Astellas Policies establish the important rules, principles, and management responsibility of the overall Astellas group worldwide (referred to as Astellas in the documents). They apply to all full-time directors and full-time and part-time officers, employees, and other temporary staff of the Astellas. They also may apply, in whole or in part, to agents, consultants, contractors, or other individuals who act on behalf of Astellas, if so stipulated in relevant contracts.
The Position Statements provide additional information regarding Astellas views on a variety of important subjects. These documents are examined periodically and updated when appropriate.
Access to Health
Position on Access to Health
Advances continue to be made in technology and medicine that address unmet medical needs. However, there still remain barriers for many people who have difficulty accessing the healthcare they need due to the lack of available treatments, poverty, healthcare system challenges and insufficient healthcare information.
Astellas' raison d'être is to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Guided by this corporate philosophy, our main efforts to expand Access to Health lie in discovering, developing and providing innovative medicines for patients. Astellas also works to advance Access to Health by engaging in initiatives in areas where improvements are needed for healthcare. To improve Access to Health, Astellas has identified four areas where we can leverage our strengths, technologies and expertise to contribute to better global health. These areas are “creating innovation”, “enhancing availability”, “strengthening healthcare system” and “improving health literacy”.
1. Creating Innovation
- Innovative medicines to satisfy unmet medical needs
Astellas’ primary contribution to improve global health is creating innovative medicines and medical solutions in therapeutic areas with a high level of unmet medical needs and delivering them to patients around the world.
- Social benefit-driven research and development
Astellas endeavors to accelerate social benefit-driven research and development, i.e., to research and develop products for diseases which Astellas believes have high unmet medical needs but have been neglected or less prioritized for commercial reason. These activities include drug discovery research, formulation development and new indications for existing products for patients suffering from such diseases.
2. Enhancing Availability
- Management of Intellectual Property (IP)
Astellas believes that IP protection of research and development results is essential to continuously creating new drugs and technologies. At the same time, we acknowledge that some developing countries need special consideration. Astellas commits to not file nor enforce patents in select countries with significant economic challenges considering the importance of improving Access to Health. These select countries will be decided by referring to those designated as Least Developed Countries (LDCs)1 defined by the United Nations or Low Income Countries (LICs)2 defined by the World Bank.
- Expanded access to investigational medicines
The general approach for making our medicines available to patients in need is through the conduct of clinical trials and subsequent registration and commercialization of our products. However, 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. As appropriate, Astellas commits to establishing expanded access plans for investigational medicines and patients that satisfy certain defined conditions in compliance with local regulations.
- Supply chain management
An effective and responsibly managed supply and distribution system is essential to ensure that high-quality products get to the right patients at the right time. Astellas is committed to ensuring the reliable supply of high-quality, safe and effective medicine to patients and customers. Astellas maintains strict quality standards and effective supply chain management to ensure the safety and continued availability of our products.
- Patient assistance/access program
In some markets, Astellas will implement programs which enable patients, who meet predetermined criteria, to obtain assistance in gaining access to select Astellas’ medicines. These programs should include a fair and transparent application process, rational criteria and an effective distribution mechanism relevant for the local market needs.
3. Strengthening Healthcare System
- Improving medical infrastructure, services and quality of care
Astellas seeks to contribute to improvements in the healthcare system through initiatives that benefit public health, enhance the quality of healthcare being provided, and bring overall value to patients, other stakeholders, and the healthcare system as a whole. Our goal through these efforts is to make a lasting improvement in local capacity.
- Technology transfer including capacity building
Astellas will contribute to the appropriate transfer of technology important to the production of medicines through collaboration with the public and/or private sector. Capacity building including sharing of know-how, training and education in manufacturing and quality management of medicines will be considered to strengthen local healthcare system.
4. Improving Health Literacy
- Increasing awareness and patient support
Astellas seeks to improve health literacy in the community and believes it is important to undertake initiatives to raise awareness and provide education that will help patients to prevent diseases, or get proper diagnosis and treatment. Astellas works, within many different regulatory environments, to provide appropriate information and opportunities for patients, families, caregivers and other stakeholders as appropriate to understand diseases and the proper use of pharmaceutical products. In addition, Astellas supports patient groups working to improve health literacy for patients. Interacting with patient groups also helps us to better understand the needs of patients.
Each of these initiatives helps facilitate Access to Health. At the same time, we believe that these initiatives will lead to enhancement of our enterprise value. In order to develop these activities, Astellas considers working with relevant partners where appropriate and will continue to work with and maintain a close dialogue with stakeholders.
- LDCs defined by United Nations
- LICs defined by the World Bank
- Policy on Social Contribution
- Position on Expanded Access to Investigational Medicines
- Position on Intellectual Property in Developing Countries
Position on Early Access and Post-Trial Access to Investigational Therapy
Astellas is committed to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.1 Enrollment in clinical trials is the most effective way to access investigational Astellas therapies before they are approved in a country. However, we recognize that in cases of serious and life-threatening disease, this may not always be an option for patients and their families or caregivers.2 With these patients in mind, Astellas evaluates and plans, when possible, for other appropriate access routes throughout the drug development process, including early access and post-trial access programs. For an understanding of how Astellas evaluates and plans for access to therapy at each phase of the product lifecycle, see Our Commitment to Improving Access to Medicines at [Links to be released in Early April].
Early access programs enable access to an investigational Astellas therapy before marketing approval following an unsolicited request by a prescribing healthcare professional. We establish these programs as important access routes for patients with serious, life-threatening diseases who have exhausted all available therapeutic options and are unable to participate in a clinical trial. Astellas continually evaluates which diseases and therapies meet the criteria for providing early access and establishes selected programs before marketing authorization, typically to run until the therapy is commercially available. Early access programs are not feasible in every country and there may be factors such as local regulations, diagnostics, manufacturing capabilities and product supply limitations that impact where early access programs are established. Where possible, we strive to include countries conducting pivotal clinical trials for the investigational therapy and countries where commercial availability is planned.
Astellas works to ensure patients with serious, life-threatening diseases, who have completed Astellas clinical trials and have no commercially available therapeutic alternatives, have uninterrupted access to the investigational therapy until it becomes commercially available in that patient’s country of residence. When applicable, the clinical trial protocol describes post-trial access. In all cases, information related to post-trial access is communicated to relevant healthcare professionals and clinical trial participants before or during study participation.
Eligibility for post-trial access and early access
Astellas commits to establishing early and post-trial access programs for investigational therapies and patients that meet the following criteria:
Criteria established to implement early access and post-trial access programs
- The investigational therapy is actively being developed to treat a serious, life-threatening disease
- Safety and efficacy data that supports continued development with the dose selected and the intent to pursue marketing approval
- Clinical trials and registration processes will not be delayed or compromised
- The investigational therapy is not commercially available in the patient’s country of residence
- There is sufficient product supply available and there are no barriers to obtaining, labeling and distributing the investigational therapy
- The program is permitted by health authorities under existing laws and regulations
Criteria established to determine patient eligibility
- The patient has a serious, life-threatening disease
- There are no commercially available therapeutic alternatives
- The benefit outweighs the risk to the patient, as determined by the patient’s physician in consultation with the Astellas Early Access Medical Lead
- The patient meets product-specific eligibility criteria
- The appropriate local and national regulations are followed with the required approvals obtained to provide an investigational therapy
- Diagnostics, equipment and physician expertise required to administer the therapy are available to the patient
- The patient can continue therapy, if needed, following commercial availability by transitioning from early access or post-trial access to a commercial access mechanism
Early access requests
All requests for early access must be made by a patient’s treating physician. Therefore, any patient seeking access to investigational therapy through an Astellas-sponsored early access program should contact their physician directly. Astellas will acknowledge receipt of all requests and begin discussing patient eligibility with the requesting physician within five calendar days. The decision to provide a patient with early access to therapy will be made by Astellas on a case-by-case basis in consultation with the patient’s physician and the Astellas Early Access Medical Lead.
Early access requests may be submitted by physicians utilizing the contact information below:
Our guiding principles
The Access to Medicines philosophy at Astellas is guided by the principles of international ethical frameworks such as the Declaration of Helsinki, ICH Good Clinical Practices and other relevant international guidelines.3,4 Astellas has controlled procedures in place to support prompt and fair decision-making, while ensuring a consistent approach for managing these programs throughout the world in compliance with applicable laws and regulations.
Access to cell and gene therapy
The access mechanisms implemented by Astellas are multifaceted, require close evaluation, and may be shaped by country specific regulations. This is especially true for more complex treatment forms such as cell and gene therapies where clinical and regulatory requirements vary and are rapidly evolving.
Additionally, cell and gene therapies typically require administration by highly trained physicians who have access to the diagnostics, equipment and resources needed to ensure the highest level of safety possible. For this reason, Astellas will continue to focus on bringing safe and effective cell and gene therapies to market as quickly as possible, with the quality controls required to develop these innovative therapies.
- Astellas. Vision and strategy. Available at https://www.astellas.com/en/about/philosophy
- FDA. Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. Available at https://www.fda.gov/media/71927/download
- WMA. Declaration of Helsinki. Available at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
- ICH. Guideline for Good Clinical Practice E6(R2). Available at https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
Date of Disclosure: March-2022
Position on Intellectual Property in Developing Countries
Astellas believes that intellectual property protection of research and development is essential to the creation of innovative new drugs and technologies. At the same time, we acknowledge that a variety of inter-related factors in select developing countries may inhibit access to care, although we do not believe that intellectual property protection is a factor in limiting Access to Health.
Intellectual property protections increase access to medicines by incentivizing research and development that creates new drugs and technologies.
Astellas commits to not filing or enforcing patents in Least Developed Countries (LDCs)*1 defined by the United Nations or Low Income Countries (LICs)*2 defined by the World Bank. We recognize that these countries can be the subject of flexibilities allowed in Declaration on the TRIPS agreement and public health (Doha Declaration)*3, in order to address social and economic concerns. Of note, LDCs have secured an exemption from the TRIPS agreement until 2033, which Astellas supports. 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.
Astellas believes in improving patient health through creating innovative new drugs and technologies. We believe compulsory licenses are appropriate only in the case of a national emergency or other circumstances of extreme urgency, in accordance with international rules, and only when all other alternatives have been exhausted. The Doha Declaration reflected in Article 31bis of the TRIPS agreement articulates the foundation for support for intellectual property rights and the need for delivery of life saving medicines to LDCs and LICs.
- LDCs defined by United Nations
- LICs defined by World Bank
- Declaration on the TRIPS agreement and public health
- Policy on Intellectual Property
- Position on Access to Health
Research and Development
Policy on Animal Care and Use
Astellas’ business philosophy is to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas takes animal welfare seriously, while also recognizing that drug discovery research that responsibly involves animals contributes to the advancement of medicine that fills critical unmet medical needs.
Astellas complies with applicable local laws and regulations on animal care and use and with internationally recognized standards.
Astellas will endeavor to meet the “4R Principles” regarding responsible involvement of animals in the development of medicines, which include: 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).
An Institutional Animal Care and Use Committee (IACUC) has been established at each location within Astellas where animal experiments are conducted to:
- Ensure compliance with applicable laws, regulations, and standards
- Confirm, assess and monitor the 4R Principles
- Review and approve experimental protocol
- Provide all personnel involved in the care and use of animals with adequate education and training
In addition, the Corporate IACUC has been also established as the ruling body of all IACUCs within Astellas.
To further assure that animals are cared for and used humanely in accordance with high ethical standards, all Astellas animal facilities have been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International.
In cases where animal experiments are outsourced to an organization outside Astellas, we shall ensure that the outsourced organization complies with applicable laws, regulations and other standards on animal care and use. In addition, we shall endeavor to have them comply with Astellas’ standards to the fullest extent possible.
Policy on Stem Cell Research and Development
Stem cell research and development has demonstrated significant progress in recent years. It is anticipated that achievements in this field will contribute to the development of new therapies for serious diseases that were previously untreatable.
Stem cells are the cells that not only have the potential to self-renew but also to differentiate into a wide variety of cells that form tissues and organs of the body (an ability called multipotency). In the adult body, stem cells function as a repair system to replenish tissues for the maintenance of homeostasis. Given their unique regenerative ability, stem cells offer potential to serve as research tools in drug discovery. In addition, stem cells or stem-cell-derived cells can be utilized directly as therapeutic agents, thereby opening a new field in medicine cell therapy.
Astellas is investigating the use of stem cells as therapeutic agents and believes that they have the potential to address previously untreatable diseases.
Although promising, we fully recognize that ongoing research with human stem cells may give rise to sensitive issues. We are especially cognizant of the social and bioethical concerns surrounding research with human embryonic stem (ES) cells.
Accordingly, this policy states our policy regarding human stem cell research and development activities. This policy applies to research and development activities performed by Astellas as well as work done in collaboration with other institutions.
- All stem cell research and development activities will comply with the applicable laws and regulations of the countries or regions in which they are conducted.
- A committee consisting of internal and external experts will oversee the ethics and scientific rigor or merit of human stem cell research and development activities. Research and development proposals will be reviewed and approved to ensure these activities are conducted ethically and for appropriate scientific purposes.
- Regarding human ES cells, we will use only those cell lines that meet the ethical standards set by leading scientific authorities around the world, for example, the Guidelines developed by the National Academy of Sciences in the USA.
Astellas will neither utilize human stem cells for human reproductive cloning nor endorse or support any such efforts.
Policy on Investigator Sponsored Research (ISR)
Astellas is committed to providing benefit to patients, healthcare professionals, and the community through quality research. Astellas recognizes that supporting external medical, scientific, or educational organizations in their research investigations is an important way to understand the needs of patients and to advance knowledge in patient care and improve health. The purpose of this policy is to define the standards that govern the relationship between Astellas and the external Investigators who engage in Investigator Sponsored Research (ISR) aimed at advancing medical and scientific knowledge for Astellas marketed products and in relevant therapeutic areas.
Astellas principles for support of ISRs include transparent and documented procedures that support compliance with applicable laws, regulations and industry codes. The policy applies to ISRs for both clinical and non-clinical research on products for which Astellas is the marketing authorization holder as well as in associated disease areas.
In alignment with this policy, all ISR concepts and proposals must be unsolicited and originate externally from the Sponsor-Investigator or Institution. The Sponsor-Investigator or Institution assumes full Sponsor responsibilities regardless of the support offered by Astellas. The Sponsor-Investigator or Institution can request drug supply and/or financial support to perform the research.
Astellas Medical Affairs is responsible for supporting ISRs, as well as the internal processes that govern the submission, review and approval of ISRs. ISR submissions are reviewed by a cross-functional scientific review committee. If approved, a fully executed written agreement that specifies the responsibilities of the Sponsor-Investigator or Institution must be in place prior to initiation of the research study. Once an agreement is entered into with a Sponsor-Investigator or Institution, Astellas will periodically communicate with the Sponsor-Investigator or Institution to ensure the study is progressing. Astellas Commercial personnel are prohibited from being involved in ISR activities including the initiation, submission, assessment, approval or ongoing management of ISRs. Astellas will review publications submitted by the Sponsor-Investigator or Institution. The review will be limited to facts related to Astellas products, intellectual property, safety/pharmacovigilance, and proper disclosure of Astellas’ support.
Policy on Publications
Publications are credible, evidence-based ways for Astellas to communicate the research results for our investigational and marketed products to the medical and scientific community. This policy is our roadmap to ensure that publications on these products are developed in co-operation with external investigators in a transparent, accurate, balanced and timely manner. This policy adheres to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharmaceutical Research and Manufactures of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) principles on the conduct of clinical trials and communication of clinical trial results.
The results of Astellas’ clinical trials are made publicly available through both peer-reviewed publications and by disclosing results on public registries or websites. Peer-reviewed publications undergo rigorous review by the authors’ peers before acceptance and subsequent publication.
This policy provides guidance on how we interact and work with authors. Astellas follows the authorship criteria and recommendations set by the International Committee of Medical Journal Editors (ICMJE). Authors are identified early in the publication planning process and before writing commences. Authors have access to all relevant study data and are engaged at all stages of the publication development. Astellas does not compensate authors for the preparation or review of publications. Astellas’ commitment to transparency is further evidenced by our disclosure of study sponsorship, editorial assistance and funding. Likewise, authors must disclose financial support and funding received from Astellas and other organizations. Additionally, Astellas protects its intellectual property rights by mandatory reviews.
Astellas submits results on Astellas-sponsored research in a timely manner, regardless of outcome.
Policy on Disclosure of Clinical Trial Data
Astellas is committed to increasing transparency and sharing clinical trial data. Realizing the full value of clinical trial data, such as scientific advancement and increasing innovation, requires that the data be appropriately accessible to the research community and others who might be able to use it. We recognize that making this clinical trial data accessible to researchers, healthcare professionals, patients, and interested members of the public will benefit public health.
Astellas complies with relevant laws, regulatory requirements and industry guidance for registration of clinical trials, posting of clinical trial information, and disclosure of clinical trial results.
Registration of Clinical Trials
Astellas commits to registering all interventional clinical trials sponsored by Astellas that seek to evaluate the safety and/or efficacy profile of an Astellas owned or in-licensed product. Clinical trials sponsored by Astellas that are covered under this policy are registered on a publicly accessible clinical trial registry (e.g., www.clinicaltrials.gov). In addition, other Astellas sponsored studies (e.g., non-interventional studies) are registered on national registries, if required by local/regional laws or regulations.
Posting of Clinical Trial Results
Astellas commits to disclosing summary results for all phase 1 to 4 interventional clinical trials sponsored by Astellas, conducted in the target patient population, with Astellas products that have health authority approval. In addition, summary results for other Astellas sponsored studies (e.g., non-interventional studies) are disclosed on national registries, if required by local/regional laws or regulations.
Summary results and a plain language summary are posted on clinical trial results website(s) (www.clinicaltrials.astellas.com and/or www.trialsummaries.com/Home/LandingPage) for clinical trials conducted with products that receive initial health authority approval after January 1, 2014. Summary results are publicly disclosed within 3 months after initial health authority approval is granted or within 12 months after trial completion for clinical trials conducted with product formulations and indications that previously received health authority approval. Additionally, summary results are posted on a publicly accessible clinical trial results website for trials conducted with products that received initial health authority approval from November 1, 2008 through December 31, 2013.
Summary results and a plain language summary are also disclosed on clinical trial results website(s) for clinical trials conducted with compounds that are terminated during development after January 1, 2014. Results are disclosed for completed trials within 12 months after compound development is terminated. Results are disclosed within 12 months after trial completion for clinical trials that are ongoing at the time that compound development is terminated.
Scientific Community Access to Study Data
Subject to compliance with the applicable laws and regulations relevant to protection of personal data, Astellas provides a platform (www.clinicalstudydatarequest.com) where researchers may request access to participant level data, trial level data and protocols from Astellas sponsored clinical trials conducted in patients that are completed after January 1, 2010.
Access to this datais granted for products and indications approved in any country after the request has been reviewed and approved by an independent panel of experts (“Scientific Review Board”) based on scientific merit and the qualifications of the researcher. Access is given by Astellas after review and approval by the Scientific Review Board and execution of a data sharing agreement.
Before participant-level data is shared, it is anonymized to respect the rights of the clinical trial subjects to privacy and to protection of their personal health information.
Position on Genetic Resources
Biological diversity brings significant benefits to human society and is closely tied to corporate activities. In rapidly progressing global development, it is recognized that the conservation of biological diversity is an important challenge to be addressed for future generations. Biological materials including genetic resources are commonly used in parts of medicines and vaccines.
As one of the legal and policy instruments related to the above, the Convention on Biological Diversity (CBD)*1 opened for signature at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992 and entered into force in 1993. Subsequently, the Cartagena Protocol on biosafety*2 entered into force in 2003 and followed by the related Nagoya Protocol*3 on access and benefits sharing in 2014.
The CBD consists of three objectives; 1) the conservation of biological diversity, 2) the sustainable use of its components, and 3) the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. Among other principles, the Nagoya Protocol sets out that a country accessing the genetic resources of another country shall be subject to the prior informed consent by the providing country. The benefits from utilizing these resources shall be shared on mutually agreed terms. Astellas supports these principles of the CBD and the Nagoya Protocol.
Astellas deals with living modified organisms (LMOs) in accordance with the Cartagena Protocol, which aims to ensure the safe handling, transport and use of LMOs resulting from modern biotechnology. Recently, new technologies including new breeding technology and genetic engineering have been developed. The effects of the utilization of such technologies on the environment, biological diversity and human health continue to be assessed scientifically. Conferring with academic organizations, national councils, and government authorities, Astellas is committed to managing the use of these technologies in a measured and ethical manner.
- The Convention on Biological Diversity
- The Cartagena Protocol on biosafety
- The Nagoya Protocol
Position on Human Genome Editing
Breakthroughs in genome editing techniques mark major progress in the life sciences. They foster the development of new therapeutic approaches to fight diseases and contribute to potential societal benefit. At the same time, rapidly progressing human genome editing techniques also pose unprecedented ethical, legal and other social challenges including editing of germline cells that results in heritable change.
As a leading Life Sciences company with a dedicated mission to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products, Astellas is at the forefront of these advances. In partnership with academic research institutes and biotechnology companies, Astellas employees and partners at sites around the world are developing innovative therapeutic approaches by combining an in-depth understanding of the underlying biology of diseases with innovative platforms and treatment modalities which includes genome editing/genome regulation.
Genome Editing Standards
Astellas recognizes and supports the ongoing work of the National Institute of Standards and Technology (NIST) Genome Editing Consortium, European Academies' Science Advisory Council (EASAC), U.S. Pharmacopeia, International Organization for Standardization (ISO), World Health Organization (WHO), and other globally authorized organizations to develop global standards for governance and oversight of human genome editing.
Basic & Preclinical Research
Astellas recognizes and supports the premise that basic and preclinical research using genome editing technologies of somatic cells and germline cells should be carried out in compliance with appropriate legal and ethical rules and oversight in order to contribute to health and welfare for patients.
At this time, Astellas will not conduct basic or preclinical research using human germline genome editing.
Clinical Use of Genome Editing
Astellas is committed to research and development for appropriate scientific purposes in compliance with all relevant laws and guidelines. Astellas supports clinical application of genome editing techniques targeting somatic cells under the oversight of relevant regulatory authorities.
However, germline genome editing techniques have not advanced to the point where human
clinical trials would be appropriate. Astellas supports the ongoing discussion by governments and
international expert advisory committees on the regulation for clinical application of human
germline genome editing.
At this time, Astellas will not use human germline genome editing in the clinical setting.
Need for Continued Global Dialogue
Astellas recognizes that there remain many questions awaiting solutions about genome editing,
- Ethical, legal and social issues
- Long-term safety
- Value Assessment and Health Technology Assessment (HTA)
- Appropriate payment models to provide access
- Role of intellectual property
- Harmonization of Genetically Modified Organism (GMO) regulation
While each government ultimately has the authority to regulate activities on human genome
editing under its jurisdiction, development of global standards on human genome editing is
necessary to ensure maximum benefit and minimal risk to human health.
Therefore, Astellas believes governments and the international scientific community should work
together to establish norms concerning acceptable uses of human genome editing and to
harmonize regulations, in order to discourage unacceptable activities, as identified by
international expert advisory committees, while advancing human health and welfare. Astellas
also urges that this international dialogue should be inclusive and engage a wide range of
perspectives and expertise – including scientists, ethicists, health care providers, patients and their
families, policymakers, regulators, research funders, public interest advocates, and industry
representatives from across the globe.
- Friedmann T, Jonlin EC, King NMP, et al. ASGCT and JSGT Joint Position Statement on Human
Genomic Editing. Mol Ther. 2015;23(8):1282. doi:10.1038/mt.2015.118
- National Academies of Sciences Organizing Committee for the International Summit on Human
Gene Editing report: https://www.nationalacademies.org/news/2015/12/on-human-geneediting-international-summit-statement
Value of Innovation
Policy on Intellectual Property
Protecting Astellas’ intellectual property is crucial to maintaining our competitive advantage to address unmet medical needs under our business philosophy to “contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products”. Intellectual property includes any creative works that may be protectable by intellectual property laws as patents, trademarks, trade secrets, copyrights, and know-how.
In light of its importance to Astellas, appropriate steps, including compliance with all applicable laws and regulations, shall be taken to protect and maintain Astellas’ intellectual property. Additionally, Astellas’ intellectual property shall be used in an appropriate manner to enhance corporate value.
Astellas employees must promptly report any inventions or other creative works that could qualify for intellectual property protection made in the course of their work for Astellas. Astellas retains the right in such inventions or creative works in accordance with applicable laws and Astellas’ policy.
Since the premature disclosure of an invention may preclude our ability to obtain patent protection, Astellas employees must use due care to avoid the intentional or inadvertent disclosure of patentable inventions.
Astellas respects the valid and enforceable intellectual property rights of others and takes necessary measures to avoid infringement.
Position on Value and Pricing of Medicines
Astellas contributes to improving the health of people around the world by providing innovative medicines to patients. We do this by investing in leading-edge research and development for innovative medicines and by supporting patients to the access to the medicines they need.
Astellas engages with many stakeholders in the healthcare community to find ways to meet the dual imperatives of working towards affordable access for patients while maintaining proper incentives for companies required to sustain the promise of future innovative medicines.
Astellas believes that the price of medicines should be a fair reflection of the value they bring to patients, healthcare systems, and society as a whole. Improved patient outcomes in mortality, morbidity and quality of life are our first and foremost priorities. However, we also believe that when determining the value of medicines, stakeholders must take into consideration: the novelty of the science; the strength and quality of the evidence; the clinical benefits relative to existing treatments; the economic benefits for both patients and healthcare systems; and the ability of healthcare systems to provide broad access to patients. Throughout the research and development process, we engage with a range of relevant stakeholders, including healthcare providers, payers and patients, to gain diverse perspectives on these and other factors.
Astellas understands affordability of medicines is one factor that can impact patients’ access to medicines. We work with a broad array of healthcare stakeholders to develop sustainable solutions to address issues of affordability. As part of this, we explore various pricing and access solutions, such as patient access initiatives and value-based approaches to the pricing of our medicines, both of which take into consideration a variety of factors, including geographic and socio-economic circumstances.
Astellas is committed to working with stakeholders to find durable solutions that enable patients to have affordable access to our medicines, while still enabling us to invest in innovative new medicines.
Environment and Public Health
Policy on Environment, Health & Safety
Astellas conducts business activities in harmony with the global environment and due regard for employees’ health and safety. Environment, Health & Safety (EHS) issues are recognized as key elements of our corporate management and are considered for every aspect of the business.
We strive to comply with applicable laws and regulations relating to EHS, and proactively aim to achieve stringent standards, setting ourselves higher targets than those required by regulations.
We have established the EHS management systems, which demonstrate our commitment to continual improvement through organized activities.
We regularly assess the potential EHS impacts and risks for all our business operations and make sustained efforts to reduce those potential impacts and risks through our EHS objectives and targets.
We develop effective products and technologies that harmonize well with EHS.
We promote the implementation of activities that aim to reduce the potential risks that may give rise to environmental pollution or work related accidents. These activities also ensure that in the event of an emergency we can act promptly and appropriately in order to minimize damage.
We provide continual training in EHS education for all employees so that they can keep abreast of EHS issues and embrace their social responsibility.
We are committed to social and corporate accountability and openly communicate EHS information in a timely and appropriate manner to our stakeholders.
Policy on Product Safety
The Astellas’ business philosophy is to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. This policy documents Astellas’ commitment and principles as they relate to the safety and reliability of Astellas investigational compounds and authorized medicinal products. The policy demonstrates product safety is a steadfast priority throughout the corporation.
Astellas is committed to:
- Compliance with all legal and regulatory requirements for pharmacovigilance activities and responsibilities
- Preventing any harm arising from the use of Astellas products
- Protecting patient and public health, utilizing the most current methodologies for comprehensive medical and scientific safety data analyses
- Providing timely and reliable safety information to all Astellas stakeholders.
The policy further ensures use of a global pharmacovigilance system to continuously monitor the safety profile of Astellas products and to detect any changes to their risk-benefit balance. The system is supported by a robust organizational structure, human resources, information technology and functional processes focused on the safe, effective and appropriate use of our medicines. Astellas is committed to carrying out the intent of the global product safety system. Overall, patient safety is embedded within the entire organization, and this policy supports that position.
Position on Climate Change
Astellas recognizes climate change and its potential consequences as a global environmental issue that threatens the sustainability of our business to serve patients. To mitigate threats to our business activities such as severe weather conditions, precipitation pattern change, spread of infectious disease, and energy source portfolio change caused by climate system change, Astellas’ focus is on reducing greenhouse gas (GHG) emissions from our business activities. This will help to contribute toward preventing dangerous anthropogenic interference with the climate system.
Astellas is committed to fulfilling its corporate environmental responsibilities with a long-term and broad view for climate change mitigation and adaptation.
Astellas, a company dedicated to improving the health of people around the world, conducts business activities in harmony with the global environment. Environmental issues are recognized as key elements of our corporate management and are considered in every aspect of the business.
Astellas established an Astellas Environment and Safety Policy and Astellas Environment and Safety Guidelines in 2005, and is implementing measures to reduce energy demand proactively and to reduce GHG emissions by improving our energy efficiency.
Astellas believes that the activities of reducing GHG emissions and improving energy efficiency contribute to not only the company’s long-term sustainability but also significant cost savings in the long-term.
- Strive to reduce GHG emissions resulting from improvement of energy efficiency through activities such as installing highly efficient equipment and manufacturing processes that take into account energy/resource conservation and controlling air-conditioning operation efficiently.
- Strive to reduce GHG emissions from sales vehicles by efficient use.
- Promote the use of energy that generates less GHG or renewable energy.
- Endeavor to cooperate with suppliers and business partners to support them in reducing their GHG emissions.
- Endeavor to communicate proactively with our stakeholders and enhance corporate transparency by making disclosures in an appropriate manner.
Position on Counterfeit/Falsified Medicines
A counterfeit medicine1 is a medicine that has been deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient ingredients or with fake packaging.
Similarly, falsified medicines1 are medical products that deliberately/fraudulently misrepresent their identity, composition or source. As the distinctions between these two terms are subtle, for the purpose of this document both terms will be used in the same context.
Counterfeiting/falsification of healthcare products is a serious and growing concern because it causes ineffective and potentially dangerous products to enter the marketplace. Moreover, it can undermine confidence in product safety and effectiveness while putting patients’ health and lives at risk.
There is abundant evidence of essential medicines, including life-saving medicines, being counterfeited/falsified globally. In addition, distribution of medicines through questionable entities posing as legitimate online pharmacies continues to be a serious problem, while spread of the corona virus disease (COVID-19) has further increased the demand for online pharmacies.
A review of internet drug outlets in the US revealed that 94.8 percent of these so-called pharmacies do not follow basic patient safety and pharmacy practice standards.2 Instances of illicit medicine sales through social media by unauthorized/unlicensed parties are also increasing very rapidly.
With the increase in internet connectivity, questionable entities trafficking in counterfeit/falsified medicines have gained access to the global marketplace. Although this issue impacts all countries, countries where there are weak or non-existent regulatory systems bear the greatest risk of counterfeit/falsified medicines. It was observed that 1 in 10 medical products in the supply chain of low-and middle-income countries was counterfeit/falsified according to the research by WHO.3
Astellas takes a firm position against counterfeit/falsified medicines, and other illicit activities that perpetuate the illegal medicines trade. However, Astellas recognizes that the Company cannot tackle this issue alone and that it has no official power to intervene directly.
Our goal in this regard is to help ensure that patients receive only genuine, legitimately distributed Astellas products. Given the potential for negative impact to patients’ health caused by counterfeit/falsified medicines and the risk that Astellas’ products may be the target of counterfeiting/falsification, Astellas operates an Anti-Counterfeit Committee. This committee governs internal product security activities targeting counterfeiting/falsification, diversion and theft, and a multi-functional team of subject matter experts who undertakes countermeasures as follows:
- Astellas fully cooperates with health & regulatory authorities, law enforcement entities and other pharmaceutical companies on a global level with regard to investigations, enforcement actions and other activities related to counterfeit/falsified medicines. Astellas maintains active membership in the Pharmaceutical Security Institute (PSI), a trade organization that provides a platform for member companies to share intelligence on pharmaceutical crimes affecting their products, collaborates on investigations of mutual interest and interacts regularly with key pharmaceutical-focused law enforcement contacts globally.
- Astellas monitors both virtual (internet) and physical markets to ensure a current and comprehensive understanding of activities involving our products occurring outside of the legitimate supply chain.
- Astellas develops technical security measures (authentication and anti-counterfeit technologies) and the processes to manage them for our most at-risk products.
- As the terms “counterfeit” and “falsified” were both used to form the basis of legislation in numerous countries and are referenced in national policies of drug regulators, health authorities and private sector entities across the globe - abandoning one term in favor of the other is simply not feasible for all stakeholders. Therefore, for the purpose of this document both terms will be used in the same context.2
In 1992, the World Health Organization (WHO) defined counterfeit medicines as “medicines that have been deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient ingredients or with fake packaging.” The term “counterfeit” and its associated definition was widely accepted by both governments and industry for many years.
In 2006, member states began to debate over use of the terms “counterfeit” vs. “falsified” as there were implications that the former was associated more with intellectual property and trademark protection while the latter was primarily concerned with public health.
Prompted by the need for clarity and simplification of terminology as well as an end to the decade-long debate, WHO officially adopted “Falsified” in 2017, providing the following definition: “Falsified medicines are medical products that deliberately/fraudulently misrepresent their identity, composition or source.” Of particular note was that the newly published definition for “falsified” was clearly a derivative of the original definition for “counterfeit”.
- National Association of Boards of Pharmacy (NABP) Internet Drug Outlet Identification Program: Progress Report for State and Federal Regulators, June 2018.
- The WHO Member State Mechanism on Substandard and Falsified Medical Products, April 2019.
Position on Prevention of Misuse and Abuse of Medicines for Doping in Sport
Abuse of medicines to enhance performance in sport is considered a serious public health issue by sport associations and public authorities worldwide. Doping in sport is understood primarily as the misuse and abuse of commercially available medicines, as well as those in development.
In 2010, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the World Anti-Doping Agency (WADA) signed a Joint Declaration on Cooperation in the Fight against Doping in Sport*1. This has been further reinforced by the launch of the brochure “2 FIELDS 1 GOAL: Protecting the Integrity of Science and Sport”*2 which aims to achieve the goals of this joint declaration. Together with the launch of the brochure, WADA has released a booklet titled “The Points to Consider: Identification of Compounds with Potential for Doping Abuse and Sharing of Information with WADA”*3. These 2 documents provide guidance on how the pharmaceutical industry can support WADA in their fight against the use of doping in sport.
Astellas supports this global initiative and is committed to our collective social responsibilities in this field. In support of this commitment, Astellas has signed a Memorandum of Understanding with WADA to contribute to the fight against doping and in this way contribute to improving public health*4. Astellas commits to cooperate with WADA and our alliance partners in the following ways:
- Identifying medicines in development with a potential for sport-related doping abuse
- Cooperating by sharing relevant information on medicines with doping potential with WADA to support WADA in their development of detection methods for these Medicines
- Minimizing the risk of misuse of medicines with doping potential during clinical trials to avoid opportunities for abuse
- Collaborating with WADA on appropriate communication plans when medicines developed by Astellas are associated with doping cases.
- IFPMA & WADA Joint Declaration on Cooperation in the Fight against Doping in Sport
- 2 Fields 1 Goal: Protecting the Integrity of Science and Sport
- Points to Consider: Identification of Compounds with Potential for Doping Abuse and Sharing of Information with WADA
- World Anti-Doping Agency and Astellas Announce Global Initiative to Prevent Misuse and Abuse of Medicines for Doping in Sports
Ethics and Integrity
Policy on Conflicts of Interest
Astellas is committed to conducting its business throughout the world in accordance with high ethical standards and applicable laws, regulations, industry codes and Astellas policies and procedures. Avoidance of conflicts of interest is essential to conduct business ethically, with integrity and objectively. This policy is a formal statement of Astellas policy, which is intended to highlight and reinforce the conflicts of interest provisions of the Astellas Group Code of Conduct. The policy is designed to ensure that all Astellas Personnel will act and make business decisions that impact Astellas strictly on the basis of Astellas’ best interests. This also requires that Astellas personnel avoid situations that present or create the appearance of a potential conflict between their personal interests and the interests of Astellas.
Where Astellas operates in a country with local laws, regulations or industry codes that set a higher standard than this policy, Astellas must comply with the higher local standard. Astellas’ commitment to compliance goes beyond merely following applicable laws, regulations, and industry codes. Astellas personnel are always expected to act with integrity and make ethical decisions in all aspects of Astellas’ business.
Conflicts of interest arise when personal interests, relationships, associations, investments or activities (whether direct or indirect) may influence or be perceived to influence objectivity, judgment or actions in conducting business for Astellas. Conflicts of interest include situations that create the appearance of a potential conflict between personal interests and the interests of Astellas. For example, they may include a situation where Astellas personnel, a family member or someone with whom an employee has a close personal relationship has a substantial financial interest in an Astellas business partner.
It is impossible to describe in this policy all situations in which there may be an actual, potential or perceived conflict of interest between the personal interests of Astellas personnel and the interests of Astellas. Astellas personnel are expected to use common sense and a commitment to the highest sense of ethics in applying the principles of the policy to their particular circumstance. Transparency is critical in determining whether a prohibited conflict of interest exists, and Astellas personnel must consult with their Ethics and Compliance department to help make this determination.
Astellas personnel who become aware of, or reasonably believe that there has been a potential or actual violation of this policy, or any other Astellas policy or procedure, or law, regulation or industry code, relating to conflicts of interest, must report the matter to Astellas in good faith.
Astellas personnel also have an affirmative obligation promptly to disclose any potential conflicts of interest that arise during the course of their employment or arrangement with Astellas, prior to undertaking any activity that may raise a potential conflict of interest.
This policy will be applied impartially to all employees regardless of their rank, status, seniority or position within Astellas.
Astellas personnel who violate this policy may be subject to disciplinary action, up to and including termination of employment, in accordance with applicable laws and Astellas policies. In some cases, Astellas may have a legal or other obligation, or may otherwise determine that it must report violations of this policy to the appropriate enforcement authorities, as in some cases, violations of Astellas policy or procedure also may involve violations of law.
Policy on Global Anti-Bribery and Anti-Corruption
Astellas is committed to conducting its business throughout the world with integrity, the highest ethical standards, and in compliance with applicable anti-bribery/anti-corruption (“ABAC”) laws, rules, regulations, codes and guidelines.
What constitutes bribery may vary from country to country. Many ABAC laws apply beyond the territorial boundaries of the country where they were created. Some ABAC laws prohibit bribery not only of government officials but also apply to non-government employees.
Astellas ensures that a consistently high and ethical standard is applied to interactions with government officials, government organizations, health care professionals and health care institutions across the globe.
Astellas prohibits bribery or other corrupt activity, either directly or through the engagement of third parties, in all of its interactions with government officials, government organizations, health care professionals and health care institutions. Astellas requires all of its employees and third party representatives to maintain appropriate relationships with government officials, government organizations, health care professionals and health care institutions in a manner that ensures free and fair competition in all aspects of the conduct of our business.
As part of their interactions with government officials, government organizations, health care professionals and health care institutions, Astellas prohibits all employees, either directly or indirectly, from:
- offering, promising, giving or authorizing, soliciting or accepting bribes which may include money, hospitality or anything else of value;
- providing any financial or other advantage; or
- ignoring or countenancing the activities of any Astellas employees or agents who offer, promise, give, authorize, solicit or accept any bribe in relation to Astellas’ business;
when the purpose of doing so is to:
- obtain or retain business for Astellas;
- influence any act or decision in connection with Astellas business activities;
- obtain an improper advantage;
- violate a duty of loyalty; or
- reward improper conduct.
Policy on Confidential Information
The Astellas’ business philosophy is to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In order to obtain the trust from society and conduct competitive business, the protection of confidential information is essential. Astellas personnel and selected individuals who act on behalf of Astellas work with confidential information on a daily basis. This policy sets forth global rules and guidelines about how to best protect and prevent the loss of this vital Company asset.
Confidential information includes information about Astellas medicines and business, that Astellas has not made available to the general public. It has many types and is stored in various ways. It also includes information lawfully in Astellas’ possession that belongs to third parties. All Astellas employees have a responsibility to take the appropriate steps to safeguard confidential information. This includes securely maintaining electronic and hard copy information, putting proper safeguards in place to transfer information to partners in the course of business, ensuring secure disposal where appropriate, appropriately exchanging information between Astellas entities, and preventing against inadvertent disclosures. Astellas also respects confidential information belonging to third parties by not accepting such information unless authorized to do so, and, when authorized, by handling it in accordance with the written agreement governing the information.
Policy on Global Data Privacy
Astellas operates in many different countries and is committed to conducting its business throughout the world in accordance with applicable laws and high ethical standards. Personal information is central to our business. We work to obtain and use personal information both fairly and transparently. This policy is implemented to ensure that the personal information we keep is held securely.
This policy is a global minimum standard for data privacy. Astellas shall comply with the relevant local standard and applicable privacy laws.
Astellas will take reasonable steps to:
- Process personal information fairly and lawfully;
- Obtain personal information only for specified and lawful purposes, and shall not further process data in any manner incompatible with those purposes;
- Ensure personal information is adequate, relevant and not excessive in relation to the purposes for which they are processed;
- Ensure personal information is accurate and, where necessary, kept up to date;
- Not keep personal information for longer than is necessary for the purposes it was collected;
- Safeguard the rights of data subjects under the applicable privacy laws;
- Take appropriate technical and organizational measures against unauthorized or unlawful processing of personal information and against its accidental loss, destruction and/or damage;
- Transfer personal information in compliance with the applicable privacy laws. Where appropriate, Astellas will carry out due diligence as well as put in place adequate contractual arrangements and use restrictions; and
- Send marketing communications in compliance with the applicable privacy laws and obtain data subject’s consent where legally required.
Astellas will endeavor to gain agreement on the principles set forth in this policy in arrangements with third parties and ensure that the service providers which process personal information on our behalf strictly protect such personal information according to the applicable agreement.
Article I. Statement of Commitment
Astellas discloses information to all of its customers, shareholders, community and other stakeholders in a timely, proper, and fair manner. Astellas also actively engages in dialogue with them and reflects their comments in its business activities properly. Through disclosure and dialogue, Astellas is committed to further enhance its transparency and strive to build and maintain a trust relationship with its stakeholders.
Article II. Applicable Information
Astellas treats as “Material Information” the information that it is required to disclose by law (e.g., Financial Instruments and Exchange Act) or under the rules and regulations of the stock exchanges where the Company’s shares are listed (collectively, “Law, Rules and Regulations”), as well as the information to which the above-mentioned rules do not apply but may have an impact on the investment judgment of investors, and promptly discloses such information. Corporate information concerning management strategies, business activities, etc. that does not correspond to Material Information but is considered useful to better understand Astellas is also covered by this Policy and actively disclosed.
(NOTE) Astellas also properly discloses clinical trial data, information about collaboration with healthcare professionals, etc., under its policies separately established based on local guidelines and rules, in order to further improve its transparency.
Article III. Methods of Disclosure
Astellas discloses information in accordance with Laws, Rules and Regulations. Material Information will be made public through the Timely Disclosure Network (TDnet) provided by the Tokyo Stock Exchange and, promptly after such public disclosure, made available via press releases and the Company's website. Information other than above will also be disclosed in a manner appropriate for the content.
Article IV. Internal System Related to Disclosure
- In order to ensure the transparency of business activities and to gain greater confidence from all of its stakeholders, Astellas set up the Corporate Disclosure Committee that promotes and manages disclosure activities of financial and non-financial information which impact the capital market. The Corporate Disclosure Committee is tasked with discussion on formulating, revising and operating this Disclosure Policy, disclosure strategy related to applicable information, the appropriateness of disclosure activities, etc. The Committee consists of a chairperson who is the Chief Financial Officer and cross-functional members who are appointed by the chairperson.
- Authorized spokespersons are responsible for disclosing applicable information to shareholders, investors and other market participants.
- A monitoring process is in place to evaluate the operation and maintenance of internal systems related to the timely disclosure of Material Information.
Article V. Protection of Personal Information
When information is disclosed, Astellas handles personal information appropriately according to the relevant policy separately established and is committed to protect such personal information.
Article VI. Response to Incorrect Reporting and Important Changes
If any previously disclosed information is found to be incorrect, Astellas promptly issues a correction. In addition, if any new development renders previous disclosures significantly misleading, Astellas promptly updates and discloses the new information.
Article VII. Disclosure to Capital Market Participants and Dialogue with Shareholders and Investors
In addition to the above, when information is disclosed, Astellas gives due consideration to the following in order to ensure the fair and proper disclosure to shareholders, investors and other capital market participants. Astellas also engages in constructive dialogue with shareholders and investors.
1. Dialogue with Shareholders/Investors and Internal Feedback
Astellas engages in constructive dialogue with its shareholders and investors via interviews, briefings and other various opportunities. Also, comments in the dialogue will be channeled back to the management and relevant personnel so that such comments can be properly reflected in business activities.
2. Handling of Nonpublic Information
To avoid the selective disclosure of nonpublic Material Information to a limited group of capital market participants, Astellas ensures that the concerned personnel handle the information according to internal rules.
3. Quiet Period
To prevent the leakage of financial results before scheduled releases, Astellas defines the four weeks prior to each of the quarterly announcements of financial results as a “quiet period,” during which Astellas refrains from making any comments that differ from the most recently disclosed information related to financial results. However, even during such period, information will be disclosed, as appropriate, pursuant to the Timely Disclosure Rules, if a significant deviation from the business forecast included in the last disclosure is expected. Astellas may answer questions on the information that has already been made public even in the quiet period.
4. Handling of Forward-Looking Information
When Astellas discloses business forecasts and future prospects related to business strategies, research and development, etc., Astellas discloses them with cautionary statements, giving due consideration to the facts that they are based on the currently available information and certain assumptions judged as rational; they include known or unknown risks and uncertainties; and a number of factors could cause actual results to differ materially from those described in such forward-looking statements.
5. Response to Uncertain Information
When rumors or news regarding corporate information of Astellas potentially have a significant influence on capital markets and the truth needs to be established, Astellas discloses information through proper channels such as the Timely Disclosure Network (TDnet).
6. Business Forecast by Third Parties, etc.
In principle, Astellas does not comment on opinions, recommendations, or business forecasts regarding Astellas made by third parties. However, if there is a significant error or mistake on factual information, Astellas may point that out.
End of document
Global Policy for Records and Information Management
Proper record keeping is important to the successful management of our business and to maintaining public confidence in Astellas. According to Astellas Group Code of Conduct, the Global Policy for Records and Information Management (the “Policy”) is designed to further enhance the company’s ability to meet its business needs and comply with applicable legal and regulatory requirements through the systematic control of our business records throughout their lifecycle (from creation through disposition). As a general rule, all Company records (physical and electronic) are required to be maintained and destroyed in accordance with the Policy.
“Records” are recorded information in any media, format or location, received or created by Astellas, which is evidence of or supports its business operations, and has informational value requiring retention for a specific period of time in accordance with the Records Retention Schedule. A Retention Schedule specifies an organization’s record retention policy at the “record class” level and associates legal and regulatory requirements with these record classes.
Astellas’ Records and Information Management processes and procedures shall be globally aligned.
Astellas’ Records shall be managed in a manner that meets Astellas’ business needs as well as applicable legal, contractual and regulatory obligations.
Astellas’ Records shall be protected and maintained in such a way as to remain trustworthy and accessible throughout their lifecycle.
Astellas personnel shall incorporate the management of Records and Information into their business operations.
Any Record or Information created or received in the course of Astellas business is the property of Astellas and does not belong to any one individual, function, business unit, affiliate and/or department.
Records and Information shall be appropriately destroyed in the normal course of business when the retention and preservation requirements have been met in accordance with the Policy.
Policy on Advisory Engagements
Astellas may engage healthcare professionals (HCPs) and other external advisors in order to obtain outside expert advice, opinions and feedback on the development and commercialization of Astellas products and compounds or other appropriate business needs.
Astellas is committed to conducting its business throughout the world in accordance with applicable laws, rules, regulations, codes, guidelines and in accordance with high ethical standards. The purpose of this policy is to establish the governing principles when conducting advisory engagement activities.
Whenever Astellas hires an HCP for advisory engagements including advisory boards, scientific expert meetings, roundtable meetings, or other consulting arrangements to provide services for the Company, we require the following conditions be met:
- There is a legitimate business need for the services on the part of Astellas;
- The arrangement is not a disguised way of inducing the HCP to prescribe, purchase, or recommend Astellas products or as a way of rewarding him/her for doing so;
- The HCP is selected based on his/her qualifications, expertise, capabilities, experiences and/or other appropriate criteria directly related to the identified need;
- A written contract is in place prior to the commencement of the services that accurately describes the nature of the services and the basis for remuneration;
- All compensation reflects fair market value for the services provided;
- Any meeting or event we organize or sponsor for the HCP to perform services is held at an appropriate venue that is conducive to the purpose of the meeting or event; and
- Any travel, lodging, and meals we provide to the HCP in relation to his/her performance of services are consistent with relevant Company policies.
Policy on Crisis Management
Astellas established a global policy of Crisis Management to set forth a global framework that enables a flexible, timely and effective response to a crisis event. The policy reflects Astellas’ practice of proactively identifying, evaluating and responding to significant events with appropriate prioritization and a globally consistent approach.
Astellas defines a crisis event as a specific situation that is unexpected, significant and could cause a severe negative impact to external and/or internal factors of Astellas if not addressed immediately or if mishandled. A crisis event can also be a situation that has not yet fully materialized but has the potential to cause significant negative consequences if mishandled and/or not timely addressed.
Examples of crisis events include, but are not limited to, situations related to patient safety, social responsibility, business operations, compliance matters, and employee safety.
Under the policy, roles and responsibilities have been identified at a global and regional level and communication channels have been established for event reporting purposes. The policy also establishes a process for responding to crisis events.
The application of the policy in real-world business situations ensures that potential negative impacts to Astellas’ business activities and society, as a whole, caused by a crisis event will be appropriately and timely addressed.
Policy on Respect in the Workplace/Prevention of Discrimination and Harassment
Astellas is committed to maintaining a work environment that encourages respect for the dignity of each individual, and to providing its employees with a work environment free from unlawful discrimination and harassment. This policy reflects Astellas’ commitment to conducting its business throughout the world in accordance with applicable laws and high ethical standards. Astellas values the contributions of its employees and believes that working together in a respectful environment is key to our continued success. This policy provides a global minimum standard for positive behaviors and defines conduct that is prohibited in the form of discrimination, harassment and bullying.
Everyone has a responsibility to help maintain a positive and respectful work environment at Astellas and help prevent unethical or unlawful activities/actions. Employees are encouraged to exhibit positive behaviors such as treating everyone fairly, maintaining a workplace where employees can openly communicate, and respecting individual differences.
Astellas prohibits illegal acts of discrimination and harassment based on age, color, disability, employment status, ethnic origin, marital status, nationality, race, sex, sexual orientation, religion or belief, gender identity or expression, veteran status, or any other characteristic protected by applicable law. Astellas also considers bullying and power harassment behaviors as inappropriate, regardless of whether they are illegal in the country of employment. Bullying is offensive, intimidating, malicious or insulting behavior that can make a person feel vulnerable, upset, humiliated, undermined or threatened. Power harassment is bullying that additionally involves the misuse of power.
Astellas employees who become aware of, or reasonably believe that there has been a potential or actual violation of this policy, or any other Astellas policy or procedure, or law, regulation or industry association code relating to discrimination and harassment must report the matter to the Company in good faith. Violations of this policy may be subject to potential disciplinary action in accordance with laws and/or regulations in the country of the employee’s employment or assignment.
Astellas prohibits retaliation against anyone who in good faith reports a concern about harassment, discrimination, or other issues, or cooperates with an investigation thereof, even if the concern is ultimately determined to be unfounded.
Policy on Medical Affairs and Commercial Activities
The ethical and compliant execution of medical and commercial activities relating to Astellas products and therapeutic areas is essential to meeting the needs of patients and the success of our global business. The purpose of this policy is to establish the principles governing appropriate commercial and medical activities and provide direction on certain of these activities, including the ethical and compliant collaboration between Commercial and Medical Affairs when conducting these activities.
Commercial is responsible for promoting the safe and effective use of Astellas products consistent with Astellas policies, applicable laws, rules, regulations, Codes and Guidelines and the product’s labeling and prescribing information approved by local regulatory authorities.
Medical Affairs is responsible for conducting medical activities that are intended to ultimately benefit patient care and experience. These activities advance the understanding and science behind compounds in development and the appropriate safe and effective use of Astellas products through medical leadership and excellence. Medical Affairs is also responsible for engaging in scientific exchanges that generate and result in the appropriate dissemination of relevant, scientifically accurate, objective, truthful and not misleading information about Astellas investigational compounds and marketed products.
The ethical and compliant collaboration and interaction between Medical Affairs and Commercial, both externally-focused and internal, are critical to the success of Astellas. Together, they will advance the science, understanding and appropriate use of Astellas products, help to meet the needs of patients and our other stakeholders, provided that the independence and integrity of the Medical Affairs and Commercial functions is maintained.
For these reasons, collaboration and interaction between Medical Affairs and Commercial must be conducted in a manner that is compliant with applicable local laws, rules, regulations, Codes and Guidelines. These activities should also maintain the independence and integrity of the Medical Affairs and Commercial functions. Specifically:
- Commercial cannot direct or dictate medical activities or scientific exchange
- Medical Affairs cannot direct or dictate the commercial activities or promotional activities of the Commercial organization.
Policy on Review of Materials for Promotion to Healthcare Professionals
The promotion of prescription drug products by Astellas is an important element in educating healthcare professionals (HCPs) about the safe and effective use of our products and helps us to meet the medical needs of patients. The promotional materials used and claims made as part of these educational efforts are subject to internal review processes and will be consistent with the approved local labeling and local regulations.
To ensure that the promotional materials used and claims made as part of these educational efforts do not violate any internal policies and/or regulatory requirements, it is important to have consistency in our approach in their development and review worldwide. To achieve this goal, we have developed this policy which establishes a common set of principles that universally apply to the review of promotional materials and claims intended for HCPs.
All Astellas affiliates should develop promotional materials and claims about our products that are:
- Not misleading
- Supported by scientific evidence, and
- Consistent with the labeling and prescribing information approved by local regulatory authorities.
In addition, all promotional materials and claims must be reviewed and approved by the appropriate functions consistent with local process prior to their being used. Medical Affairs must be involved in the review and approval process to confirm that the promotional materials and claims are supported by substantial scientific evidence. Legal, Regulatory Affairs or Ethics & Compliance must also be involved in the review to confirm compliance with local regulations, internal policies and this policy. Sales personnel should not be involved in the review and approval process.
Adherence to this policy helps ensure that a consistently high ethical standard is applied to promotional materials used and claims made to HCPs wherever we conduct our business. These high quality materials and the truthful and accurate information they contain will help HCPs better understand the safe and effective use of our products that ultimately benefit the patients for whom they are prescribed.
Policy on Social Contribution
Astellas’ raison d'être is to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Our company Charter of Corporate Conduct further states that as good corporate citizens, we shall actively engage in charitable and other activities that benefit society. Astellas believes that we need to enhance our sustainability through earning trust from society for both Astellas and our products.
This policy identifies the strategic approach that Astellas applies and the priority areas for Astellas’ social contribution activities worldwide. It is not intended to cover our commercial programs.
1. Approach for social contributions
Astellas aims to conduct all of our activities strategically to ensure they create sustainable, long-term benefit for our patients and communities around the world. Astellas will utilize our resources (e.g., people, skills, expertise) to implement our social contributions effectively. Astellas will partner with industry associations, charitable organizations and other stakeholders to contribute to addressing healthcare-related challenges that cannot be solved by a single entity. Astellas evaluates and measures the impact of our social contribution activities based on well-accepted, identifiable metrics and will modify and adjust future goals where appropriate. Astellas will report on our activities in an appropriate manner to our stakeholders.
2. Priority areas for social contributions
Based on the relevance to Astellas’ core business and societal expectation of Astellas, we will focus our resources for social contribution in three areas listed below in order of priority.
- 1st priority: Addressing Access to Health issues*
- 2nd priority: Advancement of Medical Sciences
- 3rd priority: Philanthropy/Community Development
In determining our social contributions in these focus areas, Astellas will put more emphasis on the activities which:
- Are healthcare-related
- Are in areas where unmet medical needs exist
- Utilize Astellas’ strengths, technologies and expertise
- The public, government or other major Non-Governmental Organizations do not generally support
- Have a meaningful and long-lasting beneficial impact on society
*Access to Health issues: In the global healthcare environment, there still remain barriers for many people who have difficulty accessing the healthcare they need due to the lack of available treatments, poverty, healthcare system challenges and insufficient healthcare information. Astellas refers to these problems as Access to Health issues.
Position on Human Rights
Astellas’ raison d'être is to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas believes that the rights and dignity of the people using our products both during and after development are paramount. Astellas recognizes it has a responsibility to respect human rights of our stakeholders.
Astellas is committed to respecting the human rights of all people (within and outside the Company) and upholding high labor standards. Wherever we operate, we comply with applicable local labor and employment laws and respect internationally-recognized basic human rights and labor standards, such as the International Bill of Human Rights, the UN Guiding Principles on Business and Human Rights (UNGPs), and the International Labour Organization's (ILO's) Declaration on Fundamental Principles and Rights at Work. In addition, Astellas is a signatory of the UN Global Compact, endorsing the Ten Principles and supports the transparency requirements of the UK’s Modern Slavery Act and similar legislation.
Astellas respects children’s human rights such as those enshrined in the Children's Rights and Business Principles in not only prohibiting child labor but also conducting pharmaceutical research and development related to the development of pediatric formulations.
We also expect our business partners to meet basic human rights and labor standards.
When violations of these rights occur, Astellas recognizes the need and right for victims to have access to effective remedies (judicial and non-judicial).
1. Human Rights to Which Astellas Pays Special Attention
While Astellas is committed to respecting all human rights, we pay particular attention to the rights on which our business activities can have a significant impact:
- Human Rights in Clinical Trials and Other Research and Development Activities Astellas is committed to maintaining the highest scientific and ethical standards in our pharmaceutical research and development. We comply with internationally-accepted standards for non-clinical and clinical research, including the International Council for Harmonization Guidelines and the ethical principles articulated in the Declaration of Helsinki, as well as applicable laws, regulations and industry codes.
In our clinical trials (including post marketing clinical trials), we put the health and safety of trial subjects first, ensuring the respect and protection of their human rights, including rights to dignity, self-determination, privacy and confidentiality of personal information. We obtain appropriate informed consent from everyone taking part in Astellas-sponsored clinical trials.
We handle human biological samples (e.g. blood, tissues and cells) and associated data in a highly responsible and ethical manner. We ensure that appropriate informed consent is obtained from donors (or parents, custodian, or legal representative), as required by relevant local laws, regulations, guidelines or industry codes.
- Counterfeit Drugs and Product Safety
Astellas is committed to ensuring an uninterrupted supply of high-quality products for our patients around the world. We maintain strict product quality standards and a robust supply chain across the world to ensure the efficacy, safety and supply of our products. Our efforts toward patient safety also include implementing appropriate measures against medical errors and drug counterfeiting.
In recognition of the fact that the safety profile of products can continue evolving post marketing, we are also dedicated to monitoring the safety of our products continuously throughout their lifecycles, according to applicable laws, regulations and industrial codes, such as the Good Pharmacovigilance Practices (GVP). We collect, evaluate, and timely report product safety information to health authorities around the world in compliance with applicable laws and regulations.
- Access to Health
Advances continue to be made in technology and medicine that address unmet medical needs. However, there still remain barriers for many people who have difficulty accessing the healthcare they need due to a lack of available treatments, poverty, healthcare system challenges and insufficient healthcare information. While the protection of the right to health is primarily the responsibility of states, pharmaceutical companies like Astellas can play a role in contributing toward improving the health of people by expanding access to health. To this end, we are working on a range of initiatives including: aiming to achieve the United Nations Sustainable Development Goals, combating diseases which have been commercially neglected, preventing and controlling non-communicable diseases, and supporting technology transfer.
Astellas believes intellectual property enhances innovation and discovery and is committed to enhancing access to health through innovation, especially in developing countries. Astellas commits to not filing or enforcing patents in Least Developed Countries (LDCs)*1 defined by United Nations or Low Income Countries (LICs)*2 defined by the World Bank. We recognize that these countries can be the subject of flexibilities allowed in Declaration on the TRIPS agreement and public health (Doha Declaration) in order to address social and economic concerns. For more details about our policy and position of intellectual property, please find “Policy on Intellectual Property” and “Position on Intellectual Property in Developing Countries”.
*1: LDCs defined by United Nations
*2: LICs defined by World Bank
- Human Rights in the Workplace
Employees are a core of our operations, as they enable all we do and are the driving force to realize our mission. Astellas respects the human rights of our employees, including the rights to non-discrimination, freedom of association and collective bargaining, freedom from forced labor and privacy. In addition, we work to promote diversity and inclusion in the workplace and provide a safe and rewarding work environment for our employees. We promote respect for these rights in our business partners.
We comply with child labor laws and regulations and support all ILO labor standards outlined in ILO Conventions (C138 and 182).
- Human Rights in the Community and Environment
Astellas respects the human rights of our neighbors in areas where we operate or have business office and facilities. We continuously monitor and address the environmental impacts of our business operations on our neighbors.
This position statement applies to Astellas’ worldwide operations. Astellas continues to execute the commitments made herein and to fully embed respect for human rights within all areas of the company. Astellas also works to employ our position on human rights in local context through implementation of relevant policies and procedures.
Astellas also expects our business partners to respect human rights in their own operations through our Business Partner Code of Conduct.
We understand the need for employee feedback and the right to remedy, and so we have reporting mechanisms through which employees can file complaints, without fear of reprisal or retaliation and on a confidential basis. This system can be used by both employees and external stakeholders. It allows users to report concerns through telephonic and web-based applications, and it allows anonymous reporting wherever such reporting is allowed by law.
3. Stakeholder Engagement
Astellas believes that corporate respect for human rights is an ongoing and evolving process. Astellas is committed to ongoing engagement with relevant stakeholders to continue to understand and address human rights impacts linked to our business from the perspective of those affected. For example, Astellas’ third-party lifecycle management program reviews key attributes of our significant business partners. We will continue to build upon these efforts and improve our overall human rights performance through public reporting on our approach.
This position statement has been developed by the Corporate Advocacy Department, which is responsible for providing strategic direction and oversight for Astellas’ human rights work, with the input from cross-functional departments within the Astellas group. It has been approved by the Chief Executive Officer (CEO).
- International Bill of Human Rights (consists of the Universal Declaration of Human Rights, the International Covenant on Economic, Social and Cultural Rights, and the International Covenant on Civil and Political Rights and its two Optional Protocols)
- UN Guiding Principles on Business and Human Rights (UNGPs)
- International Labour Organization's (ILO's) Declaration on Fundamental Principles and Rights at Work
- Ten Principles of the United Nations Global Compact
- Children's Rights and Business Principles
- Declaration of Helsinki
- ILO Conventions
- Astellas Group Code of Conduct
- Astellas Business Partner Code of Conduct
- Policy on Respect in the Workplace/Prevention of Discrimination and Harassment
- Position on Access to Health
- Position on Counterfeit Medicines
- Policy on Intellectual Property
- Position on Intellectual Property in Developing Countries
Position on Patient Organization Engagement
Patient organizations play an active role in representing the patient voice to society and the healthcare community. Patient organizations are an important stakeholder for Astellas.
Astellas believes that engaging with patient organizations has the potential to advance our ability to develop effective medical treatments by better understanding the patient’s perspective and desired outcomes and enriching our understanding of the broader healthcare environment. By working together and developing long-term relationships with patient organizations, we can achieve our shared objective of improving the experiences and outcomes for patients and caregivers.
Patient organizations work with patients and caregivers and possess a unique knowledge of their unmet needs. Astellas respects the immense value these insights can offer to help Astellas better understand the patient journey. For example, where appropriate and possible, we will work with patient organizations to enhance our research and development quality. Astellas is currently engaging in efforts to include patient input in the optimal design and execution of clinical trials and identification of additional relevant endpoints important to patients.
Astellas believes that we can build trust with patients and other relevant stakeholders and deliver even more value within the healthcare ecosystem through working with patient organizations. For example, we strive to help patients and their caregivers better understand and manage their conditions by supporting the critical work by patient organizations to improve the health literacy of their members.
Patient engagement requires working together with integrity, in a transparent, ethical and professional manner. Astellas accomplishes this when relationships are based on an independent, mutually respectful, authentic and trustworthy foundation. Astellas is committed to pursuing the development of these meaningful relationships and transparent interactions with patient organizations in compliance with the relevant laws, local regulations, and rules and guidelines of the innovative pharmaceutical industry.
Position on Tax
Astellas has a substantial business and employment presence in many countries around the globe and pays various taxes, including corporate income taxes and other business taxes, as well as taxes associated with its employees. At the same time, Astellas has a responsibility to its shareholders to appropriately manage its taxes to enhance its enterprise value on a sustainable basis, while complying with relevant tax codes.
The approach to managing taxes is aligned to the Astellas Group Code of Conduct*1, which sets out what is expected of all officers and employees of Astellas. To meet these commitments, Astellas takes the following approach to tax in all of the territories where it operates.
I. Tax Governance
We have robust internal policies and procedures to ensure that there is alignment across our business and we meet our tax obligations. In addition, we identify, assess and manage tax risks within the framework of these policies and procedures and account for them appropriately.
Our global tax policy and transfer pricing policy are approved by the Chief Executive Officer and are implemented across the Astellas Group.
The Global Tax Head is responsible for ensuring that our policies establish appropriate procedures, which are maintained and applied consistently around the world, and that the global tax team has the skills and the experience to follow the procedures and perform their duties in accordance with them.
II. Tax Compliance
We have a tax code of conduct, in which we commit to complying with the local tax laws and regulations in each country where we operate. We aim to be a good corporate citizen by observing applicable laws and regulations, including the intent of such rules, and strive to pay the right amount of tax in the right place at the right time.
III. Transfer Pricing
To determine the pricing of transactions among entities within the Astellas Group, we apply OECD guidelines and country-specific rules, which include the appropriate application of relevant transfer pricing methods based on the analysis of the functions performed and risks assumed as well as appropriate documentation.
In addition, we enter into bilateral Advance Pricing Agreements (APA) with tax authorities where appropriate. The APAs provide long-term certainty for both the tax authorities and Astellas.
IV. Relationship with Tax Authorities
We seek to build and sustain relationships with governments and tax authorities that are constructive and based on mutual respect. We work collaboratively wherever possible with tax authorities to resolve disputes and to achieve early agreement and certainty.
V. Attitude to Arranging Tax Affairs
In structuring our commercial activities, we consider the tax rules of the countries where we operate with a view to achieving sustainable growth. For example, we often look to take steps to appropriately reduce the risk of double taxation (i.e. the same income taxed twice in two different jurisdictions). Any structuring that is undertaken will have a business purpose or commercial rationale. Furthermore, we support the objectives of the OECD’s BEPS*2 project to address tax avoidance.
VI. Statutory disclosure requirements
This statement is intended to satisfy any statutory disclosure obligation that may exist in the territories where the Astellas Group operates, which includes but is not limited to satisfaction of the requirements under paragraph 16(2) of Schedule 19 to Finance Act 2016 in the UK by Astellas Pharma Inc. and its UK subsidiaries in respect of financial year ended 31 March 2022.
- Astellas Group Code of Conduct
- BEPS (Base Erosion and Profit Shifting)