Astellas is committed to ful lling its social responsibilities in the course of conducting business activities, aiming to contribute to improving the health of people around the world. We respect human rights in every stage of our value chain, from research and development to the provision of information regarding our products. We also strive to ensure compliance with the Pharmaceutical and Medical Device Act and other relevant laws and regulations.
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 the 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, comprising 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 on potential conflicts of interest on the part of research institutions, researchers and other parties. In fiscal 2015, the committee met 10 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 Stem Cell Research and Development
Astellas believes that there is a possibility of supplying new stem cell-based treatment methods to address diseases that previously had no known treatment methods. To achieve this, Astellas is advancing research and development activities focused on using stem cells in therapy.
Astellas also recognizes that research into human stem cells could give rise to concerns that warrant close examination. In particular, Astellas is fully aware of the necessity to pay full attention to the social and bioethical issues associated with research using human embryonic stem cells (ES cells).
Based on these principles and awareness, Astellas has established its “Policy on Human Stem Cell Research and Development*,” which sets forth the basic matters it must comply with in the course of conducting human stem cell research and development. Specifically, in all of its research and development activities involving human stem cells, Astellas will comply with the relevant laws, ordinances and regulations of the countries and regions where it undertakes these research and development activities. Moreover, Astellas will set up a committee comprising internal and external experts, from which it will obtain oversight and advice on the ethical aspects and the scientific legitimacy and merit of these research and development activities. All the proposals on research and development programs involving human stem cells will be reviewed and approved by the committee to ensure that these research and development activities are implemented ethically and in line with a legitimate scientific purpose. Furthermore, when establishing and using human ES cells, Astellas will take steps to satisfy the ethical standards established by the world’s major scientific authorities, including the guidelines laid out by the National Academy of Sciences of the United States of America.
Ethical Considerations in Animal Testing
Astellas has established a Global Policy for Animal Care and Use, and conducts animal testing based on this policy. 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.
Astellas performs experiments using genetically modified organisms, or materials containing pathogens, 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 detailed procedures in place for handling experimental materials. In addition, we have set up the Biosafety Committee as a body to review whether the experiments meet the standard required by these rules. In addition, laboratory personnel receive regular training courses once a year (995 participants in fiscal 2015), in order to rigorously enforce safe and proper biosafety management and use of these organisms and suchlike.
Treatment of Intellectual Property
Astellas believes that appropriately protecting intellectual property is crucial to maintaining our competitive advantage to address unmet medical needs.
Intellectual property includes any creative works that may be protectable by intellectual property laws, such as patents, trademarks, trade secrets, copyrights, and know-how. Astellas has established a Policy on Intellectual Property*1. Considering the importance of improving Access to Health, Astellas is committed to not filing nor enforcing patents in select countries with significant economic challenges. These select countries are decided by referring to those designated as Least Developed Countries (LDCs) defined by the United Nations or Low Income Countries (LICs) defined by World Bank. Astellas is also committed to considering the licensing of patents in other developing countries on a case-by-case basis*2.Close
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 the efficacy and safety of the new drug candidates 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 governance committees inside the Company that evaluate the ethical acceptability and scientific validity of clinical studies from their planning phases. In addition, prior to initiating a clinical trial, Astellas obtains an approval from an Institutional Review Board independent of the Company, after the board evaluates the clinical trial from the perspectives of ethical acceptability and scientific validity. Furthermore, we implement education and training for employees and other staff members who are involved in clinical trials, and monitor medical institutions that perform trials to ensure that clinical trials are administered properly in line with GCP. In the course of performing clinical trials, Astellas confirms that clinical 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 purpose and methods of the trial, the expected benefits and disadvantages, matters related to compensation for health impairment and other details. Moreover, we properly administer the trial data so as to protect the privacy and confidentiality of the personal information of clinical trial subjects. We regularly confirm that outsourced clinical trials are conducted based on the same standards.
Disclosure of Study Information and Results
In order to enhance the transparency of clinical study information in conjunction with maximizing its value and ensuring that it leads to the advancement of science and promotion of innovation, Astellas has drawn up a global policy on the disclosure of clinical trial information and results*1. This policy provides a detailed description of Astellas’ basic point of view on enhancing accessibility to clinical study data and related study results, such as the registration of clinical trial information, disclosure of clinical trial results, and disclosure of study data to scientists and healthcare professionals.
More specifically, Astellas provides patient level data anonymized in accordance with the applicable laws and regulations to scientists and healthcare professionals who requested the data through an external website*2. In addition, we disclose summaries of study results through an Astellas website*3 to enable doctors and the general public to access them, along with working to build a website that will give patients access to summaries of study results prepared for non-experts.
Expanded Access to Investigational Medicines
Astellas has set forth its approach to supplying investigational medicines to patients for purposes other than clinical studies in its Position on Expanded Access to Investigational Medicines*.
Astellas recognizes that patients with serious or life-threatening diseases may have exhausted all of their available treatment options, may not qualify for a clinical trial and may seek access to investigational medicines. In these cases, in response to a request for investigational medicines from a primary physician, Astellas fairly, impartially and rapidly evaluates whether or not the patient meets the required conditions and commits to establishing an expanded access plan as appropriate. The expanded access program will target countries where the clinical development of an investigational medicine is progressing and the drug is scheduled to obtain approval. Moreover, this procedure will be implemented in accordance with the regulations of the country where expanded access is requested.
Quality and Reliability Assurance
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.” These counterfeit medicines in legitimate supply chains not only leads to the loss of opportunities for patients to receive medical treatment, but could also have serious health consequences. Counterfeit medicines have therefore become a serious problem worldwide.
Astellas operates the Anti-Counterfeit Committee, led by the technology and quality assurance divisions, and has a product security division. Through these organizations, Astellas conducts monitoring, surveys, and countermeasures targeting not only counterfeit medicines, but also diversion, smuggling, theft and other such activities. When selling products, Astellas systematically introduces effective anti-counterfeit technologies, including serialization stipulated by regulations, based on pharmaceutical laws and regulations and risks in each market where products are sold, as well as product characteristics.
Moreover, Astellas works to gather information and implement other countermeasures in collaboration with the relevant authorities and pharmaceutical companies worldwide. One example is Astellas’ participation in the activities of the PSI*. Moreover, 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 proactively endeavor to support and cooperate with national governments, judicial authorities and others, to crack down on counterfeit medicines.
Astellas has a recall system in place 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, and a decision on a product recall is made based on the judgment of the committee.
In fiscal 2015, Astellas initiated three voluntarily product recalls. As of June 2016, we have not received any reports of health impairment related to these recalls.
Doping is an issue closely related to abuse and misuse of medicines in sports. It is a serious priority for the pharmaceutical industry given that it is not only associated with a risk of inducing serious side effects, but it can also become a breeding ground for the unauthorized distribution and counterfeiting of medicines. Astellas is working to identify the compounds under development that have the potential to be used in doping and to prevent the misuse of those compounds.
In October 2016, Astellas made a global agreement with the World Anti-Doping Agency (WADA)T to partner on the prevention of misuse and abuse of medicines for doping in sports owhich aims to contribute to the eradication of doping and improvement of public health.
Doping in sports relies primarily on the misuse and abuse of commercially available medicines, as well as compounds in development that are not as well-known or easily detected. To support WADA in its efforts to address this issue, Astellas identifies compounds solely developed by Astellas or its affiliates with the potential for sport-related doping abuse and cooperates in sharing relevant information to aid WADA in the organization’s development of detection methods for these compounds. Additionally, Astellas cooperates with WADA to minimize the risk of misuse of compounds with doping potential during clinical trials to avoid opportunities for abuse.
Quality Assurance Policy
Astellas has set forth global policies concerning quality assurance in the Astellas Quality Assurance Manual. Based on this manual, we prepare guidelines and standard operating procedures concerning quality assurance systems and operational management and procedures for a variety of quality assurance related activities at the global, regional and national levels. Education and training programs are implemented to promote understanding and awareness of these matters.
These documents are revised periodically and as necessary. We respond swiftly to developments in the external environment, such as regulatory changes and amendments.
Improving the Pharmacovigilance System
Astellas is continuously improving the pharmacovigilance system by strengthening collaboration between the pharmacovigilance organization and other relevant departments, affiliates and licensing partners. This is to support provision of trustworthy products and the proper use of those products, along with addressing regulatory requirements.
In 2015, Astellas broadened the scope of training related to the handling of information concerning the safety of Astellas products from the staff closely involved with the PV system, to all employees including contractors of affiliates. Moreover, working closely with the departments responsible for contracts and outsourcing, Astellas clarified the required conditions for pharmacovigilance activities and established the mechanism to reflect those conditions in contracts between external service providers and departments other than the pharmacovigilance organization, as necessary.
Through these and other activities, Astellas strives to undertake responsible pharmacovigilance activities on a global, Company-wide basis.Close
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.
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 working to prevent medical malpractice in this respect, through measures including printing product names directly on capsules and tablets, as well as printing product names and dosage on packaging sheets (blister sheets) so that the product name and dosage can be easily identified even after the blister sheet is split apart.
To prevent misreading of labeling on blister sheets, Astellas also endeavors to make products easier to identify visually by adopting easily discernible colors and font types for the blister sheets of certain products.
Introducing Universal Design into Product Packaging
We have introduced universal design to certain product packaging. For example, the universal design packaging of Bonoteo 50 mg tablets, which is administered once every 4 weeks, features packaging with good openability. To prevent patients from forgetting to take the drug, there is an area provided on the packaging to write in the day when the drug should be taken. A small label to be used as a calendar is also attached. In addition, the packaging uses a universal design font type for easy reading.Close
Provision of Product Information
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 Group 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. Our MSLs work to ascertain the treatment-related needs of healthcare professionals by engaging in in-depth discussions based on medical and scientific principles.
Responding to Inquiries
Astellas believes that it has a responsibility to provide accurate medical information in response to inquiries from patients and medical professionals. By fulfilling this responsibility, Astellas seeks to assist with the safe and effective use of our products.
In countries throughout the globe, we have Medical Information Call Centers that respond to a variety of inquiries. In larger call centers, we have systems that allow for 24-hour responses to urgent inquiries, even on business holidays. Systems are also in place to ensure the continuation of the centers’ functions in emergency situations, such as in the event of natural disasters. In fiscal 2015, we responded to approximately 135,000 calls.
Astellas makes continuous efforts to improve its medical information services, with the aim of providing accurate, appropriate and consistent information. As part of these efforts, in March 2015 Astellas launched a new global medical information system where global content can be developed and shared. The new system will document responses from affiliates around the world, enabling this information to be viewed on a global basis. The new system is also useful for analyzing matters of high interest based on inquiries or about which there is insufficient information. By sharing the findings of this analysis with the relevant departments, Astellas seeks to more accurately address the requests of patients and medical professionals.Close
Promoting CSR Procurement
Astellas considers it important to fulfill its social responsibility across the entire supply chain, including suppliers. To achieve this goal, Astellas has formulated the Astellas Business Partner Code of Conduct, which requires business partners to do their business in accordance with CSR measures. We also conduct global questionnaire-based surveys based on the Code, along with requesting our business partners to sign off on the Acknowledgement of Astellas Business Partner Code of Conduct. As of March 31, 2016, we had obtained survey responses from approximately 800 companies, covering suppliers of direct materials, as well as major suppliers of indirect materials and major facility and equipment suppliers.
Furthermore, we conduct on-site audits of suppliers in countries that pose a high CSR procurement risk.Close