WRITTEN QUESTION E-0609/02 by Erik Meijer (GUE/NGL) to the Commission. Measures to prevent medicines containing contaminated ingredients from being supplied from the EU to third countries on account of child mortality in Haiti.
Date: 2002-03-05
Institutions: European Parliament, Provisional data
Subjects: Haiti, Netherlands, export monitoring, pharmaceutical industry, pharmaceutical legislation, pharmaceutical product, self-regulation, toxic substance

12.12.2002

EN

Official Journal of the European Communities

C 309 E/31

The Commission defends human rights both in the political dialogue with the countries concerned and
through cooperation schemes.

Human rights issues, including individual cases, are raised at association council meetings with Moroccan
and Tunisian ministers, which normally take place every year. They also figure on the agenda of the
association committees, which normally also meet every year. The association agreement with Algeria was
only initialled on 19 December 2001 and has yet to enter into force, so human rights issues are raised by
the Union’s troika at
In the
communication it sent the Council in preparation for April’s Valencia conference of Euro-Mediterranean
foreign ministers (1), the Commission suggested stepping up the political dialogue with the Mediterranean
countries, including the Maghreb countries; it recommended that the ministers agree that questions related
to human rights and democracy be raised systematically in all contacts between the EU and the partners
with a view to promoting a structured approach to progress.

its regular (cid:1) normally twice-yearly (cid:1) meetings with that country.

In December 2001 the Commission adopted the European Initiative for Democracy and Human Rights
(EIDHR) Programming Document 2002-2004, which covers all non-member countries, including those of
the Mediterranean. The chief beneficiaries of
this initiative are non-governmental and international
organisations. The 29 target countries selected for the EIDHR in the period 2002-2004 include Algeria,
Tunisia, Israel and the West Bank and the Gaza Strip. Activities in these countries should focus on
democratisation, good governance and the rule of law.

The MEDA Programme, for which Algeria, Morocco and Tunisia are eligible, provides for cooperation on
judicial reform and women’s issues.

(1) SEC(2002) 159 final.

(2002/C 309 E/036)

WRITTEN QUESTION E-0609/02

by Erik Meijer (GUE/NGL) to the Commission

(5 March 2002)

Subject: Measures to prevent medicines containing contaminated ingredients from being supplied from the

EU to third countries on account of child mortality in Haiti

1.
Is the Commission aware that in 1995 the Dutch company Vos B.V. of Alphen aan den Rijn (part of
Helm AG of Hamburg) supplied glycerine contaminated with diethylene glycol (antifreeze) to Pharval in
Haiti, which used it as an ingredient in Afebril, a paracetamol-based antifebrile syrup, as a result of which,
in 1996, at least 60 children died of kidney dysfunction, and that legal proceedings in the Netherlands
relating to this case have been concluded by fining the company without any trial taking place?

2.
Is it a regular occurrence for raw materials to be supplied to Third-World countries from EU Member
States from which medicines can be manufactured but which do not comply with the requirements
applicable to the production of medicines within the EU?

3.
Can the Commission confirm the following statement made on 18 December 2001 by the
Netherlands Minister of Health in the national parliament: ‘Within the European Union … we worked on
the matter for a good while, and I have recently ascertained definitively that the European Commission is
not in favour of adopting European rules on it’, and her written statement of 4 February 2002 that the
Commission ‘only imposes rules regarding raw materials which are processed within the EU and does not
impose any requirements on non-active ingredients, auxiliary agents?’

Is the Commission aware of the guarantees for medicine ingredients called for by the World Health
4.
Organisation (WHO)
just as in the case of imports of pharmaceutical
products, businesses could only receive a licence if they applied GMP (Good Manufacturing Practice) and/
or GDP (Good Distribution Practice)?

in November 1997, whereby,

C 309 E/32

Official Journal of the European Communities

EN

12.12.2002

Do EU Member States have the power to impose independent and unilateral statutory requirements

5.
for exports of medicine ingredients?

Apart from the adoption of national

6.
is there any other way of
improving the monitoring of raw materials for export with a view to the preparation of medicines
elsewhere, in order to permanently prevent any repetition of such fateful transactions as those referred to
in questions 1 and 2? What will the Commission do to this end?

legislation by Member States,

Answer given by Mr Liikanen on behalf of the Commission

(18 April 2002)

The Commission is aware of

1.
to the
contamination of a medicinal product with diethylene glycol leading to the death of some 100 children
in Haiti in 1996.

the unfortunate problem that occurred with respect

2.
In accordance with the current Community legislation, manufacturers of medicinal product within
the Community are required to comply with Good Manufacturing Practice (GMP) and be in possession of a
manufacturing authorisation irrespective of whether the product is for use within the Community or for
export. The Member State concerned is required to ensure, by means of repeated inspections that the legal
requirements concerning medicinal products are complied with.

3.
Starting materials for medicinal products (both active and non-active substances) manufactured or
marketed within the Community for use in medicinal products for supply within the Community must
comply with strict quality control criteria in accordance with part 2 of the annex to Directive 2001/83/EC
of the Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal
products for human use (1). It is not therefore true to say that the current legislation does not impose any
requirements on non-active substances, known as excipients or auxiliary agents.

In the proposals for the review of the pharmaceutical legislation adopted by the Commission in November
2001 (2), additional requirements for GMP for active substances used as starting materials in medicinal
products are laid down. The possibility to extend these rules in the future to other substances, including
non-active substances or excipients has also been included in these proposals. However strict controls on
suppliers and quality control criteria continue to apply for all starting materials used in the manufacture of
medicinal products whether for use within the Community or for export.

The Commission is aware of several

4.
initiatives that have been taken by the World Health
Organisation (WHO), with respect to the quality of pharmaceutical starting materials triggered by the
Haiti incident. A scheme for the certification of pharmaceutical starting materials based on either GMP
inspection or self-certification is currently under development. This voluntary scheme provides for the
issue of a certificate for a starting material if the manufacture has been performed in accordance with GMP
and distribution steps performed in accordance with Good Distribution Practice (GDP). This is a voluntary
scheme.

5. Member States may impose independent statutory requirements for exports of starting materials. In
this case they are required to inform the Commission of any pending legislation in order to ensure
compliance with Community legislation.

6.
According to WHO, excipients are rarely produced specifically for pharmaceutical purposes. The
majority of the frequently used pharmaceutical excipients are mainly utilised in food or cosmetics, which
may be, but probably are not, produced according to GMP. Certain excipients even have their main use in
completely different fields like paint, building materials, refrigeration, etc. This makes monitoring of those
excipients intended to be used specifically for pharmaceutical manufacture more difficult.
In the
Community, the onus is placed on the manufacturer to ensure that all starting materials are purchased
from approved suppliers, in accordance with the relevant specification. Member States are required to
ensure by means of repeated inspections that these requirements are complied with. Similar control
systems should be put in place in developing countries.

12.12.2002

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Official Journal of the European Communities

C 309 E/33

Apart from these legal requirements, the Commission has supported the development of self-regulatory
mechanisms by the international excipient industry. Several Good Manufacturing Practice codes have been
developed. The Commission intends to continue to encourage such self-regulatory mechanisms.

(1) OJ L 311, 28.11.2001, p. 67.
(2) COM(2001) 404 final.

(2002/C 309 E/037)

WRITTEN QUESTION E-0615/02

by Rosa Miguélez Ramos (PSE) to the Commission

Subject: Discriminatory treatment of official languages

(5 March 2002)

Recent years, coinciding with the current Commission’s mandate, have seen an emerging imbalance in the
treatment of the various official languages in favour of English. In the specific case of the Commission, it is
not known whether the College of Commissioners has taken any decision favouring English above the
other languages.

This new predomination of one language runs counter to the spirit of political integration and harmonious
and balanced union among the peoples of Europe. At internal level it clearly places those Commission
officials who are not of Anglo-Saxon origin at a disadvantage. In certain services, someone (cid:1) it is not
known exactly who (cid:1) has decided to work solely in English.

Which Commission services work exclusively in English? Who approved this decision? On what legal
basis? What type of documents and materials has the Commission decided to have drawn up and
distributed exclusively in English?

Answer given by Mr Prodi on behalf of the Commission

(26 April 2002)

The Commission has not taken any decision favouring English over the other official languages. Neither
the Commission nor the administrative hierarchy has given instructions that its departments should use
English exclusively to draft and distribute documents or materials. There is no department in which
English is used exclusively.

The Commission would draw attention to its policy in this respect:

(cid:1) documents intended for use outside the Commission are drawn up in the official languages of the
Community in the case of instruments of general application and in the languages of those to whom
they are addressed in other cases;

(cid:1) documents for internal use are drafted in the languages corresponding to the actual needs of the

Commission and its departments based on operational efficiency.

(2002/C 309 E/038)

WRITTEN QUESTION E-0641/02

by Rodi Kratsa-Tsagaropoulou (PPE-DE) to the Commission

Subject: MEDA funding and transparency

(6 March 2002)

Article 8(c) of the amended MEDA Regulation (1) (No 2698/2000) requires the Commission, as part of the
policy to improve transparency and information, to publish he results of the invitations to tender,
including information on the number of received tenders, the date of the award of the contract, and the
name and the address of the successful tenderers, in the Official Journal of the European Communities and
on the Internet.