WRITTEN QUESTION No. 1172/97 by Carmen DÍEZ DE RIVERA ICAZA to the Commission. Vaccines, medicines and BSE
Date: 1997-04-03
Institutions: DIEZ DE RIVERA ICAZA, European Parliament
Subjects: animal disease, animal product, cattle, derogation from EU law, market approval, pharmaceutical legislation, pharmaceutical product, public health, vaccine

C 45/14

EN

Official Journal of the European Communities

10. 2. 98

(98/C 45/17)

WRITTEN QUESTION E-1172/97

by Carmen D(cid:14)·ez de Rivera Icaza (PSE) to the Commission

(3 April 1997)

Subject: Vaccines, medicines and BSE

In view of the most recent events in Italy, I would ask:

1.  What is the Commission(cid:146)s position on vaccines made with bovine brain cells?

2.  How widespread are vaccines of this type in the various Member States?

3.  What products in the various risk categories are still in circulation within the Union?

4. 

Is there a European Register of Medicines which pose a risk of BSE?

Answer given by Mr Bangemann on behalf of the Commission

(6 June 1997)

1. - 3.
The Commission is concerned about the use of bovine brain material in any pharmaceutical product,
particularly those which are intended for injection. In December 1996, the Commission proposed a general ban
on the use of certain tissues, including bovine brain. However, the proposal was rejected by a simple majority in
the Council. The Commission is currently reflecting on follow-up action.

It should be borne in mind that, since the end of 1991, a set of provisions (directives and scientific guidelines, as
described  by  the  Commission  in  its  answer  to  written  question  No  2335/96  from  Ms  Breyer (1))  has  been
introduced  with  a  view  to  minimizing  the  risk  of  transmitting  the  agent  responsible  for  bovine  spongiform
encephalopathy (BSE) to man via medicines. The Commission is taking steps to ensure that this set of provisions
is updated in the light of the latest scientific findings. Furthermore, by way of a precaution, the Commission
intends to amend the Annex to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws
of  the  Member  States  relating  to  analytical,  pharmaco-toxicological  and  clinical  standards  and  protocols  in
respect of the testing of proprietary medicinal products (2), so as to prohibit the manufacturers of such products
from using substances derived from cattle, sheep or goats and which carry an infection risk associated with the
agent  responsible  for  BSE.  This  ban  would  apply  to  all  such  substances,  whatever  their  place  of  origin.
Exemptions  would,  however,  be  allowed  in  the  case  of  medicinal  products  for  which  there  is  no  therapeutic
alternative, so that these products can temporarily be kept on the market.

A number of vaccines are manufactured from materials of bovine origin. Since most of these vaccines are

2.
authorized on a purely national basis by the Member States, the Commission has no precise data on them.

4.
No medicinal product is classified as posing a known risk of contamination by the agent responsible for
BSE. If there were such a risk, the medicinal product in question would have to be withdrawn from the market
immediately.

(1)  OJ C 83, 14.3.1997.
(2)  OJ L 147, 9.6.1975, as last amended by Directive 93/39/EEC of 14 June 1993 (OJ L 214, 24.8.1993).

(98/C 45/18)

WRITTEN QUESTION E-1200/97

by Nikitas Kaklamanis (UPE) to the Commission

(3 April 1997)

Subject: Temporary number plates for cars intended for sale

In the EU there are cars which are bought in one Member State and taken to other Member States to be sold. The
country in which they are bought issues temporary number plates for the journey (e.g. (cid:145)Zoll-Nummer(cid:146) plates in
Germany and (cid:145)plaque de transit(cid:146) plates in Belgium).

The issuing of such plates entails a hefty charge of approximately DM 700, with insurance cover, which is added
to the final cost of the vehicle and must be paid by the consumer.