Elements of Astellas’ Global Ethics & Compliance Program
* A Culture of Integrity runs through and is interdependent with an effective Ethics & Compliance Program.

The Astellas Ethics & Compliance Program has at its core a values-based ethical culture of integrity which enables innovation and bold ideas by supporting ethical, compliant and intelligent business risk-based decisions as a core competency for all employees. Our actions and decisions are made to ensure sustainable value is delivered to patients through the provision of risk-balanced, proactive, agile, innovative, expert and practical ethics and compliance guidance.

The Ethics & Compliance Program continues to develop and mature, while standardizing and enhancing the effectiveness of its global program in partnership with the business, through an ongoing cycle of Prevention, Detection, Response and Evaluation.

Prevention

A values-based ethical culture of integrity begins with Astellas leadership which takes accountability and oversight for creating a psychologically safe environment where employees are empowered to make appropriate ethical and compliant decisions. This is strengthened through the efforts of Astellas’ global, regional and local compliance committees and their awareness, knowledge and understanding of ethics and compliance in the context of business operations and activities.

Our comprehensive Ethics & Compliance Program is designed to prevent potential non-compliance or unethical behaviour. Astellas takes steps designed to mitigate risks and to prevent non-compliance through established global policies, processes and systems, tools and controls, and associated training and communications covering ethics and compliance related risk areas.

Compliance risk assessments help identify areas of current and emerging risk which require appropriate mitigation through the design and implementation of standards and controls, appropriate oversight and due diligence of our third-party suppliers and distributors, and targeted and impactful training and communications.

The Ethics & Compliance function deploys multiple online and live training programs to continue to foster compliance awareness and understanding among employees. All employees, including new employees, must complete compliance training on topics such as the Astellas Group Code of Conduct, data privacy, anti-bribery and anti-corruption compliance, and conflicts of interest. In addition, global Ethics & Compliance training programs include a survey to determine training effectiveness. The results of these surveys help Astellas in ensuring training programs are meeting the needs of employees and in turn, update the training to make it even more effective.

Detection

While great efforts are placed on preventing instances of non-compliance, all employees are responsible for ensuring compliance with Astellas policies and the laws, regulations and guidelines that govern our industry. Our goal in Ethics & Compliance is to enable employees and Astellas to make ethical and compliant decisions by providing guidance, clarification and training.

Astellas has partnered with EthicsPoint to provide us with an anonymous and confidential method to hear employees’ suggestions, concerns or reports of alleged misconduct. Reporters have the option of using their names or remaining anonymous if allowed by local laws and regulations.

Additionally, proactive monitoring of business activities and processes may provide opportunities for early detection and risk identification allowing us to help the organization avoid non-compliance in the future through lessons learned discussions, communications and training, and process improvement.

Response

If non-compliance is detected or reports are received alleging non-compliant activities or actions, Astellas will promptly investigate in a fair, robust and objective manner to fully understand the facts and circumstances. If a matter is substantiated, Astellas implements appropriate and proportionate consequences with leadership accountability and support to maintain consistency, objectivity and enforcement of all laws, regulations, policies, SOPs, guidelines and Astellas values.

Reports do not always result in disciplinary action. Many times, we check into the facts and find there is no misconduct, but opportunities for further training and education. We coach individuals on how to provide clear communications or directions to avoid misunderstandings. If there is misconduct, however, we want to address it as soon as possible. Speaking up contributes to making Astellas a better workplace for everyone.

Evaluation

Astellas Ethics & Compliance has processes in place to continuously assess and evaluate maturity and effectiveness of the Ethics & Compliance Program. Evolving established key performance indicators such as training, investigations, disciplinary actions and standardization of programs provide the Astellas Board and Leadership with the awareness and oversight to ensure an adequately and appropriately resourced and empowered Ethics & Compliance Department.