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. Senior management is committed to implementing effective measures to prevent, monitor and eliminate bribery.
Following an anti-bribery and anti-corruption review that was undertaken by an independent external consultant in 2021, the policies and procedures were reviewed and revisions were made to existing policies and procedures to enhance oversight and risk management. During 2023, these policies and procedures were reviewed against the onboarding due diligence process for all third parties and training was arranged for employees through an online learning portal. All employees are required to repeat general anti-bribery training annually.
OXB (US) LLC is committed to complying with the US Foreign Corrupt Practices Act and other applicable anti-corruption laws and has an employee-facing policy to maintain compliance with such laws.
Following the acquisition of ABL Europe (recently renamed Oxford Biomedica (France) SAS), and post period-end, the anti-bribery and corruption policies and processes are being reviewed with a view to aligning across OXB’s sites to strengthen and enhance the onboarding due diligence processes with regards to all third parties.
Whistleblowing
Oxford Biomedica’s compliance activities include the prevention and detection of misconduct through policy implementation, training and monitoring. As part of this effort, 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 both UK and US-based employees, and there are procedures in place to protect whistleblowers. A similar reporting channel will be rolled out to employees in Oxford Biomedica (France) in 2024.
Clinical trials
Oxford Biomedica instils transparency, safety and ethics in all aspects of its business, including the design and conduct of its clinical trials with patient safety as a paramount concern. 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 as well as the internationally accepted guidelines for the conduct of ethical clinical trials, specifically ICH-GCP and the Declaration of Helsinki.
Quality Assurance 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.
Oxford Biomedica’s standard operating procedures and the legislative framework covers the risk assessment procedures of the 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).
In line with its strategy to become a pure-play CDMO, Oxford Biomedica discontinued work on internal product development in the second half of 2023. As a pure-play CDMO the Group will not be running clinical trials.
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 Statement 2023 in compliance with section 54 of the UK Modern Slavery Act, which can be downloaded from the Group’s website www.oxb.com.
Many of Oxford Biomedica’s facilities are 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. OXB (US) LLC 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. Post period-end, the Group plans to roll out the Group Supplier Code of Conduct to all major suppliers in the US and France over the course of 2024 and continue to develop tools and processes to educate its people on how to engage with new and existing suppliers on this topic.
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 “R’s” 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.
In addition , 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 pre-clinical 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).
The New Product Committee approves pre-clinical projects reviewing design and animal numbers, and includes ethical review considerations.
Please note that from the end of 2023, Oxford Biomedica is no longer developing products and is therefore not carrying out any animal testing.