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.
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. The Corporate Disclosure Committee is tasked with discussion on formulating, revising and operating this Disclosure Policy, disclosure strategy related to corporate information, the appropriateness of disclosure activities, etc. The Committee consists of a chairperson and cross-functional members who are appointed by the president and CEO.
- Authorized spokespersons are responsible for disclosing corporate 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
Policy on Disclosure of Clinical Trial Data
At Astellas, we recognize that making clinical trial information and results more widely available to researchers, healthcare professionals, patients, and interested members of the public will benefit public health. Therefore, Astellas is committed to increasing transparency and sharing of clinical trial data. Realizing the full value of clinical trial data, such as scientific advancement and increasing innovation, requires that the data be accessible to the research community and others who might be able to use it. For this reason, Astellas has updated its global policy on the disclosure of clinical trial data. Astellas will comply with relevant laws, regulatory requirements and industry guidance, as well as the Astellas Global Code of Conduct, regarding the registration of clinical trial information and disclosure of clinical trial results.
This policy applies to all Astellas products, including those in-licensed from non-Astellas companies, and pertains to phase 1 to phase 4 interventional trials, in patients, that seek to evaluate the safety and efficacy profile of an Astellas product. For products where Astellas has a co-research, co-development or co-marketing/co-promotion agreement, it is recognized that the responsibility for disclosure is dependent on the agreement between parties. Astellas will endeavor to gain agreement on the principles set forth in this policy in arrangements with third parties, but at all times Astellas will comply with the relevant laws and regulatory guidance.
This policy does not apply to investigator-initiated trials for compounds in development or investigator sponsored research for marketed compound, as such trials are not sponsored or conducted by Astellas. Astellas, however, encourages the registration of these trials and the disclosure of results.
What is the Astellas policy for registering clinical trials?
Astellas commits to registering the existence of all Astellas sponsored phase 1 to phase 4 interventional trials, in patients, that seek to evaluate the safety and efficacy profile of an Astellas owned or in-licensed product. Trials sponsored by Astellas that are covered under this policy will be registered on a publicly accessible clinical trials registry. Trials may also be registered on national registries, if required by local laws or regulations.
Astellas recognizes that there are registries that extract information from various sources. Astellas cannot guarantee these registries are maintained with updated information or their accuracy, and accordingly disclaims any liability arising from use of these registries.
What is the Astellas policy for disclosing results of clinical trials?
Astellas commits to disclosing summary results of all Astellas sponsored phase 1 to phase 4 interventional trials, in patients, that seek to evaluate the safety and efficacy profile for Astellas products that have regulatory approval. This policy applies to products that receive regulatory approval after January 1, 2014 consistent with the EFPIA/PhRMA principles for responsible clinical trial data sharing dated July 18, 2013, and includes the summary results for trials covered under this policy and included in the application to support regulatory approval. Summary results for trials completed after January 1, 2014 with products that received regulatory approval before this date will also be disclosed on a publicly accessible clinical trial results database. Summary results will be posted on a publicly available website, including national clinical trial databases as and when required by law or regulation.
Astellas is working to provide a summary of clinical trial results for patients who participate in clinical trials and wish to receive a summary of the results. Astellas will continue to establish standards and operating procedures for creating these summaries for patients to ensure these are as useful and informative as possible.
What is the Astellas policy for publishing results of clinical trials?
Astellas seeks to have clinical trial data of its sponsored trials presented and published, regardless of their outcome, at scientific congresses and in peer-reviewed journals.
How can the scientific community access clinical trial data?
Subject to compliance with the applicable laws and regulations relevant to protection of personal data, Astellas will provide a platform where researchers may request access to patient level data, study level data and protocols from Astellas sponsored clinical trials conducted in patients that are completed after January 1, 2010. Access to this data may be 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 will be given by Astellas after review and approval by the Scientific Review Board and execution of a data sharing agreement. Before patient-level data is shared it will be anonymized to respect the rights of the clinical trial subjects to privacy and to protection of their personal health information in accordance with the applicable laws and regulations.
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 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 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.
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.
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
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 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 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 Social Media
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
- Review and approve experimental protocol
- 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 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.
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.
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 Intellectual Property in Developing Countries
Astellas believes that intellectual property 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, although we do not believe that intellectual property protection is a primary factor in limiting Access to Health.
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 World Bank.
Astellas also commits to considering licensing patents in other developing countries on a case-by-case basis. On the other hand, we believe compulsory licenses are appropriate only in the case of a national emergency or other circumstances of extreme urgency and when all other alternatives have been exhausted.
Position on Expanded Access to Investigational Medicines
Astellas is committed to making our medicines available to patients in the most efficient manner to address their unmet medical needs. The general approach 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.
Astellas commits to establishing expanded access plans for investigational medicines and patients that satisfy the following conditions:
- The disease or condition being studied is serious or life-threatening
- The patient has exhausted all available treatment options
- The provision of expanded access does not delay, interfere or compromise the completion of the clinical trial process and registration of the medicine
- The medicine is in active clinical development and not available on the commercial market
- Patient is ineligible for clinical trials
- There is sufficiently robust preliminary safety and efficacy data including dosing information
- The potential benefit to the patient outweighs the risks
- The patient’s physician, the institutional review board/ethics committee and regulatory authority have authorized the provision of the investigational drug
The decision to provide the medicine to a patient will be made by Astellas based on a fair and impartial evaluation of the requests that meet the conditions described above. This decision will be made in a timely manner to be responsive to the patient’s needs but with appropriate consultation and discussions with Astellas medical and clinical teams, the patient’s physician, regulatory authorities and outside experts. As a general guideline, a response will be provided to expanded access requests within 7 days of receipt if not sooner.
This procedure will be implemented in compliance with local regulations in the country where expanded access is requested. Expanded Access programs will be targeted for countries where active clinical development is underway and registration of the medicine is planned. Generally once a medicine is approved and on the market in a country, the expanded access program will no longer be available.
Astellas provides information on Expanded Access programs appropriately.*Patients should speak with their physicians in regards to seeking eligibility and access to the Astellas Expanded Access Programs.
- Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results by PhRMA (June, 2015)
- BIO Principles on Expanded Access to Investigational, Unapproved Medicines (April, 2015)
- A vision towards a life sciences strategy for Europe by EFPIA (2014)
Position on Counterfeit Medicines
A counterfeit medicine is one which is 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.1
Counterfeiting of healthcare products is a serious and growing concern because it causes fake 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 as well as life‐saving medicines being counterfeited worldwide. In addition, distribution of medicines through questionable entities posing as legitimate online pharmacies continues to be a serious problem. A review of internet drug outlets revealed that more than 95 percent of these so‐called pharmacies do not follow basic patient safety and pharmacy practice standards.2
Astellas takes a firm position against counterfeit 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. Furthermore, Astellas will not assume liability for damage claims related to counterfeit products.
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 medicines and the risk that Astellas’ products may be the target of counterfeiting, Astellas operates an Anti‐Counterfeit Committee. This committee governs internal product security activities targeting counterfeiting, diversion and theft, and a team comprising experts from relevant divisions takes several countermeasures as follows:
Astellas fully cooperates with health & regulatory authorities, law enforcement entities and other pharmaceutical companies on a local, regional and global level with regard to inquiries, enforcement actions and other activities related to counterfeit 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.
- Previous World Health Organization (WHO) definition of counterfeit medicines. Term has changed to Substandard, Spurious, Falsely Labeled, Falsified and Counterfeit (SSFFC) Medical Products, which is not widely used in industry as of yet.
- National Association of Boards of Pharmacy (NABP) Internet Drug Outlet Identification Program: Progress Report for State and Federal Regulators, July 2012.
Position on Prevention of Misuse and Abuse of Medicines for Doping in Sport
Abuse of medicines to enhance performance in sports is considered a serious public health issue by the sport associations and public authorities worldwide. Doping in sport relies primarily on 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. This has been further substantiated by the launch of the brochure of 2 Fields 1 Goal: Protecting the Integrity of Science and Sport1, that 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 WADA2. 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 meet its social responsibility in this field. Therefore, 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.
Astellas commits to cooperate with WADA in the following ways:
- Identifying compounds in development with a potential for sport-related doping abuse
- Cooperating to share relevant information on compounds with doping potential with WADA to support WADA in their development of detection methods for these compounds
- Minimizing the risk of misuse of compounds with doping potential during clinical trials to avoid opportunities for abuse
- Collaborating with WADA on appropriate communication plans when compounds developed by Astellas are associated with doping cases.
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 people using our products both during and after development are paramount. Astellas recognizes that the company has a responsibility to respect human rights of our stakeholders.
Astellas is committed to respecting the human rights of all people (inside and outside the company) and upholding high labor standards. Wherever we operate, we comply with internationally-recognized basic human rights and labor standards, including the Universal Declaration of Human Rights and those articulated in the Ten Principles of the United Nations Global Compact, as well as applicable local labor and employment laws. In addition, we expect our business partners to meet basic human rights and labor standards.
Astellas is also committed to implementing and upholding the UN Guiding Principles on Business and Human Rights (UNGPs). The UNGPs clarify that states have a duty to protect the human rights of all people and corporations have a responsibility to respect these rights. When violations of these rights occur, a joint responsibility requires victims to have access to effective remedies (judicial and non-judicial).
1. Human Rights to Which Astellas Pays Particular Attention
While Astellas is committed to respecting all human rights, we pay particular attention to the rights on which our business activities can have the greatest impact:
- Product Safety and Counterfeit Drugs
Astellas ensures 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 that the safety profile of medicines can continue evolving post marketing, we are also dedicated to monitoring the safety of our products continuously throughout their lifecycles. We collect, evaluate, and timely report product safety information to health authorities around the world in compliance with applicable laws and regulations.
- 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 Harmonisation 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. We also respect and protect 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, as required by relevant local laws, regulations, guidelines or industry codes.
- 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. 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.
- Human Rights in the Workplace
At the core of our operations is our employees, who enable all the work 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, and freedom from forced labor. In addition, we work to promote diversity and inclusion in the workplace and provide a safe and rewarding work environment for our employees. We also strive to promote respect for these rights in our business partners.
We understand the need for employee feedback and the right to remedy, and so we have implemented reporting mechanisms through which employees can file complaints, without fear of reprisal and on a confidential basis.
This position statement applies to Astellas’ worldwide operations. Astellas is fully ready to implement the commitments made herein and to continue to fully embed respect for human rights within our company. Astellas works to implement 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.
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. We will continue to build upon these efforts and improve our overall human rights performance through public reporting on our approach.
- Universal Declaration of Human Rights
- Ten Principles of the United Nations Global Compact
- UN Guiding Principles on Business and Human Rights (UNGPs)
- Declaration of Helsinki
- 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