WRITTEN QUESTION E-2745/02

by Ian Hudghton (Verts/ALE) to the Commission

(30 September 2002)

Subject: Vaccine to combat infectious Salmon Anaemia

Can the Commission confirm recent reports that an application for approval of a vaccine to combat Infectious Salmon Anaemia has been submitted to the EU?

If so, can the Commission further indicate when it expects to take a decision on this crucial vaccine and what the details are of the vaccine, which is reputed to provide a protection level of more than 90 per cent? Can the Commission confirm that this is being considered as a matter of urgency because of the severe adverse impact that ISA has had on salmon farmers and of the urgent need for a vaccine?

Upon approval, can the Commission indicate whether funding will be made available to salmon farmers in order to allow the vaccine to be properly distributed and to ensure that ISA is eradicated?

Answer given by Mr Byrne on behalf of the Commission

(24 October 2002)

Due to the present legislation on granting of marketing authorisations at Community level(1), the Commission is not in the position to give any information regarding possible applications submitted to the European Agency for the Evaluation of Medicinal Products (EMEA) since such documents are regarded as falling under the intellectual property rights of the company. Equally the Commission cannot take a position on any possible future marketing authorisation on Community level for a veterinary medicinal product including vaccines.

Community legislation only provides for vaccination against ISA in case of an outbreak of the disease and under certain strict conditions. Contingency plans for emergency vaccination against ISA must be drawn up by the Member States in accordance with Annex E to Council Directive 93/53/EEC of 24 June 1993, introducing minimum Community measures for the control of certain fish diseases(2), and submitted to the Commission for approval.

At the moment there is not sufficient scientific knowledge or practical experience concerning ISA vaccines and vaccination against this disease. Furthermore, no vaccine is currently authorised as a veterinary immunological product (vaccine)(3). Therefore, no contingency plan containing provisions for vaccination against ISA has been approved.

Council Decision 90/424/EEC on expenditure in the veterinary field(4), in combination with Commission Regulation (EC) No 2722/2000(5), establishes the conditions under which the Financial Instrument for Fisheries Guidance (FIFG) could, in relation to ISA, provide for a financial contribution for measures taken such as eradication programmes, which, in principle, might include vaccination, and monitoring programmes.

In accordance with these provisions, the Commission may co-finance these actions upon presentation and approval of appropriate programmes.

(1) Council Regulation (EEC) 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, OJ L 214, 24.8.1993.

(2) OJ L 175, 19.7.1993.

(3) Authorised in accordance with Council Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, OJ L 311, 28.11.2001.

(4) OJ L 224, 18.8.1990.

(5) Commission Regulation (EC) No 2722/2000 of 13 December 2000 establishing the conditions under which the Financial Instrument for Fisheries Guidance (FIFG) may make a contribution towards the eradication of pathological risks in aquaculture, OJ L 314, 14.12.2000.