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?

4. Is the Commission aware of the guarantees for medicine ingredients called for by the World Health Organisation (WHO) in November 1997, whereby, 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)?

5. Do EU Member States have the power to impose independent and unilateral statutory requirements for exports of medicine ingredients?

6. Apart from the adoption of national legislation by Member States, 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?

Answer given by Mr Liikanen on behalf of the Commission

(18 April 2002)

1. The Commission is aware of the unfortunate problem that occurred with respect to the contamination of a medicinal product with diethylene glycol leading to the death of some 100 children in Haiti in 1996.

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.

4. The Commission is aware of several 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.

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.