## RESEARch 

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

Astellas conducts research on human subjects and research on specimens derived from humans, following obtained appropriate consent in accordance with the laws, regulations and guidelines of relevant countries. In Japan, Astellas offers 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. Furthermore, Astellas has an Astellas Research Ethics Committee, which consists of nine members of both genders, including 4 outside members. The Committee deliberates on the scientific propriety and the ethical acceptability of research. In fiscal 2013, the Committee met 12 times and deliberated on 27 issues. 

## Ethical Considerations in Animal Testing 

Astellas has established the Institutional Animal Care and Use Committee, in which outside members participate as committee members, overseeing the Company’s animal testing and breed- ing plans in Japan. In fiscal 2013, the Company established the Global Policy for the Use and Care of Animals. 

Astellas’ initiatives in animal testing are recognized by AAALAC International*. As a result, all of Astellas’ animal testing facilities in Japan and our U.S. subsidiary Agensys have acquired accredita- tion from AAALAC International. In fiscal 2013, the Tsukuba Research Center and the Yaizu Technology Center received follow-up audits by AAALAC International to renew their accredi- tations. In March 2014, the accreditations of both facilities were renewed. 

* 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 both from scientific and ethical standpoints to verify the quality of animal control and use programs. 

## clInIcAl DEVEloPmEnT 

## Protection of Human Rights, Privacy and Confidentiality of Personal Information of Research Subjects, and Assurance of Reliability in Clinical Trials 

In clinical trials, we investigate new drug candidates developed through drug discovery research in further detail, and assess their efficacy and safety in patients. Under the Helsinki Declaration*, clinical trials must be fully ethically planned and safely conducted with full consideration to protecting the human rights and privacy 

## Biosafety Control 

Experiments using genetically modified organisms, or materials containing pathogens are performed under the World Health Organization (WHO) Laboratory Biosafety Manual and the Centers for Disease Control and Prevention (CDC)/National Institute of Health (NIH) Biosafety in Microbiological and Biomedical  Laboratories , as well as the laws of individual countries. In Japan,  Astellas has established biosafety management rules in compli- ance with the Cartagena Protocol on Biosafety* and related ministerial ordinances, and has set forth detailed handling proce- dures. 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 (1,037 participants in fiscal 2013), in order to rigorously enforce safe and proper biosafety management and use of these organisms and suchlike. In the U.S., we conduct such experi- ments based on the rules established by the occupational health and safety (OHS) authorities. 

* Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms 

## Handling of Intellectual Property 

Astellas regards its intellectual property (patents in particular) relating to new compounds or other findings as valuable busi- ness assets. Employees receive ongoing training to raise their awareness on obtaining patents and swiftly making patent appli- cations and acquiring rights. At the same time, we emphasize respecting the rights of others. We make sure our research does not infringe on third-party patents, and if necessary, we obtain approval to use them so as not to infringe on the patent estate of others. 

In fiscal 2013, we unified the standards underlying our approach to intellectual property on a global basis by establishing the Global Policy on Intellectual Property. 

of clinical trial subjects. Furthermore, it is crucial to conduct assessments in clinical trials scientifically and accurately in order to develop new drug candidates into drugs that can be used confidently by patients. Accordingly, Astellas has a clinical devel- opment framework in place to ensure compliance with GCP and relevant laws and regulations. Moreover, our clinical trials are conducted only at medical institutions complying with the rel- evant laws and regulations. 

