214. Legislation and enforcement procedures within the EU and in the UK in particular ensure that companies may only place medicines on the market once they have been authorised following the consideration of scientific data demonstrating that they are of good quality, are effective when used according to label recommendations, and are safe. Safety includes the assessment of possible hazards to treated animals, other animals, people using the medicines, the environment and, where relevant, consumers of food from treated animals. However, our discussions with the fish farming industry indicate that present and proposed authorisation procedures for vaccines and veterinary medicines may result in some adverse effects on the welfare of farmed fish. It is important that the products of fish farming should be safe for human consumers but we share the concern expressed by the industry and animal protection societies that welfare may be adversely affected because efficacious medications are either not authorised or are not authorised quickly enough. It is also possible that new products may not be developed because of the high cost of generating the data needed for approval.
215. We have been told that in the application for marketing authorisations by pharmaceutical companies, fish are considered minor species. We understand that the data required for authorisation for each species are very expensive to obtain and the process is not usually cost-effective for minority species. It is hoped that data from major species can be used and that delays in authorisation can be minimised so as to encourage the timely application for new or existing products which would be effective for fish as well as other species.
216. A European Commission Regulation setting out Maximum Residue Limits (MRLs) for medicines is currently being implemented, and from January 1997, or a later date if agreed, the pharmacologically active ingredients must have an MRL. This could mean the loss of a number of medicines which are currently available, and this could result in serious welfare problems in the fish farming industry if the outstanding issues are not addressed.
217. The main drugs and chemicals used in the fish farming industry which do not have marketing authorisation for use and which need careful consideration are formalin, malachite green, chloramine, benzalkonium chloride, oxolinic acid, fenbendazole and benzocaine. Some of these ought not to be used without a veterinary prescription and are subject to a minimum withdrawal period of 500 degree-days. The fish farming industry might consider holding regular meetings with relevant sections of the pharmaceutical industry to liaise on disease and medicine developments.