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Constraints on making medicines available are the 5 R’s:

Regulation across countries needs to be consistently applied and ‘gold plating of standards needs to be avoided. Repetition of studies across national borders causes major increases in cost and time to market. Resources: in terms of money, people and time are generally the highest hurdle. Pharmaceutical companies have to investigate the opportunity costs of investing in marine finfish products as opposed to investing in more lucrative areas (e.g. companion animals or horses). Return on Investment: Costs of licensing veterinary medicinal products are not covered by sales potential in marine finfish farming. Need to weigh the opportunity cost of investing in something other than marine finfish farming. Synergies which can be gained from spin -off in developed aquaculture markets. Stage of development of new species farming. When is an industry big enough to pay for its services? Re- setting of goal posts: Re- validation of licences always requires more studies to keep products in the market place.

2 initiatives are proposed

1. Community funding should be available to develop in vitro tests which can be placed in the European Pharmacopoeia to replace the current in vivo standards for batch potency and safety tests for fish immunological products. [Reason: Every year tens of thousands of fish are killed by pharmaceutical companies to fulfil the criteria required by the European Pharmacopoeia for demonstration of potency and safety tests for every batch of fish vaccine produced. Eliminating those in vivo tests will reduce the number of fish recorded as being used in animal research across the EU].

2. An EU funded external audit should be commissioned to show how Member States (including EEA, especially Norway) deliver the outcome of registration of veterinary medicinal products in aquaculture. The report should be made publicly available. [Reason: All Directives are centrally produced and controlled. Practical experience on the ground shows that Member States apply these Directives variably. The whole outcome chain should be investigated, e.g. distribution, labelling, conduct of trials, study requirements and regulatory negotiations conducted while developing licences.]

Dr. Lydia Brown is a veterinarian, graduating from Liverpool University Veterinary School. She holds a PhD from the University of Stirling for her studies in the field of reproductive endocrinology in fish. Dr. Brown takes a special interest in veterinary professional matters and has been President of the Royal College of Veterinary Surgeons, the body charged with overseeing the veterinary profession in the public interest, in the UK. She is also a Fellow of the Royal College of Veterinary Surgeons (FRCVS), which she obtained by thesis and has an MBA from the University of Warwick. She holds a senior position with the pharmaceutical company, Alpharma having overall company responsibility for both the UK and Ireland.

Contact details : lydia.brown@alpharma.com