Astellas has established a committee inside the Company that  evaluates and monitors the ethical propriety and scientific validity  of clinical studies from their planning phases. In addition, we  implement education and training for employees and other staff  members who are involved in clinical trials, and conduct monitor- ing of medical institutions that perform trials to ensure that clinical  trials are performed properly according to GCP. In the course of  performing clinical trials, Astellas confirms that trial subjects have  provided their informed consent to participating in clinical trials,  i.e., they have given their consent based on a full explanation of  the substance of the trials and other details. Moreover, we prop- erly administer the trial data so as to protect the privacy and  confidentiality of personal information of the trial subjects. * 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. Astellas provides disclosure of information on conflicts of interest*  to ensure transparency in its relationships with medical institutions  performing clinical trials. In Japan, Astellas discloses research expenses and other fees/ charges paid to medical institutions in line with the Transparency  Guidelines of the Japan Pharmaceutical Manufacturers Association  Ensuring Transparency in Relationships With  Medical Institutions in Clinical Trials Anti-Counterfeiting Activities Product Recalls The World Health Organization (WHO) defines a counterfeit  medicine as “one which is deliberately and fraudulently   mislabeled with respect to contents and/or source.” Counterfeit  medicines in commercial distribution not only prevent patients  from receiving medical treatment, but could also impair people’s  health. Counterfeit medicines have therefore become a serious  problem worldwide. Under these conditions, Astellas has established the  Anti-Counterfeit Committee to help prevent and respond to  counterfeit medicines globally. It has also appointed members to  investigate and take action against counterfeit medicines. When  selling products, Astellas systematically introduces effective  anti-counterfeit technologies based on risks in each market  where products are sold and product characteristics. Additionally, Astellas carries out educational activities to  prevent the spread of counterfeit medicines, in collaboration with  members of the pharmaceutical industry and international  organizations, such as the WHO, as well as the Pharmaceutical  Security Institute and the Transported Asset Protection Association.  We also support and cooperate with law enforcement agencies,  such as INTERPOL, as well as national governments, judicial  authorities and others to crack down on counterfeit medicines. Astellas has a recall system that is activated when the safety,  efficacy or quality of a product is brought into question. The  system ensures that the relevant information is promptly passed  on to medical institutions and other affected parties, and a recall  of the product in question. If an event affecting safety, efficacy or quality occurs, an inter- nal committee is convened to assess the risk posed to patients.  A process is in place whereby a decision on a product recall is  made based on the judgment of the committee.  In fiscal 2013, Astellas voluntarily recalled six products on a  global basis. As of June 2014, we have not received any reports  of health impairment related to these recalls. Astellas has formulated a global policy on the disclosure of  clinical trial information and results. At the same time, we are  working to disclose information on clinical trials by publishing  academic papers on the trial results. Astellas believes that significant benefits of public health are  acquired from disclosure of study information and results widely,  not only to medical professionals and patients, but also to  researchers and the general public. Besides providing informa- tion to patients who are eagerly awaiting the development of  new drugs, we also believe that the disclosure contributes to  medical progress by inducing the effective use of trial results  obtained through the cooperation of trial subjects. We also  believe that disclosure of this information is crucial to the  advancement of medicine. on our website (http://www.astellas.com/jp/transparency/  index.html (Japanese only)). These efforts are directed at improv- ing transparent relationships with these medical institutions.  * Conflicts of Interest: When companies entrust clinical trials to medical  institutions, a variety of potential conflicts of interest arise between the two  parties, including those concerning the payment and receipt of research  fees. For the purpose of making the relationship between the two parties  transparent, the potential conflicts of interests that arise between the two  parties as a result of performing clinical trials must be disclosed.  Disclosure of Study Information and  Publication of Study Results QUAlITy AnD RElIABIlITy ASSURAncE (REGUlAToRy AFFAIRS (RA), QUAlITy ASSURAncE (QA), clInIcAl AnD RESEARch QUAlITy ASSURAncE (cRQA), PhARmAcoVIGIlAncE (PV)) Annual Report 2014 _  Astellas Pharma Inc.  55 Review of Operations