Promoting Compliance Management
No matter how successful or strongly performing a company may be, it will be unable to continue growing within society if it does not practice good compliance. As a global pharmaceutical company, the Daiichi Sankyo Group therefore practices management founded on compliance.
- Message from the Compliance Officer
- Continued Operation of the Compliance System
- Establishment of Global Marketing Code of Conduct
- Dissemination of the ICP
- Compliance Training and Educational Activities
- Use of Compliance Reporting System
- Protection of Personal Information, Exhaustive Information Security, and Compliance with the Individual Number Act
- Initiatives for Anti-Corruption
- Promotion of Compliance in Procurement
- CSR Procurement Promotion
- Measures for Ensuring the Transparency of Corporate Activities
- Research Support Initiatives
- R&D Ethics
- Message from the Compliance Officer
Daiichi Sankyo Co., Ltd.
Head of Corporate Affairs Division
The Daiichi Sankyo Group has put forth “integrity” as one of its core values and has clearly defined compliance as part of the criteria it uses in making decisions and judging value. In conducting our global business operations, we remain compliant with all relevant laws and regulations and conduct compliance management with a strong focus on ensuring the highest level of ethics and social consciousness, which is essential for a life science-oriented company.
To guide us in these efforts, we have established the Daiichi Sankyo Group Corporate Conduct Charter and the Daiichi Sankyo Group Individual Conduct Principles (ICP), which are applied throughout our operations. Based on the essence of the Charter and the ICP, the Company and other Group companies have developed compliance conduct standards appropriate to their respective regions and social requirements. Awareness regarding these standards is being entrenched among all executive officers and employees.
Directives for Initiatives
- Appropriate operation of the global compliance system
- Enhance compliance education and conduct effective monitoring at domestic Group companies
- Steadily implement measures for ensuring transparency of corporate activities
Examples of Initiatives
Continued Operation of the Compliance System
The vice president of the Legal Affairs Department of the Company plays a central role in promoting compliance throughout the Daiichi Sankyo Group and the Compliance Group is responsible for advancing concrete activities.
In Japan, the head of the General Affairs Division serves as the compliance officer, a position that entails managing our entire compliance program, which includes the Daiichi Sankyo Code of Conduct for Compliance and related rules and annual objectives. The compliance officer also serves as the chairperson of the Company’s Corporate Ethics Committee in Japan. This committee is a deliberation and decision-making body for compliance that meets twice per year, in principle, and is made up of 11 members, including the chairperson and nine other internal representatives, as well as an appointed external attorney, who ensures that the committee operates in transparent and reliable manner.
In addition, a compliance officer is appointed at each Group company in Japan and overseas to promote and oversee compliance programs at their respective company.
In April 2016, we established the Global Compliance Advisory Committee as an advisory organ to the Corporate Ethics Committee to further evolve its global compliance system. Full-time members of the new committee include compliance officers from subsidiaries in Europe and the United States, and the committee is responsible for examining global policies and annual targets for the Group.
Establishment of Global Marketing Code of Conduct
In the past, the Company and other Group companies have implemented internal codes inspired by the IFPMA Code of Practice of the International Federation of Pharmaceutical Manufacturers and Associations as well as the industry codes based on the IFPMA Code of Practice in various countries and regions. We took another step forward with the establishment of the Global Marketing Code of Conduct on October 1, 2016. This shared, Group-wide code is designed to ensure even higher levels of ethics in the Group’s interactions with healthcare professionals, medical institutions, and patient groups and in pharmaceutical promotions. This code was introduced to all domestic and overseas Group companies during fiscal 2016 and is now being put into practice.
Dissemination of the ICP
Global companies have recently come to be expected to establish broad-ranging global policies regarding the requirements for the behavior of individuals across their organization. Moreover, this policy must be adhered to and disclosed outside of the company to demonstrate that its global business activities are being conducted with integrity.
In light of this expectation, we developed the ICP, a shared, Group-wide policy regarding the behavior of individual executive officers and employees established as a supplement to the Daiichi Sankyo Group Corporate Conduct Charter. The ICP was put into effect at Group companies in Japan and overseas in April 2015. We are taking proactive steps to promote understanding of the ICP among all Group employees and encourage compliance with this policy. As part of these efforts, training programs are conducted at all Group companies and departments and training sessions are conducted. Members of the Legal Affairs Department are dispatched to provide direct support on-site to selected affiliates for the training program.
Compliance Training and Educational Activities
Ongoing compliance training and educational activities are an indispensable part of advancing our compliance programs.
In fiscal 2016, we held interactive training programs at all Group companies and departments in Japan. Conducted in small, group sessions, these programs were designed to foster understanding with regard to the ICP, encourage strong corporate ethics, and cultivate an open workplace environment.
In addition, external specialists were commissioned to provide training to officers of the Company and Group companies, the compliance officer, and others in order to further enhance compliance management at the Daiichi Sankyo Group.
We also conduct e-learning programs, distribute educational information on intranet sites, and provide compliance training DVDs that can be borrowed by any division. Through these and other proactive initiatives, we work to raise compliance awareness among all employees.
Employees at overseas Group companies are also provided with ongoing training using case studies and e-learning programs.
- 【VOICE】Efforts to Put a Face on Compliance Promotion
Senior Director, Compliance Group
Legal Affairs Department, Corporate
Daiichi Sankyo Co., Ltd.
The Compliance Group of the Legal Affairs Department is responsible for promoting compliance on a Group-wide basis.
In fiscal 2016, we deployed a program of activities based on the concept of “putting a face on the Compliance Group.” Compliance training is conducted individually by each organization at domestic Group companies. Through this program, members of the Compliance Group sat in on the trainings of 276 out of the 493 organizations in the Group during fiscal 2016. Moreover, members in attendance offered guidance based on concrete examples of compliance violations and took park in discussion-oriented trainings at each organization. Having Compliance Group members sit in on the trainings of various organizations in this manner had palpable benefits in helping employees realize their individual responsibilities with regard to compliance, which was accomplished through the use of examples, and in improving understanding of ethical standards, which was fostered through more active discussion.
In fiscal 2017, we will continue to implement initiatives of this manner. At the same time, we will contribute to the establishment of more detailed global anti-bribery and anti-corruption policies in order to help foster even higher levels of compliance awareness.
Use of Compliance Reporting System
The Company has in place compliance reporting systems that can be used to report legal violations, harassment, or other issues at the Company or at Group companies in Japan to the Legal Affairs Department or an external law firm, etc. Swift and appropriate action is taken to address any issues reported.
Furthermore, each Group company in Japan provides reporting channels, such as a hotline or e-mail system.
The Company and Group companies in Japan have formulated internal rules related to internal compliance reporting clearly specifying that confidentiality will be maintained and that the individual reporting will be protected from any unfavorable treatment as a consequence of reporting.
Outside of Japan, we are establishing compliance reporting systems that are matched to the circumstances in specific countries and regions. For example, Daiichi Sankyo, Inc., of the United States, employs an external compliance reporting system that is available on a 24-hour basis. Meanwhile, Daiichi Sankyo Europe GmbH, of Germany, installed an external reporting system that has been made available to all European companies under Daiichi Sankyo Europe’s jurisdiction and in all relevant languages.
Protection of Personal Information, Exhaustive Information Security, and Compliance with the Individual Number Act
Collecting personal information is a routine part of a pharmaceutical company’s business activities. However, due to the sensitive nature of this information, misuse can cause serious damage to the lives of individuals. Recognizing this fact, the Company and domestic Group companies have established internal rules related to information management and the protection of personal information and are promoting information security. In addition, explanatory forums on the revised Act on the Protection of Personal Information are held for information management representatives at the Company and domestic Group companies, and we implement other measures to ensure personal information is handled appropriately. In regard to the Act on the Use of Numbers to Identify a Specific Individual in the Administrative Procedure (“Individual Number Act”), which was enacted in Japan in October 2015, we regularly evaluate the individual number safety management precautions of subcontractors. In addition, e-learning programs are instituted targeting employees at the Company and domestic Group companies as part of our efforts to ensure compliance with this law. Furthermore, we have thorough precautionary measures in Japan in place to prevent loss and theft of Company computers that are taken off the premises. Employees also carry emergency contact cards that indicate which official is to be contacted in the event of an information security emergency. Furthermore, security measures are installed into the hard drives of Company computers as an added precaution against information leakage.
Initiatives for Anti-Corruption
Daiichi Sankyo is committed to preventing bribery and corruption, and does not provide, promise, or offer any money, gifts, or other advantages to domestic or foreign public officials or other third parties for the purpose of illicitly gaining or securing business advantages. The laws and regulations against bribery and other forms of corruption in countries around the world are growing stricter with each coming year. Thus, it is becoming increasingly important for companies developing their operations on a global scale to implement initiatives for preventing bribery and other forms of corruption.
One of the Individual Norms defined in the ICP states our commitment to preventing corruption and bribery. To uphold this commitment, we continue efforts to actively incorporate such topics into compliance training programs. In addition, we are currently preparing for the launch of a more detailed global anti-bribery and anti-corruption policy in October 2017 to further enhance our efforts on this front.
Promotion of Compliance in Procurement
The Group has formulated its Global Procurement Policy, based on which it conducts global procurement activities founded on compliance.
Global Procurement Policy—Basic Principles
- 1. Appropriate quality and stable supply
- 2. Optimal purchasing prices
- 3. Fair and impartial selection of suppliers and mutual growth with business partners
- 4. Legal compliance
- 5. CSR procurement
Domestic Group companies position compliance as a procurement mission and stipulate that strict compliance must be practiced regarding the procurement-related laws, such as the Antimonopoly Act and the Act against Delay in Payment of Subcontract Proceeds, Etc., to Subcontractors, among others. In addition, we have established the CSR Procurement Standard to encourage all of our suppliers to engage in socially responsible actions. Based on this standard, we request that suppliers conduct regular CSR self-inspections so that we can maintain an understanding of the state of compliance at suppliers and request improvements as necessary.
Furthermore, the Company and domestic Group companies are working to clarify the procurement process and realize optimal procurement based on such internal procurement rules.
CSR Procurement Outline
CSR Procurement Promotion
To further promote CSR procurement practices, the Supply Chain Unit implements initiatives on a three-year cycle. During fiscal 2015, the first year of this cycle, we asked domestic suppliers of raw materials to take CSR Self-Assessment Questionnaire.
These assessments evaluated suppliers based on the six perspectives of how they (1) comply with laws and enhance socially responsible activities (promotion of voluntary employment, prevention of child labor, payment of appropriate wages, guarantee of reasonable work hours, management of safety, etc.), (2) promote fair trade and ethics (free competition, information disclosure, etc.), (3) consider the environment (resource conservation, waste reduction, biodiversity preservation, etc.), (4) secure optimal quality and costs (quality assurance, safety evaluation, etc.), (5) ensure stable supply (raw material management, system construction, etc.), and (6) keep information security (personal information protection, etc.). Based on the findings of these assessments, we intend to work together with major business partners during fiscal 2016, the second year of the three-year cycle, to realize improvements in terms of CSR procurement. In fiscal 2017, the third year of the cycle, we plan to confirm the progress of these improvements. Going forward, we will continue our initiatives to practice socially responsible procurement activities together with partners (suppliers). This concept will guide us in promoting CSR procurement activities as part of our efforts to ensure sustainability in our corporate activities while securing superior quality, steady supplies, and low costs.
Measures for Ensuring the Transparency of Corporate Activities
We work to ensure the transparency of our relationships with healthcare professionals, medical institutions, and patient groups in Japan based on defined policies, and we disclose information on payments to such entities on the Company’s corporate website. Overseas, we disclose information on payments to healthcare professionals and medical institutions by calendar year based on the applicable law, including for instance, Physician Payments Sunshine Act for payments in the United States and EFPIA HCP/HCO Disclosure Code for payments conducted in Europe. We also comply with applicable regulations and codes of each country.
Research Support Initiatives
As part of its measures for supporting clinical research, the Company introduced the Daiichi Sankyo Opens Applications for Investigator-Initiated Studies Program in July 2017. This program enables researchers to apply for support directly through the Company’s corporate website. Through this program, we support researchers after confirming that their projects are in compliance with our Ethical Guidelines for Medical and Health Research Involving Human Subjects, which were revised in 2017.
With regard to scholarships, we introduced the Daiichi Sankyo Scholarship Program in April 2016. Through this program, universities and other research institutions can submit applications for scholarships directly through the Company’s corporate website.
Maintaining social trust is crucial to our company’s business activities. In life science-oriented industries, in particular, higher ethical standards are required because of the impact of our work on patients. In fiscal 2016, Daiichi Sankyo’s R&D Division defined “ethics and patient safety first” (a statement that encapsulates our commitment to prioritizing ethics and patient safety above scientific or business interests) as its global R&D unit core value.
We are committed to improving patients’ lives including our responsibilities for drug safety, and we therefore emphasize values based on bioethics.
・Ethical Considerations in Research Using Human Biological Materials
Before conducting clinical trials, it is necessary to estimate and predict both the pharmacological effects and side effects of a drug using biological materials from humans, such as tissues, cells, blood, or genes, as well as information from human subjects. Daiichi Sankyo is accelerating its research on biomarkers using. Focused on the oncology field, these research activities are aimed at realizing swifter determination of effectiveness in clinical trials and avoiding unnecessary treatment. In recent years, there have been rapid advances in basic and regenerative medicine research using human-derived cells, such as embryonic stem (ES) cells and induced pluripotent stem (iPS) cells. In accordance with Japanese guidelines, including the Ethical Guidelines for Medical and Health Research Involving Human Subjects and the Ethical Guidelines for Human Genome / Gene Analysis Research, Daiichi Sankyo has established in house regulations, namely the Detailed Regulations for Ethical Research on Human Tissue, Information and Other Human Material Research, along with the Ethical Research Practice Committee on Research on Human Tissue, Information and Other Human Material. With members including external specialists, this committee is charged with the task of objectively ascertaining the necessity and ethics in research using human materials and information. When conducting research, we obtain voluntary prior consent from research subjects and manage their genetic and other information in accordance with the revised Act on the Protection of Personal Information. According to the Act and Ethical Guidelines, we have also begun announcing necessary research subjects on the Company’s corporate website. Researchers engaged in research using human materials and information receive research ethics training from the Association for the Promotion of Research Integrity.
・Ethical Considerations in Animal Experiments
Animal experiments must be conducted in an appropriate manner as prescribed by research ethics and with due consideration paid to the welfare of laboratory animals.
Daiichi Sankyo has established in house regulation, the Detailed Regulations on Animal Experimentation based on Japanese laws and guidelines, including the Act on Welfare and Management of Animals and the fundamental guidelines issued by the Ministry of Health, Labour and Welfare and related activities. Acting in accordance with these rules, we practice the 3Rs of animal research.*1 All animal-use protocol must be reviewed by the Company’s Institutional Animal Care and Use Committee, and only the protocols that have received approval can be enacted. Moreover, researchers conducting animal research are required to undergo specialized education each year. To confirm that the animal care and use programs are in compliance with Japanese laws and guidelines, we conduct annual self-inspections and also seek accreditation from third-party certifying organizations. The Kasai R&D Center has received its certification from the Japan Health Sciences Foundation’s Center for Accreditation of Laboratory Animal Care and Use. The Shinagawa R&D Center has received and renewed its full accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International).
- *1.Replacement (methods that avoid using animals), Reduction (use of fewer animals), and Refinement (minimize or eliminate pain and distress)
・The 3Rs of Animal Usage
The Institutional Animal Care and Use Committee reviews animal-use protocol prior to enactment and, on top of stringent evaluation, enforces the following regulations with regard to the 3Rs of animal usage.
The availability or appropriateness of completely replacing the usage of animal test subjects with alternative testing measures or replacing a portion of animal tests with animals that are lower from a phylogenic perspective is investigated, and only those animal experiments for which no alternative is found are conducted.
The number of animals to be used is justified by determining the minimum number of subjects necessary for accomplishing the experiment’s goals based on statistical data. Even if the specifications of the experiment call for spare animals or the exclusion of certain animals, the usage of additional animals will not be approved unless deemed scientifically necessary.
Procedures may only be performed on animals if it is determined that the procedure in question will cause the minimum amount of pain and distress necessary for accomplishing the experiment’s goals. All animal usage protocol applications must include considerations of humane end points in addition to experimental end points.
The principles and ways of thinking about the 3Rs of animal usage are always changing. For this reason, we periodically invite external experts to give lessons on this subject, thereby conducting education based on updated information to ensure that our researchers always possess the level of ethics that society expects in animal usage. In addition, researchers undergo training from instructors certified by the Japanese Society for Laboratory Animal Resources on techniques for use in performing experimental procedures on animals.
・Handling of Biohazards and Genetically Modified Organisms
Daiichi Sankyo practices strict compliance with the Act on Prevention of Infectious Diseases and Medical Care for Patients Suffering from Infectious Diseases and the Act on Domestic Animal Infectious Diseases Control. Daiichi Sankyo has so established an internal biosafety manual that includes rules for the safe handling of pathogens and pathogen-containing materials. The Biosafety Committee fulfills the role of determining proper operating rules. In addition, Daiichi Sankyo has formulated internal rules for recombinant DNA experiments to ensure that genetically modified organisms are managed appropriately in accordance with the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (Cartagena Act on Biosafety). Furthermore, the Recombinant DNA Safety Committee checks all research protocol to ensure compliance with the Cartagena Act on Biosafety prior to commencement. Training is also provided to recombinant DNA researchers to help prevent accidents. Such training includes the research ethics training provided by the Association for the Promotion of Research Integrity.
・Fair Utilization of Genetic Resources
Concerning the preservation and sustainable use of biodiversity, and fair and equitable sharing of the benefits arising out of the utilization of genetic resources, we abide by the Convention on Biological Diversity. Moreover, we are giving full consideration to recent domestic developments leading up to the enactment of the Nagoya Protocol, which was adopted during the tenth meeting of the Conference of the Parties to the Convention on Biological Diversity (COP 10).
・Ethics in Clinical Trials
The Daiichi Sankyo Group conducts its domestic and overseas clinical trials in accordance with the Declaration of Helsinki, which defines the standards for ethical medical research involving human subjects, while also adhering to good clinical practices for pharmaceutical clinical trials and complying with the pharmaceutical regulations of relevant countries. This means that trials are only conducted after obtaining voluntary informed consent from participants, while also ensuring their human rights are protected, personal information is securely managed, and their lives, health, and well-being are safeguarded.
All clinical trials conducted by Daiichi Sankyo are evaluated in terms of ethical standards and scientific validity based on established internal processes to ensure that medical tests are appropriate.
・Collaboration with Contract Research Organizations
For its clinical trials, Daiichi Sankyo has formulated the Global Policy of Clinical Trials Standards. With these standards in place, we endeavor to ensure the highest degree of respect for the human rights and well-being of all individuals participating in trials. At the same time, we seek to guarantee that clinical trials are ethically sound and create results that are both highly reliable and scientifically viable. We also plan and conduct global clinical trials in accordance with Good Clinical Practices and in compliance with local regulations in each country.
Daiichi Sankyo sometimes outsources part or all of business in global clinical trials to contract research organizations (CROs). However, even in such cases, we expect CROs to comply with Daiichi Sankyo policies and standards for clinical trials. For this reason, we investigate CROs as part of the selection process before outsourcing to determine if they have the necessary capabilities to perform trials in adherence with this policy, and CROs are selected in consideration of evaluations of these investigations. Daiichi Sankyo agrees with CRO that the persons in CRO who have received the necessary training for the standard operating procedures based on Daiichi Sankyo policies and standards carry out their business when Daiichi Sankyo outsources to CRO. We have our responsibility to manage CROs by overseeing and evaluating their activities continuously after having contracted.
・Disclosure of Clinical Trial Information
Daiichi Sankyo is committed to disclose information from the clinical trials it sponsors and recognizes that there are important benefits associated with making clinical trial information available to various related parties, and we therefore practice proactive clinical information disclosure. We have continued to adhere to local regulations and to support the guidelines and policies from industrial organizations by registering information on clinical trials and their results in various databases and making this information available through these databases. Furthermore, we recognize that providing clinical trial data to outside researchers serves to foster understanding regarding pharmaceuticals and spread scientific insight. Accordingly, such data sharing is important for advancing medicine to better aid patients. Based on this recognition, we began providing access to clinical trial data through the dedicated system via the clinicalstudydatarequest.com data disclosure portal in February 2016. Through defined processes using this portal, researchers from outside of the Company can access and analyze clinical trial data that has been anonymized to protect personal information related to patients.