Ethics & Compliance Focus Areas

At Astellas, our fundamental mission is to provide our patients with safe, effective medical products that improve their health and well-being. To achieve that mission, it is essential that we engage with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs), and patient organizations to provide them with accurate information about our products, their approved uses, and if necessary, instruction on the appropriate techniques for using the products. Astellas believes that the medical and scientific exchange between manufacturers and healthcare providers are essential to our provision of innovative and reliable pharmaceuticals and contributes to improving the health of patients around the world.

 

Astellas also is committed to engaging in appropriate financial relationships with HCPs and HCOs. Astellas enters into consultant agreements, which are a type of fee-for-service agreement, with HCPs and other business experts when there is a documented and reasonable business need for their unique advice, expertise, or services. All such agreements are based on defined eligibility criteria, based on a fair market value, and are never entered into as a reward or incentive for past, present, or future product use or recommendation. Additionally, Astellas adheres to all transparency requirements across the globe, disclosing financial relationships (transfers of value) in accordance with local law and code. Such disclosures are not only to stakeholders and legislative bodies, but also to the public, fulfilling our obligations of corporate accountability.

 

Healthcare Compliance is an important aspect of our Ethics & Compliance function and helps to ensure that all Astellas interactions with HCPs, HCOs and patient organizations are conducted in a legal and ethical manner and always for the ultimate benefit of patients. Our commitment to the highest standard of ethics is at the center of our global business. Compliance with both the letter and the spirit of all applicable laws, regulations, guidelines and company policies is a critical part of that commitment. All Astellas employees are expected to act with the highest ethical standards and in full compliance with applicable laws, regulations, industry guidelines and internal company policy. This helps to protect the independence of medical decision making and to limit even the appearance of improper influence or impropriety, reinforcing trust in Astellas, our brands, and our integrity.

At Astellas, we place delivering value for patients at the core of everything we do and that includes safeguarding and ensuring the appropriate use of the personal information that is entrusted to us by individuals within the course of our business. Physicians, patients, employees, suppliers, and other individuals may share their personal information with Astellas, and they trust us to keep that information safe, to use it transparently, and to always handle it with care.

 

All Astellas employees and third parties working on behalf of Astellas are committed to respecting and protecting the personal information that people share with us. The Astellas Ethics & Compliance (E&C) Privacy Office ensures that Astellas has a robust Privacy Program in place and provides advice and guidance to business to ensure the appropriate collection, processing, sharing, and retention of personal information across Astellas. In particular, Astellas E&C Privacy has established a documented and structured Privacy Management Framework, which covers 21 basic data processing activities and allows the formation of a consistent Global Privacy Strategy. The organizational structure and the privacy tools and process that have been introduced allow the early identification of privacy risks and their effective remediation at a global scale. At the same time, the Astellas E&C Privacy Office works with our global, regional and affiliate E&C Business Partners to ensure we adhere to all applicable privacy laws and regulations and monitor Astellas’ compliance with them in all countries where Astellas operates.

 

Astellas’ Global Data Privacy Policy and the privacy processes, controls, and security measures Astellas has put in place, constitute the essential framework to protect our organization, its assets and the personal information we are processing.

Astellas has a zero-tolerance policy towards corruption. Astellas strictly prohibits bribery and corruption in any aspect of its business and is committed to complying with all applicable laws, including anti-corruption laws, consistent with its commitment to conducting its business with ethics and integrity.

 

This is a core commitment of Astellas embodied in the Astellas Group Code of Conduct and the Astellas Group Policy on Anti-Bribery and Anti-Corruption Compliance. In addition, Astellas is a signatory to the United Nations Global Compact, including its 10th Principle Against Corruption, and the Tokyo Principles for Strengthening Anti-Corruption Practices.

 

Astellas’ ABAC program is designed to provide reasonable assurance of compliance with Astellas’ commitment against corruption. The program consists of ABAC policies and procedures, trainings and communications, risk assessments, monitoring and auditing, reporting and investigation activities.

 

Astellas has ABAC policies and procedures that embody its commitment against corruption. These policies and procedures are consistent with the U.S. Foreign Corrupt Practices Act, the UK Bribery Act, and other applicable local anti-bribery and corruption laws and regulation. Astellas prohibits all forms of bribery and corruption, including facilitation payments.

 

Astellas is committed to empowering its employees with the knowledge and tools they need to help Astellas fulfill its public commitment against corruption. Astellas requires all employees to complete ABAC foundational training regularly, including annually for those in high-risk countries and for third-party distributors. This training is available in 22 languages. Additionally, Astellas provides specialized ABAC training to target audiences based on their functions or roles in the company, as well as where we have identified risks and needs. The Astellas Global ABAC Policy reflects Astellas’ commitment to conduct business with integrity and the highest ethical standards and to comply with the letter and spirit of all applicable ABAC laws and regulations.

 

Astellas conducts compliance risk assessments and compliance monitoring, including on aspects of its ABAC compliance program. Astellas Ethics & Compliance also works closely with the Astellas Legal Department to investigate potential incidents of ABAC non-compliance and with the Astellas Internal Audit Department on the audit of Astellas affiliates and third parties covering activities that may involve ABAC risks. Astellas continuously seeks to improve its ABAC program based on these activities to assure the program remains effective and up to date in addressing changing risk.

 

Astellas has established an internal control environment designed to comply with J-SOX regulatory requirements to ensure financial reporting integrity as well as fraud prevention and detection. Its financial controls provide complementary assurance of compliance with its anti-corruption commitment.

 

A core principle of our ABAC compliance program is to prohibit third parties from engaging in activities that we prohibit for our own employees. This principle is embodied in the Astellas Group Policy on Anti-Bribery and Anti-Corruption Compliance and the Astellas Business Partner Code of Conduct. To adhere to this principle and mitigate and manage the risk arising from third parties providing services on our behalf, Astellas has established a process to conduct bribery and corruption compliance due diligence assessments on third parties interacting with healthcare professionals or government officials on our behalf. In addition, Astellas periodically exercises audit rights over third parties, and has risk-based ABAC clauses for contractual arrangements with third parties.

Another core element of an effective ethics and compliance program is how a company approaches its own conflicts of interest. That is because the foundation of an effective and robust ethics and compliance program is based on how a company manages its own internal behavior.

 

Conflicts of interest refer to situations where outside activities or other personal interests could impair an employee’s objectivity or judgment when performing their duties. Conflicts of interest also encompass situations where there is a potential conflict between the interests of an employee and Astellas. The Astellas Global Conflict of Interest Policy and accompanying training reinforces for our employees that they are expected to conduct their business activities with ethics and integrity even when no one is observing or there are no potential legal violations. Astellas believes that maintaining this baseline expectation regarding conflicts of interest contributes to our employees conducting their business with ethics and integrity when engaging with stakeholders outside the Company and where legal risks are involved. Engagement in the disclosure process and global training efforts continue to enhance the ability of internal stakeholders to identify potential conflicts, resulting in increased business ownership of compliance.

Astellas is committed to conducting its business in a fair and competitive environment and does not negotiate or reach any agreements with its competitors regarding sales conditions, such as prices, sales plans and strategies, or market and customer shares. We limit our engagement with competitors and avoid any conversation concerning these topics when engagement is necessary, so that such interactions are not construed to reflect the existence of such an agreement.

Astellas relies on its ability to trade worldwide. Astellas markets and sells its products globally, and works cross-border on product development, clinical trials, and other activities, which may involve imports and exports of items. Given the global nature of Astellas’ business, it is critical that Astellas complies with all applicable Trade Controls and Customs regulations. In this respect Astellas International Trade Compliance (ITC) has set up control frameworks regarding Export Control & Sanctions, Business Partner Screening and Customs Compliance to safeguard that Astellas’ products can move smoothly around the globe, delivering value for patients.

 

Astellas is committed to complying with all relevant import, export, and other trade control laws and regulations. The ITC department ensures that all required licenses, permits and customs data are in place prior to an item being imported, exported or domestically transferred. At the same time, ITC provides advice, guidance and training to business partners to create awareness and ensure trade compliance.