WRITTEN QUESTION E-2745/02 by Ian Hudghton (Verts/ALE) to the Commission. Vaccine to combat infectious Salmon Anaemia.
Date: 2002-09-30
Institutions: European Parliament, Provisional data
Subjects: Community certification, FIFG, fish disease, fish farming, market approval, pharmaceutical legislation, vaccination, vaccine, veterinary drug, veterinary legislation

6.3.2003

EN

Official Journal of the European Union

C 52 E/209

Control measures to be taken against IHN, and other diseases included in list II of Annex A to Council
Directive 91/67/EEC of 28 January 1991, concerning the animal health conditions governing the placing
on the market of aquaculture animals and products (1), are laid down in particular in Council Directive 93/
53/EEC of 24 June 1993,
introducing minimum Community measures for the control of certain fish
diseases (2). In principle, this Directive imposes that in case of IHN being suspected or confirmed within
any area of the Community, certain movement restrictions must be applied and investigations carried out.
The legislation also gives tools for Community approval of programmes and status for zones and farms
with regard to IHN. Specific requirements, as regards sampling, movements and eradication measures
apply to such zones and farms.

The entire territory of Denmark, Ireland, Sweden and the United Kingdom, as well as several zones and
farms in Germany, Spain, France and Italy have approved status for IHN (3). In other zones and farms,
programmes (cid:1) with a view to achieve approved status (cid:1) are applied (4).

As regards infectious salmon anemia (ISA), it is included in list I of the above-mentioned annex. The rules
applying to list I diseases are more stringent than those for list II diseases. Obligatory control measures that
apply when ISA is suspected or confirmed throughout Europe are laid down in Directive 93/53/EEC.

The species listed in Directive 91/67/EEC as susceptible to IHN are salmonid species and Pike fry (Esox
lucius).

(1) OJ L 46, 19.2.1991.
(2) OJ L 175, 19.7.1993.
(3) Commission Decision 2002/308/EC of 22 April 2002, OJ L 106, 23.4.2002.
(4) Commission Decision 2002/304/EC of 19 April 2002, OJ L 104, 20.4.2002.

(2003/C 52 E/232)

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)

legislation on granting of marketing authorisations at Community level (1),

the
Due to the present
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.

C 52 E/210

Official Journal of the European Union

EN

6.3.2003

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
(cid:1) 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.

(2003/C 52 E/233)

WRITTEN QUESTION P-2753/02

by Isabelle Caullery (UEN) to the Commission

(25 September 2002)

Subject: Blocking of electromagnetic waves

Can the Commission clarify whether current legislation, and in particular consolidated Directive 89/336/
EEC (1) on electromagnetic compatibility and Recommendation 1999/519/EC (2) on the limitation of the
exposure of the general public to electromagnetic fields, permits a Member State to put in place or
authorise the putting in place of systems that prevent the emission of radio waves, in particular from
telephone and mobile telephone relay stations, in certain public places such as hospitals?

(1) OJ L 139, 23.5.1989, p. 19.
(2) OJ L 199, 30.7.1999, p. 59.

Answer given by Mr Liikanen on behalf of the Commission

(24 October 2002)

The Honourable Member asks whether it would be in accordance with Council Directive 89/336/EEC of
3 May 1989 on the approximation of
the Member States relating to electromagnetic
compatibility, and Council Recommendation 1999/519/EEC of 12 July 1999 on the limitation of exposure
of the public to electromagnetic fields (0Hz to 300GHz), for Member States to allow the sale of equipment
for preventing emissions of electromagnetic waves, notably from mobile telephony base stations and hand
sets, in particular for application in hospitals.

the laws of