Regulatory breakthrough will improve medicines availability says NOAH

European Commission proposals to improve animal medicine availability have now been put into action. In a move welcomed by NOAH, the Commission's proposal to allow extrapolation of Maximum Residue Limits (MRLs) for major species to be used to set MRLs for minor food producing species has now been taken up by the EU's Committee for Veterinary Medicinal Products. The animal health industry, through the European Federation for Animal Health, FEDESA, has been in discussion with the European authorities on establishing a more pragmatic approach to product authorisation, with this move a key aspect.

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

At its most recent meeting, the CVMP for the first time recommended the extrapolation of MRLs for 12 substances to all food-producing species. This change of approach means that it should become more feasible for companies to develop niche products and minor species indications, as there will be less development costs.

"This is another positive step forward in the campaign to improve the availability of veterinary medicinal products across Europe," said NOAH chief executive Philip Sketchley. "And healthy food comes from healthy animals. The potential problems that a lack of authorised animal medicines can bring has been recognised by the industry, the veterinary profession and the regulators alike. Extrapolation of MRLs was picked up by Professor Marsh and his team in their report on veterinary medicine dispensing in the UK as one way to help solve the problem, and endorsed by the UK Government in their recent response to the Marsh Report," he said.

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

8 February 2002

Notes for Editors

1. For further information contact Phil Sketchley or Alison Glennon at NOAH, tel. +44 (0)20 8367 3131.

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

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

4. The reasoning for this CVMP initiative is explained in the CVMP paper "Implementation of the note for guidance on risk analysis approach for residues of veterinary medicinal products in food of animal origin" (EMEA/CVMP/069/02), released on 16/01/2002.

5. Previous EU regulatory moves towards increasing the availability of animal medicines include the release of the CVMP note for guidance on risk analysis approach (EMEA/CVMP/187/00, January 2001) and the release of the Commission's document on the availability of veterinary medicinal products (05/12/00)