Resolutions 2004

Resolutions voted by the General Assembly of the F.E.A.P.

(2004 - Budapest)

PROPOSAL FOR A NEW COUNCIL DIRECTIVE ON ANIMAL HEALTH CONDITIONS FOR THE PLACING ON THE MARKET AND IMPORT OF FISH AND THEIR PRODUCTS AND MINIMUM MEASURES FOR THE PREVENTION, AND CONTROL OF CERTAIN FISH DISEASES.

AVAILABILITY OF MEDICINES FOR FARMED FISH

RESOLUTION 1

(Fish Health & Hygiene Commission)

The FEAP Commission of Fish Health has been actively involved, since 2000, in consultation for the drafting and of the proposed new Council Directive on fish health, replacing the Directives EC 91/67, EC 93/53 and their amendments.

The member associations of FEAP agree unanimously that the proposed Directive, in its present form, does not meet the justified, professional expectations of the European fish farming industry.

The FEAP believes that the conditions contained in the current draft Directive will compromise future fish health status in Europe and that it proposes an inflexible, complex and onerous framework, for both industry and Member States, that does not achieve the stated aims of the Directive.

The documents that have been provided to the FEAP, relating to the draft Directive on which the industry has been asked to comment, are incomplete. The FEAP insists that it should be consulted on the full text and complete annexes before submission of the proposed Directive to the European Council.

In addition, the FEAP has been informed that Member States’ representatives are equally concerned about the consultative procedure being followed and the timetable being imposed by DG SANCO. The FEAP affirms that the preparation of such an important European Directive and its associated decision-making processes should follow reasoned and transparent approval procedures.

RESOLUTION 2

AVAILABILITY OF MEDICINES FOR FARMED FISH

(Resolution of the Dublin PROFET conference 16-17 April 2004)

At a PROFET Workshop held in Dublin, supported by the European Commission within the PROFET project and attended by delegates from European countries where marine finfish are farmed, a session entitled “The availability of medicines for farmed fish” drew a consensus from the Workshop that urgent action is needed at national and EU levels to improve the situation of the availability of medicines before the welfare of the farmed fish stocks in Europe are seriously compromised. The delegates included fish farmers, veterinarians and representatives of Government agencies, the European Commission and the European Medicines Evaluation Authority (EMEA).

The main reasons for the current limited availability of licensed products to treat illnesses and parasites in farmed fish were identified as being:

The overall cost of the licensing process (>€ 500,000 for a licence in one country but even more for additional countries).
The time required for the process is estimated at 2 FTE man years per licence. The preparatory work that has to be made, including all trials work, equals 2 years or more. For the regulatory review and providing responses to questions, up to 1 year of work. For post marketing studies, this represents a continuous cost.
The costs of licensing veterinary medicinal products are not covered by the sales potential of these products in marine finfish farming.
The costs of defending each licence that comes up for regular review is too high.
The market is inhibited by the non-transferability of licences from one Member State to another.
There are significant differences in the interpretations of European regulations from Member State to Member State.
The pharmaceutical market is now dominated by a small number of international companies.
The cost of purchasing the licensed product itself - especially when profits in the farming industry are low.
The unsuitability of the wording of the “Cascade Principle” outlined in Directive 90/676/EEC i.e. “…small number of animals…”
An uneven ‘playing field’ for the sector concerning imported fish e.g. the use of Furazolidone & Chloramphenicol and other generic products in non-EU countries. The question was raised as to whether residue checking of imports is sufficient?

The workshop agreed that the following actions were necessary to prevent a “welfare crisis” in the farmed fish industry:

Authorised products should be licensed for salmonids or finfish rather than one species (cf. the situation for terrestrial animals).
Remedies licensed in one Member State should be recognised in another Member State - A single market within the EU is required with regard to veterinary medicines.
Recognition that the cascade principle has to be used by veterinarians at present is routine rather than an exceptional circumstance.
The time frame for a newly licensed product for aquaculture should be extended to 15 years.
Generic products should be made widely available under an amended cascade principle which also takes into account the numbers of animals being treated in aquaculture.
Community funding should be available to develop in vitro tests that can be placed in the European Pharmacopoeia to replace the current in vivo standards for measuring batch potency and the safety tests for fish immunological products. [Reason: Every year tens of thousands of fish are killed by pharmaceutical companies to fulfil the criteria required by the European Pharmacopoeia for demonstration of potency and safety tests for every batch of fish vaccine produced. Eliminating these in vivo tests will reduce the number of fish recorded as being used in animal research across the EU].
An EU-funded external audit should be commissioned to show how Member States (including the Member States of EEA) deliver the outcome of registration of veterinary medicinal products in aquaculture. The report should be made publicly available. [Reason: All Directives are centrally produced and controlled. Practical experience on the ground shows that Member States apply these Directives in a variable manner. The whole outcome chain should be investigated, e.g. distribution, labelling, conduct of trials, study requirements and regulatory negotiations conducted while developing licences.]
The professional production sector should be directly consulted by the EMEA on all relevant issues dealing with regulation and policy on medicines for farmed fish.
The professional production sector should also work closely with veterinarians and the Pharmaceutical companies in Europe to achieve the goals set out above.

This Resolution was approved by the Aquaculture Working Group of the European Commission’s Advisory Committee on Fisheries and Aquaculture on the 22^nd April 2004 .