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.
AstraZeneca supports the principles of the Nagoya Protocol to protect and value biodiversity. Some of our medicines impact biodiversity on our planet because they are sourced from biological materials. In 2019, for example, our medicine that has the most impact on genetic resources was assessed against the EU Nagoya Protocol regulations. The assessment was conducted using a due diligence tool developed specifically for governing and recording our utilisation of genetic resources in accordance with regional and national access and benefit sharing legislation. The assessment identified an in-scope material and we formally notified the Swiss Government of our use of the material prior to product launch. This is the first time we have had a genetic resource in scope of Nagoya legislation. Our bioethics governance ensured no delay to our medicine manufacture and supply.
Exploring technological alternatives to human biological samples
The use of human biological samples, such as solid tissue, biofluids and their derivatives, plays a vital role in developing a deeper understanding of human diseases and their underlying mechanisms, which helps us create effective, new and personalised medicines. In rare circumstances, we may use human fetal tissue (hFT) or human embryonic stem cells (hESC). In these cases, an internal review of the scientific validity of the research proposal will be conducted and permission to use the tissue will be granted only when no other scientifically reasonable alternative is available.
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.