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.
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 subjects in accordance with the Declaration of Helsinki* as well asthe laws, regulations and guidelines of relevant countries.
In Japan, Astellas provides training for researchers in areas such as bioethics, genomic research and related clinical research based on a strong commitment to respecting the human rights of research subjects and protecting the privacy and confidentiality of their personal information.
The Astellas Research Ethics Committee has been established with outside members participating in the committee to determine the ethical acceptability and scientific propriety of research plans in a fair and impartial manner.
* Declaration of Helsinki: 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 Policy on Animal Care and Use. We have established the Corporate Institutional Animal Care and Use Committee with outside members participating in the committee, to determine whether to conduct animal testing based on the 4R Principles*1. All of Astellas’ animal testing facilities have acquired accreditation from AAALAC international*2.
*1 4R Principles: Developing non-animal testing alternatives and replacing animals of phylogenetically lower species (Replacement); reducing the number of animals involved to the minimum necessary to achieve the scientific purpose(Reduction); avoiding the infliction of distress on animals wherever possible (Refinement); and scientifically and ethically justifying animal use in light of their significance, necessity, predictability and other criteria (Responsibility).
*2 AAALAC International: The Association for Assessment and Accreditation of Laboratory Animal Care International. An international 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.
Biotechnology and Biohazard Control
Astellas handles genetically modified organisms and performs experiments using materials containing pathogens in compliance with the World Health Organization Laboratory Biosafety Manual*1, the U.S. Centers for Disease Control (CDC) Biosafety Manual*2 and the U.S. National Institutes of Health Guidelines*3, as well as the laws of individual countries.
*1 Laboratory Biosafety Manual 3rd Edition
*2 Biosafety in Microbiological and Biomedical Laboratories 5th Edition
*3 NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Use of Genetic Resources
Astellas has published its Position on Genetic Resources, and is committed to full compliance with the relevant laws and regulations of countries supplying genetic resources, and to the fair distribution of profits derived from the use of such resources according to the conditions mutually agreed upon with each country. This commitment is based on the concept of genetic resource utilization and the associated distribution of profits set out in the Nagoya Protocol*1 adopted by the Conference of the Parties to the Convention on Biological Diversity*2. The impacts of the use of new genetic modification technologies on the environment, biodiversity, and human health are not fully known. Therefore, Astellas will proceed cautiously when using these technologies while remaining mindful of the need to preserve biodiversity and consider ethical issues.
*1 Nagoya Protocol: Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization
*2 The Convention on Biological Diversity: International convention on the sustainable use and conservation of biological diversity
Treatment of Intellectual Property
Appropriate protection of intellectual property is critical to addressing unmet medical needs and maintaining a competitive advantage. With this in mind, Astellas has established a Policy on Intellectual Property. In view of the importance of improving people’s access to health, Astellas participates in the Patent Information Initiative for Medicines (Pat-INFORMED) implemented by the World International Patent Organization (WIPO) to ensure easy access to Astellas’ patent information on medicines by health agencies tasked with the procurement of medicines in various countries.
Moreover, we are committed to not filing or enforcing patents in countries facing 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 the World Bank.
Respect for Human Rights, Protection of the Privacy and Confidentiality of the Personal Information of Clinical Trial Subjects, and Assurance of Reliability in Clinical Trials
Astellas conducts clinical trials to assess the efficacy and safety of new drug candidates in patients under the Declaration of Helsinki, Good Clinical Practice (GCP) and all relevant laws and regulations with full consideration to protecting human rights and the privacy and confidentiality of clinical trial subjects’ personal information. Clinical study protocols developed by Astellas are evaluated and approved for ethical acceptability and scientific validity by internal and external evaluation committees.
In conducting clinical trials, Astellas confirms that clinical trial subjects have provided informed consent, having received a full explanation of the purpose and methods of the trial, its expected benefits and disadvantages, matters related to compensation for health impairment and other details. Moreover, we implement education and training for any employees or staff members involved in clinical trials, and monitor medical institutions that perform clinical trials to ensure full GCP compliance.
In addition, we manage trial data appropriately to protect the privacy and confidentiality of the personal information of clinical trial subjects. Periodic assessments are also made to check that any outsourced clinical trials are conducted in accordance with the same standards.
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 Information on Clinical Trials and Trial Results
Astellas is committed to increasing transparency and providing disclosure of clinical trial data. Maximizing the value of clinical trial data, and putting it to good use in driving scientific advancement and increasing innovation, requires that the clinical trial data be appropriately accessible to the research community and others who might utilize it. The Policy on Disclosure of Clinical Trial Data has been published on the Company website to present Astellas’ position on this matter.
Specifically, Astellas provides patient-level data that have been anonymized in accordance with applicable laws and regulations through an external website*1 to those scientists and healthcare professionals requesting it. Doctors and the public can confirm summaries of clinical trial findings via the website for clinical trial data disclosure. This website also gives patients access to plain language summaries of study results prepared for non-experts*2.
*1 Patient-level data are provided through the following website: http://www.clinicalstudydatarequest.com
*2 Results of the clinical trials are provided through the following website: https://www.astellasclinicalstudyresults.com/Welcome.aspx
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.
* For details, please visit the following website:
Patient Centricity in Clinical Drug Development
Real-world considerations in clinical trials are increasingly important in ensuring that our studies address current medical practices and patient needs.
Patient centricity is now a focus for regulatory authorities and the pharmaceutical industry. The patient-centric approach is being discussed at all points in the drug development value chain, from discovery through to commercialization.
We are pursuing patient centricity in clinical development. To do so, we are trying to incorporate insights from real-world data into the planning of clinical trials by understanding how healthcare is provided to patients. Efforts are being made to include patient input in how to optimally design clinical trials, recruit participants, and identify relevant endpoints that patients care most about.
For example, we use patient-reported outcomes (PROs) such as questionnaires and patient diaries to monitor and assess patients’ health conditions. In addition, we use real-world data for estimation of target populations based on the morbidity rate and ineligible cases in screening, and feasibility of studies in clinical trial facilities. As a pilot project, we established a patient-friendly website for an investigational drug to support patient/caregiver-focused recruitment and health literacy recommendations. Especially in the muscle disease field, we are working with patient organizations. Working closely with those organizations, we are striving to reflect valuable insights from patients and caregivers in clinical trial designs. Through these activities, we try to make it easier for patients to participate in clinical trials, as we work to obtain trial results with greater clinical significance.
Quality and Reliability Assurance (Regulatory Affairs, Quality Assurance, Clinical and Research Quality Assurance, Pharmacovigilance)
The distribution of counterfeit medicines in legitimate supply chains not only leads to the loss of opportunities for patients to receive medical treatment but could also have adverse health consequences. This has become a serious problem worldwide.
Astellas operates the Anti-Counterfeit Committee, led by the supply chain management and quality assurance divisions, and has a product security division. These parts of Astellas conduct monitoring and surveys, and implement countermeasures targeting not only counterfeit medicines, but also diversion, smuggling, theft and related activities. When selling products, Astellas systematically introduces effective anti-counterfeit technologies, including product serialization of secondary product packaging as stipulated by regulations, based on pharmaceutical laws and regulations and risks in each market where products are sold, as well as product characteristics. In addition, Astellas carries out educational activities to prevent the spread of counterfeit medicines in collaboration with members of the pharmaceutical industry and organizations such as the World Health Organization (WHO), the PSI* and the Transported Asset Protection Association. We also proactively endeavor to support and cooperate with national governments and judicial authorities to crack down on counterfeit medicines. Astellas publishes its Position on Counterfeit Medicines on its website.
*PSI: Pharmaceutical Security Institute
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 relevant information is promptly passed on to medical institutions and other affected parties, and that a recall of the product in question is instigated. Astellas voluntarily initiated three product recalls in fiscal 2017. As of March 2018, no reports of any related health impairments had been received.
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.
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.
Improving the Pharmacovigilance (PV) System
Astellas is continuously improving its PV system by strengthening collaboration between the internal PV function and other relevant departments, affiliates and licensing partners. This is to support the provision of trustworthy product information and proper product use, along with regulatory compliance.
Astellas regularly provides product safety awareness training not only to staff closely involved with the PV function but also to all employees and contractors including affiliate staff, to maintain and strengthen swift and appropriate collection of product safety information. For external service providers outsourced by departments other than the PV division, Astellas updates their contracts to add requirements for safety management information collection as necessary. Through these measures, Astellas is building a system for collecting information over a wide scope.
In addition, Astellas is exploring utilizing real-world data such as large healthcare databases for safety signal detection of Astellas products to help minimize risk by enhancing collaboration between PV and other functions. Furthermore, Astellas PV has started exploring and assessing automation technologies and artificial intelligence technologies that can be used for safety data monitoring, processing and reporting, and earlier identification and analysis of safety signals. We plan to use these technologies to strengthen our safety data management systems.
Strengthening of Quality Assurance Systems at Affiliates
Astellas has constructed a robust global quality assurance system to ensure the supply of pharmaceuticals of uniformly high quality to patients worldwide.
The past quality assurance system comprised the four main regions of Japan, the Americas, EMEA and Asia & Oceania. We are trying to incorporate quality assurance activities taken by each affiliate into this global quality assurance structure. Through this change, we are developing quality management systems consistent with our quality assurance policy on a global, Company-wide basis. This will reinforce our sales affiliates globally receive proper support in improving quality and training personnel.
Technology Development & Manufacturing
Stable Supply and Quality Control
Astellas places highest priority on ensuring stable manufacture and supply of safe and effective pharmaceuticals to patients. To ensure this, we have established our own Good Manufacturing Practice (GMP)-compliant quality standards as the basis for consistently achieving high levels of quality control. We apply these standards to manufacturing facilities and equipment, and to all stages from raw material procurement and storage to production and shipment.
For example, Astellas, Takeda Pharmaceutical Company Limited, Teva Takeda Pharma Ltd. and Teva Takeda Yakuhin Ltd. have co-established a shared storage and joint distribution platform in Hokkaido, Japan. The platform aims to ensure a stable supply of pharmaceuticals even in an emergency by natural disaster as well as enhancing efficiency and quality management of products distribution.
Sharing logistics with the other companies together enabled us to set up a new logistics base by enhancing cost-effectiveness. The joint distribution platform also reduces the environmental burden through reduction of carbon emission as well.
As a large-scale disaster such as an earthquake and a volcanic eruption is predicted in Japan, diversifying logistics bases is essential to prevent a shortage of pharmaceuticals which might affect the health of patients.
The platform Awarded by the Minister of Economy, Trade and Industry in the 2018 Excellent Green Logistics Awards hosted by Ministry of Economy, Trade and Industry of Japan.
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.
Relationship with Local Communities
To promote sustainable pharmaceutical manufacturing, Astellas arranges opportunities for dialogue with local residents and communities near its manufacturing sites. By proactively disclosing its initiatives, Astellas is working to build good relationships with them.
At the Kerry Plant in Ireland, Astellas is launching annual events with the local community to protect the environment, ensure health and safety, and save energy. Each year, the event themes revolve around environmental protection, health and safety, and energy conservation, and local children draw pictures with the themes. These are made into a calendar which is sold locally, with all proceeds donated to the Irish Kidney Association. Every year, over 1,000 entries are received from 12 schools, and the event is now being developed into a regular community event. In 2017, we received the SEAI* Award as one of Ireland’s leading companies.
SEAI: Sustainable Energy Authority of Ireland is an Irish government-affiliated organization supporting the reduction of CO2 emissions.
Provision of Product Information (Sales & Marketing and Medical Affairs)
Ensuring Proper Use
Astellas’ Medical Representatives (MRs) provide information on appropriate usage based on on-label information to healthcare professionals to ensure that Astellas pharmaceutical products are used safely and effectively. In promotion of Astellas products, MRs observe high ethical standards and strictly observe the Astellas Group Code of Conduct, local codes of conduct, and the relevant laws and regulations in each country.
Medical Science Liaisons (MSLs) engage with healthcare professionals to exchange scientifically based information to advance their understanding and the safe and effective use of our products in patient care. MSLs observe high ethical standards and provide reliable, clear, fair, balanced and unbiased medical and scientific information. MSLs refrain from promotion of products, and observe high ethical standards, making compliance their top priority.
Responding to Inquiries
Astellas has a responsibility to provide truthful, balanced and unbiased medical information in response to inquiries regarding our products. By fulfilling this responsibility, Astellas supports 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 our larger call centers, we have systems that allow for 24-hour responses to urgent inquiries, even on business holidays. In fiscal 2017, we responded to approximately 160,000 inquiries.
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, a global medical information system is used where medical responses from Group companies around the world are documented. This enables the responses to be communicated to our customers in a simple, swift and accurate manner. At the same time, we can analyze feedback from patients and medical professionals and inform the life cycle management of our products.
Promoting CSR Procurement
Astellas considers it important to fulfill its social responsibilities 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 the Acknowledgement of Astellas Business Partner Code of Conduct. As of March 31, 2018, we had obtained survey responses from approximately 900 companies, covering suppliers of direct materials, as well as major suppliers of indirect materials and major facility and equipment suppliers. In fiscal 2017, we widened the scope of the survey to include pharmaceutical wholesalers, licensees, distributors and banks. Furthermore, we conduct on-site audits of suppliers in countries that pose a high CSR procurement risk.