The safety of the patients who take our medicines is of fundamental importance to us
We want to be recognised for our high-quality science and for the impact we can make on serious disease – and to be trusted for the way in which we do that. This means setting and living up to high standards of ethical practice across all aspects of our research activity worldwide, including clinical trials and research with animals.
Our Code of Conduct requires that our research be conducted in accordance with all relevant external laws and regulations. Our Code 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.
What we're doing
Patient safety and product security
From the discovery of a potential new medicine and continuing throughout its development, launch and marketing we work to ensure that we become aware of any risks to patient safety. Clinical trials cannot replicate the complete range of patient circumstances that exist among larger and more diverse patient populations. Rare side effects can often be identified only after a medicine has been launched and used in far greater numbers of patients and over longer periods of time. Therefore, pharmacovigilance, the practice of monitoring the effects of medical drugs after they have been licensed for use, is a responsibility to our patients that we take very seriously.
We develop patient risk management plans for our medicines to help us identify and reduce risks to patients and, where appropriate, we provide these to the regulatory authorities. Plans are reviewed regularly and updated with new safety information as our knowledge of the medicine’s safety profile evolves. Our global patient safety database is the central source of information for patient safety across our organisation and for reporting to regulatory authorities.
We work with regulators to develop prescribing information that provides healthcare professionals with the benefit and risk information they need, including indications for use, dosing recommendations, warnings and contra-indications, as well as what side effects might be experienced. We also make information available directly to patients, as appropriate, about our medicines and how they should be taken. We have comprehensive and rigorous systems in place for detecting and rapidly evaluating adverse effects, including mechanisms for highlighting those that require immediate attention. We work to ensure that any new safety data that becomes available through our continuous monitoring processes is provided to regulators, doctors, other healthcare professionals and, where appropriate, patients.
Product counterfeiting is a serious patient safety concern as counterfeit medicines often fail to provide effective treatment and sometimes cause direct harm to patients. It is impossible to estimate on a global scale how common counterfeiting is due to its nature: an illegal trade operating below the radar.
Although the scale, complexity and covert nature of counterfeiting activity mean it is impossible to prevent entirely, we aim to protect patients by disrupting counterfeiting networks and operations, and making it as difficult as possible for people to counterfeit our products.
Our Global Product Security strategy focuses on three key areas:
- Building strong partnerships – to strengthen enforcement, raise awareness and provide advocacy to increase the likelihood of regulation in this area being effective and efficient
- Working in enforcement – to combat illegal activity through reporting and professional investigation of suspicions
- Securing our products – through the introduction of pack features and enhanced integrity of the end-to-end supply chain.
As there is no global law enforcement agency or regulator, pharmaceutical companies like AstraZeneca can often act as an interface between authorities in different countries. Investigations conducted by Global Security helped secure the arrest of over 100 people involved in illegal activities in the Asia Pacific and Latin America regions alone in 2014. After a counterfeiting incident in Latin America, our Global Security investigation led to law enforcement dismantling an entire organised crime gang.
What to do if you have a concern about product counterfeiting
If you are concerned that the AstraZeneca medicine you have may not be genuine please contact your doctor (physician), pharmacist (or other healthcare professional) or your health authority. You can also contact AstraZeneca either through this website or in the country where you are based.
AstraZeneca urges patients and healthcare professionals to be alert to the possibility of counterfeiting. Patients can protect themselves from the risks associated with counterfeit medicines by obtaining their medicines from licensed and regulated outlets. Patients should be vigilant when examining their medicines, paying attention to altered or unsealed packaging or changes in the product packaging.
Patients should be aware of the danger of purchasing prescription medicines online/via the internet (the WHO notes that the chances of receiving a counterfeit or substandard medicine are substantially increased by purchasing via unregulated sources on the internet). Any patient wishing to purchase a prescription medicine via the internet should only use online pharmacies that are part of an accredited scheme (for example VIPPS, Verified Internet Pharmacy Practice Sites, in the US).
Clinical trials are the means by which we study the effects of a potential new medicine in humans. Potential new medicines normally undergo three phases of testing before they are submitted to regulatory authorities for an approval to market.
At any one time, AstraZeneca may have hundreds of clinical trials underway in different locations around the world. We take very seriously our responsibility to deliver consistently high standards of ethical practice and scientific conduct in all our trials, wherever they take place.
A potential new medicine is tested in humans only after rigorous and extensive pre-clinical research has confirmed its potential efficacy and safety. All medicines have side effects that may affect some people and so the safety of any medicine needs to be assessed in terms of its benefit and risk profile.
We can’t eliminate completely the risks to clinical trial participants, but we aim to minimise these as much as possible. Our top priority is to make sure that those taking part in our studies are not exposed to any unnecessary risks and that, before they give their consent, they understand fully what taking part in a trial means.
Implementing the highest standards
Our standards are global and apply to all AstraZeneca clinical trials, in all locations, whether they are being conducted by us or on our behalf by external contract research organisations (CROs). If our policies differ from local regulations, we adopt whichever standard is higher.
Our Standard Operating Procedures and policies require that all staff involved in clinical trials and all investigators are trained in ICH guidelines and local Good Clinical Practice regulations. Our standards apply to all AstraZeneca-sponsored clinical trials, in all locations but the conduct of our trials in emerging countries is a specific focus for our compliance monitoring and assurance activities.
Ensuring informed consent
We have a responsibility to ensure that anyone taking part in one of our clinical trials fully understands the potential benefits and risks before they sign up.
Our informed consent process ensures that, along with information on benefits and risks, participants understand the purpose of the trial and how it will be conducted. We also make it clear that they could potentially receive a comparator drug or placebo rather than the new treatment and the likelihood for that.
We work on an ongoing basis with regulatory authorities and our trade associations to ensure consent forms strike the right balance between detail and readability. Much of the detail included is required by law, but they must also be easily understood by participants.
Research use of 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, thereby helping to develop effective, new and personalised medicines.
In carrying out this important area of research, we maintain policies and processes to ensure that we both comply with the law and meet regulatory concerns. AstraZeneca greatly appreciates the generosity of those donating human biological samples for research. We place an emphasis on informed consent that protects the rights and expectations of donors and families throughout the process of acquisition, use, storage and disposal of the samples. Protecting the confidentiality of a donor’s identity is of the utmost importance and a key part of our process includes the coding of biological samples and associated data to maintain the anonymity of the donor (including genetic data).
Stem cell (human induced pluripotent stem cells – hiPSC, or human embryonic stem cells – hESC) technology may offer new opportunities to develop innovative and safer medicines and would help ensure better treatments for patients. The majority of our stem cell work utilises hiPSC – generated by ‘reprogramming’ adult cells to become more stem cell-like. hiPSC provide a less ethically sensitive option to hESC because they can be obtained safely from adult volunteers and do not involve embryos, and we are actively evaluating both technologies. We use hESC when there is no alternative technology that would provide the scientific information required to increase our knowledge of serious disease. We are interested in the potential of stem cells to differentiate into mature human cells allowing more accurate prediction of drug metabolism and certain safety / toxicity outcomes in man. Another area of interest for AstraZeneca where stem cells may prove valuable is for the development of more biologically relevant in vitro models for disease modelling and drug target efficacy evaluation. This would represent a significant step forward in increasing the human relevance of early drug development studies, and help us overcome current limitations that a restricted supply of normal cells presents, as well as potentially reduce animal testing.
In rare circumstances, AstraZeneca may use human fetal tissue. In these circumstances, 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. As with acquisition and/or use of all HBS, AstraZeneca also insists its third party vendors adopt the highest ethical standards and we have been rigorous when assessing the ability of tissue suppliers to meet our quality and ethical expectations. We are committed to minimising the use of fetal tissue by exploring technological alternatives.
AstraZeneca is not involved in any research on human reproductive cloning, for which there is a UNESCO international ban or country-level legislative bans.
Animal studies continue to play a vital role in the search for new and improved medicines. The vast majority of all medicines we have available today have involved some animal research, and animal studies are required by regulators before they approve a new medicine to be tested in humans during clinical trials.
While we will always focus on replacing animal studies with better, more accurate models, we know that in the interim it is essential to provide the best possible case and the highest welfare standards available. Our Bioethics Policy defines the principles, behaviours and ethical standards governing our research and development worldwide.
AstraZeneca is committed to being transparent about our use of animals in research, and as such we have become a signatory of The Concordat on Openness in Animal Research, launched in July 2014. It commits us and other signatories to being clear about when, how and why we use animals in research; enhancing our communications with the media and the public about our research using animals; being proactive in providing opportunities for the public to find out about our research using animals and reporting annually on our progress.
We understand the use of animals is a controversial topic and we encourage you to get the facts and learn more by reading our Research with animals PDF below.
Applying the 3Rs
Our Global 3Rs Awards help to find and implement the best 3Rs ideas, which can be used company wide. Prizes include funds to help develop these ideas share them with the rest of the research community, which benefits animal welfare globally.
In 2014, 33 entries were received. Entries were judged by an internal and external panel of experts in the field, including a representative from the UK’s NC3Rs.
The overall winner of the 2014 3Rs Awards was a project that improves the welfare of fish by letting them choose their anaesthetics.
Fish are used to assess the potential impact of new medicines on the environment, but surprisingly little is known about appropriate anaesthesia in fish. For some experiments the fish need to be anaesthetised to minimise pain and distress. This is done by flowing anaesthetic into the water in the fish tank. However, some chemical substances in the water can be unpleasant or uncomfortable for the fish. This work has shown that zebra fish detect and actively avoid seven of the nine most commonly used anaesthetics and etomidate appears to be the best anaesthetic.
AstraZeneca has implemented the use of etomidate in work with adult zebra fish and shared its results more broadly through publications, thus having even wider impact. This work has stimulated further research in this area, and several laboratories are undertaking wider investigations in this new field.
Find out more about our high standards across our research activities globally:
Selection of position papers
AstraZeneca Subject Matter Experts have provided the following position statements which express our company's position and belief on pivotal biopharmaceutical and bioethical issues: