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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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 Declaration of Helsinki, clinical trials must be ethically planned and safely conducted with full consideration to protecting the human rights and privacy 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 development 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 relevant laws and regulations.

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 monitoring 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 properly 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.

Ensuring Transparency in Relationships With Medical Institutions in Clinical Trials

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 on our website (http://www.astellas.com/jp/transparency/index.html (Japanese only)). These efforts are directed at improving 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 Results

In order to enhance the transparency of clinical study information, Astellas revised its global policy on the disclosure of clinical trial information and results*1 in May 2014. The new policy provides detailed description on Astellas' basic policies on the clinical trial information registration, disclosure of clinical trial results, and disclosure of study data to scientists and healthcare professionals.

As an initiative to enhance accessibility to clinical study data and related study results, Astellas has launched an external website*2 to successively disclose anonymized study data in accordance with the laws and regulations of various countries.

Astellas believes that disclosure of this information is crucial to the advancement of medicine and will contribute to even better treatment options for patients.

*1 For details, please visit the following website
https://www.astellas.com/about/policies-and-position-statements?param=expend-tit-data
*2 For details, please visit the following website
http://www.clinicalstudydatarequest.com
*3 Summaries of study results are disclosed on the following website:
http://www.astellasclinicalstudyresults.com/Welcome.aspx

 

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Quality and Reliability Assurance (Regulatory Affairs, Quality Assurance, Clinical and Research Quality Assurance, Pharmacovigilance)

Anti-counterfeiting Activities

The World Health Organization (WHO) defines a counterfeit medicine as follows: "A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source." Counterfeit medicines in legitimate supply chains not only lessen the therapeutic benefit expected from receiving medical treatment, but could result in treatment failure or even death.
Counterfeit medicines have therefore become a serious problem worldwide.

Under these conditions, Astellas operates the Anti-Counterfeit Committee, led by the technology and quality assurance divisions, and has a specialized anti-counterfeit division in place.
Through these organizations, Astellas conducts monitoring, surveys, countermeasures and other actions targeting not only counterfeit medicines, but also diversion, smuggling, theft and other such activities.

When selling products, Astellas systematically introduces effective anti-counterfeit technologies based on pharmaceutical laws and regulations (including serialization) and risks in each market where products are sold, as well as product characteristics.

Moreover, Astellas takes proactive steps to gather information and implements other countermeasures in collaboration with the relevant authorities and pharmaceutical companies worldwide. One example is Astellas' participation in the activities of the PSI*. In July 2014, Astellas also helped to host the 2014 APAC Pharmaceutical Security Conference. 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 PSI 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.

*PSI: Pharmaceutical Security Institute

Product Recalls

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 relevant information is promptly passed on to medical institutions and other affected parties, and that a recall of the product in question is instigated.

If an event affecting safety, efficacy or quality occurs, an internal 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 2014, Astellas initiated three voluntarily product recalls. As of June 2015, we have not received any reports of health impairment related to these recalls.

Anti-doping Measures

Doping is associated with a risk of inducing serious side effects triggered by the abuse or misuse of pharmaceuticals. It can also facilitate the unauthorized distribution and counterfeiting of medicines. Therefore, doping is a serious issue for the pharmaceutical industry. In January 2015, Astellas participated in an international anti-doping conference jointly hosted by the World Anti-Doping Agency (WADA), UNESCO and the Japan Anti-Doping Agency (JADA) in Tokyo. In light of this conference and recent trends, Astellas is exploring specific measures to support WADA in fighting against doping.

Quality Policy

We have created the Astellas Quality Assurance Manual, which covers group-wide policies concerning quality assurance. Based on this manual, we prepare guidelines and standard operating procedures concerning operational management and procedures for a variety of quality assurance tasks and quality assurance systems at the global, regional and local levels. Education and training programs are implemented to promote understanding and awareness of these matters. These documents are revised periodically and as necessary. We have a system in place that is able to respond swiftly to developments in the external environment, such as regulatory changes and amendments.

Enhancing the Pharmacovigilance System

Astellas is continuously improving business process and system with the aim of establishing a high-quality pharmacovigilance system that can address regulatory requirements in all countries where we conduct business. Specific initiatives completed with establishing an organization that can globally integrate and implement pharmacovigilance work which was previously conducted in each region and, with integrating the new database on safety information worldwide in April 2014. We also established the Astellas Corporate Pharmaceutical Products Safety Policy, which defines the roles that should be fulfilled by all employees, including contract employees. These initiatives have further enhanced the consistency and effectiveness of Astellas pharmacovigilance functions in supporting all products from the clinical development to post-marketing stages.

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Technology Development & Manufacturing

Stable Supply and Quality Control

In drug manufacturing, we place the highest priority on ensuring a stable supply of safe and effective pharmaceuticals to patients. To ensure this, we have established our own quality standards in compliance with GMP and also meeting our high expectations to products' quality. We apply these standards to manufacturing facilities and equipment, as well as all stages from the procurement of raw materials through to storage, manufacturing processes and shipments. We are also working to improve packaging designs for patients and healthcare professionals to reduce the risk of any misuse of medicines.

Measures to Prevent Medical Malpractice and to Improve the Distinguishability of Pharmaceuticals

Astellas strives to supply products from the users' perspective to ensure that healthcare professionals and patients do not mistake one pharmaceutical for another. We are taking a number of steps to prevent medical malpractice in this respect, including printing product names directly on capsules and tablets, and printing product names and dosage on packaging sheets (blister sheets) so that the product name and dosage can be identified even after the blister sheet is split apart. To make products easier to identify visually, we have adopted easily discernible colors and font types for the blister sheets of certain products. This is part of our efforts to make it harder to misread blister sheet labeling.

Introducing Universal Design into Product Packaging

We have introduced universal design to certain product packaging. One example is the universal design packaging of Bonoteo 50 mg tablets, which is administered once every 4 weeks and features packaging with outstanding opening and resealing properties. To prevent patients from forgetting to take the drug, there is a space provided on the packaging to write in the day when the drug should be taken. A decal to be used as a calendar is also attached. In addition, the packaging uses a universal design font type.

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Provision of Product Information (Sales & Marketing and Medical Affairs)

Ensuring Proper Use

Astellas' Medical Representatives (MRs) and Medical Science Liaisons (MSLs) gather and provide information to ensure that pharmaceutical products are used properly. MRs and MSLs observe high ethical standards. At the same time, MRs and MSLs make compliance their top priority, observing the Astellas Global Code of Conduct, local codes of conduct, and the relevant laws and regulations in each country.

In addition to providing information on the accurate and appropriate use of our products and possible adverse effects, our MRs supply the latest knowledge and findings on diseases associated with our products to people on the medical front lines. In these ways, they contribute to the treatment of patients. Furthermore, our MSLs work to ascertain medical needs by having in-depth discussions on medical and scientific issues with healthcare professionals.

Responding to Inquiries

We also have systems to respond to product-related inquiries from local healthcare professionals, patients and MRs in various countries. In countries throughout the globe, Astellas has Medical Information Call Centers, which serve as contact points for a variety of inquiries. At our large contact centers, we have systems that allow for 24-hour responses, even on business holidays. We also have systems that ensure the continuation of the centers' functions in emergency situations, such as in the event of natural disasters or influenza pandemics. We responded to over 130,000 calls this past year.

In addition to serving as contact points for those outside the Company, the Medical Information Call Centers function as in-house information hubs that gather and evaluate information about the proper use of pharmaceuticals and feed it back to the relevant departments. In fiscal 2014, there were several cases where proposals were made to relevant departments based on information provided from external sources, resulting in improvements that enabled Astellas to better answer the needs of patients and the healthcare front lines. Among these improvements were revisions to package inserts, and changes in packaging and labeling, which led to improvements in the proper use of products by the patients.

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Procurement

Promoting CSR Procurement

Astellas considers it important to fulfill its social responsibility across the entire supply chain, including suppliers. To this end, we have formulated our CSR Procurement Guiding Principles, which require business partners to do their business in accordance with CSR measures. We also conduct questionnaire-based surveys regularly in compliance with the principles. The surveys have so far covered business partners of direct and indirect materials, as well as service suppliers and facility and equipment suppliers. To date, we have obtained survey responses from 612 companies. Furthermore, we conduct on-site audits of suppliers in countries that pose a high CSR procurement risk.

In May 2015, we revised and reissued the CSR Procurement Guiding Principles as the Astellas Business Partner Code of Conduct, in order to drive the advancement of CSR procurement. Specifically, we incorporated subjects such as the safety of chemical handling processes and hazard information -a CSR element unique to the pharmaceuticals industry- into the existing principles, with a view to expanding their application beyond Japan to countries overseas. Concurrently, we fully revised our documents related to CSR procurement. We are strengthening CSR procurement by conducting a global questionnaire-based survey using a new form, along with requesting our business partners to sign off on the Acknowledgement of Astellas Business Partner Code of Conduct.

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