WRITTEN QUESTION E-0634/00

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

(3 March 2000)

Subject: Eradication of infectious bovine rhinotracheitis (IBR)

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 Bayovac IBR marker vivum and attenuated Rhinobovin marker 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 Bayovac IBR marker inactivatum and killed Rhinobovin marker, 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?

2. Does the Commission consider it necessary to ask Italy to lift its ban on marketing authorisation for Bayer's inactivatum vaccine and Hoechst's killed 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 inactivatum 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authorisation holders informed the EMEA that Bayovac IBR marker vivum and Rhinobovin marker had been voluntarily withdrawn in all Community markets pending the outcome of the Community referral.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

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.