Internal Standards and Guidelines for CSR

（１）Research
①Human Tissue Research
②Ethical Considerations in Animal Experimentation
（２）Development
（３）Procurement
Ethics in Procurement
（４）The Environment
Basic Environmental Policies
（５）Safety and Health
Basic Safety and Health Policy
（６）Corporate Citizenship Activities
①Sumitomo Pharma's Basic Stance on Social Contribution Activities
②Guidelines for Collaborations with Patient Groups
（７）Compliance
①Compliance Standard
②Guidelines Concerning Transparency in Collaborations with Medical Institutions (in Japanese only)
③Guidelines Concerning Transparency in Collaborations with Patient Groups (in Japanese only)

Declaration of Conduct (Guidelines for Daily Application)

The Declaration of Conduct is the code of conduct that should be practiced routinely by managements and employees of the Sumitomo Pharma and its subsidiaries (the “Group”) to promote our Sustainability Management, and provides a basis for the Group to be united in implementing our corporate activities. Through dissemination to subsidiaries, postings on our intranet, and conducting regular education, we will aim at thorough compliance of the Declaration of Conduct by managements and employees of the Group. The Declaration of Conduct (Guidelines for Daily Application) comprises specific examples for individual aspects of the Declaration of Conduct that we are committed to abide by in our corporate activities.


At the Group, managements and employees aim to be companies that are trusted by society and have a strong presence through continuous business development. We are determined not only to comply with all laws and regulations, but also to ensure that all corporate activities are carried out in accordance with this Declaration of Conduct. The pledges below express our commitment to continuously contribute to improving corporate values and solving social issues.
Top managements of the Group recognize their roles to realize the spirit of this Declaration and take the lead in an exemplary manner to implement the Declaration within the corporation, while encouraging their business counterparts to follow the same example.
In the event the Declaration is violated, top managements should take charge to resolve the situation and make efforts to determine the cause of infringement and prevent similar violations in the future. At the same time, top managements should disclose information in a timely and appropriate manner, explain what has occurred, and, upon determining the source of competence and responsibility, impose strict disciplinary action against those responsible, including top managements themselves.

1. Follow through on our Slogan "Innovation today, healthier tomorrows."

We constantly pursue self-innovation to deliver patient first innovative products and services with speed so that people around the world can lead healthier and more fulfilling lives.

Specific examples of conduct in Sumitomo Pharma

1Sustainable provision of innovative values
  • We always focus on impacts and quality, and consider how to provide value beyond conventional ways.
2Development and provision of products, information and services from perspective of the customer including patients and healthcare professionals
  • We implement business activities to place the patient first.
  • We develop and provide high quality and safe products, information and services.
  • We appropriately support the customers.
3Assess and reflect customer needs
  • We aim to meet unmet medical needs for patients and customer, considering them thoroughly from multiple points of view.
  • We share customer needs with related departments and respond promptly and appropriately.

2. Pursue trustworthy corporate activities.

We comply with laws and regulations, and conduct transparent and fair corporate activities with the highest level of ethics.
We resolutely sever all relations with antisocial forces and organizations that present a threat to the order and security of civil society.

Specific examples of conduct in Sumitomo Pharma

1Fair and transparent corporate activities
  • In research and development, we create objective and accurate data, and never engage in illegal acts such as falsification or concealment.
  • We take all possible measures to prevent accidents and issues related to our products' quality and safety.
  • We promptly take necessary safety measures in case of an adverse reaction suspiciously due to our products.
  • We operate business activities fairly and transparently.
  • We maintain accurate records and financial controls.
  • We compete fairly. We do not bribe or pay kickbacks.
  • We never do business with antisocial forces and organizations that pose a threat to the order and security of civil society.
2Cooperation with Healthcare Professionals, Relationship with Patient Organizations
  • In cooperation with healthcare professionals and other stakeholders, we comply with applicable laws, regulations and policies to ensure fair and transparent activities.
  • In collaboration with patient organizations, we conduct our activities with high ethics, respect the independence of patient organizations, ensure transparency and make efforts to improve credibility.
3Handling of compliance violations
  • We speak up when we realize we've made a mistake or taken actions that violate our Declaration of Conduct, our policies, or the law.
  • We consult and report any questions regarding compliance violations to the compliance hotline.
4Respect of the rights of third parties
  • We fairly obtain information from third parties.
  • We respect third parties’ intellectual property and copyright and do not slander their reputation and honor.

3. Transparently disclose and properly manage information.

We disclose corporate information in a timely and appropriate manner.
We take appropriate measures to protect and manage personal and customer information acquired through corporate activities.

Specific examples of conduct in Sumitomo Pharma

1Appropriate information disclosure
  • We report and distribute correct information immediately to customers and authority concerned in case of inadequate product quality and/or a safety issue.
  • We disclose corporate information that is likely to influence share prices to shareholders and investors in a timely, appropriate and fair manner.
  • We obtain approval by appropriate divisions before the disclosure.
2Appropriate information management and protection
  • We do not utilize personal information of customers, partners and employees for something other than the intended purpose.
  • We fairly obtain personal information and customers' information.
  • We correctly report information obtained through business activity to appropriate departments.
  • We responsibly manage and protect personal information, customers' information, technical and business information to prevent this information from being leaked or altered.
  • We appropriately manage confidential information before the disclosure.

4. Improve individual capabilities and collaborate with peers.

We work together with respect for diversity, character and personality of peers in an effort to create a healthy and safe work environment.
We focus on doing our best work as we strive for results in an organization that provides opportunities to grow and develop new skills.

Specific examples of conduct in Sumitomo Pharma

1Creating a workplace environment in which employees can focus on their work with a sense of security
  • We prioritize the creation of a safe working environment and strive to maintain and improve the mental and physical health of our employees.
  • We comply with rules of each business facility and try to operate a workplace in rewarding and satisfying atmosphere
2Emphasis on exerting abilities, cooperating with people inside and outside the Group, and developing human resources
  • We value each other's diversity, character and personality in working together as a team to achieve maximum results.
  • The Group and its managers create opportunities for employees to develop their skills and for personal growth, and do their best to evaluate employees fairly and transparently.
  • Employees make efforts toward self-improvement and through their work, enhance their skills and manifest them in achieving results.
3Emphasis on self-discipline, independence and creativity
  • We always take on challenges independently and positively even in difficult situations.
  • We share goals and information needed to achieve them in workplace.
  • We value dialogue and conscientiously listen to suggestions and opinions as well as constructive criticism.
4Creation of a workplace culture with integrity
  • We draw the line between business and private affairs, and act rationally at all times.
  • We speak up to supervisors immediately in case of a potential problem.

5. Respect human rights.

We respect the rights of all people associated with our company in conducting corporate activities.
We seek ways to work with our business partners, including suppliers, and other relevant stakeholders to promote respect for human rights.

Specific examples of conduct in Sumitomo Pharma

1Elimination of all discriminatory words and actions
  • We do not tolerate any form of discrimination or harassment, either inside or outside the Group, such as that based on race, nationality, ethnicity, gender, age, religion, faith, belief, sexual orientation, gender identity (LGBTQ), academic background, disability, disease, form of employment, or profession.
  • We do not tolerate any form of harassment including sexual harassment and power harassment in the workplace.
2Elimination of discrimination in the workplace
  • We respect the human rights described in the Universal Declaration of Human Rights and the International Labour Organization (ILO)'s core labor standards and the rights of all people associated with the Group in conducting corporate activities.
  • We promote human rights, including freedom of association and the right to collective bargaining, prevention of child and forced labor, and elimination of discrimination with respect to employment and occupation in conducting corporate activities including our business counterparts.
  • We encourage business partners including suppliers and other stakeholders to respect human rights.
3Clinical trials and clinical research area
  • We give utmost respect to the human rights of clinical trial participants.
  • We adequately provide the necessary information to medical institutions, and should we become aware of any safety issue or determine that the relevant drug has no efficacy, we will immediately ensure the safety of trial participants. We subsequently revise the relevant research plan and appropriately determine whether or not to continue the trials or research.
  • We are prepared for any occurrence of health damages to the subjects in clinical and trials and research that we conduct or support.

6. Positively address global environmental issues.

We engage in all aspects of our corporate activities in consideration of the environment.

Specific examples of conduct in Sumitomo Pharma

1Build environmental awareness
  • We independently address global environmental issues as important requirements.
  • We closely monitor environmental issues including climate change and energy.
2Efficient use of resources and energy
  • We reduce consumption of electricity, water, gas, gasoline, etc., and strive to use resources effectively.
  • We implement measures for the conservation of resources and reduction of waste.
  • We separate waste into specified types and actively promote recycling of waste materials.
  • We promote use of products with a small environmental impact, such as eco-marked products and energy-saving products.
3Environmental activities at home
  • We independently make efforts to address global environmental issues at home.

7. Build harmonious relationships with society.

We value communications with all of our stakeholders and promote initiatives contributing to the realization of a sustainable society.
We consider the local culture and customs of the countries and regions in which we operate, and contribute toward local economic and social development of those communities.

Specific examples of conduct in Sumitomo Pharma

1Communication with society
  • We value promoting dialogue with broad stakeholders.
  • We pay attention to social demands and feedback on our actions.
2Appropriate behavior as member of society, corporate citizen
  • We always think about the impact of our behaviors on society.
  • We do not speak or act against public decency and ethics, either in the workplace or outside of work.
3Engagement with local communities
  • We value communication with local communities.
  • We contribute to development of local communities through corporate activities.
4Active involvement with communities
  • We actively engage in social contribution activities and volunteer activities.
  • We maintain a great interest in the life of communities as a member of society.
  • As a member of a health-related company, we make efforts toward achieving healthy lifestyles, and maintain a high level of interest in matters such as prevention and early detection of diseases, healthcare programs and other policies.

SMP Group Human Rights Policy

This Policy applies to Sumitomo Pharma Co., Ltd. ("SMP") and all of SMP's affiliates and subsidiaries worldwide with signatures below (collectively, the "SMP Group Companies").

1.SMP Group Companies' Position on Human Rights
  1. ①Compliance with Standards, Laws and Regulations
  2. ②Respect for Human Rights in our Business Activities
2.SMP Group Companies' Approach to Human Rights Issues
  1. ①Providing Education and Raising Awareness
  2. ②Human Rights Due Diligence
  3. ③Responding to Identified Human Rights Impacts
  4. ④Remedy
  5. ⑤Grievance Mechanisms
  6. ⑥Disclosure

Sustainable Code of Conduct for Business Partners

Based on our "Declaration of Conduct" and "Compliance Standards", we have compiled five priority categories that we expect our business partners to work on from the perspective of sustainability in this Code of Conduct. We expect our business partners to comply with this Code of Conduct and we promote collaboration with business partners who adopt and apply this Code of Conduct.

CSR Policies and Approach

(1) Research

Human Tissue Research

Our mission is to create excellent medicines that help people around the world live healthier and more fulfilling lives, and we use cutting-edge science and technology to accomplish this. We have established an R&D system designed to drive daily progress on our goal of providing society with much-anticipated medicines as quickly as possible.

Science and technology related to the life sciences have made remarkable progress in recent years. By using the decoded human genome and advanced technology exemplified by the production of induced pluripotent stem cells (iPS cells), scientists have made it possible to reveal the causes of disease and the mechanisms of action of medicines previously unknown. This technological progress is also leading to profound changes in the process of R&D.

The use of human tissues (refers to blood, bodily fluids, tissue, cells, excrement taken from humans and the DNA, etc. extracted from them; includes human ES cells and human iPS cells) has also made it possible to elucidate the phenomena in human body which are undiscoverable in animals. The conventional approach was to use animal models to predict a drug's efficacy and adverse reactions, followed by assessment in clinical trials. Recently, by using human tissues in addition to animal models, researchers are able to develop more effective medicines with a clear mechanism of action and fewer adverse reactions.

Research using human tissues is therefore becoming essential in the creation of excellent medicines. On the other hand, it requires special ethical considerations. For this reason, we established the Rules for the Research Ethics Committee on July 15, 2016. The rules require ethical considerations including paying due consideration to human dignity, giving sufficient explanation in advance to the providers of human tissues and obtaining their voluntary agreement (i.e., informed consent), rigorously protecting personal information, and fairly reviewing the research plan (e.g., the significance and necessity of using human tissues and the potential degree of social contribution of the research).

We have been reviewing research plans in accordance with these rules, in advance of each research project using human tissues. We have also established written standards for ethics review and made public the Rules for the Research Ethics Committee and the membership of the committee.

For more information on the Research Ethics Committee, please see "R&D" (in Japanese only).

Ethical Considerations in Animal Experimentation

In order to verify safety and efficacy in the process of creating new drugs, it is imperative that animal testing be conducted in compliance with all laws. At Sumitomo Pharma, we believe that the animal testing process must be based on scientific rationale, and we make every effort to ensure that all testing is carried out with consideration of animal welfare and respect for animal life.

In animal experimentation, Sumitomo Pharma follows in-house procedures that conform to Japan's Act on Welfare and Management of Animals and the Basic Policies for the Conduct of Animal Experiments in Research Institutions under jurisdiction of the Ministry of Health, Labour and Welfare. Our Institutional Animal Care and Use Committee strictly reviews all experimental protocols, including outsourced tests, in terms of the "4Rs" (adding an additional "R" for the "responsibility" of those carrying out and commissioning the testing to the conventional "reduction" of the number of animals used, "replacement" with alternative testing methods, and "refinement" to relieve pain and distress). As part of our efforts to maintain and improve the ethical and scientific integrity of our animal experimentation, we also continually implement in-house inspection and assessment of the animal testing process.

Sumitomo Pharma has earned Japan Pharmaceutical Information Center (JAPIC)* accreditation as an animal testing facility in compliance with the basic policies of the Ministry of Health, Labour and Welfare. JAPIC, an arm of the Japan Health Sciences Foundation, evaluates animal testing research institutions under the jurisdiction of the Ministry for appropriate conduct in line with the Ministry's basic policies.

  • *JAPIC is an organization within the Japan Health Sciences Foundation that conducts third-party inspections and evaluations of animal experimentation and other work at animal testing research institutions under the jurisdiction of the Ministry of Health, Labour and Welfare. JAPIC determines whether such facilities are conducting appropriate experiments based on a scientific perspective, while promoting voluntary ethical management of animal testing programs and considerations of animal welfare. JAPIC took over the Center for Accreditation of Laboratory Animal Care and Use at the end of March 2021 with its dissolution, and continues to operate in the same way.

(2) Development

(3) Procurement

Ethics in Procurement

1Balanced and fair transactions with our business partners
  • We will enter into and maintain transparent transactions, while striving to always create business opportunities with new business partners based on balanced, fair and free competition.
  • We will enter into transactions by observing mutual benefit and establishing trustful relationships.
2Reasonable selection of suppliers
  • In the selecting suppliers, we will base determinations on economic rationality, with comprehensive consideration of suppliers' management base stability, quality, price, supply stability, technical development, environmental stance, etc.
  • We will not enter into a reciprocal transaction for the direct purpose of selling Sumitomo Pharma's products and services.
3Mutual evolution
  • Through sound transactions with business partners, we will strive for mutual evolution while deepening mutual understanding.
4Thorough compliance with laws and regulations and protection of confidentiality
  • We will prevent the illegal acquisition or leaking of confidential and proprietary information of Sumitomo Pharma and business partners, while complying with not only relevant law, rules and regulations but also the letter and spirit of these laws and regulations.

(4) The Environment

(5) Safety and Health

Basic Safety and Health Policy

Sumitomo Pharma will ensure that workplace environments are safe and comfortable for individual employees to work in so that all directors and employees can have peace of mind and concentrate on their work, allowing them to maximize their autonomy and creativity. In all of our business activities, we will pursue safety and health companywide and seek to ensure the safety of our employees and promote and maintain their health. We will also work to ensure the safety and health of the communities in which we operate and all outside parties in our workplaces.

  1. ①While continuing to strive to conduct business activities free from accidents and disasters, we will ensure the safety of our employees.
  2. ②In addition to abiding by laws, regulations and other requirements for occupational safety and health, we will make continuous efforts to improve our standards of safety and health management.
  3. ③Through education and activities that raise awareness about safety and health, we will seek to improve the safety and health awareness of all employees.
  4. ④We will work to help employees maintain physical and mental health and to create workplace environments where people can work with peace of mind.

(6) Corporate Citizenship Activities

Basic Stance on Social Contribution Activities

In its Declaration of Conduct, Sumitomo Pharma declares its intent to "7. Build harmonious relationships with society," and we engage in social contribution activities befitting a good corporate citizen.

Focusing on activities related to our business including raising awareness of diseases and educational support, environmental conservation activities, and donations/supportive activities, we have identified the following pivotal action items as our basic stance on social contribution activities we promote to fulfil our corporate citizenship.

  • Ensure that our employees always have an awareness that our business is dependent on public trust and credibility
  • Respect and understand diverse values and cultures nurtured in various communities and by people
  • Be aware of harmonious relationships with society and fulfill responsibilities as well as contributions as a member of society

We have further established systems that allow each employee to better take part in philanthropic activities.

  • Guidelines Concerning Collaborations with Patient Groups (in Japanese only)（PDF/150KB）

    • (7) Compliance

    SMP GROUP QUALITY POLICY

    Sumitomo Pharma Co., Ltd. ("SMP") and all of SMP's affiliates and subsidiaries worldwide who signed below (collectively the "SMP Group Companies"), are fully committed to quality assurance as a primary objective in all aspects of operation. As responsible pharmaceutical companies, we, the SMP Group Companies, shall work to produce and supply customers with high-quality products.

    1. 1.We, the SMP Group Companies, shall provide satisfactory quality products to customers based upon consistent monitoring of customer needs.
    2. 2.We, the SMP Group Companies, shall develop and apply practices leading to high-quality products, beginning with the start of product development and continuing throughout all stages of production and commercialization.
    3. 3.We, the SMP Group Companies, shall establish and maintain a consistent quality system for all phases of operation from procurement of raw materials through product manufacturing, distribution, and sales.
    4. 4.We, the SMP Group Companies, shall act in accordance with the relevant legal and regulatory requirements, and establish and comply with quality standards at the global level based on current scientific and technological knowledge.
    5. 5.We, the SMP Group Companies, shall have all our executives and employees involved in quality raise and strive to retain a high level of awareness and knowledge on the quality.

    SMP GROUP SAFETY POLICY

    Sumitomo Pharma Co., Ltd. ("SMP") and all of SMP's affiliates and subsidiaries worldwide who signed below (collectively the "SMP Group Companies"), believe that as responsible, ethical, pharmaceutical companies, we, the SMP Group Companies, shall work, not only to bring safe and effective medicines to patients, but once the medicines have been brought to patients, we shall continue to monitor the safety of our products and take the necessary measures to ensure the ongoing safety of patients.

    1. 1.Keeping our focus on the patients, we, the SMP Group Companies, shall develop measures to ensure the continual safety of our products through collaboration with healthcare professionals and shall win the public trust of patients and healthcare professionals by providing them with the safety measures.
    2. 2.We, the SMP Group Companies, shall collect and manage safety information on our products at every stage of the product lifecycle from development to post-marketing phase and make the best use of this information to develop safety measures for our products.
    3. 3.We, the SMP Group Companies, shall maintain the safety of our products by establishing an efficient and pro-active system for world-wide collection, analysis, evaluation, transmission, and sharing of safety information throughout the entire company.
    4. 4.We, the SMP Group Companies, shall improve the safety of our products by providing consumers with information on the proper use of the products based on scientific evidence.
    5. 5.We, the SMP Group Companies, shall have all our executives and employees involved in safety be highly educated and trained in the management of drug safety and shall enhance the consciousness of our commitment to it; we shall also continuously maintain our expertise on drug safety through ongoing education and training.
    6. 6.We, the SMP Group Companies, shall contribute to our business by always turning our eyes to global trends in pharmaceutical industry and thinking globally of what we need to do.