Compliance Training and Communications

Compliance training and communications targeted at the business are important to conducting business activities grounded on high ethical standards and integrity. Astellas regularly educates employees on both existing and emerging compliance risks as well as policies and processes that help us manage those risks. In fiscal 2018, the Ethics & Compliance function deployed multiple online and live training programs to foster compliance awareness and understanding among employees. These training programs included updated anti-bribery/anti-corruption compliance training for employees in high-risk functions, new ethical decision-making training for senior leaders and updated Code of Conduct training. In addition, all of the global Ethics & Compliance training programs deployed in fiscal 2018 included a survey to determine training effectiveness. The results of these surveys will assist Astellas in ensuring training programs are meeting the needs of employees and in turn, update the training to make it even more effective.

Astellas’ Integrity in Action program reinforces the importance of taking responsibility, acting ethically and leading by example. As part of Astellas’ ongoing commitment to this program, our training and communication materials continue to embed the Astellas Way values and a patient-focused mindset, so employees can see how policies and procedures help them live the Astellas mission.

All employees, including new employees, are required to 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.

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Continually Enhancing and Sustaining an Ethical and Compliant Culture at Astellas

Astellas leaders and managers are critical to the effective promotion and protection of the Astellas core values of integrity, ethics and compliance within their teams. In fiscal 2018, Ethics & Compliance function deployed workshops to leaders and managers dedicated to providing insight into key ethical concepts that impact decision-making and the practical tools leaders and managers can use, as well as help their teams use, to support ethical decision-making. Employees who participated received four months of follow-up ethics-related materials to reinforce the concepts learned in the workshop.

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Compliance Risk Assessments

The ability to effectively assess compliance risk at local, regional and global levels is a foundational element of Astellas’ compliance program. These assessments enable Astellas to more quickly identify and better respond to existing and emerging compliance risks.

The internal activities assessed in compliance risk assessments (“CRAs”) continue to include transfers of value in any form to healthcare professionals, market access activities, interactions between the Company and government officials or healthcare professionals, and meals, gifts, or hospitality.

In fiscal 2018, Astellas continued to conduct CRAs based on a globally consistent process, in a number of countries around the globe. The CRAs involved both the assessment of external environmental risk in each of the countries as well as assessment of internal risks within the affiliate arising from business operations. The results are discussed with the local management team to develop a Risk Mitigation Plan, which is then tracked until closure. The findings of the CRAs continue to help Astellas enhance compliance programs in each country, and monitor trends in risks at the regional and global levels. The Ethics & Compliance function works closely with the business throughout the assessment process and helps develop and support any risk mitigation plans developed to address the identified risks.

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Compliance Monitoring

Compliance monitoring is a key component of any compliance program. Astellas monitors existing and emerging compliance risks and trends across a variety of activities. Doing so allows us to better anticipate potential issues before they become actual problems for the Company. In fiscal 2018, Astellas continued to enhance its monitoring program and activities in each region. Compliance monitoring yielded results that not only informed our compliance program, but also provided management with insights to inform their decision-making on various process improvements. One of the many positive outcomes of our ongoing enhancements to the monitoring program this year was the creation of monitoring tools that enable Ethics & Compliance to provide visualizations of monitoring results on demand.

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Conflicts of Interest

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 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 internal 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.

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Transparency

More and more countries and government organizations are requiring transparency with respect to pharmaceutical company relationships with healthcare professionals and healthcare organizations. Astellas engages in appropriate relationships with healthcare professionals and organizations throughout the world. The disclosure of relevant financial relationships with healthcare professionals and organizations reflects our commitment to corporate accountability to both internal and external stakeholders. Astellas is committed to fulfilling its transparency requirements through the work of its global transparency team in coordination and collaboration with multiple business functions across the organization.

In Japan, Astellas has continued to make public financial relationships with healthcare professionals or organizations and patient organizations in accordance with the Transparency Guideline published by the Japan Pharmaceutical Manufacturers Association. In the Americas, Astellas adheres to reporting requirements set forth by the federal Sunshine Act, U.S. state laws, and Brazil state reporting requirements. Across Europe, Astellas discloses transfers of value to healthcare professionals or organizations based on the disclosure requirements established by the European Federation of Pharmaceutical Industries and Associations. In Australia, Astellas’ external transparency reporting meets the requirements of Medicines Australia’s Code of Practice.

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