8 February 2002

Regulatorybreakthrough will improve medicines availability says NOAH

European Commission proposals toimprove animal medicine availability have now been put into action. In a movewelcomed by NOAH, the Commissions proposal to allow extrapolation of MaximumResidue Limits (MRLs) for major species to be used to set MRLs for minor foodproducing species has now been taken up by the EUs Committee for VeterinaryMedicinal Products. The animal health industry, through the European Federationfor Animal Health, FEDESA, has been in discussion with the European authoritieson establishing a more pragmatic approach to product authorisation, with thismove a key aspect.

MRLsare set by the EU authorities based on assessing safety and residuesinformation produced by companies in line with very strict scientificrequirements. On top of this, huge safety margins are built into thecalculation. But to produce this information is very expensive and whilecompanies agree that food safety is paramount, there is no scientific basis torepeat the residue studies in full for every species of animal for which themedicine is to be used. Because of the cost, companies cannot afford to developmany products for so-called minor species which includes, in the EU, sheep because there will not be enough sales to cover the development costs. UnderEU law it is illegal to use medicines in species for which there is no MRL;this threatens animal welfare.

At its mostrecent meeting, the CVMP for the first time recommended the extrapolation ofMRLs for 12 substances to all food-producing species. This change of approachmeans that it should become more feasible for companies to develop nicheproducts and minor species indications, as there will be less developmentcosts.

Thisis another positive step forward in the campaign to improve the availability ofveterinary medicinal products across Europe, said NOAH chief executive PhilipSketchley. And healthy food comes fromhealthy animals. The potential problems that a lack of authorised animalmedicines can bring has been recognised by the industry, the veterinaryprofession and the regulators alike. Extrapolation of MRLs was picked up byProfessor Marsh and his team in their report on veterinary medicine dispensingin the UK as one way to help solve the problem, and endorsed by the UKGovernment in their recent response to the Marsh Report, he said.

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NOAHhas always maintained there is no scientific basis or legal requirement for thesetting of individual MRLs for each species. This move is certainly a step inthe right direction and should help encourage new products for minor speciesand uses onto the market, said Mr Sketchley.

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Notes for editors

1. Forfurther information contact Phil Sketchley or Alison Glennon on 020 8367 3131,or e-mail noah@noah.co.uk or visitthe NOAH website www.noah.co.uk

2. TheNational Office of Animal Health was formed on 1 January 1986 to represent theUK companies which research, develop, manufacture and market licensed animalhealth products. The association now has 38 corporate members and 11 associatemembers. In 2000 NOAH's members accounted for around 95% of the 357 million UKanimal health market, with additional valuable exports.

3. Thelist of 12 substances for which the extrapolation will apply is danofloxacin,difloxacin, enrofloxacin, erythromycin, florfenicol, flumequine, lincomycin,paromomycin, spectinomycin, tilmicosin, trimethroprim and tylosin.

4. Thereasoning for this CVMP initiative is explained in the CVMP paperImplementation of the note for guidance on risk analysis approach for residuesof veterinary medicinal products in food of animal origin (EMEA/CVMP/069/02),released on 16/01/2002.

5. PreviousEU regulatory moves towards increasing the availability of animal medicinesinclude the release of the CVMP note for guidance on risk analysis approach(EMEA/CVMP/187/00, January 2001) and the release of the Commissions documenton the availability of veterinary medicinal products (05/12/00)