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Any information on the products contained herein is not intended to provide medical advice nor should be used as a substitute for the advice provided by your physician or other healthcare provider.
Astellas is committed to fulfilling its social responsibilities in the course of conducting business activities as a pharmaceutical company, based on the Raison D'être of “Contribute to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.” We respect human rights in every stage of our entire 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 Research Utilizing Specimens and Information Derived from Humans
Astellas conducts research on human subjects and research utilizing specimens and information derived from humans after appropriately obtaining the consent of the subjects in accordance with the Declaration of Helsinki*1 as well as the laws, regulations and guidelines of relevant countries.
In Japan, Astellas provides training for employees that conduct research, in areas such as bioethics, genome 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 external experts participating in the committee to determine the ethical acceptability and scientific propriety of research plans in a fair and impartial manner.
*1 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 Stem Cell Research and Development
Astellas is advancing research and development activities using stem cells in order to supply new treatment methods to address diseases that previously had no known treatment methods.
On the other hand, Astellas also recognizes that concerns which need careful consideration could arise when promoting research using human stem cells. In particular, it is necessary 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 validity and legitimacy of these research and development activities. All research and development programs will be implemented upon investigation by the committee from an ethical and scientific standpoint. 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.
Astellas conducts animal testing based on its Policy on Animal Care and Use*1, which was created based on various relevant laws, regulations and guidelines related to animals such as the Act on Welfare and Management of Animals. We have established the Corporate Institutional Animal Care and Use Committee with external experts that verify the 4R Principles*2 and determine whether to conduct animal testing. All of Astellas’ animal testing facilities have acquired accreditation from AAALAC international*3.
*1 For details, please visit the following website: https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-animal#r_and_d*2 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).
*3 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
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, Astellas handles experimental materials containing genetically modified organisms and pathogens.
*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
Based on its Position on Genetic Resources*1, Astellas is committed to full compliance with the relevant laws and regulations of countries supplying genetic resources upon obtaining such 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 in accordance with guidelines related to genetic resource utilization and the associated distribution of profits set out in the Nagoya Protocol*2 with regard to the Convention on Biological Diversity*3. 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 with regard to these technologies while remaining mindful of the need to preserve biodiversity and consider ethical issues.
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*1.
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. The patent information for XTANDI, Lexiscan, Gonax, Suglat, Tarceva and XOSPATA are listed in the Pat-INFORMED database.
Astellas commits to not filing or enforcing patents in Least Developed Countries (LDCs) defined by the United Nations or Low Income Countries (LICs) defined by the World Bank.
Astellas also commits to considering flexibilities in licensing patents in other developing countries on a case-by-case basis, in order to address pressing health challenges, while recognizing these challenges are the shared responsibility of multiple actors, including the pharmaceutical industry*2.
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 regularly 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 protect the privacy and confidentiality of the personal information of clinical trial subjects by managing trial data appropriately. Periodic assessments are also made to check that any outsourced clinical trials are conducted in accordance with the same standards.
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*1 has been published on the Company website to present Astellas’ position on this matter.
Astellas registers clinical trials, posts clinical trial information, and discloses clinical trial results. Astellas provides patient-level data that have been anonymized in accordance with applicable laws and regulations through an external website*2 to those scientists and healthcare professionals requesting it in the case that review panel consisting of third party experts evaluates and approves the request based on scientific usefulness and scientist eligibility. In addition to disclosing summaries of clinical trial findings from phase 1-4 interventional studies after the approval or discontinuation of the study so that healthcare professionals and the public can confirm them via the website, this website also gives patients access to plain language summaries of study results prepared for non-experts*3.
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. This procedure will be implemented in accordance with the regulations of the country where expanded access is requested.
The pharmaceutical industry is actively working on patient centricity in clinical drug development, and is discussing it at all points in pharmaceutical development.
We are listening to the opinions of patients and their families by working with patient organizations, and discussing the design of clinical trials and setting key outcome measures.
Moreover, with the launch of the website for patients, we are actively introducing information related to clinical trials and diseases to patients and their families. In addition, we have improved the ease with which informed consent and explanatory documents used for clinical trials can be read. Through these efforts, we try to make it easier for patients to participate in clinical trials so that we can obtain trial results with scientific significance for patients.
Quality and Reliability Assurance
The infiltration of counterfeit/falsified medicines into the legitimate supply chain not only leads to the loss of opportunities for patients to receive effective medical treatment but could also have severe adverse health consequences. This has become a serious problem worldwide.
As a countermeasure, Astellas commissioned an Anti-Counterfeit Committee comprised of leaders from multiple stakeholder functions (quality assurance, supply chain, etc.), and has also established a product security function to oversee daily activities relevant to product-related security risks. These entities monitor the global market for suspicious activities affecting Astellas products, and implement countermeasures targeting not only counterfeit/falsified medicines, but also diversion, theft and other illicit activities that potentially affect our products and/or present a potential risk to patients. Astellas systematically introduces anti-counterfeit measures, including, but not limited to, product serialization as stipulated by current regulations and pharmaceutical laws. In addition, Astellas regularly engages in various collaborative activities with other members of the pharmaceutical industry to help prevent the spread of counterfeit/falsified medicines. We also proactively endeavour to support and cooperate with national regulatory and judicial authorities to crack down on counterfeit/falsified medicines.
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.
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.
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 2 product recalls in fiscal 2019. As of March 2020, there were no reports of any related health impairments received.
History of product recall
The number of recall
* Authority-initiated recall
Astellas has established its own quality standards in compliance with current Good Manufacturing Practice (cGMP) and applies these standards to Astellas Group manufacturing sites. In fiscal 2019, Astellas underwent 2 US FDA inspections globally overall, of which Astellas only received a single Form 483.
*Form 483: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
US FDA inspection history
The number of FDA Inspection
Warning Letter issued
Form 483 issued
Location of Form 483 issued
* The Norman plant in the U.S was transferred to the Avara Norman Pharmaceutical Services, Inc. in August 2016.
Astellas has set forth the quality assurance function and activities in the Quality Manual. The Quality Manual sits on the apex of the document management system hierarchy. Underneath the Quality Manual, policies, standard operating procedures, and guidelines exist defining 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.
Strengthening of Quality Assurance Systems at Affiliates
Astellas has developed a robust global quality assurance system so that it can ensure patients worldwide a supply of uniformly high quality of pharmaceuticals. This quality management system was developed to be consistent with our quality policy on a global, company-wide basis. The organizational structure of the global quality assurance system incorporates the quality assurance activities of all Astellas affiliates. Our sales affiliates globally receive ongoing support in strengthening our quality culture whilst educating our personnel to the highest standards.
Improving the Pharmacovigilance (PV) System
Astellas is continuously improving its pharmacovigilance (PV) system by strengthening collaboration between its PV function and other relevant functions, affiliates and licensing partners. This is to respond to expansion of product strategies and advance the provision of trustworthy product information and proper product use, along with compliance with regulatory requirements.
Astellas has been building a system to collect product safety information from a variety of sources. The Company annually 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 functions other than the PV function, Astellas adds requirements for the collection of product safety information in their contracts as necessary.
Astellas has been maintaining safety databases and procedures used globally to respond to environmental change. In fiscal 2018, it completed a major upgrade of its safety database and procedures to meet regulatory requirement changes. In fiscal 2019, it continued to implement electronic submissions of safety reports to local regulatory authorities to meet new requirements.
Astellas is exploring utilizing real-world data such as large healthcare databases for evaluation of its product safety to help minimize risk by enhancing collaboration between PV and other functions. Furthermore, Astellas has started exploring and assessing automation technologies and artificial intelligence technologies that can be used for monitoring, processing and reporting of product safety information, and early identification and analysis of safety signals. We plan to use these technologies to strengthen our PV system.
Technology Development & Manufacturing
Stable Supply and Quality Control
Astellas places highest priority on ensuring robust manufacture and stable supply of safe and effective pharmaceuticals to patients. To ensure this, we have established our own standards aligned with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) as the basis for consistently achieving high levels of quality. We apply these standards to manufacturing facilities and equipment, and to all stages from raw material procurement and storage to production and shipment.
Astellas is continuously investing in various manufacturing facilities with the aim of maintaining and strengthening stable supply. In 2020, construction of the Center for Active Ingredient for Biopharmaceuticals was completed at Astellas Pharma Tech’s Toyama Technology Center. Bio-drug substances for clinical trials and commercial use are manufactured at the Center and supplied according to global standards. In addition, construction of the Third Fermentation Building has commenced. When the construction is completed, the active pharmaceutical ingredients of immunosuppressant Prograf® that suppress rejection after organ transplants will be manufactured at the facility. By constructing such in-house state-of-the-art manufacturing facilities, we aim to build a more robust manufacturing system capable of supplying high quality products going forward.
Astellas has quality systems for auditing both internal sites and external manufacturing and distribution partners. The risk-based auditing approach determines the sites audit frequency and intensity.
Internal audits are conducted on all Astellas organizations that conduct current Good Manufacturing Practice (cGMP) and/or current Good Distribution Practice (cGDP) activities at all points across the product lifecycle and across the supply chain, in accordance with documented policies and procedures.
Quality audits are conducted for new or established external partners of Astellas. Such audits are performed to evaluate compliance with cGMP, cGDP and applicable Astellas requirements.
In fiscal 2019, Astellas performed a total of 332 audits, including 33 internal audits and 299 quality audits of external partners globally.
Supply Chain Management Structure for Stable Supply
Supply chains are becoming more complicated than ever due to the increase in global products and diversification of modality, along with the increase in partnerships and cooperation with suppliers.
Taking these environmental changes into account, Astellas is strengthening its supply chain management globally by building a framework to centrally manage demand forecasts, inventory data and supply plans for regions all over the world, encompassing the manufacture of drug substances through to finished product supply.
Moreover, in addition to building a global logistics and distribution network to develop the functions and capabilities which flexibly meet the various needs for products, including cold chains, Astellas is advancing logistics and trade compliance, including for imports and exports, to enhance the stable supply management.
Furthermore, in the area of commercial supply chain, Astellas has established a function at three locations: Japan, the Netherlands, and the US to continuously develop the supply chain process adapting to the environment changes and strengthened the management framework in global operations.
Shared Logistics for Stable Supply
One of the most important missions for a pharmaceutical company is to continuously improve BCP (Business Continuity Plan), and maintain and continue a stable supply of pharmaceutical products even when natural disasters occur. The Ministry of Health, Labour and Welfare released Japanese GDP (Good Distribution Practice) Guidelines which require greater strictness with respect to ensuring quality in storage and shipment under GDP. Meanwhile, MLIT (Ministry of Land, Infrastructure, Transport and Tourism), METI (Ministry of Economy, Trade and Industry), and MAFF (Ministry of Agriculture, Forestry and Fisheries) are promoting “White Logistics,” an initiative aimed at addressing working style reform, driver shortages, CO2 reduction among other issues facing logistics. Under this initiative, consignors cooperate with logistics partners to implement activities for improvement and reform, and build sustainable logistics frameworks.
Under the environment changes surrounding logistics, 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 diverse and stable supply of pharmaceuticals with adequate contingency, even in the event of a large-scale natural disaster, as well as enhancing efficiency and quality management of product distribution. Astellas will continue initiatives that advance the sharing and standardization of the pharmaceutical logistics within the industry.
The joint distribution platform in Hokkaido has reduced costs. It has not only enabled us to set up a new logistics base but also has reduced the environmental burden through the reduction of carbon emissions. In recognition of these points, Astellas received the Minister of Economy, Trade and Industry Award in 2018 for the Green Logistics Excellent Business Award.
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. We also adopt blister card packaging* for pharmaceuticals that require care with dosage frequency from the perspective of preventing medical malpractice.
In addition, to improve patients’ medication compliance and ease of swallowing, Astellas is also reducing the size of the tablet and changing the formulation.
* Blister card packaging: Plastic packaging formed to fit the shape of the product.
Introducing Universal Design into Product Packaging
We have introduced universal design to certain product packaging.
Relationship With Local Communities and Consideration for the Environment
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.
For 16 years at the Kerry Plant in Ireland, Astellas has been holding an event on an annual basis in which children from the local community draw pictures themed on protecting the environment, health and safety, and saving energy. These are made into a calendar which is sold locally, with all proceeds donated to the Irish Kidney Association. Every year, close to 1,000 entries are received from local schools, and the event has now developed into a regular community event. Various other initiatives are being carried out to deepen relationship with the local community, including cardiopulmonary resuscitation training in the community, science-themed awareness events with local schools, and dialogue meetings with experts on special themes such as dialogue with wildlife experts. During 2019 and 2020, Kerry Plant has won “Building Project of the Year” from SEAI*1, “Excellence in Environment” from Chambers Ireland*2 and “Sustainability Project of the Year” from Pharma Industry Awards*3. Furthermore, in recognition of these environmental activities in Ireland, Kerry Plant received the “Green Award*4.”
Astellas is also carrying out such activities at various business locations in Japan, including providing volunteer support for shoreline clean-ups and a summer festival at a facility for disabled persons, as well as holding plant tours as part of university work experience programs being held with the aim of promoting engineering careers in pharmaceutical related companies.
*1 SEAI: Sustainable Energy Authority of Ireland is an Irish government-affiliated organization supporting the reduction of CO2 emissions.
*2 Chambers Ireland: Ireland’s largest business organization serving as a network of major-city chambers of commerce.
*3 Pharma Industry Awards: Award given to companies that contributed sustainable society in Ireland’s pharmaceutical industry.
*4 Green Award: Award recognizing continuous dedication, leadership and platform for innovation in environmental activities in Ireland.
Response to Climate Change
In order to contribute to achieving sustainable society, Astellas recognizes that, among business activities carried out in harmony with the global environment, response to climate change and reduction of greenhouse gases are important corporate focuses. Accordingly, for some time now, we have actively implemented measures to reduce GHG emission, including the introduction of wind power generation and biomass boilers at manufacturing sites overseas, the use of renewable energy derived power, and the introduction of hybrid vehicles for sales staff in Japan and overseas. Furthermore, in 2018, after backcasting*1from goals that society should aim for 2050, Astellas revised its targets for reducing GHG emissions in the medium to long term, and set a target by fiscal 2030 by a 30% compared with fiscal 2015 (baseline year: 221,000 tons). That target has been recognized as one that is grounded in science according to the Science Based Targets (SBT) initiative*2.
As part of initiatives aimed at achieving medium- to long-term targets, from April 2020, the Tsukuba Research Center, Tsukuba Biotechnology Research Center and the Takahagi Chemistry & Technology Development Center in Japan have switched the energy supplier for all of their energy consumption, adopting the “Aqua Premium*3” plan provided by TEPCO Energy Partner, Incorporated. Through the adoption of Aqua Premium, the approximately 31,000 tons (2019 results) of GHG emission caused by the electric power consumption of those three facilities can be completely eliminated from fiscal 2020.
Going forward, Astellas will continue to contribute to the health of people all over the world by harmonizing its business activities with the global environment.
*1 Backcasting: A thinking method that starts with defining a desirable future and then working backwards to identify measures and actions.
*2 Science Based Targets (SBT) initiative: An organization jointly established in 2015 by four organizations: the CDP, the United Nations Global Compact, the World Resources Institute, and the World Wide Fund for Nature. An international initiative led by the organization is to encourage companies and national governments to set GHG reduction targets to achieve the “2 degrees Celsius target” as agreed under the Paris Agreement of 2015.
*3 Aqua Premium: A charging plan offered by TEPCO Energy Partner, Incorporated that allows customers to buy only hydroelectricity, which does not emit GHG at the time of generation.
Provision of Product Information
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 act with high ethical standards and strictly comply with the applicable laws and regulations, industry codes and company policies including Astellas Group Code of Conduct.
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 also act with 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 2019, we responded to approximately 100,000 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 communicate these insights to support the life cycle management of our products.
We have recently implemented a new global medical information system that sets the stage for new and improved services for our customers.
Sustainable Procurement Initiatives
Astellas considers it important to fulfill its social responsibilities across the entire supply chain. To achieve this goal, Astellas has formulated the Astellas Business Partner Code of Conduct, which requires business partners to implement initiatives in accordance with social responsibilities and sign the Acknowledgement of Astellas Business Partner Code of Conduct.
Risk Assessments of Significant Business Partners
Astellas conducts a global assessment that includes an evaluation of sustainability risk in the selection process for significant business partners*, the business partners that have a particularly significant impact on Astellas’ business continuity among others. The sustainability risk assessment involves judging a risk level based on a combination of the business partner’s response to a questionnaire, external database information, a basic assessment by in-house experts on risks related to sustainability such as human rights, the environment, occupational health and safety and personal information protection, and, if necessary, the results of a local on-site audit carried out by an Astellas employee. The questionnaire has been updated in January 2019 to improve the accuracy of the risk assessment and been implemented in Japan, North America and Europe since February 2019. In addition, it has been expanded in stages to marketing subsidiaries in South America and Asia since March and April 2020, respectively.
If Astellas identifies a risk that can be improved during the business partner selection process, it encourages the business partner to make the improvement and monitors its initiatives. Astellas does not engage in business if it identifies a critical risk and it judges the risk is difficult to be improved.
Moreover, business divisions continue monitoring risk status even after business transactions have begun and the supplier’s sustainability risk level is assessed once every two years through a questionnaire. If necessary, the assessment takes place even within the two-year period.
* Business partners that have a significant impact on Astellas’ business continuity, such as suppliers of raw materials (regardless of whether they are direct or indirect materials), outsourcing companies, pharmaceutical wholesalers, sales alliance partners and banks.
On-Site Audits of Suppliers
In the year ended March 2020, Astellas employees conducted on-site audits at 13 companies in eight countries and assessed the risk related to wastewater treatment plants, employees’ working environments and efforts to protect employees from exposure to chemical substances. In cases where items were pointed out, Astellas indicated an improvement proposal, requested a plan for corrective measures be drawn up and is currently following up on progress of the improvements based on the corrective measures plan.