Oxford Biomedica is committed to the highest standards of ethical conduct and integrity in its business activities in the UK and overseas.
Anti-bribery
Oxford Biomedica’s policy on preventing and prohibiting bribery is in full accordance with the UK Bribery Act 2010 as well as other relevant overseas legislation and all employees receive training in this matter. Oxford Biomedica does not tolerate any form of bribery by, or of, its employees, agents or consultants or any person or body acting on its behalf. This prohibition includes the prohibition of facilitation payments made to government officials for carrying out or speeding up routine procedures. Senior management is committed to implementing effective measures to prevent, monitor and eliminate bribery.
During 2021, an anti-bribery and anti-corruption review was undertaken by an independent external consultant. The consultant reviewed the current policies and procedures and met with the Board and 17 members of the senior management team within Oxford Biomedica to understand how such policies and procedures were implemented. The consultant found that there was a strong culture of “doing the right thing” within Oxford Biomedica. Following the review, it was agreed that, in order to reinforce the current policies and procedures, additional training would be arranged for employees during the course of 2022.
Oxford Biomedica Solutions is committed to complying with the U.S. Foreign Corrupt Practices Act (the “FCPA”) and other applicable anticorruption laws and has an employee-facing policy to maintain compliance with such laws.
Whistleblowing
Oxford Biomedica’s compliance activities include the prevention and detection of misconduct through policy implementation, training and monitoring. As part of this effort, Oxford Biomedica’s employees are encouraged to report suspected cases of misconduct in confidence and without fear of retaliation. Concerns and allegations are thoroughly investigated with disciplinary action taken where necessary, up to and including dismissal and reporting to relevant authorities.
An anonymous confidential reporting channel is provided for employees, and there are company procedures to protect whistleblowers.
Clinical trials
Oxford Biomedica instils transparency, safety and ethics in all aspects of its business, including the design and conduct of its clinical trials. Oxford Biomedica’s trials are designed with patient safety as a paramount concern and the protocols are agreed with the relevant national regulatory authorities, as well as local ethics committees and institutional review boards at clinical trial sites, before any patients are treated. Oxford Biomedica has standard operating procedures in place under a controlled Quality Management System to ensure compliance with appropriate legislation for Good Clinical Practice (GCP) as well as the internationally accepted guidelines for the conduct of ethical clinical trials, specifically ICH-GCP and the Declaration of Helsinki.
Quality Assurance (QA) audits are undertaken to give independent assurance that the practices and procedures undertaken for Oxford Biomedica’s clinical trials are in accordance with the relevant legislation and guidelines thereby providing assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial patients are protected. The QA function at Oxford Biomedica puts in place an annual GCP risk based audit strategy which is reviewed on a quarterly basis.
Oxford Biomedica’s standard operating procedures and the legislative framework also covers the risk assessment procedures of the company’s trials. These assessments include consideration of any specific risks to the patient population proposed for the clinical trials especially if any trial were to include vulnerable patients.
Oxford Biomedica is committed to transparency, and information on ongoing clinical trials is provided on the website. Relevant trials in the EU and EEA are automatically posted on the EU Clinical Trials Register (www.clinicaltrialsregister.eu) and Oxford Biomedica discloses its trials on a US government-sponsored website (www.clinicaltrials.gov).
For details on Oxford Biomedica’s policies and approach on ethical R&D see Ethics in R&D.
Human rights and anti-slavery
Oxford Biomedica fully respects human rights and conducts its business in accordance with the letter and spirit of UK Human Rights legislation and the UK Modern Slavery Act 2015. The Board of Directors has approved a Modern Slavery Transparency Statement in compliance with section 54 of the UK Modern Slavery Act, which can be downloaded here. Oxford Biomedica’s facilities are all located in the UK, where its policies accord with human rights regulations and its supply chain operates in territories with strong commitments to human rights safeguarding. Oxford Biomedica Solutions is based in the US and is committed to ensuring its business practices are conducted in compliance with all applicable federal and state legislation in relation to the preservation of human rights and prevention of human trafficking.
Animal testing
It is a regulatory requirement that all new therapeutic products must be appropriately tested for safety before they are administered to patients, and there is currently no alternative to using animal models as part of this process.
Oxford Biomedica is committed to following the principles of the three “Rs” in safety testing: replacement, refinement and reduction of animal testing. These principles ensure that animal testing is only employed when necessary and where there are no alternatives. This includes the following strategies:
- Minimising the use of animal models by cross-referring LentiVector® platform data packages for regulatory authorities
- Optimising in in vitro work with models with multiple configurations, with only the best candidates being moved to in vivo
- Maximising the use of cell lines, human organoids and making use of primary tissue where possible in R&D work to reduce the need for in vivo testing
The New Products Committee approves preclinical projects reviewing design and animal numbers, and includes ethical review considerations. A formalised ethical review process for the New Product Committee has been drafted and will be implemented in 2022.
In addition to this, Oxford Biomedica only works with Contract Research Organisations (CROs) that are accredited to international ethical bodies. Each institution has an internal ethical review of the preclinical work to be conducted (Institutional Animal Care and Usage Committee), and the CROs have international accreditation with AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care).
Further information regarding governance at Oxford Biomedica can be found in our 2021 Annual Report.