopoeia. The Com-
mittee does not see any justification for such a change,
which would conflict with existing Community and national
legislation and does not appear justified on public health
grounds.

6. Additional proposals

6.1.
The Committee is worried that there is still a long way
to go before the free movement of goods comes into being in
the field of medicinal products and before the conditions
governing all EU citizens’ access to medicinal products are
progressively aligned, in keeping with the calls made by the
Committee in all its earlier opinions.

6.2.
The Committee therefore calls upon the Commission
once again to ensure that rapid progress is made in EU
legislation so that the necessary objectives can be achieved.
These objectives were set out by the Committee some time
ago in its own-initiative opinion on the role of the European
Union in promoting a pharmaceutical policy reflecting citizens’
improving care, boosting innovative research and
needs:
controlling health spending trends (1). In view of developments
in the sector, the Committee would like to highlight once
again a number of aspects which a Community pharmaceutical
policy can no longer ignore.

6.3.
The Committee recommends in particular that the
labelling of medicinal products authorised prior to Directive
92/27/EEC and the accompanying package leaflets be standard-
ised within an appropriate timeframe in order to put an end
to the differing presentations for one and the same product
which are to be found in the Member States at the moment.
The Committee thinks that there is a particularly urgent need
to press ahead with the standardisation of the summary of
product characteristics and the package leaflets accompanying
generic medicines.
In addition to the standardisation of
package leaflets, the Committee thinks that better use should
be made of the recommendations contained in Directive 92/
27/EEC so that medicinal products can be used on the basis of
detailed and comprehensible information.

The Committee welcomes the Commission’s efforts to
5.6.
extend and improve the supply of veterinary medicinal prod-
ucts. This applies in particular to cases where there is a

(1) OJ C 14, 16.1.2001.

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6.4.
The Committee notes that the differing arrangements
for fixing prices and reimbursing costs are mainly to blame for
the fragmentation of the single market, although it admits that
the Member States themselves must keep a watch on their
expenditure in the field of medicinal products. However, this
problem cannot be avoided if the competitiveness of the
European pharmaceutical
industry is to be guaranteed. It
therefore calls on the Commission to continue to do what
it can to obtain more satisfactory results than the G-10
pharmaceutical group of high-ranking representatives.

The Committee welcomes the planned revision of
6.5.
Directive 89/105/EEC on transparency, for the authorisation
and price-fixing systems used in some Member States have
proved not to be transparent or consistent with the basic aims
of the current reform of the Community procedures.

6.6.
In view of the growing movement of persons between
Member States and the need to guarantee uniform protection
for patients’ health, the Committee recommends the gradual
introduction of uniform rules for the mandatory prescription
of medicinal products in the Member States. The general
criteria classifying substances and preparations as prescription-
only have already been laid down in the consolidated direc-
tive (1). These criteria are not applied uniformly by the
Member States. This confuses the general public and generates

( 1) Article 71 of Directive 2001/83/EC of 6.11.2002 (OJ L 311,
the relevant ESC opinion in OJ C 368,

28.11.2001); cf.
20.12.1999.

Brussels, 18 September 2002.

uncertainty with regard to the safety of medicinal products.
The concrete provisions for the mandatory prescription of
substances and preparations could be specified by EC regu-
lation. In order to avoid unintentional repercussions on social
insurance systems, the harmonised provisions should apply
only to medicinal products which are brought onto the market
after the EC regulation enters into force.

6.7.
The Committee recommends that the Community
contribute to the fight against drugs in international sport (2).
It therefore proposes that the Commission formally accede to
the European anti-doping convention of 16 November 1989.
With reference to the list appended to this convention, a ban
should be introduced on medicinal products which are used
for doping purposes in sport. This ban should cover these
products’ marketing, their use to treat third parties and their
prescription by doctors.

6.8.
The Committee recommends that a programme for
developing veterinary medicinal products for rare animal
diseases be drawn up and implemented. This programme
should be similar to that already launched for medicinal
products for human use (3).

(2) Cf. the Communication from the Commission to the Council, the
European Parliament, the Economic and Social Committee and
the Committee of the Regions — Community support plan to
combat doping in sport (COM(1999) 643), ESC opinion, OJ
C 204, 18.7.2000.

(3) Cf. the ESC opinion (point 3.1.7) on the proposal for a European
Parliament and Council Regulation (EC) on orphan medicinal
products (COM(1998) 450 final), OJ C 101, 12.4.1999.

The President

of the Economic and Social Committee

Göke FRERICHS