Opinion of the European Economic and Social Committee on the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions — Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment COM(2005) 535 final
Date: 2006-07-05
Institutions: European Economic and Social Committee
Subjects: EU law, simplification of legislation

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Official Journal of the European Union

16.12.2006

4.2.1
This draft regulation creates the preconditions for
closing the regulatory gap that exists between its subject matter
and the draft directive on medical devices. The general principle
of risk evaluation applies to both advanced therapy medicinal
products and medical devices. Complications may arise with
combination products (i.e. medical devices containing tissue
engineered elements). In such cases, both quality and safety
must be guaranteed, and the evaluation must also cover the

efficacy in use of an innovative medicinal product in a specific
medical device.

4.3
In conclusion, the Committee endorses the proposed
regulation while also stressing certain areas of concern for
which clear solutions will be needed in order for the directive
to be implemented successfully.

Brussels, 5 July 2006.

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND

Opinion of the European Economic and Social Committee on the Communication from the
Commission to the European Parliament,
the European Economic and Social
the Regions — Implementing the Community Lisbon
Committee and the Committee of

the Council,

programme: A strategy for the simplification of the regulatory environment

COM(2005) 535 final

(2006/C 309/04)

On 9 December 2005 the European Commission decided to consult the European Economic and Social
Committee, under Article 262 of the Treaty establishing the European Community, on the abovementioned
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 31 May 2006. The rapporteur was Mr Cassidy.

At its 428th plenary session, held on 5 and 6 July 2006 (meeting of 5 July 2006), the European Economic
and Social Committee adopted the following opinion by 146 votes in favour and six abstentions.

1. EESC conclusions and recommendations

This opinion is a referral from the Commission and is a
1.1
follow-up of its Communication of March 2005 Better Regu-
lation for Growth and Jobs in the European Union (1).

Simplification should result in a high quality regulatory

1.2
framework, easier to understand and more ‘user friendly’.

Simplification should increase respect for EU legislation

1.3
and, in the process, reinforce its legitimacy.

The Committee believes that Member States have a
1.4
heavy responsibility to ensure that EU measures are properly
transposed into their national
law and enforced. The
Committee recognises that the Interinstitutional Agreement on
Better Lawmaking (2) provides a ‘code of conduct’ for Member
States in better transposition and application of EC directives.

(1) COM(2005) 97 of 16.3.2005.
(2) OJ C 321, 31.12.2003.

What is important is that the resulting regulatory framework at
national level is both as balanced in terms of content and as
simple as possible for business, employees, consumers and all
civil society players.

1.5
The Committee wishes socio-professional actors to be
associated with the ‘comitology’ procedures of simplification of
regulation, on a model similar to the SLIM committees, but in
a more systematic way and upstream of this regulation, rather
than a posteriori as it was the case of the SLIM experiments.

The Committee would like to see more consultation
1.6
between the Commission and stakeholders similar to that
which has lead to the Communication under discussion.
It
believes that this would be a material assistance to the ‘co-regu-
lation’ (3) referred to in the Communication's paragraph 3d. It
regrets, however, the absence of any reference to ‘self-regu-
lation’ (4), something for which the EESC has been calling for
some time (5).

(3) OJ C 321, 31.12.2003.
(4) OJ C 321, 31.12.2003.
(5) Information report on ‘The State of co-regulation and self-regulation in
the Single Market’, CESE 1182/2004 fin, 11.1.2005, rapporteur: Mr
Vever.

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However, the Committee acknowledges that there is a
1.6.1
danger with self-regulation that
instead of rules which are
binding on stakeholders, the stakeholders themselves conclude
voluntary agreements which they may or may not choose to
comply with.

1.14
Simplification and better lawmaking are complemen-
tary activities involving Council and Parliament as well as the
Commission, with the advice of the EESC and the CoR where
necessary.

The European Court of Justice is playing an increasing
1.7
role in the interpretation of European Community directives
and has found itself having to interpret the sometimes ambig-
uous wording of directives which emerge from the ‘co-decision’
process. The ECJ is also being required increasingly to give
guidance to national courts where their activities are comple-
mentary. The Committee notes the progress made by the ECJ
in reducing by 12 % the number of cases pending concerning
Member States failure to notify, incorrect application and non
conformity with EC directives.

1.8
The Committee acknowledges the importance of this
Commission Communication in implementing the Lisbon
in which progress has been lamentably slow
programme,
owing to the reluctance of governments of Member States to
carry out the commitments they entered into at Lisbon.

The EESC particularly welcomes

1.9
the Commission's
commitment to make more extensive use of information tech-
nology and hopes that the Commission will ensure that what-
ever arrangements are set up for improved IT, they will be
that national
compatible with national arrangements
arrangements should be compatible with the EU's!).

(or

The Committee

1.15
frequently
reiterates
expressed in previous opinions on the importance of alleviating
the regulatory and financial burdens on business, especially
SMEs.

support

its

2. Introduction

2.1
The Committee has over the years delivered a number
of opinions on Simplification going back to a request from the
European Council in 1995 when a working party was set up to
consider ways of simplifying EU rules.

In this series of opinions, the EESC has concluded that:

— there should be a dialogue between the EESC and the
Committee of the Regions as well as with the Economic
and Social Councils in the Member States;

— the simplification process does not need new ideas; what it
needs is the effective implementation of the ideas which
have already been expounded by the European institutions
and by the Lisbon European Council;

— legislative proposals

should respond to the following

criteria:

The EESC has always supported the declaration by the
1.10
Six Presidencies ‘Advancing regulatory reform in Europe’ of 7
December 2004 (6) and hopes that the presidencies to follow
will support the same declaration (7).

— are the provisions understandable and user-friendly?

— are the provisions unambiguous in intent?

The EESC is aware of

1.11
the European Parliament's
reports on better regulation and in particular the Gargani
report on Strategy for the simplification of the regulatory environ-
ment (8).

that

acknowledges

The Committee

1.12
current
Commission is making a determined effort to build on the
SLIM and BEST sectoral
initiatives. The framework action
(February 2003-December 2004) resulted in the screening of
about 40 policy sectors and the adoption by the Commission
of about 40 simplification proposals. To date, nine simplifica-
tion proposals related to that programme are still pending.

the

1.13
The Committee acknowledges that the enlargement of
the European Union to 25 Member States has also increased
the regulatory burden both on the Commission services and on
new Member State bureaucracies.

(6) A joint statement of the Irish, Dutch, Luxembourg, UK, Austrian

and Finnish Presidencies of the EU.

— are the provisions consistent with existing legislation?

— does the scope of the provisions need to be as wide as

envisaged?

— are the time scales for compliance realistic and do they

allow business and other stakeholders to adapt?

— what review procedures have been put

in place to
ensure even enforcement and to review effectiveness
and costs?

— there is a great deal of support from ‘stakeholders’ for the

idea of more self and co-regulation;

— the possibilities have not been properly explored for less detailed
and less finicky regulation, offering scope for co-regulation and
self-regulation (9).

There is a necessary interaction between simplification
2.2
and better
implementation and enforcement. The current
Commission Communication shows signs of having taken
account of some of the conclusions of previous EESC reports

(7) 2007: Germany January to June; Portugal July to December; 2008:

Slovenia January to June; France July to December.

(8) A6-0080/2006, adopted on 16.5.2006.

(9) Information report on The State of co-regulation and self-regulation in
the Single Market, CESE 1182/2004 fin, 11.1.2005, rapporteur: Mr
Vever.

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recognising that ‘simplification is not a new issue’. The series of
Commission Communications dates back to 1997,
two
years after the EESC's first call for simplification.

i.e.

— reinforce the consistency of the acquis;

— improve the proportionality (12) of the acquis.

3. Summary of the Commission Communication

3.1
The Communication recognises that the requirement is
for simplification, not only at Community but also at national
level to make things easier and more cost-efficient for citizens
and operators.

3.2
An important part of the new simplification strategy at
EU level is a review of the acquis. It sets out an ambitious 3
year rolling programme from 2005 to 2008 based on stake-
holders' practical experience with an approach based on contin-
uous in-depth sectoral assessment.

The last is probably the most far-reaching concern of stake-
holders.

The Commission's Communication in its Annex 2 lists 222
measures for simplification. The Commission's simplification
programme covers the period 2005 to 2008.

The first Company Law Directive (68/151/EEC) was
3.6
simplified, updated and modernised in 2003 to maximise the
potential of modern information tools and technologies and to
enhance transparency regarding public limited liability compa-
nies. However, the modified Directive could well be included in
a possible recast or codification exercise. A public consultation
has been launched at the end of last year to collect stake-
holders' views on such options.

The Commission's approach to simplification is based

3.3
on five instruments (10):

4. General comments

a) repeal — the elimination of irrelevant or obsolete legisla-

tion;

b) codification — the consolidation of an act and all

its
amendments into a new instrument without changing the
substance;

c) recasting — consolidation as above but with some change

of substance;

d) modification of the regulatory approach — identifying a
more legally effective approach to that currently in use e.g.
substituting a regulation for a directive;

e) reinforcement of the use of information technology (11)

— facilitating the use of IT to improve efficiency.

The Commission's Communication recognises that

3.4
it
can only succeed with support from other EU Institutions and
above all of Member States. An important part would be the
recognition by the latter of the need to keep the implementa-
tion of EU legislation as close as possible to the original direc-
tives agreed under the co-decision procedure and not to add on
(or ‘gold-plate’).

3.5
The Communication takes account of the findings of the
widespread consultation process with the Member States and
stakeholders. The conclusion of the process is that EU propo-
sals should:

— clarify and improve the legibility of legislation;

— update and modernize the regulatory framework;

— reduce administrative costs;

(10) Action plan for Simplifying and improving the regulatory environment
COM(2002) 278 final and Codification of the Acquis communautaire,
COM(2001) 645 final.

(11) The Commission proposes to bring forward an initiative in the area
of e-government with a launch of an e-government Action Plan in
2006.

4.1
Generally, ‘simplification’ must not be misunderstood as
a means of achieving deregulation ‘through the back door’.
Social standards — and in particular standards for the protec-
tion of employees, consumers and the environment — must
not be undermined or watered down as a result of administra-
tive simplification.

The Committee welcomes

4.2
the Communication and
supports the Commission in pointing out that the success of
simplifying the regulatory environment depends as much on
the Member States and their regulatory agencies as it does on
the European Institutions.

It would be helpful

4.2.1
if a code of conduct could be
drawn up as previously suggested in EESC opinions (13) (see
also Appendix I).

The EESC recalls the fact

4.2.2
the
simplification programme will not depend solely on the
Commission's ability to deliver, but also on the co-legislators'
capacity to adopt within a reasonable timeframe the simplifica-
tion proposals tabled by the Commission.

the success of

that

4.2.3
It should be recalled that the interinstitutional agree-
ment on ‘better lawmaking’ stipulates in its § 36 that ‘within six
months of the date upon which this Agreement comes into force, the
European Parliament and the Council, whose task it would be as
legislative authority to adopt at the final stage the proposals for
simplified acts, need to modify their working methods by introducing,
for example, ad hoc structures with the specific task of simplifying
legislation’.

4.3
The Communication acknowledges the importance to
SMEs and to consumers of the simplification initiative. Poorly
drafted EU or national legislation leaves consumers uncertain as
to their rights and their possibilities of redress.

(12) Regulations should be proportionate to the aims to be achieved.
(13) (OJ C 125, 27.5.2002)
(OJ C 14, 16.1.2001).

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also welcomes

The Committee

4.4
the Commission's
commitment to improving the process of producing Impact
Assessments, not only in the context of burdens on business,
but also in their impact on consumers, on disadvantaged
groups (such as people with disabilities) and on the environ-
ment. In line with the declared goal of the Lisbon process of
creating ‘more growth and employment’,
impact assessments
for employees and employment in general would also be very
positive. Especially welcome is the suggestion that there should
be more use made of ‘one-stop-shops’ and its reference in
certain directives to ‘virtual’ or ‘self-testing’ in the context of
motor vehicles.

It would be helpful if the Commission could produce an
4.5
impact assessment to justify its withdrawal of proposals as it is
now doing for new proposals.

5. Specific comments

that

The Communication implies

5.1
the process of
adapting directives to technical progress (‘comitology’) needs to
be made more transparent — something urged frequently by
the European Parliament. Member States have a responsibility
in this, however. The comitology work is carried out by
‘national experts’ and there is considerable evidence to suggest
that these ‘experts’ do not take account of their government's
views in their comitology activities (an example of this is the
1979 Birds Directive to which the technical annexes were
added by ‘experts’ after ministers had given their approval in
Council to the directive itself).

and other

‘stakeholders’

The importance of simplification to consumers, social
5.2
should be highlighted.
partners
Conflicts between national
implementing legislation and the
original EC directives on which they are based add greatly to
the work load of the European Court of Justice (ECJ) whose
role is ‘interpretation’ but which is increasingly finding itself
having to fill in details which appear to be overlooked or for
which the requirement for Council unanimity has failed to
produce a satisfactory text e.g. in taxation matters. However,
the fact that the ECJ is increasingly being given the role of a
political decision-maker is a problem. The ECJ lacks a clear
political basis for this, besides exceeding its remit. It therefore
takes decisions which should be taken by democratically
elected authorities.

Brussels, 5 July 2006

5.3
The EESC acknowledges that the Commission itself has
made an effort and there have been several hundred repeals
and declarations of obsolescence, which should have signifi-
cantly contributed to reducing the volume of the acquis but not
necessarily reducing burdens on business, on employees, on
consumers or on other ‘stakeholders’. The Committee acknowl-
edges that there are still areas where more legislation is needed
at EU level in order to defend the environment and the rights
of employees, consumers and disadvantaged groups (such as
people with disabilities or other minorities), and to make sure
that they all can have full access to the benefits of the single
market.

5.3.1
On the other hand the most commonly employed
system to date is that of updating. While this permits the intro-
duction of certain necessary changes so as to update the regula-
tions, the aim of simplification is not always achieved; indeed,
on the contrary, measures are sometimes superimposed so that
old and new regulations exist side by side in some Member
States causing confusion to stakeholders. Enforcers in Member
States may be left in doubt as to whether or not they are acting
in accordance with their legal institutions.

5.3.2
The simplification features of each simplification
proposal of the Rolling Programme should be clearly spelled
in the corresponding exploratory memorandum, and,
out
the accompanying Impact Assessment. The
where relevant,
Commission services should carefully monitor these proposals
inter-institutional decision-making
in the course of
process
simplification dimension is
the
to ensure
preserved, as required by Interinstitutional Agreements (on the
‘codification technique’ (14), on the ‘recasting technique’ (15) and
on ‘Better Lawmaking’ (16)).

their
that

5.4
The Committee draws attention once again to its long
series of opinions on the need for better regulation and simpli-
fication, particularly to its most recent opinion on ‘Better
Lawmaking’ (17)
for an exploratory
opinion of the UK Presidency.

in response to a request

The Committee reiterates its frequently expressed wish
5.5
that the process of better regulation and simplification should
continue following the Six Presidencies declaration (18).

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND

(14) OJ C 102, 4.4.1996.
(15) OJ C 77, 28.3.2002.
(16) OJ C 321, 31.12.2003.
(17) CESE 1068/2005, OJ C 24, 31.1.2006, rapporteur Mr Retureau.
(18) Advancing regulatory reform in Europe — A joint statement of the
Irish, Dutch, Luxembourg, UK, Austrian and Finnish Presidencies of
the European Union of 7.12.2004.