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.
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 several groups such as the IFPMA “Fight the Fakes” Campaign and Alliance for Safe Online Pharmacies (ASOP Global) to educate patients on counterfeiting.
The sale of counterfeit drugs is a growing problem, and one that poses a significant threat to consumers and patients around the globe. Our Global Product Protection (GPP) team is committed to protecting patients by securing the supply chain and taking measures to combat illegal activity.
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.
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.
In 2019, we expanded the scope of our Stem Cell Research Position into a Biotechnology Position that 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:
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.
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.
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 (IEC) / Institutional Review Board (IRB) and from the appropriate authorities as required by regulations.
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. In the first six months of FY2020, we received 119 calls and web entries through the Takeda Ethics Line. Takeda has a policy of nonretaliation for any employee who raises a concern in good faith.