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WRITTEN QUESTION E-2745/02
by Ian Hudghton (Verts/ALE) to the Commission
(19 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?
E-2745/02EN
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 , 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 , 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) . Therefore, no contingency plan
containing provisions for vaccination against ISA has been approved.
Council Decision 90/424/EEC on expenditure in the veterinary field , in
combination with Commission Regulation (EC) No 2722/2000 , 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. |
