Astellas is committed to fulfilling its social responsibilities in the course of conducting business activities. We respect human rights in every stage of our value chain, from research and development to the provision of product information. We also endeavor to ensure compliance with the Pharmaceutical and Medical Device Act and other relevant laws and regulations.

Research

Ethical Considerations in Research on Human Subjects and Specimens Derived from Humans

Astellas conducts research on human subjects, and obtains and conducts research on specimens derived from humans after appropriately obtaining the consent of trial subjects in accordance with the Helsinki Declaration* as well as the laws, regulations and guidelines of relevant countries.

In Japan, Astellas provides training for researchers in areas such as bioethics, genomic research and clinical studies, based on a strong commitment to respecting the human rights of research subjects, protecting privacy and ensuring the reliability of research.

In addition, Astellas has the Astellas Research Ethics Committee, which consists of 10 members of both genders, including 5 outside members. The Committee fairly and impartially determines the ethical acceptability and scientific propriety of research plans, including perspective from information in potential conflicts of interests on the part of research institutions, researchers and other parties. In fiscal 2014, the Committee met 12 times and deliberated on 34 issues.

*Helsinki Declaration: A statement of ethical principles for medical research involving human subjects, addressed to physicians and others who are involved in medical research on human subjects.

Ethical Considerations in Animal Testing

Astellas conducts animal testing based on its Global Policy for Animal Care and Use. We have established the Corporate Institutional Animal Care and Use Committee, in which outside members participate as committee members, at our animal testing facilities.

Astellas' initiatives in animal testing are recognized by AAALAC International*. As a result, all of our animal testing facilities have acquired accreditation from AAALAC International.

*AAALAC International: The Association for Assessment and Accreditation of Laboratory Animal Care International. An organization that promotes the humane treatment of animals through voluntary accreditation and assessment programs. Studies are undertaken from both scientific and ethical standpoints to verify the quality of animal control and use programs.

Biosafety Control

Experiments using genetically modified organisms, or materials containing pathogens are performed under the World Health Organization Laboratory Biosafety Manual*1 and the Centers for Disease Control and Prevention/National Institute of Health Biosafety in Microbiological and Biomedical Laboratories*2, as well as the laws of individual countries. In Japan, Astellas has established biosafety management rules in compliance with the Cartagena Act*3 and related ministerial ordinances, and has set forth detailed procedures for handling experimental materials. We have also set up the Biosafety Committee to review whether the experiments meet the standard required by these rules. Laboratory personnel receive regular training courses once a year (1,000 participants in fiscal 2014), in order to rigorously enforce safe and proper biosafety management and use of these organisms and suchlike. In the U.S., we use such experimental materials based on the rules established by the occupational health and safety authorities.

*1 Laboratory Biosafety Manual 3rd Edition
*2 Biosafety in Microbiological and Biomedical Laboratories 5th Edition
*3 Cartagena Act: Law concerning the conservation and sustainable use of biological diversity through regulations on the use of living modified organisms.

Treatment of Intellectual Property

Astellas regards its intellectual property in connection with new drugs, particularly patents for new drug candidates, as valuable business assets. Employees receive ongoing training to raise their awareness on filing patent applications swiftly and obtaining patent rights. At the same time, we emphasize respecting intellectual property rights of third parties. We make sure our research does not infringe on third-party patents, and if necessary, we receive a license from patent owners.

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