Ethics

Medical Ethics

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.

Ethical sales and marketing

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 Takeda 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.

We partner 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 with such groups as the IFPMA “Fight the Fakes” Campaign and Alliance for Safe Online Pharmacies (ASOP Global), we contribute to efforts that educate patients on this growing concern.

We set high security standards and requirements for supply chain partners worldwide and perform due diligence and audit against these requirements. We’ve also developed innovative anticounterfeiting solutions for products and packaging to deter and detect counterfeiting, theft, diversion and tampering.

Bioethics

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. Our Takeda Shonan (TSHO) Research ethics review committee makes sure we conduct our R&D activities with the highest standards of ethics and integrity.

We work to stay ahead of emerging trends related to ethics and compliance in R&D 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, Takeda has 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 ethics topics so Takeda can develop robust and principled positions on these issues into the future.

 

Animal research

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 Takeda 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 Takeda’s behalf are subject to welfare audits, either virtual or on-site, to monitor that their practices are in line with our principles and commitments.

Takeda is 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. Takeda is also proud to present an annual 3Rs award to recognize colleagues who exemplify and demonstrate commitment to 3Rs principles and best practices. The Animal Care and Use Program at Takeda is overseen by the Global Head of Preclinical and Translational Sciences at Takeda who reports to the Head of Research, who ultimately reports to the President of R&D at Takeda

Clinical research

We also 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 Takeda’s 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 Takeda’s 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. Takeda has 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 the Takeda 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. More information can be found on Takeda’s PTA mechanisms at Takeda.com.

Takeda provides clinical trial investigators with site specific patient-level data from investigational sites upon trial completion. Takeda is 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 Takeda’s 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. More information on Takeda’s clinical trials can be found at Takeda Clinical Trials.

Ethics and 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, helping us make ethical decisions today, and in the future. To promote ethical behavior and provide guidance to our employees, the Takeda Global Code of Conduct is available in multiple languages and lays out a core set of principles for conducting business at Takeda.

Promoting ethics and compliance across Takeda’s operations 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. Takeda group companies execute and reinforce their ethics and compliance programs in line with the Takeda Global Code of Conduct and applicable global policies. These policies are approved by the Business Review Committee (BRC).

Takeda aims to maintain the highest level of corporate ethics. The Takeda Ethics Line, where employees can ask a question or voice a concern, is available online and by phone to all employees around the world, 24 hours a day. Takeda has a policy of nonretaliation for any employee who raises a concern in good faith.

Commitment to Human Rights

Takeda exists 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’re 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:

Patient	People	Planet
Sustainable access to our medicines	Health and safety	Greenhouse gas emissions
Product quality and product safety	Diversity, equity and inclusion	Water stewardship
Clinical trials	Labor rights in the workplace	Waste generation
	Privacy and data protection
	Third-party labor rights

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

At Takeda, 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.