Bioethics


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.



Highlights


Biodiversity management

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.



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 85% of the animals we use. In 2019 we used approximately 144,000 animals in our own facilities, and a further 35,000 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

We recognise and celebrate our scientists and animal care staff for exceptional commitment to the 3Rs— replacement, reduction and refinement of animals in research. Our C-SAW Global 3Rs Awards is a competitive and highly visible awards programme that recognises excellence in 3Rs science and encourages continuing improvements in animal welfare across our company and with our external partners. Alongside the 3Rs Awards, we also call for nominations for exceptional individuals and teams in the categories of “Culture of Care” and “Openness” about animal research. See highlights from 2019 below.



A novel molecular biology approach that would reduce the numbers of animals needed to screen lipid nano-particles by tagging the molecules of interest.

A refinement to anaesthetic methods in rats, allowing the use of less invasive nose cones instead of intubation during procedures.

A comprehensive programme of work and publications that ultimately provided the science for regulators in Europe to replace some animal studies previously using fish with non-animal alternatives. 

A cross-site collaborative project to encourage the uptake of refined methods of handling laboratory rodents.

An innovative approach to giving our employees an insight into the world of animal research, by developing a 360 virtual tour of one of our facilities.


Read more about Bioethics in our Sustainability Report.