Our standards
The welfare of all the animals that 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 Bioethics Policy and standards apply across all our internal animal research and to research conducted on our behalf by contract research organisations (CROs) worldwide.
Our 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. As well as mandatory inspections by government authorities, we have a formal programme of regular peer reviews of our internal animal research facilities, conducted by our own qualified staff.
We review and if required update our standards every two years to make sure that they continue to support our drive for continuous improvement. The next review is planned for 2012.
We support the introduction of new legislation across European Union member states which has created consistent standards regarding the use of laboratory animals. We actively contributed to discussions to ensure that the new EU Directive 2010/63/EU on the protection of animals used for scientific purposes, which became law in November 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 is now being transposed into national legislation over a two year timeframe and we are actively contributing to consultations in Sweden and the UK, where our main European R&D sites are based.
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 contract research organisations where 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 conduct audits to make sure that our expectations are being met.
AstraZeneca has a strategic goal of 40% of our development pipeline coming from external collaboration by 2014. Where animal studies are involved, the collaborators are required to comply with the principles of our Bioethics Policy and we audit through a risk-based audit framework.
Do you use non-human primates?
Yes. We use non-human primates 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 for the development of new medicines.
Our research is increasingly focused on biologics, which means that our primate use has been increasing in recent years - particularly in 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. Our commitment is that from 2013, all our external partners will meet our new global standards for AstraZeneca primate studies. Where necessary, we are working with them to monitor progress as adoption is paced differently for different partners.
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, now embedded into EU law via the new Directive 2010/63/EU on the protection of animals used for scientific purposes, 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 for facilitating other natural behaviours, such as foraging).
All of our primate research during 2011 was undertaken on our behalf by internationally recognised external centres and these organisations all meet our current requirements for the housing and care of primates.
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. This alliance further establishes AstraZeneca’s presence in China, an important emerging market, and will support us in our efforts to bring new medicines to patients around the world. We have provided SIMM with expertise to assist in the design and construction of a new safety evaluation unit that will comply with our Policy and standards for primate use. We continue to work with SIMM through ongoing resource commitment, including secondment of AstraZeneca experts, to deliver full operation of the unit during 2012.
We set out that independent audit and accreditation would be sought before the unit becomes fully operational in 2012. In 2011, SIMM gained accreditation for animal care and welfare from the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC). AAALAC is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programmes. AstraZeneca veterinary professionals will continue to audit the unit to ensure it meets the requirements of our Policy and standards for primate use. SIMM will also be seeking Good Laboratory Practice (GLP) accreditation from the Organisation for Economic Co-operation and Development (OECD). OECD is an inter-governmental organisation whose mission is to promote policies that will improve the economic and social wellbeing of people around the world. If accreditation is granted, OECD , as well as AstraZeneca global research quality management, will audit on a regular basis to verify the compliance with OECD GLP principles.
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.