WRITTEN QUESTION E-3877/03 by Francesco Fiori (PPE-DE) to the Commission. Breach of Community principles — Article 24 of Law 289/2002.
Date: 2003-12-16
Institutions: European Parliament, Provisional data
Subjects: award of contract, competition law, infringement of EU law, public contract, public sector, services contract, small and medium-sized enterprises, supplies contract

C 78 E/664

Official Journal of the European Union

EN

27.3.2004

Does the Commission not consider that the Community’s principles imply the need for harmonised rules
placing all producers under the same conditions of competitiveness and reliability in the Community
context, with safeguards against international competition based on product quality, especially in the case
of products relating to human health?

Does the Commission not consider it necessary to propose and implement at European level a Community
regulation to deal with this entire problem and ensure, through inspections of imports, suitable guarantees
and standards of precautionary protection for substances and pharmaceuticals consumed within the
Union?

Answer given by Mr Liikanen on behalf of the Commission

(5 February 2004)

legislation does not

Present Union pharmaceutical
foresee any obligation for Active Pharmaceutical
Ingredients (APIs) to be produced according to Good Manufacturing Practice (GMP) standards. Therefore,
being aware of this situation, the Commission adopted on 26 November 2001 new legislative proposals (1)
that introduce the requirement for pharmaceutical manufacturers to only use active substances which have
been manufactured according to GMP requirements for medicinal products. After agreement has been
reached, following the second reading in the Parliament on 17 December 2003, the Commission is now
anticipating the final adoption of the new legislation in early 2004. Bearing in mind the 18 month
implementation period of the new legislation, the provisions for APIs could be applicable from the end of
2005.

Nevertheless, the current situation in the Union already makes it possible that GMP inspections of API
manufacturers may voluntarily be carried out by the competent authorities of Member States whenever
these authorities find reasons for concern. In those cases, Union inspectors may conduct inspections
the requirements of Annex 18 (‘Good Manufacturing Practice for Active Pharmaceutical
against
Ingredients’) to the Union Guide to Good Manufacturing Practice, which already covers internationally
agreed GMP standards for APIs. This guideline will become mandatory as soon as the new legislation
enters into force.

(1) Proposals for Directives 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 amending Directive 2001/82/EC on the
Community code relating to veterinary medicinal products.

(2004/C 78 E/0708)

WRITTEN QUESTION E-3877/03

by Francesco Fiori (PPE-DE) to the Commission

(16 December 2003)

Subject: Breach of Community principles (cid:1) Article 24 of Law 289/2002

Article 26 of the Italian law No 488 of 23 December 1999 lays down the rules governing the supply of
goods and services to the public sector on the basis of procedures open to public scrutiny. Article 24(3) of
Law No 289 of 27 December 2002 reinforces the obligation to use the framework conventions defined by
the Consip SpA for the bodies indicated in table C and for institutional bodies.

The general principles which, according to the Italian government, underlie this provision are the
objectives of competition and transparency, with the aim of achieving savings, containing expenditure and
ensuring efficiency in the supply systems concerned.

27.3.2004

EN

Official Journal of the European Union

C 78 E/665

Nonetheless, the Italian government intends to pursue those objectives via the above-mentioned law, which
appears to be in breach of both the Italian constitution (numerous regions have appealed to the
Constitutional Court on the same point) and Community law and principles. Three points may be raised
here:

(a)

(b)

(c)

the opportunity given to the Italian legislative branch of independently revising (downwards) the
Community threshold set by the Community directives and by the corresponding incorporating laws;

inconsistency of
Community competition law;

the centralised supply system mediated through the Consip procedures with

the creation of a legislative and administrative framework unfavourable to the development of small
businesses.

In view of the above, what measures will the Commission take in support of the SMEs’ associations whose
members appear to be the inevitable target of this legislation?

Answer given by Mr Bolkestein on behalf of the Commission

(2 February 2004)

The Commission has examined the legal aspects relating to the centralised procurement system set up in
Italy by Consip on a number of occasions and has never found any breach of Community law which
would warrant instituting infringement proceedings. It would first like to draw the Honourable Member’s
attention to the proposal for a Parliament and Council Directive on the coordination of procedures for the
award of public supply, services and works contracts which is intended to replace the three directive
currently in force. Article 11 of the common position adopted by the Council on 20 March 2003 does in
fact lay down that ‘Member States may provide for the possibility of contracting authorities procuring
works, supplies and/or services by having recourse to purchasing groups’, adding that
‘contracting
authorities which procure works, supplies and/or services by having recourse to a purchasing group …
shall be deemed to have complied with the provisions of this Directive provided that the purchasing group
has complied with them.’

First of all, with regard to the Honourable Member’s statement that Italy might revise the application
threshold set by the Community directives for public contracts downwards, it should be noted that the
provisions of these Community directives impose minimum obligations on the Member States, whilst
allowing the latter to set stricter rules in order to open up public contracts to wider and more general
competition. Indeed, as the Court of Justice has often repeated, the Community directives in question are
legislative texts which coordinate, but do not harmonise, procedures for the award of public contracts at
European level.

Furthermore, it should be observed that from the point of view of Community law, all public contracts are
(cid:1) in principle (cid:1) subject to disclosure obligations. For contracts in which the amount is lower than the
Community thresholds, as the Court of Justice has clarified in its case-law, there is an obligation to ensure
that they have been adequately advertised, taking into account the amount and nature of the contract. It is
up to the Member States to determine how these should be advertised, leaving them free to decide whether
this should be done at European level, notably through publication in the Official Journal of the European
Union (1).

In the light of the foregoing, it should be explained that the application threshold in the directives has not
been amended by the provision in the law mentioned by the Honourable Member. It is clear that the
national
transposing the
aforementioned Community directives, wished to refer in full to the methods of publication provided for
by these provisions, including in particular those relating to the publication of a contract notice in the
Official Journal of the European Union.

in simply referring to the application of

the national

legislator,

rules

Secondly, with regard to the comment that the centralisation of procurement would create a legislative and
administrative environment which was unfavourable to the development of small businesses (SMEs), the
Commission would emphasise that the issue of the impact of centralising procurement through the Consip
on reference markets and particularly on the activity of SMEs is a problem which falls within the
competence of the national competition authority, which has already looked at the system in question on
a number of occasions, as, on a more general
level, have the competent political and administrative
authorities.

C 78 E/666

Official Journal of the European Union

EN

27.3.2004

In this respect, the Commission would add that it is aware of the fact that the national competition
authority has sent a number of recommendations to the Consip which seek to avoid excessive restrictions
on competition in the invitations to tender it launches (cid:1) recommendations which the Consip does in fact
seem to follow. In addition, the national political and administrative authorities,
i.e. the government,
Parliament and Consip, have recently held talks on how to limit the potential negative effects of the
aforementioned centralised procurement system on the activities of small and medium-sized enterprises.

The Commission would point out that the recent Decree-Law No 143/2003, which was converted into
Law No 212/2003 published in the national Official Journal 131/L of 11 August 2003, made significant
changes to the field in question (cid:1) including, in particular, the annulment of Article 24(3) in Law No 289/
2002 mentioned by the Honourable Member (cid:1) precisely in order to reduce the impact of the centralised
procurement system on the activities of small and medium-sized enterprises. According to information
currently at the Commission’s disposal, other changes to the legislation in force are planned as part of the
process of approving the financial law for 2004.

(1) This possibility is, moreover, explicitly covered by the aforementioned directives, which lay down (cid:1) see Article 13
of Directive 93/36/EEC for supplies and Article 21 of directive 92/50/EEC for services (cid:1) that contracting
authorities may arrange for the publication in the Official
Journal of the European Communities of notices
announcing public supply and service contracts which are not subject to the publication requirement laid down in
these Directives.

(2004/C 78 E/0709)

WRITTEN QUESTION E-3878/03

by Johannes Blokland (EDD) to the Commission

(16 December 2003)

Subject: Research into the effects of medicinal products on children

Is the Commission aware that the majority (cid:1) possibly 70 % (cid:1) of medicinal products prescribed for

1.
children have not undergone any research to ascertain their effects on patients of this age group?

2. What percentage of medicinal products evaluated by the European Agency for the Evaluation of
Medicinal Products (EMEA) have also been found to be suitable for use by children?

3. What efforts is the Commission making to encourage manufacturers to perform more research into
the effects of medicinal products on children?

Is Community funding made available for such research, and if so, what are the relevant

4.
appropriations and how are they being used?

Answer given by Mr Liikanen on behalf of the Commission

(30 January 2004)

The Commission is fully aware that many medicines used to treat children are not specifically studied

1.
nor authorised for such use, and is working to remedy the situation.

2.
In October 2003, the European Medicines Evaluation Agency (EMEA) performed a review of the
authorisation status for children of the 191 active substances used in medicines authorised through the
Community procedure, on the basis of an EMEA scientific evaluation. Sixty-two (32 %) were appropriately
authorised for the use of children. Of the remaining active substances 51 (27 %) were medicines indicated
for diseases not relevant to children (e.g. cancers occurring only in adults).

Current Community pharmaceutical legislation does not compel industry to study medicines for the
3.
use on children. However,
the existing regulatory framework already provides incentives to orphan
products. Regulation (EC) No 141/2000 of the Parliament and of the Council of 16 December 1999 on