Code of Conduct for Nippon Shinyaku Group

  • We are always aware of our social responsibilities and act with high ethical standards based on our business philosophy and management policy. We comply with laws, regulations and internal rules and build a relationship of trust with our society.

    Key Points of Conduct

    Since our founding, we have complied with laws and regulations, adhered to internal rules, and conducted corporate activities according to high ethical standards so as to earn the trust of society. Our mission is to maintain and develop this tradition.
    In addition, we are required to enhance the trust of society further by contributing to society through our business activities.

    1Basic Stance

    • As a healthcare company handling products that affect the health of people, we will achieve regulatory compliance and behave according to high ethical standards, including those of bioethics.
    • We strive to develop and operate an effective compliance system and continuously raise awareness to enhance ethical standards further.
    • In cases where the pursuit of profit by the company or the pursuit of results by individuals is in conflict with ethically correct conduct, we will opt for ethically correct conduct.
    • Even in cases where we outsource some of the operations of the various processes, including product research, development, manufacturing and marketing, we will be aware that we bear the final responsibility and explain to outsourcees our basic stance in order to respond with a sense of unity.

    2Laws and Internal Rules

    • We understand and comply with the details and spirit of domestic and overseas laws and regulations and internal rules.
    • In the event we discover any violation or suspected violation of domestic and overseas laws and regulations, voluntary industry codes, or internal rules, we will report to or consult with the contact desk in accordance with the whistleblowing system (Hotline).

    3Conflict of Interest

    • In the event of a conflict between the company’s interest and personal interest, the company’s interest will take precedence.
    • We will give due consideration in order to prevent inappropriate conflicts of interest from occurring at business partners.
    • We will not take advantage of our functional status or authority to receive, seek or promise illicit or improper profit (money, goods, entertainment, benefit) from or to our business partners.
  • We, as employees who handle products related to life, do everything we can to foster nature and the quality of our work, facing challenges creatively.

    Key Points of Conduct

    We are required to have the qualities and a high level of social responsibility appropriate for a member of a corporation handling healthcare products.
    Therefore, not only must we achieve regulatory compliance and adherence to internal rules concerning our functions, including research, development, manufacturing and marketing, we must also enhance our knowledge and skills in each area of expertise, explore and enlighten ourselves in a broad range of fields related to such areas of expertise, including science, history, culture and economy, and make tireless efforts to deepen our qualities and insight so that they are viable both domestically and internationally.
    Such self-enlightenment will serve as a foundation for us to take on the challenge of stepping up to a higher level in our operations and will be actualized as performance and achievements. Taking on challenges in a creative manner supported by high qualities is the attitude required of us and the path we must take.

    1Research and Development

    • We will make aggressive efforts in the research and development of innovative drugs and functional food that contribute to the advancement of medicine and improvement of QOL while giving ethical consideration.
    • Upon research and development, we will comply with the Pharmaceutical Affairs Act (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices), the Food Sanitation Act, and other related laws and internal rules.
    • We will check whether substances synthesized in the R&D process or obtained externally are regulated by law and respond in accordance with such regulations.
    • When using genes or tissues collected from human bodies, we will comply with relevant laws as well as adhere to internal rules and take thorough measures to protect personal information, such as human tissue. Upon conducting gene modification experiments, we will comply with laws and regulations and ensure thorough management to prevent genetically modified organisms from affecting wild animals and plants.
    • When engaging in joint research with a medical institution or research institution, we will also respect the rules of the other party.
    • Upon supporting clinical trials, we will be mindful of conflicts of interest and appropriately release information related to funding in an effort to improve transparency in accordance with the Clinical Trials Act and voluntary industry codes.

    2Non-clinical Tests and Clinical Tests

    • For non-clinical and clinical tests, we will comply with laws and regulations, including the Pharmaceuticals and Medical Devices Act and the GLP and GCP, as well as adhere to internal rules.
    • Upon conducting non-clinical and clinical tests, we will prepare objective and accurate data on the efficacy and safety of pharmaceuticals and will not engage in any fraudulent acts, such as falsification and data hiding. In addition, we will not demand outsourcees and joint research institutions to engage in such fraudulent acts.
    • When conducting tests using animals, we will comply with relevant laws and internal rules and give due consideration to animal protection in accordance with the 3R Principle on animal testing.
    • We will conduct clinical tests after fully examining non-clinical test data in advance on whether clinical tests are worth conducting for the drug subject to the tests.
    • We will respect the human rights of the subjects of clinical testing to the maximum extent possible. We will provide necessary information to the medical institution conducting the test in a timely and appropriate manner. In the event possible issues are detected in efficacy and safety, we will strictly determine whether the test should be continued or not and immediately reconsider the testing plans. Furthermore, we will respond with sincerity to any health damage the subjects may suffer.
    • When requesting a clinical test, we will sign a written contract with the medical institution, etc. We will ensure transparency in the payment method of expenses to medical institutions and will not make payments under a false pretext.
      In particular, we will maintain sound relationships with civil servants and physicians, who are deemed civil servants, so as not to be deemed to have engaged in bribery as prescribed in the criminal law or to breach the National Public Service Ethics Act or other ethics-related laws and standards or be suspected thereof.
    • In manufacturing investigational compounds, we will strive to ensure manufacturing and quality management equivalent to the manufacturing of products in consideration of the fact that the compounds will be administered to people and in order to secure the credibility of clinical tests.
    • We will conduct research and development of functional food pursuant to 1 through 7 above.

    3Application for Approval of Pharmaceuticals

    • Upon applying for the approval, re-examination and reassessment of manufacturing and sales of pharmaceuticals, we will use only documents that contain accurate descriptions of the data and facts based on tests conducted properly, and we will not engage in any fraudulent acts, such as using data of tests carried out beyond relevant laws and internal rules and falsifying or replacing data.
    • We will thoroughly supervise any tests related to the application for the approval, re-examination and reassessment of manufacturing and sales of pharmaceuticals conducted by outsourcees, ensuring that the implementation of the tests and the acquisition of data are carried out appropriately.

    4Manufacturing

    • We will ensure a stable supply of quality-assured pharmaceuticals and functional food in a timely and appropriate manner.
    • Upon manufacturing, we will ensure appropriate manufacturing and quality management across the entire process (including processes at manufacturing outsourcees) pursuant to the GMP for pharmaceuticals and the Food Sanitation Act for functional food.
    • Should a problem arise in the quality of a product, we will promptly provide the necessary response as well as investigate the cause and take measures to prevent a recurrence.
    • We will take the appropriate steps in handling the ingredients used in the manufacturing of products, such as complying with the relevant laws, adhering to internal rules, and giving consideration to the impact on employees’ health during the manufacturing process as well as the impact on the environment due to external discharge.
    • We will strive to ensure a stable supply of products in accordance with our BCP (business continuity plan) at times of natural disasters, such as earthquakes, floods and storms, and other emergencies.

    5Post-marketing Quality, Efficacy and Safety

    • We will promptly take the necessary steps, such as shipping quality-assured pharmaceuticals and functional food to the market and gathering and examining information on quality and safety from the market.
    • For pharmaceuticals, we will conduct post-marketing safety management and surveillance in compliance with relevant laws and adherence to internal rules in order to establish, re-examine and reassess proper administration methods.
    • Should suspicion of an adverse event arise due to our drug, we will promptly report to the authorities in accordance with the law and internal operating procedures and take measures to ensure safety as needed.

    6Distribution, Imports and Exports

    • We will distribute, import and export products, equipment, devices and software in a lawful and appropriate manner.
    • We will pay close attention upon exporting specific kinds of goods (including samples sent to overseas research institutions) or technology by adhering to the Catch-all Control, etc.

    7Promotional Activity

    • We will engage in fair and transparent promotional activity toward medical institutions by adhering to the Fair Competition code, the JPMA Code of Practice and the Guidelines concerning Promotional Activity of Ethical Drugs.
    • We will strive to acquire medical and pharmaceutical knowledge, as well as provide information on products to healthcare professionals to the extent approved for manufacturing and marketing in an appropriate manner.
    • We will maintain sound relationships with civil servants and physicians and pharmacists, who are deemed civil servants, so as not to be deemed to have engaged in bribery as prescribed in the criminal law or to breach the National Public Service Ethics Act or other ethics-related laws and standards or be suspected thereof.
    • We will engage in appropriate promotional activity for functional food by complying with the Food Sanitation Act so as to provide satisfaction and a sense of security to customers.

    8Hiring of Consultants, etc.

    When hiring a healthcare professional, functional food researcher or other experts to serve as a consultant or advisor, we will ensure that the amount of consideration is commensurate with the service and sign a written contract.

  • We respect the individual’s human rights and personality and maintain a safe and pleasant working environment.

    Key Points of Conduct

    We must make solid efforts to create a corporate culture in which individual human rights and personalities are respected, thereby encouraging individuals to exercise their initiative and creativity to the fullest and enabling the company to grow in return. Sexual harassment, power harassment, maternity harassment and any other form of harassment inflict undue harm to the honor and dignity of individuals, deteriorate the work environment, and demoralize the entire workplace.
    It is important to make efforts to maintain the safety and health of employees by creating a comfortable work environment.

    1Protection of Human Rights

    • We will respect the diverse values, human rights and personalities of one another both within and outside the company and will not tolerate discrimination or abuse on the basis of race, nationality, ethnicity, gender, age, religion, thought or beliefs, sexual orientation or gender identity, academic background, mental or physical disorder, illness, etc. In addition, we will indicate our respect of human rights to clients and seek their understanding.
    • We will respect individual human rights and personality and will not tolerate sexual harassment, power harassment, maternity harassment or any other form of harassment.
    • In the event we become a victim of or see or hear about harassment and believe that a solution is difficult, we will report it to the harassment consultation desk.

    2Fair Personnel Evaluation and Development of Human Resources

    • We will ensure appropriate assessment of personnel by evaluating our employees’ work results fairly in accordance with predefined evaluation standards.
    • We will seek to place the right people in the right jobs and develop human resources so that each employee can achieve growth.

    3Safety and Health

    • We will comply with the Labor Standards Act, the Industrial Safety and Health Act, and other labor-related laws and regulations.
    • We will create a comfortable work environment that takes into consideration employees’ safety and health with the aim of preventing industrial accidents as well as maintaining and enhancing employees’ health.
    • In the event of a pandemic of an infectious disease, etc., we will act appropriately in accordance with internal rules and instructions of the emergency task force in an effort to ensure safety and prevent the spread of infection.

    4Workplace Culture

    • To enable all employees to maximize their talents, we will deepen mutual trust through communication and build a vibrant, cheerful and employee-friendly workplace culture.
    • We will promote work-life balance so that each employee can achieve a comfortably affluent and prosperous life.
  • We promote sustainable business activities for the global environment and we are committed to the maintenance and improvement of these.

    Key Points of Conduct

    We must be fully aware that we coexist with nature and conduct business activities in harmony with the global environment in order to pass down our rich natural environment to future generations. To that end, each employee must make relentless efforts on a daily basis.

    1The Environment

    • We will strive to enhance our environmental awareness and give due consideration to the environment in our daily business activities in order to contribute to the realization of a sustainable society.
    • We will comply with environment-related laws, regulations and internal rules.
    • We will promote environment conservation activities through targeted efforts.
    • We will make efforts to achieve the three R’s (reduce, reuse, recycle) concerning efficient and reduced use of resources and energy and waste in order to ensure continuous use of limited resources. We will also work aggressively to reduce emissions of greenhouse gas.
    • We will ensure proper use and management of chemical substances used in manufacturing and research by complying with relevant laws and regulations and adhering to internal rules.
  • We actively communicate with our stakeholders and disclose corporate information in a timely and appropriate fashion, building a relationship of trust.

    Key Points of Conduct

    In order to strengthen confidence in our business management, it is important to accurately convey our business philosophy, management policy and business details to our stakeholders, which include patients, clients, users, shareholders, investors and employees, through our products, services and public relations. To that end, we must earn the trust of our stakeholders by listening to their opinions and communicating with them.

    1Communication with Stakeholders

    • We will strive to earn accurate understanding and evaluation of our corporate activities by our stakeholders through communication and seek to build a relationship of trust.
    • We will engage in corporate activity by listening to the opinions of our stakeholders in earnest.
    • When providing information using our website or engaging in digital communication using social media, etc., we will do so by complying with relevant laws and regulations as well as adhering to voluntary industry codes and internal rules.
    • In collaborating with patient groups, we will maintain high ethical standards and respect their independence. We will also strive to achieve sufficient mutual understanding of the purpose and details of collaborations with patient groups. We will strive to strengthen trust by ensuring the transparency of monetary aid we provide to patient groups.

    2Disclosure of Information

    • We will disclose information related to corporate activity in a timely and appropriate manner.
    • We will ensure accurate financial reporting as well as disclosing corporate information that may impact corporate earnings in a timely and appropriate manner.。

    3Accuracy of Accounting Records, Development and Implementation of Internal Control, and Compliance with Tax Laws

    • We will accurately record business activity upon creating and storing accounting records.
    • We will develop and implement internal control with the aim of ensuring the effectiveness and efficiency of operations, reliability of financial reporting, compliance with laws and regulations, and protection of assets.
    • We will comply with tax laws, constantly acknowledging that the payment of taxes is an obligation of companies and citizens.
  • We maintain sound and appropriate relationships with the political and administrative authorities and with our clients, and we engage in the fair, transparent and free competition.

    Key Points of Conduct

    We will practice free competition based on market principles. Therefore, we will always be mindful of laws and regulations, industry rules, and internal rules, and we will not engage in any acts that may be considered collusion or interdependence with politics or the government. It is also important to maintain fair, appropriate and transparent relationships with clients and users in Japan and abroad.

    1Relationship with Politics and the Government

    • We will maintain a transparent and fair relationship with politics and the government, and we will not provide improper gifts, entertainment or any other favors or profits.
    • When we pay money to political parties, politicians and political organizations, we will do so appropriately, irrespective of their pretext, by complying with laws and regulations.

    2Marketing and Advertising Activities

    • We will practice free competition based on market principles and engage in transparent and fair activities.
    • In engaging in marketing activities, we will not solicit transactions by providing illegal or improper gifts, entertainment or rebates to clients and users.
    • Our advertising activities will be based on fair and appropriate content and expression so as not to lead to falsity, misleading advertisements, social discrimination or human rights violations.

    3Purchasing Activity

    • We will engage in transparent purchasing transactions by complying with the Act against Delay in Payment of Subcontract Proceeds, etc. to Subcontractors. We will also clarify the authority and responsibilities of the purchasing organization and persons in charge.
    • We will place emphasis on CSR procurement and promote appropriate purchasing activities.

    4Entertaining of Civil Servants, etc.

    We will not give, offer or promise to give illegal money and goods to civil servants both in Japan or abroad. We will resolutely reject any demands for provision of illegal money and goods.

    5Donations

    When providing donations or subsidies to medical institutions, universities and external organizations, we will comply with laws and regulations and adhere to internal rules, not demand anything in return, and not use them as a means to solicit transactions.

  • We fully value and properly handle company assets including information.

    Key Points of Conduct

    Company assets include tangible assets, such as machinery, equipment, other various goods, cash and deposits, and intangible assets, such as intellectual property that includes sophisticated technological information and knowhow, management strategy information and market analysis information. It is important to fully recognize the value of such assets, handle them appropriately and put them to good use proactively as managerial resources.
    Furthermore, refraining from unlawful acquisition or utilization of corporate secrets, both our own and of others, creates fair competitive relationships between companies. Therefore, we must prevent any unlawful acquisition or utilization of corporate secrets.

    1Use of Company Assets

    We will make good use of company assets proactively only for operating the company’s business and will not use them unlawfully to benefit ourselves or a third party.

    2Information System

    • We will use the company’s information systems and devices properly and effectively, and we will not use them unlawfully to benefit ourselves or a third party.
    • We will prepare for cyberattacks and other information security threats and strive to enhance information security measures and literacy.

    3Treatment of Intellectual Property Rights

    • We will respect and not infringe the intellectual property rights of a third party in the same manner we treat our own.
    • We will recognize the importance of intellectual property rights and strive to utilize the achievements of research and development lawfully.
    • We will adhere to regulations concerning employee inventions.

    4Treatment of Confidential Information and Respecting the Confidential Information of a Third Party

    • We will recognize the importance of confidential information gathered in the course of business activities and will manage it appropriately.
    • We respect the confidential information of a third party and will not acquire, use or disclose it unlawfully. With regard to confidential information of a third party obtained before joining the company or through secondment, we will not disclose it within the company or use it for the benefit of the company.
    • We acknowledge that confidential information stored as electronic information bears the same value as written confidential information, and we will manage it appropriately.
    • We will not misappropriate confidential information of our own or of another company for the benefit of ourselves or a third party.

    5Protection of Personal Information and Specific Personal Information

    • We are deeply aware of the importance of personal information protection and will comply with relevant laws and regulations as well as appropriately establish and operate a system to protect personal information and prevent leaks.
    • We will take the necessary and appropriate measures, such as ensuring fair acquisition of personal information, notification and publication of the purpose of use, prohibiting unintended use, safety management measures, education of employees, restrictions on provision to third parties, and developing and implementing procedures for responding to requests to disclose personal data we possess.
    • We will ensure that we give due consideration when handling specific personal information that includes personal identification numbers, as we do when handling personal information, as well as comply with the Act on the Use of Numbers to Identify a Specific Individual in Administrative Procedures.

    6Insider Trading Regulations

    We will comply with insider trading regulations prescribed by the Financial Instruments and Exchange Act, and in the event we obtain an unpublished material fact on the business of our company, group companies or clients in the course of our duties, we will not trade the shares of said companies until after such material fact is published following certain procedures.

  • We reject unfair and illegal requests from antisocial forces and organizations which may threaten the order and safety of civil society.

    Key Points of Conduct

    We will confront so-called antisocial forces and organizations, such as corporate racketeers and crime syndicates, in a resolute manner and ban any relations therewith. We will resolutely reject any undue or unlawful demand we receive from antisocial forces or organizations.

    1Response to Antisocial Forces and Organizations

    We will not have any relations with antisocial forces and organizations that threaten social order and safety, and we will not comply with any undue or unlawful demand but deal with the matter in cooperation with the police, etc. When dealing with the matter, we will contact the department in charge (administration department) and not make any judgments individually or by ourselves.

    2Emergency Responses

    In the event of an emergency, such as acts by antisocial forces that threaten social order and safety and terrorism, we will place top priority on protecting our own safety and act appropriately in accordance with the instructions of the emergency task force.

  • As members of society, we are actively committed to social contribution activities.

    Key Points of Conduct

    We coexist with society through corporate activities. Besides fulfilling the roles and responsibilities of a company, such as providing quality products, paying taxes and generating employment, we must actively engage in social contribution activities as a member of society for the development of society and local communities.
    It is also important that each one of us strives to collaborate with society while exploiting our individual characteristics.

    1Social Contribution Activities

    • We will support organizations engaged in public-interest activities as well as sport and cultural events.
    • We will seek exchange with local communities by allowing access and visits to our plants, laboratories and botanic research institute.
    • We will engage in social contribution activities based on voluntary motivation.
  • We comply with international rules and local laws and regulations in our global business activities as well as respecting local cultures and practices.

    Key Points of Conduct

    We must conduct international business activities with a perspective of how we can coexist with the local society and contribute to its development. Based on this perspective, we will act in accordance with international rules and thoroughly comply with local laws and regulations when engaging in international business activities. We will also respect the local culture and customs and promote business activities based on mutual trust.