Page 167 - WSAVA2017
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WSVA7-0405
FISH DISEASES
LEGISLATION AND REGULATIONS - THE IMPACT OF MEDICINES’ AVAILABILITY
C. Walster1
1Stafford, United Kingdom
LEGISLATION AND REGULATIONS - THE IMPACT OF MEDICINES’ AVAILABILITY
Chris Walster BVMS MVPH CertAqV MIFM MRCVS The Island Veterinary Associates
132 Lichfield Road
Stafford ST17 4LE
UK Chris.walster@onlinevets.co.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 Extralabel 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 500oC 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.
Legislation
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 Authorisation 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
An Urban Experience
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