What is Bioethics?
Bioethics refers in the broadest sense to the range of ethical issues that arise from the study and practice of biological and medical science.
Our Approach to Bioethics
While there are many discrete subject matter areas within the field of bioethics, at AstraZeneca we consider them as an integrated whole considering our company values, including putting patients first, following the science, and doing the right thing.
The Bioethics Advisory Group (BAG) brings together the subject matter experts for the main areas of bioethical interest at AstraZeneca:
- Animals in Research
- Precise Genome Editing, Genomic Information and Human Biological Samples
- Nagoya Protocol
- Clinical Research and Patient Safety
- Privacy of Information
- Genetically Modified Organisms
The BAG is sponsored by the Chief Medical Officer. This Global Standard sets out the key policy principles and practices that apply to each of the subject matter areas.
The Nagoya Protocol is an international agreement to ensure fair reward is given to the country of origin that supplies biological resources used in R&D. It regulates access to biological materials and ensures that communities that live where the resources are sourced receive their fair share of benefits. AstraZeneca supports the principles of the Nagoya Protocol to protect and value biodiversity.
We’ve created two main resources to facilitate implementing the principles at our company. The first resource is a training video to raise awareness of our responsibilities to respect the world’s biodiversity. The second resource is an e-tool for our scientists to evaluate how the Protocol impacts their projects. The e-tool tells a scientist whether the biological material is covered by the Protocol. Making assessments as easy as possible for scientists helps to ensure our research is not adversely impacting biodiversity and that benefits from using genetic resources can be shared in accordance with legislation in the originating countries.
Human Biological Samples
Human biological samples are key to all aspects of the development of new treatments, from early research through to being used as potential therapeutics. AstraZeneca understands that use of human biological samples in research and therapy development is a potentially sensitive area and an internal global governance framework exists to guide the collection, storage, use and disposal of human biological samples and associated data. Policy and processes are implemented rigorously to ensure that human biological samples are handled in a responsible and ethical manner. In rare circumstances, following thorough review and consideration of alternative approaches, AstraZeneca will approve use human fetal tissue (hFT) or human embryonic stem cells (hESC).
Reducing use of horseshoe crabs in testing
Endotoxins are bacterial substances that are found everywhere but can cause fevers and be fatal to humans if injected into the body. Pharmaceutical products must therefore be tested to ensure safety.
To test for the presence of endotoxins, biopharmaceutical companies use horseshoe crab blood, which is very sensitive to endotoxins from bacteria. In the medical research process, an estimated 12% of horseshoe crabs die, which is a concern because certain populations are declining. Fossil records indicate horseshoe crabs have been around for 450 million years, but Atlantic horseshoe crabs are currently classified as a vulnerable species, meaning they are likely to become endangered unless the circumstances that threaten their survival are improved.
We recognise the importance of biodiversity and species survival, so we are investing in technology to reduce the amount of crab blood we use in our operations labs by 95%. In 2018, we installed this technology at two sites, which will see a reduction in annual lysate (crab blood reagent) consumption from approximately 7.5 litres to just a few hundred millilitres.
Animals in Research
What is Animals in Research?
The use of animals in research is a small but vital part of the process of bringing new medicines to patients. Although advances continue to be made in non-animal alternatives, some animal studies remain necessary to explore and understand fundamental science, as well as to establish the safety and efficacy of new medicines before they reach patients.
Mice are the most commonly used species, with rodents together making up nearly 95% of the animals we use. In 2018 we used approximately 122,000 animals in our own facilities, and a further 30,000 at external contract research organisations.
Our approach to Animals in Research
We consider the responsible use of animals to be ethically appropriate in biomedical research and product development, where suitable non-animal alternatives are not available. We share the concerns for animal welfare and recognise this as a serious responsibility. We are actively committed to high standards in animal care and to the principles of the ‘3Rs’ – Replacement, Reduction and Refinement of animals in research – as well as being open and transparent about our work with animals. The Council for Science and Animal Welfare (C-SAW) is the expert group leading our global approach to animals in research, promoting the application of the 3Rs, supporting openness about animal use, and providing assurance that we meet our standards. We apply consistent standards to all work involving animals, whether is conducted ourselves or by third parties acting on our behalf.
We have been a signatory to the Concordat on Openness on Animal Research in the UK since 2014. Whilst the Concordat is a UK initiative, we encourage our scientists and animal care teams worldwide to explore opportunities for increasing openness about the use of animals in science.
Promoting Animal Welfare and A Culture of Care
The Council for Science and Animal Welfare (C-SAW) promotes global learning and continuing professional development opportunities for employees working with animals and provides general information and educational opportunities both within and outside AstraZeneca. C-SAW runs a prestigious annual global awards scheme recognising excellence in the 3Rs (Replacement, Reduction and Refinement of animals in research), achievements in openness about the use of animals and the best examples of a caring research culture. Each year, one of the 3Rs award winners is further selected to receive a CEO Award for the 3Rs. In 2019, this went to a group developing microphysiological systems, which are new non-animals approaches holding great promise for reducing reliance on animal studies in the future. Read more about the C-SAW Award winners below.
Predicting in vivo outcome with microphysiological systems and mathematical modelling – CEO Award for the 3Rs
Complex in vitro models have become increasingly important in recent years, making progress towards the reduction and replacement of animals in science. This winning entry showed how these non-animal systems can be used to identify cause and effect mechanisms not possible in animal models, a breakthrough that has the potential to impact the design of animal studies in the future.
Target validation in zebrafish larvae reduces the usage of mice
The genomics initiative team in Gothenburg, Sweden, discovered a way to use zebrafish larvae to significantly reduce the use of mice in labs. The use of zebrafish larvae has enabled the team to screen for potentially important gene characteristics for renal disease, such as heart oedema and kidney cysts. The team uses the larvae to understand their relevance in a biological complex system before initiating any studies in higher species. Using zebrafish larvae is also faster, which could have a positive impact on our resources and getting medicines to patients.
Alternative study design and analysis of syngeneic tumour models
This is an innovative approach to experimental design and analysis that allows the stepwise enrolment of animals on to a study in ‘batches’, still achieving the necessary statistical power but with up to 40% fewer animals involved.
2018 Openness on Animal Research Winner
Showing our staff and students the day-to-day care and use of laboratory animals in our facilities is an important part of openness, but practical considerations limit the number of visits that can be conducted. One of our US teams developed an innovative training and education video, an in-house documentary, taking an in-depth look at how laboratory animals are cared for and used in biomedical research.
2018 Culture of Care Winner
A ‘culture of care’ refers to an environment where people’s behaviours and values are aligned around caring for the animals and for each other. A UK team devised and implemented a “learning and observation log”, which is a systematic framework to capture every event – large or small – that has the potential to impact animal welfare. This approach supports a culture of continuous improvement and attention to making a meaningful difference in animal care and use.