Society depends on us to conduct effective, ethical and thorough research in the development of our medicines and treatments. We set high standards of ethical practice across all aspects of our research activity worldwide, from clinical trials to research with animals.
We take every safety precaution and responsible decision required of us by regulators around the world. Our Code of Conduct requires that our research be conducted in accordance with all relevant external laws and regulations. It also requires compliance with our Bioethics Policy, which describes our commitment beyond legal compliance and defines the ethical standards, principles and behaviours governing all our research and development (R&D) activity worldwide. Our Global Standard Expectations of Third Parties document outlines our ethical standards for external partners.
We work hard to ensure we are aware of risks to patient safety relating to our business, including the side effects of our medicines and risks to patients from the illegal trade of medicines.
worth of AstraZeneca counterfeit medicines seized through operations led by our Global Security team
Concordat on Openness on Animal Research
2015 Annual Report included our progress update as a founding signatory
Clinical Trial Transparency team
launched in 2015 to continue improving our clinical trial transparency
What we're doing
Patient safety and product security
Developing a new medicine carries inherent risk, and patient safety is our top priority. We carry out extensive pre-clinical and clinical testing to establish the safety and efficacy of a potential new medicine. We submit comprehensive information to regulatory authorities responsible for approving medicines in each country or region.
Key to product security is protecting patients from the dangers of illegally traded (including counterfeits, stolen) medicines. We work closely with our partners to raise awareness of the threats to dismantle illegal trade operations and networks.
Clinical trials and transparency
The clinical trial phase is essential in the development of a new medicine. At any one time, AstraZeneca may have hundreds of clinical trials underway around the world. We take very seriously our commitment to delivering consistently high standards of ethical practice and scientific conduct in all our trials.
In 2015, we created a dedicated Clinical Trial Transparency team, whose primary task is to ensure our compliance with clinical trial policies and governance. We have committed to allowing external parties to request patient-level data and have developed a suite of 95 different patient engagements to aid communication with clinical trial patients.
Research with animals
We are committed to helping the public understand our use of animals and our methods for Replacing, Reducing and Refining the study of animals in research (the 3Rs). While we focus on replacing animal studies with better, more accurate models, we know that in the interim it is essential to provide the best possible animal care and welfare standards available, while using the minimum number of animals required to achieve the benefits.
Our global Bioethics Policy states that all research involving animals must be carefully considered and justified, that the principles of the 3Rs be applied and that the welfare of the animals we use is a top priority. An annual CEO-level award recognises the individual, team or project that has contributed most to our 3R commitment.
In 2015, we compiled our first progress report for inclusion in the first Concordat on Openness on Animal Research Annual Report.
Using human biological samples
The use of human biological samples (HBS), such as solid tissue and biofluids, plays a vital role in developing understanding of human diseases. In carrying out this research, we maintain strict policies and processes that ensure we comply with laws and meet regulatory concerns.
We are not involved in any research on human reproductive cloning, for which there is a UNESCO international ban and country-level legislative bans.
Addressing antibiotic resistance
The increasing resistance of infectious diseases to antibiotics is a global problem. We are helping lead the industry by investing in research and development, and calling on colleagues across the industry, health leaders, patients, physicians and governments around the world to come together through a multi-stakeholder approach to tackle the hurdles that prevent new antibiotics coming to the market.
We believe the fight against antibiotic resistance requires three key developments:
1. Stronger antibiotic stewardship – from selection and dosage to manufacturing controls and environmental stewardship
2. Innovative regulatory pathways that balance the data needed for registration with the unmet medical need
3. Commercial models that are conducive to bringing antibiotics to market.