Corporate Ethics & Compliance | Takeda Pharmaceuticals
Global ethics & compliance
We believe our obligation to meet ethical standards goes beyond compliance with laws and regulations. Our values of Takeda-ism, brought to life through actions based on Patient-Trust-Reputation-Business, represent who we are and how we act. They help us make ethical decisions today, and in the future. To promote ethical behavior and provide guidance to our employees, our Global Code of Conduct is available in multiple languages and lays out a core set of principles for how we conduct business.
Catalyzing a companywide culture in line with our values is the responsibility of the Chief Ethics and Compliance Officer and the Risk, Ethics and Compliance Committee. They help ensure a coordinated, companywide approach on ethics and compliance matters. We execute and reinforce our ethics and compliance programs in line with our Global Code of Conduct and applicable global policies. These policies are approved by the Business Sustainability Committee (BSC).
We aim to maintain the highest level of corporate ethics by creating a safe place for employees, and third parties, to ask question and raise concerns about potential misconduct (including human rights violations). Our employees and third parties have access to several channels to do this, including The Takeda Ethics Line, which is available online and by phone 24 hours a day. We have a policy of non-retaliation for any employee who raises a concern in good faith.
We are committed to operating with integrity. Our Global Anti-Corruption Policy prohibits us from, using third-party intermediaries to conduct activities that we are prohibited from conducting ourselves. We must assess every third-party intermediary to identify and address issues that pose any potential risks for our company. We conduct regular audits to assess instances of bribery and corruption and have implemented an ongoing monitoring program that samples and evaluates high-risk transactions against governing policy and procedure control documents. We execute root cause analysis against monitoring nonadherence and develops remediation plans to drive continuous improvement.
Ethics across our business
As the frontiers of research extend into new areas, such as research on the human genome, gene analysis and stem cell research, additional ethical concerns may arise. We continually review our ethical guidelines to keep pace. We work to stay ahead of emerging trends related to ethics and compliance in by actively participating in pharmaceutical industry associations such as PhRMA and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) programs.
Additionally, recognizing the fast pace of innovation in science and medicine and emerging ethical challenges, we have established the Takeda Ethics Advisory Council (TEAC). The TEAC is comprised of a diverse group of professionals that include prominent external ethics experts and selected Takeda leaders. The primary responsibility of the TEAC is to analyze and provide advice on emerging ethics topics so we can develop robust and principled positions on these issues into the future.
A range of medical ethics issues can arise during the course of research and development into new medicines, from the use of human tissue in research to providing protections for vulnerable populations. We've developed policies and procedures that reflect our commitment to protect patients in our studies and to adhere to the highest ethical standards in our research and development activities.
Medical research depends on the availability of human-derived specimens, such as blood, tissue, cells and other substances to predict the safety and efficacy of new medicines. In line with our values and ethical standards, we're particularly careful with regard to how these specimens are collected and used. Our Research Ethics Review Committee in Japan handles issues associated with human-derived specimens and confirms specimens are used in line with the Declaration of Helsinki, a statement of ethical principles for medical research involving human subjects developed by the World Medical Association. Our Takeda Shonan (TSHO) Research ethics review committee makes sure we conduct our R&D activities with the highest standards of ethics and integrity.
Our Biotechnology Position encompasses the research use of novel technologies, including pluripotent stem cells, genetically modified organisms (GMOs) and gene therapies.
In many cases, animal studies are essential to determine the therapeutic relevance of novel treatments for a multitude of human diseases. Every proposal for the use of animals in research is thoroughly evaluated and approved by the site Institutional Animal Care and Use Committee. We are committed to the “3R’s” of animal research and actively pursue their promotion:
Refining research procedures to avoid or minimize pain or distress.
Reducing the number of animals used in any study conducted to the minimum necessary for valid results.
Replacing the need for animal research through non-animal research methods.
Animal testing activities are approved by a company committee comprising internal and external experts and overseen by the Institutional Animal Care and Use Committee (IACUC). Additionally, all of our R&D facilities that conduct animal research are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary programs, and the adoption of recognized best practices by accredited organizations.
Training on the 3Rs is provided for Principal Investigators, Research Staff Members and IACUC Members. Contract Research Organizations who conduct animal research on our behalf are subject to welfare audits, either virtual or on-site, to monitor that their practices are in line with our principles and commitments.
We are a member of the IQ Consortium who facilitate various leadership groups aimed at sharing pharmaceutical innovation and quality best practices, including the 3Rs Translational and Predictive Sciences Leadership Group. We’re also proud to present an annual 3Rs award to recognize colleagues who exemplify and demonstrate commitment to 3Rs principles and best practices. Our Animal Care and Use Program is overseen by our Global Head of Preclinical and Translational Sciences who reports to the Head of Research, who ultimately reports to our President of R&D.
We apply our values and ethical standards to the design and conduct of clinical trials, informed consent processes and stewardship of participant data. Clinical trials are designed to contribute to the well-being of research participants and patients, and to help build knowledge. We conduct trials in compliance with legal and regulatory requirements, consistent with the Declaration of Helsinki 2013; the Good Clinical Practice (GCP) Standard of the International Conference on Harmonization (ICH); European Federation of Pharmaceutical Industries and Associations (EFPIA)/Pharmaceutical Research and Manufacturers of America (PhRMA) Principles, developed by the European Federation of Pharmaceutical Industries, and Associations and Pharmaceutical Research and Manufacturers of America, as well as other applicable international principles and standards.
We take care to protect the rights of all participants in our clinical studies, paying particular attention to vulnerable populations, such as participants in developing and emerging countries, trial participants who are socially underprivileged and other cases requiring special attention. We provide participants with a thorough explanation of expected benefits and potential side effects and follow an informed-consent process that supports participants’ ability to choose to participate in the trial. Processes are designed to help ensure the well-being of research participants and to respect patient privacy and confidential information. Outsourced investigators who we work with agree to operate in line with the ICH GCP and other applicable principles and standards. We train our employees involved in clinical trials in our policies and the Standard Operating Procedures relevant to their position, including our: Code of Conduct, Ethics & Compliance Policy Training, and bioethics standards related to the conduct of research involving human subjects.
In accordance with our global standards, a clinical study will not be initiated or substantially amended until an approval/positive opinion is obtained from a GCP-compliant Independent Ethics Committee. We have Global Clinical Quality and Global Safety Functions that focus on protecting patients and ensuring quality in our clinical trials throughout their lifecycle. Internal procedures set expectations for how quality and patient safety is managed across all countries and regions. We conduct internal audits that assess compliance with our processes and procedures and are subject to regulatory inspections as well. Escalation processes are in place such that concerns can be raised and are monitored by our Executive Team through the Global Quality Team. In many jurisdictions, clinical trial participants also have the right to lodge concerns about the processing of their personal information with their local data protection authority. A list of European data protection authorities is available here.
The goal of providing patients with early and uninterrupted access to lifesaving treatments is an important component of our Access to Medicines strategy. Post-Trial Access (PTA) helps to allow continued treatment for eligible clinical trial participants who require access to the investigational medicine after a clinical trial has completed. We provide clinical trial investigators with site specific patient-level data from investigational sites upon trial completion. We’re committed to making every effort to submit manuscripts describing results of Takeda-sponsored phase 2–3 interventional drug development trials and phase 4 interventional trials using approved compounds, and clinical studies evaluating our medical devices, within 18 months after trial completion (for marketed products), after regulatory approval, or after the decision to discontinue or terminate clinical development of investigational medicines. Learn more about our clinical trials.
We work with approximately 41,000 suppliers around the world for the materials and services we need to produce and distribute our products. Managing these supplier relationships and the flow of goods and services through our value chain is critical to the sustainability, quality and safety of our medicines — and the well-being of our patients — by ensuring continuity of supply.
Ethical sourcing and supplier risk management
The Ethical Sourcing and Supplier Risk Management program educates all our colleagues employees about the program established for the evaluation of suppliers and other third parties. After the acquisition of Shire, we had to evaluate almost 50% of our supply chain to get every supplier in accordance with the same set of standards and expectations. This program also helps make sure that our suppliers conduct business in line with our expectations, avoid exposing the business to any unnecessary risk and support the delivery of value beyond cost.
Our Ethical Sourcing and Supplier Risk Management efforts are based on our values of Takeda-ism and Patient-Trust-Reputation-Business. This work is led by our Procurement Center of Excellence (PCoE), which has three primary areas:
Ethical Sourcing and Supplier Risk Management
Supplier Performance and Innovation (SP&I)
In addition to these focus areas, the PCoE has created two teams, Data Analytics and Program Management, which facilitate continuous improvement and increase procurement capabilities and knowledge in these critical areas.
Scope 3 carbon emission reduction efforts
In FY2019, we committed to becoming completely carbon neutral by 2040, including a 50% reduction in Scope 3 emissions. This commitment will require comprehensive and long-term partnerships with our suppliers. Scope 3 emissions represent nearly 90% of our total carbon emissions across our value chain. That’s why engaging with our suppliers to reduce supply chain carbon emissions is so critical.
Supplier Code of Conduct (SCoC) and industry collaboration
Our SCoC covers areas that include the environment, human rights, labor practices, safe work, data privacy, anti-corruption, business practices, animal welfare and management systems. The SCoC has been translated into 26 languages and integrated into sourcing projects. Our supplier code is consistent with the Pharmaceutical Supply Chain Initiative (PSCI) Principles, a set of industry supplier standards and expectations established and used by more than 40 member companies of the PSCI. The PSCI is committed to promoting responsible supply chain practices through both supplier audits and supplier capability-building conferences and webinar training sessions. In addition to PSCI, Takeda joined the Pharmaceutical Environmental Group (PEG) and became involved in the Engagement Group and Climate Group to establish standards in greenhouse gas reduction efforts.
Supplier due diligence and partnerships
As a crucial initiative for delivering high-quality pharmaceuticals to patients, we added six steps to the sourcing process to assess supplier risks from a holistic perspective, including sustainability and business continuity risks. The standard diligence process evaluates whether there are potential risks in the areas of animal welfare, EHS, labor and human rights, financial health, corruption and bribery, data privacy and information security. While this is not a comprehensive list of the risks we screen for, it provides an overview of the type of information business stakeholders can expect to receive to make well-informed decisions when it comes to supplier selection.
If specific risks are identified during standard diligence, we conduct enhanced diligence, with experts from across the company as well as external resources, as required. We also partnered with our Business Services team to design a more efficient and effective process for supplier registration and qualification, better ensuring the completion of due diligence and flagging of potential risks known as Integrated Due Diligence. We have also furthered the use of EcoVadis, a digital supplier-sustainability assessment and scorecard system, to help monitor the sustainability performance of strategic, high-risk or other types of suppliers. The platform enables us to monitor KPIs for suppliers as a basis for supplier engagement and improvement. We see an opportunity to further advance supplier performance by increasing their ability to manage their own supply chain impacts.
When we identify supplier sustainability risks related to our Supplier Code of Conduct principles, or if a supplier receives a low score from EcoVadis, we begin a program of onsite labor, ethical, EHS and management system assessments based on PSCI protocols using third-party audit companies. These assessments result in corrective action plans (CAPs) to improve a supplier’s sustainability performance that are periodically reviewed by Takeda and the supplier.
As a global company, we source materials from around the world. We use the power of our spend to expand the diversity, equity and inclusion of our suppliers in a number of ways. For example, our Procurement Policy calls for including at least one small or diverse supplier in each request for proposal and requires our prime suppliers to provide second-tier reporting.
Our Supplier Diversity, Equity, and inclusion program includes, but is not limited to, fostering and maintaining relationships with small to medium enterprises, minority-owned businesses (or underrepresented groups or any group that a government deems to have minority status in the population), women-owned businesses, disability-owned businesses, LGBTQ-owned businesses, or Veteran-owned businesses.
Our Supplier Diversity, Equity & Inclusion program objectives are in keeping with our Values of Takeda-ism and Patient, Trust, Reputation and Business (PTRB):
Driving Inclusion: Reflect the diversity of the patients who benefit from our products
Partnering for purpose: Partner with small and diverse businesses and advocacy groups that can provide value to our business and throughout our supply chain to foster an inclusive and innovative supplier base
Creating economic impact: Support the communities in which we live and work through wealth and job creation
Upholding our value: Respond to the requirements of our customers – that they expect Takeda to share their values
Our Program for Diversity & Inclusion:
We require inclusion of diverse suppliers for sourcing events within our Procurement Policy and provide resources to find small and diverse suppliers.
We advocate for current and prospective diverse suppliers with our procurement and business stakeholders
We look for opportunities and innovative ways to further inclusion within our supply base and with our large and strategic suppliers
We host Supplier Days for our procurement and business stakeholders to meet current and prospective diverse suppliers
Mentoring and development
Each year, at minimum, we mentor 4-5 local current and prospective suppliers through our formal mentoring program, leading to successful business growth and recognition for positive impact on the diverse community. Diverse suppliers are paired with a Procurement lead or business stakeholder for up to one year. Through this program, we assist diverse suppliers in further developing their businesses, through educational and investment programs. We continue to develop programs to address inclusion on both a local level and will soon be expanding our program on a global level. These programs include providing a new resource within our Company (initially launched in the US) to help our employees locate current and potential diverse suppliers for their sourcing needs. We continue to grow our development and advocacy through various NGOs throughout the US, such as Diversity Alliance for Science, WBENC, NGLCC, NMSDC, Disability:IN, and NVBDC and Globally, through groups such as WEConnect International.
Supplier performance and innovation (SP&I)
The SP&I team facilitates supplier segmentation for areas of the business through a framework that, among other factors, includes risk and a sustainability rating. SP&I uses a supplier scorecard with objective data to measure and leverage supplier capabilities. This scorecard includes a KPI that tracks social and environmental risk and performance. The SP&I team also works with suppliers to identify external sources of innovation, remediate performance issues and provide continuous improvement opportunities. As we enhance our supply chain sustainability efforts, we expect to further develop our supplier relationship management efforts as well.
For our metrics and performance, refer to the Sustainability Disclosures page.
Product anticounterfeiting measures
Counterfeit, falsified and other illegally traded medicines present significant threats to consumers and patients around the globe. With the growing trend of illegal operations targeting medicines used to treat and prevent complex diseases, the industry faces increasing challenges to safeguard patient health and its products. We are taking a holistic, risk-based approach to identify and lessen the risks of falsified, illegal and other types of suspect products to keep our patients safe. A dedicated Global Product Protection team uses a strategic approach by collaborating with internal functions and external agencies to carry out this mission.
We partner actively with international and local law enforcement, regulatory agencies, other pharmaceutical companies and industry organizations to combat counterfeiting and illegal trading, while also educating patients, supply chain partners and customers on the dangers associated with these activities. Through partnerships such as IFPMA “Fight the Fakes” Campaign and Alliance for Safe Online Pharmacies (ASOP), we contribute to grassroots education for patients.
We’ve also developed innovative anticounterfeiting solutions for products and packaging to deter and detect counterfeiting, theft, diversion and tampering. Read more about our Position on Falsified Medical Products.
Putting the interests of the patient first extends to commercial activities. We don’t exert influence over, or provide rewards for, the prescription, use, administration, purchase or recommendation of our products. We don’t promise, offer or provide any money, gifts, services, hospitality or other items of value as an inducement for using our products.
To underscore this position, we’ve established various global policies, including the Global Policy on Interactions with Health Care Professionals and Health Care Entities, the Global Policy on Interactions with Patients and Patient Organizations, the Global Policy on Interactions with Government Officials and Government Entities, and the Global Anti-Corruption Policy. Our activities are conducted in compliance with relevant laws of each country, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice and codes of practice established by local industry associations.
We strive to provide medical information in an accurate, fair and balanced way through appropriate channels, and we review our promotional materials based on internal and external guidelines. These reviews may involve independent organizations, and regular monitoring also takes place. Separate Standard Operating Procedures (SOPs) govern reviews and monitoring.
Training and education is an important part of our ethics and compliance program. New employees receive ethics and compliance training, which includes our Global Code of Conduct, Anti-Corruption policy, and other policies and SOPs relevant to an employee's position.
Quality, in the decisions we make and the medicines we produce, is the foundation for executing our vision, purpose and values.
Our Global Quality organization covers all end-to-end aspects of our business, from R&D through Manufacturing, Distribution and Commercial. It also includes oversight of BioLife for plasma collection and our Vaccines business. Our Global Quality organization continually reinforces and supports the need for all quality decisions to align with our values. Our focus on quality also helps keep innovation, continuous improvement, knowledge and best practice sharing as key components in our culture.
Our Global Quality organization is built on three pillars: Science, System and People, and is fully aligned with Takeda’s functions and business partners. This organization is led by the Global Quality Officer, who reports to the president and CEO. The Global Quality Council provides oversight on global performance, trends and opportunities. We have created a standard structure for the Quality organizations in our manufacturing sites. That way, functions, roles and responsibilities stay consistent throughout the organization.
Any Quality or Good Management Practice (GMP) compliance incident that might affect distributed products is sent to Takeda Senior Management by the global Quality Incident Management team. Quality incidents are quickly evaluated, and any necessary regulatory reporting or market actions are taken. In keeping with our “as local as possible, as global as needed” approach, we’ve established local Quality Councils, which provide oversight, monitor quality and compliance, and communicate with senior management.
Quality Councils help information flow between regional/operating unit councils and Global Quality Councils, so issues get resolved at the lowest possible level and trends are more easily noticed and addressed.
Quality decisions are always taken in alignment with our company values, with a focus on the priorities of putting the Patient first, building Trust with society, reinforcing our Reputation and supporting our Business. Quality decisions are taken transparently and in alignment with our approach to partner with all global health authorities as we maintain our favorable regulatory profile.
Global Quality has made significant progress on its Quality Roadmap in support of our company’s vision. The roadmap is reviewed annually and updated as needed to make sure it reflects advancements in the regulatory and pharmaceutical environment and the company strategy.
Each of us has a responsibility to demonstrate that our work meets the highest levels of excellence and is in compliance with Health Authority requirements, putting the patient and patient safety first. We incorporate these requirements into standards and procedures that we consistently follow, documenting what we do, reporting inconsistencies and deviations, taking necessary corrective action, and by applying the highest ethical standards to everything we do. The fundamental building blocks of Our Vision for Quality are:
Science: Product and process knowledge; new technologies; analytical development
Systems: Integrated quality systems; supplier quality management
People: Knowledge, skills and leadership development; performance management; talent pipeline
In everything that we do, we focus on our Vision for Quality, which encompasses:
How we operate:
Maintaining the principles of Takeda-ism and advancing a culture of Quality
Sustaining a learning environment focusing on lessons learned and best practice sharing
Building partnerships emphasizing collaboration
Creating an environment of innovation and continuous improvement
What we focus on:
Product quality performance
Service and value management, agility
Product quality and safety
Global Quality continually emphasizes consistency and excellence in our quality decisions throughout the company. We use best practices for research, development and safety evaluation throughout the entire product life cycle. This focus enables Takeda to develop innovative, safe and effective medicines.
Global Quality partners with R&D to ensure compliance with governing laws and regulations, as well as with our own internal rules and standards. In research and nonclinical studies, we require high data integrity standards. Our clinical studies, regardless of the phase or market where they are conducted, are designed to protect the safety and well-being of our patients and the integrity of our clinical trial data. We make sure that our studies are conducted in accordance with scientifically sound protocols and that data are collected, analyzed and reported in a transparent and responsible manner.
As our products reach the production and distribution stage, standards are just as high. All investigational medicinal products and pharmaceutical products are produced and controlled in accordance with current GMP. The integrity and security of our products are protected by our compliance with Good Distribution Practice. Once products are released, we continue to ensure quality by collecting important information from clinical investigators and the market. In this way, we work to detect potential quality issues at an early stage and build continuous improvement into our quality processes.
We monitor the safety of all our products, continuously collecting safety information in the development phase of new medicines and throughout the time they are marketed. We use this information to detect any signs of safety problems. If we find a potential problem, we promptly notify health authorities, health care providers and companies marketing our products. We also provide information on appropriate product use.
We work to maintain and strengthen relationships with regulatory bodies. For example, we’re active participants in a number of industry trade groups such as International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), Global Pharmaceutical Manufacturing Leadership Forum (GPMLF) and Pharmaceutical Research and Manufacturers of America (PhRMA). This involvement includes active contributions to working teams and proposals for improving overall current good manufacturing practices (cGMPs). In addition, we participate in external conferences where global regulators, including the U.S. Food and Drug Administration (FDA), Brazilian Health Regulatory Agency (ANVISA) and European Medicines Agency (EMA), routinely present, and engage as applicable. Additionally, we are recognized as a global leader in virology; our Global Quality Pathogen Safety team routinely works with global regulatory and medical groups in addressing pathogen safety and active approaches to addressing emerging viral agents.
Centralized EHS auditing
Audits are an important way to make sure our EHS management systems are effective. A central EHS audit function leads the program, which includes management systems and compliance audits. The program utilizes independent external local auditors who are experts in national and regional regulations for the EHS regulatory compliance audits when needed. Through Corporate EHS Management System Assurance Programs including audits, we assure compliance to our obligations including our management’s expectations, our standards and operating procedures, as well as regulatory requirements.
Based on audit results, site leadership develops Corrective and Preventive Action (CAPA) plans, which are approved by Corporate EHS audit and EHS Regional Heads.
These CAPAs are tracked based on operational KPI expectations until closed. We also look at audit trends to see what we need to work on for the coming year and where we need to provide support. Audit results are reported to the Risk, Ethics and Compliance Committee of the Board of Directors. Audits are conducted based on the level of EHS risk and ISO certification requirements. Corporate EHS audits typically occur on a three-year cycle. EHS risk often depends on the type of operations, the complexity and size of the operation, past EHS performance and other factors.
Learn more about how we’re promoting internationally-recognized human rights within our business.
Human rights commitment
We exist to create better health for people, and a brighter future for the world. Our commitment to respecting and protecting human rights is an important part of our Corporate Philosophy, as reinforced within our Global Code of Conduct. As a long-standing participant in the UN Global Compact, we’re committed to respecting and promoting internationally recognized human rights within every aspect of our business, across our supply chains, and in communities where we operate. We expect the same from suppliers and third parties operating on our behalf. We do this in accordance with the International Bill of Human Rights, comprised of the Universal Declaration of Human Rights (UDHR), the International Covenants on Civil and Political Rights (ICCPR) and Economic, Social and Cultural Rights (ICESCR), and the ILO Core Labor Conventions. In addition, we are implementing the UN Guiding Principles on Business and Human Rights. We’ve identified our 11 most relevant (salient) human rights impacts informed by a comprehensive human rights impact assessment. These include:
Sustainable access to our medicines
Product quality and product safety
Health and safety
Diversity, equity and inclusion
Labor rights in the workplace
Privacy and data protection
Third-party labor rights
Greenhouse gas emissions
By focusing on these most relevant human rights impacts, we have the greatest ability to respect and promote the following individual articles of human rights:
Right to Health
Right to Equality and Freedom from Discrimination
Right to Life, Liberty and Security
Right to Adequate Living Standard
We are committed to implementing due diligence processes to identify, assess, and address our human rights impacts and aim to create a safe place for employees, and third parties, to raise concerns about potential misconduct, including human rights violations. Our employees and third parties have access to several channels to do this, including the Takeda Ethics Line.
Timely and appropriate action is taken to address any behaviors or practices that have caused or contributed to adverse human rights impacts. In addition, we are committed to analyzing and evaluating the root cause to help prevent similar issues from arising again and providing access to timely remedy where required.
The following is a related document.
Third party labor rights
Protecting Third Party Labor Rights is one of our greatest responsibilities.
As an integral part of our Third Party Risk Management process, we conduct reasonable due diligence in engaging, selecting and assessing third parties throughout their Takeda lifecycle, including for Human Rights and Labor Standards. Our Supplier Code of Conduct outlines our commitment and expectations for suppliers on modern slavery practices, including child labor, forced and bonded labor, and human trafficking.
Furthermore, as an active member of the Pharmaceutical Supply Chain (PSCI) Human Rights and Labor Working Group we have worked to build more awareness around modern slavery and share industry best practices and have focused on management team development with several members participating in Social Accountability Auditor training.
The following are some related documents on modern slavery.
The following are some related documents on conflict minerals.
Learn how we’re protecting our reputation and operating environment through our risk management system.
Guided by our Corporate Philosophy, we’ve created a risk management system, making risk management an important component of corporate governance. Functioning in coordination with internal control, our system empowers each group company to respond adequately to risks and crises and ensure business continuity and facilitates disciplined management within Takeda. With regard to risk management, the Global Risk Management Policy and the Global Crisis Management Policy respectively lay out the structure of our risk management system, including BCPs and crisis management systems of the Takeda Group.
Management of major risks
The Global Risk Management Policy provides a uniform process of identifying, measuring, mitigating, and reporting on significant risks with the objective of aligning risk appetite with strategy and improving risk responses. Major potential risks include research and development, intellectual property rights, decline of sales due to the expiration of patents, etc., side-effects, drop in prices caused by measures for constraint of cost of medicines, fluctuation of foreign exchange rates, corporate acquisitions, country risks, stable supply, litigation, and IT security and information control. The person(s) in charge of each function control and manage these risk factors in each area of charge from the aspect of qualitative and quantitative criteria in designing and implementation of mid-range and annual plans and shall take all necessary measures or remedies available to avoid and minimize such risk factors, depending on the degree and content of the risk the company is exposed to, in compliance with the countermeasures to cope therewith and any contingency plans.
We strive to ensure that all possible preventive measures are taken to avoid potential crises in accordance with the our “Global Crisis Management Policy,” which comprises basic policies, rules, and standards for crisis management. The policy also underpins systems and operations we have put in place to respond to each type of crisis swiftly and appropriately. In this way, we aim to minimize any potential harm to employees, any impact on Takeda’s our company finances, and any effect on society at large in the event of a crisis.
Crisis management structure
Our Local Operating Companies (LOCs) responsible for establishing their own crisis management systems, implementing preventive measures, and taking appropriate action if a crisis occurs. In the case of a crisis that has a major impact on our company and requires company-wide action, a “Global Crisis Management Committee,” chaired by the President & CEO of Takeda, coordinates a common understanding of the situation and any relevant information. The Committee directs each company to take countermeasures, later following up on the implementation of the countermeasures.