Opinion of the European Economic and Social Committee on the Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products COM(2008) 123 final — 2008/0045 (COD)
Date: 2008-07-09
Institutions: European Economic and Social Committee
Subjects: ESC opinion, biotechnology, market approval, marketing, medicinal product, pharmaceutical product, public health

3.2.2009

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Official Journal of the European Union

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Opinion of the European Economic and Social Committee on the ‘Proposal for a Directive of the
European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC
as regards variations to the terms of marketing authorisations for medicinal products’

COM(2008) 123 final — 2008/0045 (COD)

(2009/C 27/08)

On 3 April 2008 the Council of the European Union decided to consult the European Economic and Social
Committee, under Article 95 of the Treaty establishing the European Community, on the

Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive
2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products.

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 June 2008. The rapporteur was Mr Cedrone.

At its 446th plenary session, held on 9-10 July 2008 (meeting of 9 July), the European Economic and
Social Committee adopted the following opinion by 127 votes with seven abstentions.

1. Conclusions and recommendations

veterinary medicinal products, and Directive 2001/83/EEC on
the Community code relating to medicinal products for human
use (1).

the Proposal

The EESC approves

1.1
a Directive
amending Directive 2001/82/EC and Directive 2001/83/EC
these amendments
(COM (2008)123 final), recognising that
ensure the harmonisation of the rules regulating all medicinal
products regardless of the procedure under which marketing
authorisation has been granted.

for

Applying the same criteria to all medicinal products
1.2
ensures,
in addition to the same quality, safety and efficacy
criteria, a high level of public health protection, the efficient
functioning of the internal market, and eliminates an unneces-
sary administrative and financial burden on businesses.

The EESC has always

1.3
to
the Commission's efforts to improve the safety of
support
medicinal products, a fundamentally important factor in safe-
guarding human and animal health.

supported and continues

1.4
The EESC agrees that the Commission should be empow-
ered to extend the scope of Regulation (EC) No 1084/2003 to
post-authorisation variations,
the procedure
applied, thus avoiding any obstacles to the free movement of
medicinal products; and emphasises the importance of future
provisions the Commission will have to adopt.

regardless of

1.5
The EESC once again emphasises its conviction that we
must waste no time in completing the single market also in
those sectors where this has not occurred or is only partial.

2. Context

2.2
The abovementioned legislation was an extension of a
profound reform initiated in 1993 through the creation of the
European Medicines Agency (EMEA), as set out in Regulation
(EEC) No 2309/93, and the implementation of new marketing
authorisation procedures for pharmaceuticals (2).

2.3
Based on the principle of the free movement of goods,
this regulation foresaw two procedures for marketing authorisa-
tion for medicinal products as of 1 January 1995:

a) A ‘centralised’ procedure for authorisations issued by the
EMEA, applicable
compulsory for
biotechnological medicinal products and optional for newly
formulated pharmaceutical products.

throughout

the EU,

b) A so-called ‘decentralised’ national procedure

enabled
authorisation by a competent national authority. This proce-
dure made it possible to apply specific ‘mutual recognition’
rules for the marketing of medicinal products authorised by
a specific Member State in other EU countries.

2.4
The purpose of these marketing authorisation procedures
was to ensure a proper assessment of the benefit/risk ratio and
to define high quality, safety and efficacy criteria for the precise
purpose of safeguarding human and animal health in the EU.

2.1
In November 2001, the Commission presented sweeping
regulatory reforms on medicinal products via two instruments,
i.e. Directive 2001/82/EC on the Community code relating to

(1) OJ L 311, 28.11.2001.
(2) OJ L 214, 24.8.1993.

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Official Journal of the European Union

3.2.2009

Directive

2001/82/EC and Directive

2.5
2001/83/EC
strengthen these essential guarantees, setting out specific provi-
sions for pharmacovigilance in order to achieve a high level of
public health protection, with more frequent monitoring as well
as enhanced and more targeted notification criteria for undesir-
able side effects.

2.6
During the course of periodic checks on the functioning
of the authorisation system for pharmaceutical products, the
Commission identified problems relating to variations that
could occur downstream of Member State authorisations, which
account for over 80 % of total marketing authorisations for
medicinal products.

2.7
These variations coming after national authorisation are
addressed by Regulation (EC) No 1084/2003 and Regulation
(EC) No 1085/2003, but the latter only cover manufacturing
procedures, pharmaceutical packaging and intellectual property.
They do not address fundamental issues such as, for instance,
the inclusion of new therapeutic indications or methods of
administration.

2.8
As a result, the post-authorisation procedures may in
some cases vary in individual Member States, which can lead to
different rules and classifications being applied to the same
product. This may result in different levels of health protection
being applied due to differences in the therapeutic classification
or use of the same product, not to mention the fact that it
could constitute a sometimes artificial obstacle to the intended
freedom of movement of medicinal products within the EU.

3. The Commission proposal

In order to avoid the emergence of different conditions
3.1
for the same pharmaceutical products,
the Commission has
decided to submit a proposal to amend Directive 2001/82/EC
and Directive 2001/83/EC by requesting that the application of
Regulation (EC) No 1084/2003, currently applicable to pharma-
ceuticals under the centralised procedure, be extended to all
medicinal products regardless of the procedure under which
they have been authorised.

The proposal under consideration falls within the scope
3.2
of the simplification initiatives foreseen under Annex 2 of the
Commission Legislative and Work Programme 2008. It consists
solely in a legislative amendment to a number of articles in
Directive 2001/82/EC and Directive 2001/83/EC concerning the
application of Regulation (EC) No 1084/2003, which is thus
extended to all medicinal products.

Brussels, 9 July 2008.

3.3
Prolonging the present situation would result in unneces-
sary administrative and financial burdens for businesses wishing
to trade in several EU countries. These businesses are faced with
the different rules applied by individual Member States and their
respective administrative requirements, which, moreover, can
create a de facto artificial obstacle to the principle of free trade.

The proposal

3.4
is purely legal in nature and sets out to
amend the legal basis of Regulation (EC) No 1084/2003 by
empowering the Commission to amend the regulation's scope
in order to ensure an effective harmonisation of authorisation
rules.

The Commission emphasises that this legislative amend-
3.5
ment was based on broad consultation with all stakeholders;
and that the choice of a legal amendment — one of many
options — was the one identified as best suited to achieving
harmonisation in the post-authorisation phase, in keeping with
high public health standards and legal consistency.

3.6
The proposed amendments to a set of articles are based
on Article 95 of the EC Treaty, which provides for the use of
the co-decision procedure, and is consistent with the principle
of subsidiarity and the principle of proportionality.

4. General comments

The EESC approves the proposal

4.1
to amend Directive
2001/82/EC and Directive 2001/83/EC, recognising that these
amendments ensure the harmonisation of the rules regulating
all medicinal products, a high level of public health protection
and the efficient functioning of the internal market, whilst also
eliminating unnecessary administrative and financial burdens for
businesses.

4.2
As in previous opinions on this issue, the EESC supports
and even encourages the Commission's efforts to improve the
safety of medicinal products, a fundamentally important factor
in safeguarding human and animal health.

4.3
The EESC is therefore in favour of harmonising the rules
regulating all medicinal products regardless of authorisation
procedures through a simple legislative amendment,
thereby
simultaneously eliminating any future obstacles to free trade in
such products.

4.4
The EESC, while in favour of modifying the legal basis,
awaits the legislative proposal currently being drafted, believing
it to be of greater significance to the future of the pharmaceu-
tical sector.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS