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98 EN Official Journal of the European Communities C 95/1

(Preparatory Acts)


Opinion of the Economic and Social Committee on the ‘Proposal for a European Parliament
and Council Directive on the approximation of provisions laid down by law, regulation or
administrative action relating to the implementation of Good Clinical Practice in the conduct
of clinical trials on medicinal products for human use’ (1)

(98/C 95/01)

On 4 December 1997 the Council decided to consult the Economic and Social Committee,
under Article 100a of the Treaty establishing the European Community, on the above-mentioned
The Section for Protection of the Environment, Public Health and Consumer Affairs, which
was responsible for preparing the Committee’s work on the subject, adopted its opinion on
6 January 1998. The rapporteur was Mr Colombo.
At its 351st plenary session (meeting of 28 January 1998), the Economic and Social Committee
adopted the following opinion by 82 votes to four, with one abstention.

1. Introduction 1.4. The codified GCP guidelines only provide a

yardstick at present and are not applied uniformly in
1.1. The proposal is based on Article 100a. It is the Member States, which have hitherto been responsible
designed to align the principles and guidelines concerning for legislation in this area.
clinical trials of medicinal products for human use. The
aim is to reinforce existing practice and align procedures
for the commencement of clinical trials on human
subjects, through consistent application of the guidelines 1.5. This situation often causes serious delays in the
of the International Conference on Harmonization start of clinical trials, both because of the red tape
(ICH) (2). generated by differing procedures and the differences
between Member States’ requirements and practices.
1.2. The matter has been codified at Community
level since 1990 in the European Union guideline on
Good Clinical Practice (GCP), and was harmonized
internationally in January 1997 by the ICH. 1.6. A uniform procedure is becoming increasingly
necessary in multi-centre clinical trials, so as to attain a
1.3. The GCP standards are used by the pharmaceuti- sufficient number of cases for the statistical validation
cal industry when it undertakes clinical trials with a of the data collected.
view to obtaining authorization to market a proprietary
medicinal product, or with a view to confirming the
therapeutic effect of proprietary products that have
already been authorized. 1.7. These are the main reasons why it is desirable to
convert the principles and guidelines into a binding piece
(1) OJ C 306, 8.10.1997, p. 9. of EU legislation, so as to regulate an activity which
(2) International Conference on Harmonization of Technical now involves a large number of trials centres, often in
Requirements for Registration of Pharmaceuticals for various Member States. This procedure will become
Human Use. much more important from 1 January 1998, when
C 95/2 EN Official Journal of the European Communities 30.3.98

the national procedure will be supplemented by the 2.2. In assessing the proposal, the Committee feels it
decentralized procedure for most marketing author- desirable to seek to strike a balance between the need
izations. to:

— simplify red tape;

1.8. The main objectives of the proposal are as
— respect the deadlines for commencement of the
clinical trial;
— protection of persons taking part in trials, based on
the revised text of the Helsinki declaration and with
reference to the Council of Europe Convention on and the need to
the protection of human rights and dignity of the
human being (1);
— provide the utmost guarantees for trial subjects;
— maximum safety throughout the procedure, to be
obtained inter alia by introducing an inspection — coordinate findings so that the efficacy and safety of
system; a new medicinal product can be rigorously assessed.

— a more rigorous role for ethics committees by

making a proper distinction between the ‘lead’ ethics 2.3. Article 1(3) of the proposal states that ‘the
committee which issues the opinion on whether to principles and guidelines of Good Clinical Practice shall
authorize the trial, and the ethics committees of each be adopted in the form of a directive’. The Committee
site, which are responsible for the launch of the trial sees this as a positive step forward, as it means that
at their site; these principles and guidelines will be binding in all
Member States. The proposal will approximate the
— speeding-up of the administrative procedures needed national legislative provisions adopted recently in vari-
to begin a trial, which must always be referred to an ous Member States. Failure to harmonize these pro-
ethics committee for its opinion and notified to the visions would result in existing discrepancies remaining
competent authority of the Member State; this unaltered.
authority has 30 days to provide the sponsor with
reasoned grounds for non-acceptance of an appli-
cation; 2.4. The Committee endorses the approximation of
provisions, on condition that this does not in practice
— more thorough exchange of information between create further bureaucratic or administrative obstacles
the Member States involved in the trial. but promotes high-quality pharmacological research in
the EU. The EU must remain a magnet for trials and
innovation, as this will help to improve health protection.
2. General comments
2.5. In order to ensure that the principles and guide-
lines governing clinical trials are followed consistently,
2.1. In its own-initiative opinion on the free move- the provisions of the directive should also apply to
ment of medicines in the European Union (2), the independent research on new drugs conducted outside
Committee emphasized the importance of having a the industry (at universities, hospitals and research
pharmaceutical sector which draws its strength from centres).
the existence of a competitive, highly innovative industry
within the EU.
2.6. The Committee understands and endorses the
2.1.1. The opinion pointed out that the availability cautious way in which the Commission intends to
of innovative, safe and effective medicines plays an proceed towards the aim of a single procedure for the
important role in protecting public health and extending commencement of clinical trials, valid throughout the
average life expectancy. EU. It notes the Commission’s statement (point 5 of the
explanatory memorandum) regarding the inadequate
2.1.2. Trials on human subjects are essential for cooperation at present between Member States and the
assessing whether new products are effective and safe. difficulty of submitting a single application to the
Such trials must be conducted according to scientific European Agency for the Evaluation of Medicinal
and ethical principles, while at the same time avoiding Products (EMEA), as the agency is not yet properly
pointless and expensive studies which cover no new equipped for this.
2.7. However, the Committee thinks that forms of
cooperation should be encouraged for the purpose of
(1) Council of Europe, European Treaty Series No 164, Oviedo gradually moving towards a single EU procedure. Use
4.4.1997. should be made here of the scientific skills and knowhow
(2) OJ C 97, 1.4.1996. available at the EMEA, especially as regards ‘orphan’
30.3.98 EN Official Journal of the European Communities C 95/3

medicinal products and gene and cell therapy. The ology. It asks the Commission to align the terminology
following opportunities could, for example, be explored: on that of the ICH, which has become a reference point
for the international scientific community and to which
— at some future stage, the EMEA could be made the Commission has also actively contributed. In particu-
responsible for authorizing trials on products which lar, it asks the Commission to check on the various
have to be registered under the centralized procedure; translations of the term ‘non-interventional clinical
trials’, as the present translations could give rise to
— the Committee for Proprietary Medicinal Products
(CPMP) could act as the technical body for arbi-
tration in the event of disagreement and/or differing
interpretations between Member States.
3.2. Article 2

2.8. In order to boost cooperation, it is essential that 3.2.1. The definition of a ‘serious adverse event or
an EU database be provided as part of EudraNet serious adverse reaction’ should also mention the ICH
(a telematic network linking the relevant national provision on the advisability of seeking a medical
authorities, the EMEA and the Commission). This opinion on other possible risks.
would be used to coordinate and circulate information
between the Member States involved in a multi-centre
international trial, with an access key to guarantee the 3.2.2. It would be helpful to include a definition of
utmost confidentiality and the safeguarding of industrial ‘research coordinator’, this being the person in charge
protection. of the clinicians involved in a multi-centre trial.

2.9. The goal must be a clear and simple legal

framework which allows trials to be launched simul- 3.3. Article 4
taneously in different countries. This presupposes
respect for the deadlines laid down for the favourable
opinion from the ethics committees and for the accept-
3.3.1. The current wording does not make it clear
ance of any requests from the relevant authorities for
that the opinion of the ethics committee is mandatory.
modifications (these authorities have 30 days to notify
This weakens the position of trial subjects. The Com-
their opinion to the sponsor). It is also essential
mittee therefore suggests that Article 4(2) be amended
that persons undergoing trials are guaranteed the best
to read ‘... must be delivered ...’.
possible risks-benefits ratio.

2.10. A harmonized EU framework which is consist- 3.4. Article 7

ent with the documents of the International Conference
on Harmonization, Good Clinical Practice, pharmacovi-
gilance standards and Good Manufacturing Practice can
ensure that studies carried out in the EU are fully 3.4.1. This is the central article of the proposal. The
consistent, making it easier to check and compare the Committee feels that respect for GCP, the mandatory
data obtained. nature of the favourable opinion from the ethics com-
mittee, and the possibility for Member States to inter-
vene, together provide sufficient guarantees for trial
subjects and ensure a standard procedure in all Member
2.11. To this end, the Commission must obtain States.
greater guarantees regarding the participation of third
countries in multi-centre trials. The sponsor should be
asked to ascertain that third countries involved in trails 3.4.2. A special exemption from this procedure could
on a particular medicinal product are familiar with the be allowed for gene and cell therapy products, given the
Community guidelines and are therefore able to apply recognized sensitivity of these sectors. Since centralized
them properly. registration is mandatory for such products, the Com-
mission could, as of now, make the start of trials
contingent on the opinion of the EMEA as the body in
charge of the centralized authorization procedure for
high-tech products.
3. Specific comments
3.4.3. In order to avoid unnecessary red tape, it
should be made clear that the scientific data to be
3.1. The Committee notes that various articles of the presented to the Member State and to the ethics
directive contain incorrect or incorrectly used termin- committee are to be the same.
C 95/4 EN Official Journal of the European Communities 30.3.98

3.5. Article 8 3.7. Article 10

3.5.1. Explicit provision should be made for rigorous 3.7.1. For investigational medicinal products, it
respect for the confidentiality of data and the utmost would seem best to use the provisions on Good Manufac-
discretion regarding research under way. turing Practice (Directive 91/356/EEC) (1).

3.8. Article 13
3.6. Article 9
3.8.1. The Committee recommends that procedures
3.6.1. In cases where a trial is suspended or prohibited, and definitions be made consistent with the ICH text.
the Member State should inform not only the Com-
mission and the other Member States, but also the
sponsor, before taking any decision. (1) OJ L 193, 17.7.1991.

Brussels, 28 January 1998.

The President
of the Economic and Social Committee

Opinion of the Economic and Social Committee on the ‘Proposal for a Council Regulation
(EC) amending Council Regulation (EEC) No 1210/90 of 7 May 1990 on the establishment of
the European Environment Agency and the European Environment Observation Network’

(98/C 95/02)

On 18 November 1997 the Council decided to consult the Economic and Social Committee,
under Article 130s of the Treaty establishing the European Community, on the above-mentioned
The Section for Protection of the Environment, Public Health and Consumer Affairs, which
was responsible for preparing the Committee’s work on the subject, adopted its opinion on
6 January 1998. The rapporteur, working without study group, was Mrs Sánchez Miguel.
At its 351st plenary session (meeting of 28 January 1998), the Economic and Social Committee
adopted the following opinion by 109 votes, with three abstentions.

1. Introduction European Parliament grants discharge to the Manage-

ment Board, after consulting the Council. In the second-
generation agencies (2), on the other hand, the Manage-
1.1. In application of the principle of transparency in ment Board grants discharge to the Executive Director,
the budgetary workings of EU bodies, the Commission who is responsible for implementing the budget.
proposes to amend nine regulations covering the so-
called ‘second-generation’ agencies which, when created, 1.3. After reviewing the operation of these second-
were given different budgetary rules to those in force generation agencies, once established in their functions,
for the ‘first-generation’ agencies.
(2) The European Environment Agency, the European Train-
1.2. The first-generation agencies (1) have a budget ing Foundation, the European Monitoring Centre for
management and approval system under which the Drugs and Drug Addiction, the European Agency for
Safety and Health at Work, the Translation Centre for
Bodies of the European Union, the Office for Harmon-
ization in the Internal Market, the European Agency for
(1) Bodies set up in 1975: CEDEFOP (Thessaloniki) and the the Evaluation of Medicinal Products, the Community
European Foundation for the Improvement of Living and Plant Variety Rights Office and the European Monitoring
Working Conditions (Dublin). Centre on Racism and Xenophobia.