Fulfilling Our Ethical Obligations as a Leading Life Sciences Company

Astellas is committed to research activities to create innovative new drugs and medical solutions in compliance with applicable laws and regulations and the highest ethical standards.

Ethical Considerations in Research on Human Subjects

Astellas conducts research on human subjects and research utilizing specimens and information derived from humans after appropriately obtaining the consent of the subjects in accordance with the Declaration of Helsinki*1 as well as the laws, regulations and guidelines of relevant countries.

For example in Japan, Astellas provides training for employees that conduct research, in areas such as bioethics, genome research and related clinical research based on a strong commitment to respecting the human rights of research subjects and protecting the privacy and confidentiality of their personal information. The Astellas Research Ethics Committee has been established with internal/external experts participating in the committee to determine the ethical acceptability and scientific propriety of research plans in a fair and impartial manner. The details of the Astellas Research Ethics Committee have been released on the Ministry of Health, Labour and Welfare’s ethics committee reporting system website*2.

*1 Declaration of Helsinki: A statement of ethical principles for medical research involving human subjects, addressed to physicians and others who are involved in medical research on human subjects.
*2 For details, please visit the following website:
https://rinri.niph.go.jp/

Ethical Considerations in Stem Cells Research and Development

Astellas is advancing research and development activities using stem cells*3 in order to supply new treatment methods to address diseases that previously had no known treatment methods.

Astellas also recognizes that concerns which need careful consideration could arise when promoting research using human stem cells. In particular, it is necessary to pay full attention to the social and bioethical issues associated with research using human embryonic stem cells (ES cells).

Based on these principles and awareness, Astellas has established its “Policy on Human Stem Cell Research and Development*4,” which sets forth the basic matters it must comply with in the course of conducting human stem cell research and development. Specifically, in all of its research and development activities involving human stem cells, Astellas will comply with the relevant laws, ordinances and regulations of the countries and regions where it undertakes these research and development activities. Moreover, we have set up the committee comprising internal and external experts, from which it will obtain oversight and advice on the ethical aspects and the scientific validity and legitimacy of these research and development activities. All research and development programs will be implemented upon investigation by the committee from an ethical and scientific standpoint. Furthermore, when establishing and using human ES cells, Astellas will take steps to satisfy the ethical standards established by the world’s major scientific authorities, including the guidelines laid out by the National Academy of Sciences of the United States of America.

*3 Cells that can self-renew and are pluripotent
*4 For details, please visit the following website:
https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-development#r_and_d

Ethical Considerations in Human Genome Editing

As a leading Life Sciences company with a dedicated mission to contribute towards improving the health of people around the world through the provision of innovative and reliable pharmaceutical products, Astellas is at the forefront of advances in human genome editing techniques. 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.

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. 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. Also at the clinical use stage, Astellas is committed to research and development for appropriate scientific purposes in compliance with all relevant laws and guidelines. Astellas publishes its Position on Human Genome Editing on its website.*5

*5 For further details, please visit the website on the link below.
https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-humangenome#r_and_d

Animal Welfare in Animal Testing

Astellas conducts animal testing based on its Policy on Animal Care and Use*6, which was created based on various relevant laws, regulations and guidelines related to animals such as the Act on Welfare and Management of Animals. We have established the Corporate Institutional Animal Care and Use Committee with external experts that verify the 4R Principles*7 and determine whether to conduct animal testing. All of Astellas’ animal testing facilities have acquired accreditation from AAALAC international*8.

*6 For details, please visit the following website:
https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-animal#r_and_d
*7 4R Principles: Developing non-animal testing alternatives and replacing animals of phylogenetically lower species (Replacement); reducing the number of animals involved to the minimum necessary to achieve the scientific purpose (Reduction); avoiding the infliction of distress on animals wherever possible (Refinement); and scientifically and ethically justifying animal use in light of their significance, necessity, predictability and other criteria (Responsibility).
*8 AAALAC International: The Association for Assessment and Accreditation of Laboratory Animal Care International. An international organization that promotes the humane treatment of animals through voluntary accreditation and assessment programs. Studies are undertaken from both scientific and ethical standpoints to verify the quality of animal control and use programs.

Biotechnology and Biohazard Control

In compliance with the World Health Organization Laboratory Biosafety Manual*9, the U.S. Centers for Disease Control (CDC) Biosafety Manual*10 and the U.S. National Institutes of Health Guidelines*11, as well as the laws of individual countries, Astellas handles experimental materials containing genetically modified organisms and pathogens.

*9 Laboratory Biosafety Manual 3rd Edition
*10 Biosafety in Microbiological and Biomedical Laboratories 5th Edition
*11 NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Consideration for Biodiversity

As set out in its “Position on Genetic Resources*12,” Astellas is committed to the conservation of biological diversity in accordance with the provisions of the Convention on Biological Diversity*13 and, when using new genetic modification techniques, handles genetic resources carefully, mindful about their impact on the environment and people’s health. Astellas also follows guidelines on the utilization of genetic resources and distribution of benefits arising out of their utilization set out in the Nagoya Protocol*14 and, when accessing the genetic resources of another country, Astellas complies with the relevant laws and regulations of the providing country and ensures the fair and equitable sharing of the benefits arising out of utilization.

*12 For details, please visit the following website:
https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-resources#r_and_d
*13 The Convention on Biological Diversity: International convention on the sustainable use and conservation of biological diversity
*14 Nagoya Protocol: Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization

Treatment of Intellectual Property

Appropriate protection of intellectual property is critical to addressing unmet medical needs and maintaining a competitive advantage. With this in mind, Astellas has established a Policy on Intellectual Property*15. In addition, Astellas is a signatory to the IP PACT*16, a declaration of 10 key principles affirming our strong commitment to innovation and keeping the needs of patients at the heart of IP practices.

In view of the importance of improving people’s access to health, Astellas participates in the Patent Information Initiative for Medicines (Pat-INFORMED) implemented by the World International Patent Organization (WIPO) to ensure easy access to Astellas’ patent information on medicines by health agencies tasked with the procurement of medicines in various countries. Patent information for XTANDI®, Lexiscan(TM), Gonax®, Suglat®, Tarceva® and XOSPATA® is provided in the Pat-INFORMED database.

Astellas commits to not filing or enforcing patents in Least Developed Countries (LDCs) defined by the United Nations or Low Income Countries (LICs) defined by the World Bank.
Astellas also commits to considering flexibilities in licensing patents in other developing countries on a case-by-case basis, in order to address pressing health challenges, while recognizing these challenges are the shared responsibility of multiple actors, including the pharmaceutical industry*17.

*15 For details, please visit the following website:
https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-property#value
*16 For details, please visit the following website:
http://www.interpat.org/wp-content/uploads/IP-PACT.pdf
*17 For details, please visit the following website:
https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-countries#access_to_health