Volume 1

The revision of the EU Directive on the protection of animals used for scientific purposes / House of Lords. European Union Committee.

  • Great Britain. Parliament. House of Lords. European Union Committee
Date:
2009
Catalogue details

Licence: Open Government Licence

Credit: The revision of the EU Directive on the protection of animals used for scientific purposes / House of Lords. European Union Committee. Source: Wellcome Collection.

    120/260 (page 114)
    ae Oe a 1S See Fee ee a a a EAE Tine RTT ES SEES 1S HE SSeS NT 1 responsible for receiving information on developments in application of the 3Rs from the NCAM, and disseminating that within the establishment. 64. People authorised to conduct animal procedures should also have specific training in the application of the 3Rs. A brief introduction to the 3Rs is currently offered in Britain to new licensees, but is sorely inadequate. Training can be tailored to the functions being performed, as long as it meets a certain minimum level. The training would be provided by the NCAMs and co-ordinated by the EU Centre (discussed above). 65. The British government” and the European Commission? have accepted the potential of non-animal methods to improve science and yield quicker and more cost-effective results. Several scientific reviews have shown that many animal “models” used to study human illnesses are unreliable. Examples include multiple sclerosis, stroke, rheumatoid arthritis, Parkinson’s disease, Alzheimer’s disease and cancers of the lung, brain and bowel. For example, an extensive study examined 221 experiments using over 7,100 animals in research into six different treatments for five human illnesses.24 They found that half the animal experiments failed to correctly predict human responses to treatment. 66. Medical research on animals relies on conditions that are dissimilar to human illnesses, artificially induced in non-human species. In safety testing, most animal tests have not undergone formal validation and there are serious and unsolved inherent problems.”> To secure the health of citizens, the quality and relevance to humans of research and testing must be improved. 67. It is now widely accepted that advanced, non-animal, human-based techniques overcome many of the limitations of outdated animal experiments.2° Test-tube safety methods are more precise, versatile and reproducible than testing drugs and chemicals on animals. For example, every batch of insulin used to be tested for safety by the mouse convulsion method, using 600 mice each time. When the non-animal technique replaced the mouse test, faster and more precise results became available.*’ 68. When chemicals were tested for skin irritation using rabbits, the test took 14 days to complete. In comparison, the new test-tube methods that now replace rabbits take only 42 hours.”® 69. New human cell-based techniques to ensure the purity of injectable drugs were recently validated by ECVAM (the European Centre for the Validation of Alternative Methods). The methods greatly enhance patient safety and are replacing up to 200,000 rabbit tests each year.” They are also a major commercial success with a worldwide market of €200 million, according to the Commission’s Vice-President, Giinter Verheugen, who said: “. . . research in the development of alternatives is not only beneficial for animal welfare but also encourages the development of new markets for these methods.” 70. Ensuring that legislation provides an impetus for further development of these world-class skills in modern, non-animal technologies, will facilitate an essential competitive edge for Britain and the EU in the fast-moving world of science, whilst advancing medical progress and meeting citizens’ concerns about animal experimentation. Q9 Subsidiarity and Legal Base 71. In order to ensure harmonisation of the internal market, action at EU level is necessary in this case. EU funded research is frequently conducted across national boundaries, and markets pertaining to the use of animals in procedures are not confined to single EU MSs. Companies based in one country may contract companies based in other countries to carry out animal procedures on their behalf, and costs associated with the purchase of animals and their care, as well as the training of staff and other welfare-related elements of animal use are likely to produce a wide variation in costs across the various MSs (as is currently the case [1]).*° Because of the potential for wide variations in both the cost of animal procedures and standards of animal welfare, EU legislation should in this case be highly prescriptive and should endeavour to impose both high 22 The Government Reply to the Report of the House of Lords Select Committee on Animals in Scientific Procedures, Session 2001-2002. Presented to Parliament by the Secretary of State for the Home Department, January 2003, p 4 and p 7. Cm. 5729. Commission of the European Communities Commission Working Document on a Community Action Plan on the Protection and Welfare of Animals 2006-2010. Strategic basis for the proposed action. SEC(2006)65. COM(2006) 14 final. Brussels 23.01.06. Perel P, Roberts I, Sena E et al (2007). Comparison of treatment effects between animal experiments and clinical trials: systematic review. Br Med J 334:197. The five illnesses were: head injury, haemorrhage, acute ischaemic stroke, neonatal respiratory distress syndrome and osteoporosis. The inherent problems include: species differences, dosing discrepancies (between tests and real human exposures), and scaling up results from small, short-lived animals (mainly rodents) to larger, long-lived humans. US National Research Council Committee on Toxicity Testing and Assessment of Environmental Agents (2007). Toxicity Testing in the Twenty-First Century: A Vision and a Strategy. Anon. (1985). Reduction of the use of animals in the development and control of biological products. Lancet 2:900-902. See, for example: European Centre for the Validation of Alternative Methods (ECVAM)—ESAC Statement on the scientific validity of in-vitro tests for skin irritation testing. 5 November 2008. http://ecvam.jrc.it Europa release. Fewer tests on animals and safer drugs: New EU tests save 200,000 rabbits per year. Reference IP/03/662. 12 May 2003. [1] Commission Staff Working Paper accompanying the Proposal for a Directive of the European Parliament and of the Council on the protection of animals used for scientific purposes.