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Resolutions voted by the Presidents Meeting of the F.E.A.P.
(2007 - Adelsdorf)
 THE AVAILABILITY OF TREATMENTS FOR FARMED FISH
A PAN-EUROPEAN MANAGEMENT PLAN FOR THE CONTROL OF CORMORANTS
SUPPORT FOR THE DEVELOPMENT OF TRADITIONAL AQUACULTURE IN EUROPE
RESOLUTION 1
THE AVAILABILITY OF TREATMENTS FOR FARMED FISH
Background
For a number of years, the Federation of European Aquaculture Producers has prepared and agreed resolutions about the availability of veterinary medicinal products for aquaculture and has communicated these to the European Commission.
FEAP has warned repeatedly that the lack of available medicines has seriously compromised the welfare of farmed fish.
Fish farmers carry the responsibility for the welfare of their fish stocks but this responsibility is shared with stakeholders within the sector, including the European institutions that set the legislative framework.
The main reasons for the current limited availability of licensed products to treat prevent and treat bacterial, viral diseases (illnesses) and parasites in farmed fish have been identified as being:
- The overall cost of the licensing process
o More than € 500,000 for a licence in one country but even more for additional countries.
- The time required of the private sector for the licensing process is estimated at 2 Full-Time-Equivalent man years per licence. The preparatory work that has to be made, including all trials work, equals another 2 years or more. For the regulatory review and providing responses to questions, up to 1 year of work is needed. For post-marketing
studies, this represents a continuous cost.
- The costs of licensing veterinary medicinal products are not matched by the sales potential of these products in marine and freshwater finfish farming at the present.
- The costs of defending each licence that comes up for regular review are also 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. It is fair to say that licensing can only be supported by larger companies and there are few who see the financial return from the aquaculture market.
- The costs of purchasing the licensed product itself - especially when profitability in the fish farming industry is low.
- The unsuitability of the wording of the "Cascade Principle", in respect of fish, outlined in Directive 90/676/EEC i.e. "...small number of animals ..."
- The 'Minor Usesf or Minor Species' legislation offers no relief to farmed fish species.
- The withdrawal of traditional, inexpensive remedies, often without good scientific reason, has allowed diseases and parasites, which were previously controlled, to proliferate and has had serious implications for fish health, welfare.
o Generic, low cost, materials can never be economically championed and brought to license, under the present system.
An uneven 'playing field' for the sector concerning imported fish e.g. the availability and use of Furazolidone & Chloramphenicol and other generic products used for treatment in non-EU countries.
o The question has been raised as to whether residue checking of imports is sufficient?
Recommendations identified by the FEAP for resolving these issues include the following:
- Authorised medication products should be licensed for finfish rather than individual species (cf. the situation for terrestrial animals).
- Medication products that have been licensed in one Member State should be recognised in another Member State
o A single market is required within the EU with regard to veterinary medicines. It is necessary to re-evaluate the manner in which the data of VMP dossiers are interpreted and to assure that unreasonable objections and additional costs are not imposed by intervening national authorities.
- Recognition that the cascade principle has to be used by veterinarians at present in routine rather than as exceptional circumstance.
- The patent protection period for a newly licensed product for aquaculture should be extended to 15 years.
- Community RTD funding should be made 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.
o Reason: Each year, tens of thousands of fish are sacrificed by pharmaceutical companies to fulfil the criteria required by the European Pharmacopoeia for the demonstration of potency and the 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.
o Reference tests and standards should be devised for the European Pharmacopoeia, which should allow applicants the freedom and flexibility to present test results, generated in difference circumstances and procedures, to support the registration of aquaculture products.
o The development, support and financing of testing facilities across Europe would be a valid investment for facilitating the development of new products.
- 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 publicly available.
o 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.
- 'Minor Use for Minor Species' legislation should be changed to ensure health and welfare protection is not denied to more than one billion farmed fish grown in EU each year.
- Derogations should be provided for continued use of traditional remedies, such as salt,and a review of the science base, on which those already withdrawn, should be made.
- The professional production sector should also work closely with veterinarians and the Pharmaceutical companies in Europe to achieve the goals set out above.
Resolution
The FEAP will be campaigning on this matter, at all available levels, throughout 2008 and requests that the subject becomes a prominent part of the workplan of the European Commission's Advisory Committee on Fisheries and Aquaculture for this period.
RESOLUTION 2
A PAN-EUROPEAN MANAGEMENT PLAN FOR THE CONTROL OF CORMORANTS
Background
An ElFAC working party on the prevention and control of bird predation, specifically examining a Cormorant Management Plan, was held at the Ministry of Food, Agriculture and Consumer Protection, Bonn, Germany from 20th-21st November 2007.
The aim of the workshop was to provide a forum to initiate the work for a pan-European management plan for Cormorants, which would more appropriately take into count the aspects of management of fish stocks, fishing and aquaculture which are affected by, or vulnerable to, predation by Cormorants.
Isolated actions to reduce the cormorant population size in Europe have failed. Therefore such an initiative to start work on a pan-European management plan is timely.
Resolution
The FEAP requests that the European Commission supports the conclusions, suggestions and recommendations of the EIFAC in respect of the development of a pan-European management plan for the control of cormorants in Europe.
RESOLUTION 3
SUPPORT FOR THE DEVELOPMENT OF TRADITIONAL AQUACULTURE IN EUROPE
Background
On the 15th and 16th of November 2007, the European Commission held a conference in Brussels on 'European Aquaculture and its opportunities for development'. Taking into account the growing consumption of fish in the European Community and the already grave deficit of the trade balance in seafood products, it expressed its will to elaborate a full strategy for a
sustainable development of aquaculture in Europe. This strategy would be supported by the European research sector which, although seen as the best in the world, presently often serves the aquaculture industry that is based outside Europe rather than within Europe.
The Federation of European Aquaculture Producers (FEAP) entirely supports the initiative of the European Commission to put into the place the tools which will allow the development of our European aquaculture industry during the next decade.
However, the FEAP feels that, within this conference, great emphasis was being given to some types of fish farming at the expense of others.
Thus, the FEAP feels the Commission must consider all approaches, including traditional methodologies, as appropriate development paths for the future and should not rely only on novel systems of farming which remain as yet unproven.
The FEAP urges the Commission to adopt a more balanced approach to the development of the aquaculture industry in Europe.
Traditional systems of freshwater and marine farming, whether these be flow-through trout farming, extensive pond farming or coastal marine farming have been developed throughout Europe over the last century, each country having its own specificities. As a key example, the pond farming operations assist the maintenance of wetland areas.
These operations have constructed European aquaculture as we know it today, contributing to the economic and social development of rural areas all over Europe.
New aquaculture systems must be looked upon as forms of development initiatives which must take place alongside the consolidation and development of existing farming systems and installations.
Resolution
The FEAP trusts that the Commission will develop a strategy for the sustainable development of European aquaculture that will support all types of aquaculture production systems, new and traditional.
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