WRITTEN QUESTION E-3874/03 by Francesco Fiori (PPE-DE) to the Commission. Imports into the EU of uncertified active pharmaceutical ingredients.
Date: 2003-12-16
Institutions: European Parliament, Provisional data
Subjects: harmonisation of standards, import (EU), pharmaceutical legislation, pharmaceutical product, public health, third country

27.3.2004

EN

Official Journal of the European Union

C 78 E/663

described as ‘rest of the investment’ will have any impact on item (c) of Clause III of the Agreement.
This money will not be reclaimed from the users, neither in the form of water tariffs, nor repayments, nor
operational costs, nor in any other way.

Does the Commission not believe that treating Community funding in this way runs counter to the
following Community obligations: transparency in managing and applying European funds (recitals 26 and
57 and Articles 17 to 19, 34, 36 and 46 of Regulation 1260/1999 (1)); the ban on distorting competition
within the internal market by means of state aids (EC Treaty Article 87);
the
Community’s financial interests (EC Treaty Article 280); and the obligations on economic transparency and
the need to take due account of the principle of recovery of the costs of water-related services (Article 9
and Annex III of Directive 2600/60/EC (2)?

the protection of

On 2 June 2003, the Spanish state’s own lawyers recognised the independence of the nature of public
funds relative to the issue of including, within the regulation levies and water use tariffs, the monetary
sums financed with European funds in water regulation schemes.

Furthermore, account needs to be taken of the fact that 35 hm3 per year, of a total of 80 hm3 planned for
this water transfer, are intended for urban supply, for which it has been standard practice for years that the
users repay the investment via the tariffs. In the case of the Alicantí and Marína Baja, the fresh supplies are
basically designed to meet current rising tourist demand. This means that the Commission would be
funding, on a no-return basis, the Spanish tourist industry. Can the Commission accept this situation?

(1) OJ L 161, 26.6.1999, p. 1.
(2) OJ L 327, 22.12.2000, p. 1.

Answer given by Mr Barnier on behalf of the Commission

(4 February 2004)

The Commission is collecting the information it needs to answer the question. It will communicate its
findings as soon as possible.

(2004/C 78 E/0707)

WRITTEN QUESTION E-3874/03

by Francesco Fiori (PPE-DE) to the Commission

(16 December 2003)

Subject: Imports into the EU of uncertified active pharmaceutical ingredients

Imports from outside the EU (mostly from India, China and other emerging Asian nations) of active
ingredients which have not received inspection certificates from any European authority are threatening to
cause lasting damage to Italy’s producers of active ingredients for the pharmaceutical
industry. The
products concerned enter the EU accompanied only by paper documentation (the Certificate of Suitability
or COS) stating that they conform to the contents of the European Pharmacopeia. This is not a sufficient
health guarantee. Italy’s producers of active ingredients for the global pharmaceutical
industry enjoy a
reputation for excellence, thanks to the quality and reliability of their products, which are guaranteed by
following Good Manufacturing Practices (GMP) in line with the European guidelines (‘GMP Guide for
Active Pharmaceutical Ingredients’), and to the fact that the products have been inspected either by the
American Food and Drug Administration or by the Italian health ministry.

Given the above, what action will the Commission take with a view to protecting the health of the
European public from imports of active ingredients for the pharmaceutical
industry produced by
companies from the above-named countries?

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.