The welfare of all the animals we use continues to be a top priority. Compliance with relevant external laws and regulations is a minimum baseline and underpins our own global Bioethics Policy and animal care standards.
The requirements of our Policy and standards apply across all our internal animal research and to research conducted on our behalf by contract research organisations (CROs) worldwide. These requirements include ensuring that qualified veterinary staff are involved in the development and implementation of all animal care programmes and that everyone working with laboratory animals is trained and competent in their allocated responsibilities. We routinely have inspections by government authorities of our internal facilities.
We support the introduction of new legislation across European Union member states which has created minimum standards regarding the use of laboratory animals. We actively contributed to discussions to ensure that the EU Directive 2010/63/EU on the protection of animals used for scientific purposes, adopted in 2010, strikes a balance between improving animal welfare and maintaining the ability to conduct R&D in Europe that brings benefit for patients. The Directive has been transposed into national legislation in Sweden and the UK, where our European R&D sites are based and we continue to contribute to discussions on implementation.
Do you use external organisations for any of your animal research?
Yes. Whilst most of our animal research is undertaken at our own facilities, we do outsource a proportion of it to CROs when additional capacity and/or specialised expertise is needed. We contractually require these organisations to comply with our Bioethics Policy and standards of animal care, and we undertake audits to make sure that our expectations are being met.
Do you use non-human primates?
Yes, but only in circumstances where no other species or non-animal methods can provide the safety or clinical benefit information that we are looking for and where the outcomes of the study are likely to bring sufficiently significant advances in the development of new medicines.
Our biologics research includes the development of monoclonal antibodies targeted at important areas such as cancer and respiratory disease. Monoclonal antibodies are highly specific to human physiology, so primates are in most cases the only relevant animal model because of their similarity to humans. Primates currently represent significantly less than 1% of our total animal use.
We recognise that there are particular sensitivities around the use of primates in research. We have set global standards of primate care that apply across our primate research worldwide. These standards are based on best practice principles including the Revised Appendix A of the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes. This Appendix reflects current best practice for primate housing and accommodation and gives guidance on providing for the environmental, behavioural and social needs of the animals in a laboratory setting - for example, housing in pairs or groups and providing space for vertical and horizontal flight, as well as opportunities (through environmental enrichment) to facilitate natural behaviours such as foraging.
All of our primate research is currently undertaken on our behalf by internationally recognised external centres. AstraZeneca always directly inspects any facility that conducts studies using primates.
Our strategic alliance with the Shanghai Institute of Materia Medica (SIMM) in China is mainly to conduct pre-clinical drug safety evaluation studies that will involve primates. We provided SIMM with expertise to assist in the design and construction of a new safety evaluation unit , operational in 2012, that complies with our Policy and standards for primate use. AstraZeneca veterinary professionals will continue to audit the unit to ensure it meets the requirements of our Policy and standards. SIMM has AAALAC accreditation for animal care and welfare. AAALAC (the Association for the Assessment and Accreditation of Laboratory Animal Care International) is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programmes.
We do not currently conduct or outsource work using wild caught primates or great ape species. In the rare case where there is no credible alternative model and where a substantial medical need exists, exceptions may be considered. However, this will require rigorous secondary ethical and scientific review – in addition to our normal review processes – to challenge the need for the study and the scientific design of the work programme. Approval to proceed would be made at Board level.