The FishMedPlus Coalition was established in December 2015 for a 3 year period, follows a 3-step working approach. The aim of the Coalition is to improve the availability of authorised medicines, including vaccines, for aquatic species in the EU and EFTA countries. The availability of veterinary medicinal products for use in farmed aquatic animals is currently extremely low. This situation is a serious constraint on the prevention and treatment of disease, leading to welfare problems and hampering the growth of European Aquaculture. For this reason, many organisations active in the field of aquatic medicines came together to work collaboratively to find a solution to this problem.
3-step approach taken:
Step 1: Gap Analysis
In order to know which veterinary medicines are urgently needed, in 2016 the Coalition undertook a gap analysis. The aim was to identify the critical diseases or indications for which little or no treatment options are available.
The Coalition focused on salmon, trout, seabass, seabream and carp, which together are making up more than 94% of the weight of production in Europe.
Parasite infections are a main cause of concern in all the fish species examined. Treatment to common parasites often lacks efficacy or is not available. Secondary bacterial infection can occur between parasitic and bacterial diseases. To prevent bacterial diseases occurring (and the need to treat with antibiotics) it is necessary to be able to effectively treat parasitic infections.
The full gap analysis outcome can be seen underneath.
Step 2: Identifying barriers and solutions
Currently the Coalition is finalising the work of step 2; identifying solutions to overcome barriers to having more aquatic medicines available.
The availability of authorised aquatic vaccines and veterinary medicines can be facilitated in a number of ways, namely:
1. Via authorisation of new medicines or vaccines through stimulating the animal health industry to invest more into research and development of fish medicinal products and vaccines.
2. Via extending the marketing authorisation of already authorised products between countries (Mutual Recognition Procedure (MRP)).
3. Via extending existing marketing authorisations to other species via line extensions.
4. Via stimulating industry to invest.
The full barriers and solutions document will be published around end 2018.
FishMedPlus congratulates CMDv for publishing on their website the list of all Fish Medicines licensed in the EU. To see the list, click here.
The list is extremely useful, as now fish veterinarians and producers can easily check for products in other European Countries. The main outcomes of the listing are:
- There are 304 different veterinary medicinal products authorised in the European Union. Around 51% are vaccines, distantly followed by antibiotics, which represent the 29%.
- There is only one centrally authorised product (authorised by the by the European Medicines Agency (EMA) and can be used in all European Union countries), namely CLYNAV. This product is aimed at Atlantic Salmon.
- Almost 31% of the veterinary medicinal products are aimed to Salmon (including Atlantic and Pacific Salmon), closely followed by Rainbow Trout, which received 20% of these products.
The following graph shows the distribution on the number of veterinary medicinal products intended for the different species of fish per country. Italy is the country which has most authorised veterinary medicinal products for fish, closely followed by Greece, Norway and the UK. Eight countries only have one fish medicine authorised, namely the only one centrally authorised product.
Moreover, a new EC Regulation regarding veterinary medicines and medicated feed has been published in the EU Official Journal. The new rules aim to stimulate innovation, give incentives to increase the availability and strengthen the rules around antibiotic use. This include new rules such as a new classification of aquatic animals, longer data protection, and a union database, among others.
Note: The Coalition is chaired by Simon Doherty and previously Peter Jones on behalf of the Federation of Veterinarians of Europe (FVE) and exists of 12 experts both from the aquaculture industry, academia, legislators, the animal health industry and the veterinary profession.