Promoting Compliance Management

No matter how successful or strongly performing a company may be, it will be unable to continue corporate activities within society if it does not practice good compliance. Therefore, as a global pharmaceutical company, the Daiichi Sankyo Group practices management founded on compliance.

Basic Policy

At the Daiichi Sankyo Group, we define integrity as one of our Core Values. We have therefore positioned compliance as the standard we use in making decisions and value judgments. 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 (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.

CSR Highlights

How we address CSR issues

Continued Operation of Compliance System

In Japan, the head of the Corporate 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 13 members including 12 internal representatives and an appointed external attorney, who ensures that the committee operates in a transparent and reliable manner. Full-time Members of the Audit and Supervisory Board will also participate as observers.
In addition, a compliance officer, etc. is appointed at each Group company in Japan and overseas to promote and oversee compliance programs at their respective companies.
Furthermore, in order to ensure the effectiveness of Daiichi Sankyo Group's global compliance system, we established the Global Compliance Advisory Committee as an advisory organ to the Corporate Ethics Committee. Full-time members of the committee include compliance officers from subsidiaries in Europe and the United States, and the committee is responsible for examining the global policies and annual targets of the Group. Deliberations made at the Corporate Ethics Committee and the Global Compliance Advisory Committee are reported to the CEO, COO and the Board of Directors as Fiscal Year Promoting Activities on Compliance.

Implementation of Global Marketing Code of Conduct

The Company and other Group companies have established internal codes based on the International Federation of Pharmaceutical Manufacturers and Associations Code of Practice (IFPMA Code) or the industry codes in respective countries and regions, which reflect the IFPMA Code. In addition, 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. Furthermore, during fiscal 2016 and 2017, the Legal Affairs Department staff visited subsidiaries in the Asian region and confirmed the status of compliance with the codes, etc., through dialogues with compliance officers and employees of respective companies.

Global Marketing Code of Conduct

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.
The Daiichi Sankyo Group Individual Conduct Principles set forth “1. Prevention of corruption and bribery,” “2. Avoidance of conflict of interest” and “3. Prohibition of insider trading” as the main principles. In order to promote understanding of the ICP among all Group employees and encourage compliance with this policy, e-learning classes are conducted regularly with the policy as a theme of interactive training sessions held at each company and division/department in Japan. For overseas Group companies, Company staff visits each company and confirms the policy penetration status through dialogues with compliance officers.

Daiichi Sankyo Group Individual Conduct Principles

Compliance Training and Educational Activities

Ongoing compliance training and educational activities are an indispensable part of advancing our compliance programs.
Since fiscal 2016, we have been holding 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.
Furthermore, compliance training sessions are held by external specialists on a regular basis for the board members, audit & supervisory board members and corporate officers of the Company as well as presidents of domestic Group companies and compliance officers and so on. Such compliance training sessions are also held annually for new employees of domestic Group companies and newly-appointed management by their positions. We also conduct e-learning programs, distribute educational information on intranet sites, and provide compliance training DVDs that can be borrowed by any division for individual employees. 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.

Implementation of a Compliance Awareness Survey

A compliance awareness survey was conducted in approximately 9,000 Company and domestic Group executives and employees (including temporary and contract staff). The response ratio was 96.7% for the entire Group in fiscal 2017. We were able to ascertain the Group's strengths and issues through this survey by analyzing factors such as comprehension levels of the Group’s mission and compliance-related codes, compliance implementation, and development of in-house systems. The results of this survey were reported to the Corporate Ethics Committee, CEO and COO, and also analysis results for each organization were delivered as feedback to each unit head, Group President and persons in charge of promoting compliance in Japan in order to utilize as basic data for activities promoting compliance in the next fiscal year.

Use of Compliance Reporting System

The Company has in place compliance reporting systems that can be used to report legal violations, harassment, or other internal 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 and prevent damage from occurring or spreading. A harassment consultation desk is also located in the Human Resources Department, each business location and external organizations.
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 clearly specifying that confidentiality will be maintained; that the individual who made the report will be protected from any unfavorable treatment as a consequence of reporting; that anonymous reports will be accepted; and that punishment will be mitigated even if the individual who made the report is involved since the person reported the illegality themselves.
Furthermore, the Company also receives reports from outside the Company through the Company’s website.
Outside of Japan, we are establishing and operating compliance reporting systems according to the circumstances in specific countries and regions.
For example, Daiichi Sankyo, Inc., of the United States employs an external compliance reporting system available on a 24-hour basis. Meanwhile, Daiichi Sankyo Europe GmbH of Germany has installed an external reporting system available to all European companies under Daiichi Sankyo Europe’s jurisdiction and in all relevant languages. Both of them receive reports from outside the companies on their websites as well.

Dealing with Act on the Protection of Personal Information, Individual Number Act, and Exhaustive Information Security

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 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 the safety management of information. 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 act. When it comes to information security, it is also important to raise the awareness of each employee who is handling information or ICT in addition to looking at the issue from the perspectives of personal information protection and individual numbers. The Company and domestic Group companies provide e-learning programs on information security and trainings for all employees to help them deal with suspicious e-mails including targeted e-mail attacks. 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. With regard to computer virus, in addition to implementing measures to prevent personal computers or servers from being infected, we have also installed a system to detect and block illegal communications to the website and a system to detect manipulation by a malicious attacker. Thus, the Company takes continuous measures to deal with the cyber security attacks that have grown in recent years.

Initiatives for Anti-Corruption

•Establishment of Global Anti-Bribery & Anti-Corruption Policy

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.
Our Group clearly states preventing bribery and corruption as a basic principle per field in the Daiichi Sankyo Group Individual Conduct Principles. However, to make even greater strides toward these policies, the Daiichi Sankyo Group Global Anti-Bribery and Anti-Corruption Policy was newly established in October 2017, and includes details such as prohibiting cash payment to government officials and healthcare professionals.
We reviewed corporate policies and procedures and related operations of the Company and other Group companies, and conducted training programs for antibribery and anti-corruption.
Our Group will continue to conduct training programs for anti-bribery and anticorruption regularly, and bolster our corporate structure.We will especially take measures against bribery and other unwanted activities in business in high-risk countries. (See“VOICE” below)

Daiichi Sankyo Group Global Anti-Bribery & Anti-Corruption Policy(63.5KB)

【VOICE】Aiming to Develop High Awareness of Compliance

Naoki HatakeyamaNaoki Hatakeyama
Senior Director, Compliance Group, Legal Affairs Department,
Corporate Affairs Division
Daiichi Sankyo Co., Ltd.

The Compliance Group of the Legal Affairs Department is responsible for promoting compliance on a Group-wide basis. Group companies that posed a high risk of bribery and other corru ption were checked when implementing the Daiichi Sankyo Group Global Anti-Bribery and Anti-Corruption Policy established in October 2017. Gifts and cash payment to healthcare professionals were investigated to see whether there is any dishonest practices, confirming any dishonest practices, and instruction was given when applicable. We have also distributed anti-bribery and anti-corruption training material to overseas subsidiaries to support raising comprehension and awareness among employees. We will contribute to foster higher levels of compliance awareness through these activities.

CSR Procurement

•Promotion of Compliance in Procurement

In October 2017, our Group revised the Global Procurement Policy, which is the highest prioritized policy for procurement. It clearly states that we will formulate a Supplier Code of Conduct including six items (1. Ethics 2. Labor 3. Health and safety 4. Environment 5. Ensuring optimal quality, cost, and stable supply 6. Management systems) for all Group companies, including overseas subsidiaries, and bolster CSR procurement throughout the entire Group.

Daiichi Sankyo and Group companies in Japan position compliance as a procurement mission, and make efforts to comply with relevant laws and regulations concerning procurement, promote CSR procurement, etc. With regard to the Act against Delay in Payment of Subcontract Proceeds, Etc., to Subcontractors, Daiichi Sankyo and domestic Group companies have appointed a person in charge of the Subcontract Act in each department and strive to ensure compliance with the Act through training workshops, etc.

•Development of CSR Procurement Standard

Additionally, we have established CSR Procurement Standard (see below) to encourage suppliers to take socially responsible corporate behavior. By understanding compliance levels in procurement through check sheets when selecting a new supplier and through regular CSR self-assessment questionnaire surveys, we encourage the implementation of necessary improvements.
Furthermore, we are working to clarify the procurement process and achieve optimal procurement based on such internal procurement rules.

CSR Procurement Outline

•Implementation of CSR Self-Assessment Surveys

The CSR self-assessment surveys previously conducted were positioned as an initiative for the entire Group including overseas subsidiaries. Furthermore, we have decided to take a broader approach with this, and newly apply it to business partners (suppliers) of indirect materials as well as raw materials. For fiscal 2017, we conducted CSR self-assessment surveys for the top 100 companies for both direct and indirect materials.
Moreover, Daiichi Sankyo and domestic Group companies have also started conducting surveys toward secondary suppliers of important direct materials.
These assessments evaluated suppliers based on six perspectives; (1) Business integrity based on ethics, (2) Labor and respect for human rights, (3) Health and safety, (4) Promoting environmental management, (5) Ensuring optimal quality, costs, and stable supply, and (6) Management systems. We will work together with suppliers to implement any necessary improvements based on the results of the CSR Self-Assessment Questionnaires. Going forward, we will continue to uphold the concept of “CSR procurement activities together with partners (suppliers)” and promote CSR procurement taking into consideration not only superior quality, steady supplies and low costs, but also sustainability. Furthermore, as part of the collaboration with suppliers towards the reduction of environmental load, Daiichi Sankyo and domestic Group companies have ascertained the CO2 emissions and water usage volumes for major suppliers and have asked suppliers who have not yet set a CO2 emissions target to cooperate in setting one as an opportunity to improve. These initiatives are being conducted based on the targets set in the Science Based Targets (SBT)*1.

  • *1 An international initiative that encourages companies to set CO2 reduction targets based on scientific evidence in order to help accomplish the goal of the Paris Agreement of keeping the average increase in global temperature below 2°C.

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 European Federation of Pharmaceutical Industries and Associations (EFPIA) HCP/HCO Disclosure Code for payments conducted in Europe. It is also necessary to ensure transparency in some part of Korea and Brazil, so that Daiichi Sankyo Group as a whole strives to ensure transparency.

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. Furthermore, the Clinical Research Act came into effect in April 2018, so that the investigator is now the person responsible for clinical research. We are now conducting awareness activities for the Clinical Research Act to the investigator and the Research Secretariat. With regard to scholarships provided for the purpose of contributing to the advancement of life science such as medicine and pharmacology, we introduced the Daiichi Sankyo Scholarship Program in April 2016, in which universities and other research institutions submit applications for scholarships directly through the Company’s corporate website to ensure fairness and transparency. The following are outlines of activities of the Daiichi Sankyo’s R&D Division.

R&D Ethics

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 these materials. 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, which may have problematic ethical issues. 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. We have also established the Ethical Research Practice Committee on Research on Human Tissue, Information and Other Human Material with members including external specialists, and conduct research while objectively ascertaining the necessity and usefulness of research, and respecting the human rights and dignity of research subjects as well as fully discussing the ethical issues behind the research. 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. We also began disclosing necessary research agenda 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 (APRIN).

•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 an 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 and renewed 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 AAALAC International *2.

  • *1 Replacement (methods that avoid using animals), Reduction (use of fewer animals) and Refinement (minimize or eliminate pain and distress)
  • *2 Association for Assessment and Accreditation of Laboratory Animal Care International

•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.

1)Replacement

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.

2)Reduction

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.

3)Refinement

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-use protocol applications must include considerations of humane end points*3 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.

  • *3 Standards for suspending or cancelling animal experiments so as not to cause excessive pain to laboratory animals.

•Handling of Biohazards and Genetically Modified Organisms

Daiichi Sankyo has established an internal biosafety manual that includes rules for the safe handling of pathogens and pathogen-containing materials in order to handle them safely and complies with the laws and regulations concerning these biohazard materials including Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases and Act on Domestic Animal Infectious Diseases Control. The Biosafety Committee determines the proper operating rules for handling biohazard materials. Daiichi Sankyo has formulated internal rules for recombinant DNA experiments to ensure that genetically modified organisms are managed appropriately in accordance with the Cartagena Act on Biosafety*4. Furthermore, the Recombinant DNA Safety Committee checks all research protocol to ensure compliance with the Cartagena Act on Biosafety prior to commencement. Furthermore, we endeavor to take preventive measures against experimental accidents using the opportunity of training courses for engaged reserchers such as education on the containment of recombinant DNA experiments as well as education on research ethics that are provided by the APRIN.

  • *4 Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms

•Fair Utilization of Genetic Resources

Concerning the preservation of biodiversity, sustainable use of components 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.

•Ethics in Clinical Trials

The Daiichi Sankyo Group conducts its Japan local and Global clinical trials in accordance with the Declaration of Helsinki that defines the standards for ethical medical research involving human subjects, while also adhering to ICH-GCP*5*6 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 sponsored by Daiichi Sankyo are evaluated in terms of ethical standards and scientific validity based on established internal processes to ensure that medical research are appropriate. Moreover, an external independent committee (Institutional Review Board / Independent Ethics Committee) also reviews the same content (human rights of trial subjects, etc.) and approves it before clinical trials are conducted.
The Daiichi Sankyo provides training programs regarding GCP and Ethics related to clinical trials to people who are engaged in clinical trials.

  • *5 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice.
  • *6 Practice guidelines for clinical trials of drugs that have been prepared by the ICH, which is led by Japan, the United States and Europe.

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 GCP 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 on Daiichi Sankyo policies and standards carry out their business when Daiichi Sankyo outsources to CRO. After contracts have been entered into, we continue to confirm their operational status at regular meetings, etc., as well as evaluating them on an ongoing basis and taking responsibility for managing them.

Disclosure of Clinical Trial Information

Daiichi Sankyo is committed to the appropriate disclosure of information from its clinical trials. We believe that making protocols information and clinical trial data available to researchers, health care professionals, patients, academicians and others, in appropriate formats, advances science and medicine. We have registered and disclosed the protocol information and results of our clinical trials on various clinical trials registries such as ClinicalTrials.gov, EU-CTR and JapicCTI in accordance with the regulation and commitment of industry groups in each country.
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 a clinical data disclosure portal clinicalstudydatarequest.com in February 2016. Through defined processes using this portal, external researchers can access and analyze clinical trial data that has been anonymized to protect personal information related to patients.
In February 2018, we renewed the clinical trial information disclosure page of our corporate website to allow access to outlines and results of our clinical trials. From April 2018, we started clinical data sharing of clinical trials for pharmaceuticals approved in Japan, in addition to clinical trial data from pharmaceuticals approved in Europe and the United States.

Implementing Quality Audit of Suppliers of Raw Materials, etc.

To ensure the quality of pharmaceutical products, Daiichi Sankyo systematically conducts audits for domestic and overseas suppliers of raw materials, etc., and checks the improvement status if necessary. The subject and frequency of the audit are determined based on the results of risk assessments of quality, etc. Daiichi Sankyo will continue to conduct audits to ensure the quality of pharmaceuticals going forward.