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.
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.
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.
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.
When information is disclosed, Astellas handles personal information appropriately according to the relevant policy separately established and is committed to protect such personal information.
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.
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.
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.
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.
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.
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.
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).
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.
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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 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 results, and publication of Astellas sponsored 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. When required by local laws or regulations, noninterventional studies are registered. Trials sponsored by Astellas that are covered under this policy are registered on a publicly accessible clinical trials registry (e.g., http://www.clinicaltrials.gov/). Trials are also registered on national registries, if required by local laws or regulations.
Astellas commits to disclosing summary results of certain Astellas sponsored clinical trials. This policy applies to products that receive initial regulatory approval after January 1, 2014 consistent with the European Federation of Pharmaceutical Industries and Associations (EFPIA)/the Pharmaceutical Research and Manufacturers of America (PhRMA) principles for responsible clinical trial data sharing dated July 18, 2013, and includes the summary results for trials covered under this policy or included in the application to support regulatory approval. Summary results for trials completed after January 1, 2014 with product indications and formulations that received regulatory approval before this date are also disclosed on a publicly accessible clinical trial results database. Summary results are posted on national clinical trial databases as and when required by local law or regulation.
Astellas discloses summary results for studies conducted with compounds that are discontinued during development after confirming there is no intent for future collaboration, out-licensing or development of the molecule.
Astellas is working to provide a layperson summary of clinical trial results for studies within the scope of the policy that are conducted with Astellas products that have regulatory approval.
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.
Subject to compliance with the applicable laws and regulations relevant to protection of personal data, Astellas provides 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.
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.
Astellas will neither utilize human stem cells for human reproductive cloning nor endorse or support any such efforts.
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.
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.
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:
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.
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.
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.
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.
In determining our social contributions in these focus areas, Astellas will put more emphasis on the activities which:
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:
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.
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.
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:
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:
when the purpose of doing so is to:
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.
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:
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:
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.
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.
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 SponsorInvestigator 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 crossfunctional 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.
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.
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:
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.
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”.
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.
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.
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.
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 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.
*Information on Expanded Access protocols can be found at Astellas EAPs. Further information on Expanded Access programs at Astellas can be provided through the following contact.
- 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)
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.
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, falsification, 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.
- 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.
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:
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).
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:
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.
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
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.
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.