WRITTEN QUESTION E-1312/00 by Glyn Ford (PSE) to the Commission. Omnipaque/Iohexol and arachnoiditis.
Date: 2000-04-27
Institutions: European Parliament, Provisional data
Subjects: European social policy, competence of the Member States, drug surveillance

20.2.2001

EN

Official Journal of the European Communities

C 53 E/125

receive payment of the grant. Four months later the Twinning Society had still heard nothing back from
the Commission. Upon contacting the relevant Directorate-General directly, they were informed by a
female official there that she did not have sufficient staff to make out the cheque, or the authority to
appoint anyone to do this.

Will the Commission look into this matter and subsequently indicate what measures it intends to take to
improve the efficiency of its facilities for awarding grants for twinning?

Answer given by Mrs Reding on behalf of the Commission

(9 June 2000)

The Commission acknowledges that it has failed to answer within a reasonable deadline.

However, a contributing reason for the delay was technical difficulties in transferring the grant to the
applicant.

The account number indicated by Dorchester was not suitable to receive electronic payment. Thus, the
procedure had to be carried out through another bank, which meant an additional delay.

Now, the Commission is glad to inform the Honourable Member that the payment has been executed.

(2001/C 53 E/159)

WRITTEN QUESTION E-1312/00

by Glyn Ford (PSE) to the Commission

(27 April 2000)

Subject: Omnipaque/Iohexol and arachnoiditis

Omnipaque (or Iohexol as it is also called) is a dye that is injected into patients to enable doctors to carry
out a myelogram.

This dye is linked with arachnoiditis, a progressive, debilitating and extremely painful disease. The
symptoms take a long time to manifest themselves, with the result that many patients do not connect
them with the original dye. Indeed, many patients are mistakenly diagnoses as having arthritis.

In 1997/1998 Senator Traficant put a bill before the House of Representatives in the USA to have this dye
banned, stating that it had been proven to cause arachnoiditis.

Will the Commission indicate whether it has received details of other cases relating to the after-effects of
this dye?

Will the Commission also indicate what investigations, if any, it has carried out into this dye and its after-
effects. If the Commission has not as yet carried out any investigation into this dye, does it intend to do so
in the near future?

Answer given by Mr Liikanen on behalf of the Commission

(8 June 2000)

Omnipaque is a medicinal product whose active substance is iohexol. It is an iodised contrast agent used
in various radiological examinations. Authorisations to place it on the market have been granted by the
national authorities, which are thus also responsible for its follow-up, including pharmacovigilance.

C 53 E/126

Official Journal of the European Communities

EN

20.2.2001

The pharmaceuticals rules relating to pharmacovigilance require any undesirable effects linked to medicinal
products to be notified to the competent authorities.

The Commission has no jurisdiction in respect of medicinal products authorised by the national
authorities, except in the cases indicated by Council Directive 75/319/EEC of 20 May 1975 on the
approximation of provisions laid down by law, regulation or administrative action relating to proprietary
medicinal products (1) in which a referral procedure leads to evaluation and an opinion from the scientific
committee of the European Agency for the Evaluation of Medicinal Products and a decision by the
Commission.

To date, no referrals have been made to the Agency concerning Omnipaque. However, the Agency will be
informed of the Honourable Member(cid:146)s question.

(1) OJ L 147, 9.6.1975.

(2001/C 53 E/160)

WRITTEN QUESTION E-1320/00

by Bart Staes (Verts/ALE) to the Commission

(27 April 2000)

Subject: European school milk scheme

The Commission is proposing to radically change the school milk scheme. At the moment, the disposal of
milk in schools is fully subsidised by the European Union. In future this financing would be halved. The
other half of the financing would then have to come from the Member States, but they would be allowed
to pass on the costs to milk producers and/or the dairy industry. These sweeping proposals are
encountering a great deal of opposition, due in part to the negative consequences for milk consumption.

1. What are the grounds for the Commission(cid:146)s proposals to halve aid for the school milk scheme?

Has the Commission carried out a detailed study of the impact of its proposal on milk consumption

2.
in schools?

(a)

(b)

If not, why is that the case, and does the Commission intend to carry out a study in view of the (cid:129)
probable (cid:129) negative impact on milk consumption?

If so, what are the anticipated effects, and what conclusions does the Commission draw from the
results of this research?

Does the Commission not consider it more advisable to continue to fully subsidise the school milk

3.
scheme in view of the health benefits of milk?

(a)

If not, why is the Commission sticking to its proposal to halve aid in spite of the health benefits of
milk?

(b)

If so, will the school milk scheme be financed on a long-term basis by the European Union?

Answer given by Mr Fischler on behalf of the Commission

(7 June 2000)

Under the Commission(cid:146)s proposal of 10 December 1999 (1) for a Council Regulation amending
1.
Regulation (EEC) No 1255/1999 on the common organisation of the market in milk and milk products,
the reduction in Community aid would be more than offset by a compulsory national contribution. This
would mean that the total aid granted would rise from 95 % to 100 % of the milk target price. For the
arguments in support of this proposal, the Honourable Member is referred to the explanatory memor-
andum accompanying it.