Legislation and Regulations - The Impact of Medicines’ Availability
World Small Animal Veterinary Association Congress Proceedings, 2017
Chris Walster, BVMS, MVPH, CertAqV, MIFM, MRCVS
The Island Veterinary Associates, Stafford, UK

For treating cats and dogs we have a wide range of licenced products that cover virtually all day to day conditions we are likely to see as veterinarians. We are informed through veterinary journals and periodicals, mailings, visits from pharmaceutical companies, and colleagues on changes in regulations, legislation, or new products. What is the situation for the ornamental fish vet? At most there might be one licenced vaccine available, one or two anaesthetics, and perhaps a handful of antibiotic or ectoparasiticides licenced for use in food fish. The therapeutants we use are likely to be chosen on personal experience, information gleaned from colleagues, under the Cascade (Article 11 of Directive 2001/82/EC) in Europe (www.gov.uk/guidance/the-cascade-prescribing-unauthorised-medicines) or Extralabel use (AMDUCA - Animal Medicinal Drug Use Clarification Act) in the USA (www.avma.org/KB/Resources/Reference/Pages/AMDUCA.aspx).

What are the implications for a veterinarian using drugs as extra-label or under the Cascade? You need to follow the rules (see above websites), you need to ensure safety (any adverse effects potentially including environmental), efficacy (achieve the required result) and quality, although it can be presumed at least for quality, if it is a licenced product in another species, that quality (good manufacturing practice) is inherent. In the EU where koi (Cyprinus carpio) are classed as food fish, you will need to ascertain that the pharmacologically active substance has a maximum residue limit (MRL) under EU Commission Regulation 37/2010 and remember to tell the client the withdrawal period which in most instances would be 500°C days (add the daily water temperature up until you exceed 500). You should also inform the client that you are using the drug off-licence, what the potential risks might be and perhaps that, if anything goes wrong, the buck stops with them, otherwise you could leave yourself open to considerable liabilities. This is not the best of situations for decreasing stress in young vets, clients worried about their pet, or even the welfare of animals under our care.

Is this impact on medicines availability due to current legislation and regulation? To assess this, one needs to look at the market, current legislation (EU, UK, and USA legislation discussed), does it work and what changes, if any, might need to be made.

The Market

It is well known that to bring a new drug to market costs a lot of time and money. To recoup this investment means you need a market and a period of exclusivity. In terms of absolute number, ornamental fish dramatically exceed the combined populations of cats and dogs in several countries (e.g., UK, USA, Germany), although it might perhaps be more realistic, when looking at the market, to base it on the number of households keeping pet fish or number of tanks/ponds. Even then, pet industry figures suggest pet fish would come at least third after cats and dogs. This suggests there is a market but two problems are clearly apparent. Around 2000 species of ornamental fish are kept, although around 30 species would include 95% by number. How many licences would be required? Secondly many pharmaceutical companies have large subsidiaries supplying over the counter remedies for ornamental fish. Does this decrease the incentive to develop licenced medicines? On the plus side one fish formulary provides entries for around 300 products many of which are licenced for use in other species. However, any market development needs to be done in conjunction with the veterinary profession or failure is likely.


The Veterinary Medicinal Products Directive 2001/82/EC (as amended) is the EU Directive from which current legislation derives, e.g., this is implemented in the UK under the Veterinary Medicines Regulations (www.gov.uk/guidance/veterinary-medicines-regulations). The European Medicines Agency (EMA) regulates the three main stages of the medicinal product lifecycle - research and development, marketing authorization, and post authorisation. Of interest is minor use/minor species, the aim being to reduce the data requirements where possible to obtain authorisation (www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/01/WC500219321.pdf).

Within the UK interest is further excited by the Small (Pet) Animal Exemption Scheme (SAES), “Exempted medicines can only contain active substances which have been approved for the purposes of this exemption by the Secretary of State”. (www.gov.uk/guidance/exemption-from-authorisation-for-medicines-for-small-pet-animals). This is also known as the VMR Schedule 6 and from a veterinary perspective Schedule 6 contains little to get excited about although it did prevent removal from the market of some essential, if older, products which would have harmed fish welfare.

In the USA legislation stems from the Federal Food, Drug and Cosmetic Act 1938 (as amended) and is overseen by the Food and Drug Administration’s Center for Veterinary Medicine. Of interest is the Minor Use Minor Species Act (MUMS) (www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/default.htm) which provides for three possible advantages;

  • Conditional approval which can be granted before all data is collected
  • Designation which provides incentives such as grants for research and extended exclusive marketing rights
  • Indexing which is intended for minor species drugs “intended for uses that cannot reasonably go through the standard drug approval process”, and “indexing provides a faster and less expensive process to obtain legal marketing status for eligible products”

Of further importance is AMDUCA already mentioned above which provides for extra-label use and there are two further interesting innovations. The first is Investigational New Animal Drug (INAD)which is aimed to generate publicly available data through research studies. This has provided for the licencing of several aquaculture drugs in the USA as the generated data is available to the public including pharmaceutical companies. The Aquatic Animal Drug Approval Partnership Program (www.fws.gov/fisheries/aadap/home.htm) indicates on its website some 17 available INADs. The second is the Food Animal Residue Avoidance Databank (www.farad.org) which aims to provide open access to comprehensive, up to date information and data for food animal drugs. In theory anyone can ask the question, “I want to use X drug what might be the adverse effect”.

Does it Work?

The regulatory authorities were clearly aware that there was a problem with providing safe, efficacious, and quality medicines to minor species and took many of the steps outlined above well over a decade ago. Certainly, for ornamental fish this does not appear to have led to a golden age of licensed medicines. Perhaps the issue is market failure or simply there is not a market out there, rather than problems with the legislation?

On the face of it the US legislation and supportive programs should address all the issues from the cost of obtaining a marketing authorisation to veterinarians having access to information that can help them defend themselves against any claim. Browsing through the FARAD database shows some excellent information but not much on fish. Anyone can submit a question and expect an answer within 72 hours which seems reasonable. Presumably if a question is submitted, and an answer provided, then the resulting literature search would become available for future reference? If that is the case then it suggests not many fish questions have been submitted. Does that indicate poor awareness by veterinarians of FARAD? Or does it imply a lack of interest?

Does it work? Currently the answer is no and there needs to be a rethink.

Any Changes?

In considering current legislation and the availability of medicines for ornamental fish then the immediate answer is that we need to look again, possibly fusing some of the better ideas and concepts from around the world. As said the USA system seems to address many of the issues but does not appear to be engaging those with most to gain from it. One cannot help concluding that maybe instead of the profession spending time and energy striving for improvement, maybe we just need to get on with working under current legislation and accepting the shortfalls. Since much pharmaceutical usage in ornamental fish is based on colleague interaction then perhaps a significant and useful change would be to build international databases of expert peer reviewed information and experience on pharmaceuticals that could provide data for medicine authorisation applications and references for veterinarians considering using different pharmaceuticals. Of course, this is similar to FARAD and may raise the same problems. At the very least these issues should be discussed looking for a way forward so we as veterinarians can treat the animals under our care with safe, efficacious, and quality products.


Speaker Information
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Chris Walster
Island Veterinary Associates
Stafford, UK

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