WRITTEN QUESTION E-0634/00 by Cristiana Muscardini (UEN) and Sergio Berlato (UEN) to the Commission. Eradication of infectious bovine rhinotracheitis (IBR).
Date: 2000-03-03
Institutions: European Parliament, Provisional data
Subjects: EC Decision, animal disease, cattle, epidemic, market approval, pharmaceutical legislation, quality control of industrial products, standing committee (EU), vaccination, vaccine, veterinary drug

C 330 E/194

Official Journal of the European Communities

EN

21.11.2000

working group concerning the Council(cid:146)s proposal for the (cid:145)E(cid:146) and (cid:145)e(cid:146) distinction between manufacturer-
marked and third party marked silver articles, and so enable agreement to be reached to a directive which
will finally inaugurate a single market in silver articles?

(1) Debates of the European Parliament (December 1999).

Answer given by Mr Liikanen on behalf of the Commission

(12 April 2000)

The Commission agrees with the suggestion by the Honourable Member to distinguish between (cid:145)E(cid:146) and (cid:145)e(cid:146)
marking. It will endeavour to facilitate the in-depth discussion in the next Council working group and so
to enable agreement about the hallmarking Directive to be reached.

(2000/C 330 E/224)

WRITTEN QUESTION E-0634/00

by Cristiana Muscardini (UEN) and Sergio Berlato (UEN) to the Commission

Subject: Eradication of infectious bovine rhinotracheitis (IBR)

(3 March 2000)

Following a vaccination-related accident in the Netherlands in the spring of 1999, the Commission rightly
decided to put a temporary ban on the vaccines (cid:145)Bayovac IBR marker vivum(cid:146) and (cid:145)attenuated Rhinobovin
marker(cid:146) until the Committee for Veterinary Medicinal Products (CVMP) could carry out the necessary
scientific tests and make a final decision. However, in the absence of proof of adverse effects, it did not ban
the vaccines (cid:145)Bayovac IBR marker inactivatum(cid:146) and (cid:145)killed Rhinobovin marker(cid:146), which are officially
authorised in all EU Member States, except for Italy.

1.
Does the Commission not consider it would be advisable to speed up procedures in order to bring
the validation process for the live vaccines to an end, thereby providing assurance in the fight to eradicate
infectious bovine rhinotracheitis?

Does the Commission consider it necessary to ask Italy to lift its ban on marketing authorisation for

2.
Bayer(cid:146)s (cid:145)inactivatum(cid:146) vaccine and Hoechst(cid:146)s (cid:145)killed(cid:146) vaccine?

3.
Does it consider this isolation, decreed by the Italian Ministry of Health, to be justified when the said
Ministry is granting exemptions from the ban and is allowing the (cid:145)inactivatum(cid:146) vaccine, purchased in
France, to be given to Italian cattle due to take part in a European event (Friesian cattle show) in Brussels
on 11, 12 and 13 February?

4. Whilst respecting the fundamental need for scientific testing, does the Commission not think that any
procrastination might help to exacerbate the economic losses of Italian breeders brought about by the
delay in efforts to eradicate IBR?

Answer given by Mr Liikanen on behalf of the Commission

(14 April 2000)

1., 2. and 4.
As a result of cases of bovine viral diarrhoea (BVD) occurring in cattle vaccinated with the
nationally authorised veterinary medicinal product Bayovac (infectious bovine rhinotracheitis (IBR)) marker
vivum in the Netherlands, the United Kingdom presented to the European Agency for the Evaluation of
Medicinal Products (EMEA) a Community referral under Article 23a of Council Directive 81/851/EEC (1).
At that time the marketing authorisation holders informed the EMEA that Bayovac IBR marker vivum and
Rhinobovin marker had been voluntarily withdrawn in all Community markets pending the outcome of
the Community referral. At no time was a temporary ban imposed by the Commission. However, the
national marketing authorisations were suspended by the Irish, Italian, Dutch and British authorities

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Official Journal of the European Communities

C 330 E/195

On 21 January 2000 the committee for veterinary medicinal products (CVMP) having considered the
matter in detail reached an opinion in respect of Bayovac IBR marker vivum and Rhinobovin marker, as
authorised in Belgium, Germany, Spain, Ireland, Italy, Luxembourg, the Netherlands, Portugal and United
Kingdom. The opinion requires variation of all marketing authorisations for all such products authorised in
different Member States to ensure additional quality controls in the manufacturing process to minimise
contamination with BVD. In addition, new methods of detecting potential contamination with BVD virus
are introduced into the production process, which will also be subject to the aforementioned variations.

This opinion was forwarded to the Commission on 11 February 2000 and the Commission is currently
preparing a binding decision in accordance with the procedure foreseen in Article 22 of Directive 81/851/
EEC. In accordance with that Article, the Member States and marketing authorisation holders will have to
comply with the Commission decision within 30 days following notification, hence lifting the suspensions
of the national marketing authorisations with the implementation of the requested variations. National IBR
eradication programmes may then be continued.

The Commission fully endorses the view expressed by the Honourable Members that a decision on a
Community referral should be taken quickly in order to avoid possible economic losses of interested
parties. The possibility to adopt such decision quickly is, however, limited by the binding procedures and
time limits foreseen in Community pharmaceutical legislation and the need to carry out a proper scientific
evaluation.

3.
The committee for veterinary medicinal products concluded that the adverse reactions seen in the
Netherlands and in Italy resulted from contamination of administered live IBR vaccine. Inactivated IBR
vaccines have not been under investigation. Nevertheless the Italian authorities opted for precautionary
reasons to suspend also the inactivated vaccine. Obviously, since the inactivated vaccine was not suspended
by the Belgian authority, cattle present in Belgium may have been vaccinated with the inactivated vaccine.

(1) Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States

relating to veterinary medicinal products, OJ L 317, 6.11.1981.

(2000/C 330 E/225)

WRITTEN QUESTION E-0635/00

by Ieke van den Burg (PSE) to the Commission

(3 March 2000)

Subject: Plans for a (cid:145)child care cheque(cid:146) in Carinthia

1.
Is the Commission aware that the Governor of Carinthia, J(cid:246)rg Haider, is planning to pay Austrian
mothers in Carinthia a monthly child allowance for the first six years of a child(cid:146)s life if they stay at home
to look after their children?

Does the Commission not feel that an arrangement of this kind is inconsistent with European rules
it must be seen as

2.
concerning the coordination of social security (EEC 1408/71 (1), etc.) and that
discriminating against non-Austrian women and other inhabitants of Carinthia?

Does the Commission not feel that denying migrants and non-Austrians (or non-EU citizens) this
3.
child allowance is at odds with the European tradition that measures relating to children and child care
must apply to all inhabitants?

(1) OJ L 149, 5.7.1971, p. 2.