Ethics of Research involving animals
Other issues - continuation II
The international context of animal research
Many tests involving animals are conducted to provide safety or efficacy data for regulatory authorities, in compliance with national or international legislation. Thus, if various authorities require testing to be carried out using different study designs, a single chemical that is marketed in a number of countries might need to be tested several times. Harmonisation of test guidelines, so that a single study design is acceptable to regulatory authorities in many countries, is a very valuable means of reducing the use of animals in safety and efficacy testing. The International Conference on Harmonisation (ICH) has managed to improve mutual acceptance for the pharmaceutical industry, but much still needs to be done to extend this approach to other product areas (paragraph 15.84).
Increased efforts must be made to standardise and harmonise testing requirements, in order to ensure that the minimum number of animals is used at the global level. We therefore recommend that the UK through its National Coordinators at the Organisation for Economic Cooperation and Development (OECD) makes it a priority to identify areas in which harmonisation continues to be difficult and initiates steps to increase adoption of scientifically valid protocols that entail the least adverse welfare costs to the animals involved. We also note that under the Inter-Departmental Concordat on data sharing, regulatory authorities aim to ‘press for agreement on behalf of the UK Government for fullest provisions and procedures which enable data sharing when negotiating, updating and transposing relevant European Directives and when taking part in other international harmonisation processes.’ In order to support the proposed initiative by the National Coordinators at the OECD, we recommend that the UK Inter-Departmental Group on the Three Rs should produce or commission a report on cases where less severe protocols are not recognised internationally, whether for scientific or other reasons, and make suggestions for improving acceptance (paragraph 15.86).
International guidelines also have a crucial role with regard to welfare standards of animals involved in research. There is evidence that relevant OECD guidelines do not use important concepts such as what defines a maximum tolerated dose, severe distress, obvious pain or a moribund condition consistently. Several of the existing OECD test guidelines could also be improved with regard to issues such as environmental enrichment, and conditions of housing, as, for example, some do not specify the requirement for group housing where this would be possible. All these factors can act as potential sources of avoidable suffering for the animals, and we recommend that the OECD review and revise relevant guidelines to achieve greater consistency and to contribute to a wider application of the Three Rs in view of current knowledge (paragraph 15.87).
UK researchers commissioning or undertaking research or testing abroad
There are a number of scientific, Three R-related and logistical reasons why researchers may collaborate with overseas scientists, outsource research work or obtain animals or animal-derived products (such as monoclonal antibodies) from other countries. This interaction can provide a useful means of disseminating good practice developed within the UK. But there is also a need to ensure that the international nature of research is not used to introduce double standards. We note the position statement by the Wellcome Trust, which, as a general rule, we endorse:
‘International research supported by the Trust is expected to be carried out in the spirit of the UK legislation as well as being compliant with all local legislation and ethical review procedures.’2
Further to the requirement implied in this statement, some members of the Working Party would like to see formal provisions in place which ensure that research and testing, both nationally and internationally, is always carried out in accordance with the least-severe protocols, in order to minimise harm to animals used in research. They would also welcome the introduction of regulations that would prevent UK researchers from importing or outsourcing research or research products that it would not be possible to obtain in the UK. Other members of the group, while welcoming the aspiration behind such proposals, have reservations about their appropriateness and feasibility. Members also differ in their views as to whether UK-based research is being driven abroad because of the current, or likely future, regulatory provisions and practice. Despite these disagreements, all members of the Working Party emphasise that maintaining high standards in the UK has the potential to continue to influence regulations positively elsewhere. At the same time, the provisions of the A(SP)A and their implementation also need to be reviewed regularly in the context of national and international developments in policy and public debate (paragraphs 15.88–15.91).
20 The Wellcome Trust Policy on the use of animals in medical and veterinary research, available at: http:
//www.wellcome.ac.uk/doc%5Fwtd002764.html. Accessed on 21 April 2005.