Navigation path

Ono Pharmaceutical Code of Practice

Chapter 1　Purpose

The Ono Pharmaceutical Code of Practice (hereinafter referred to as the “Code”) aims to meet society’s expectations by promoting appropriate industry-academia collaboration, building mutual trust with researchers, HCPs, Patient Organizations, and other stakeholders, maintaining high ethical standards throughout OPJP’s corporate activities, and ensuring strict compliance with Applicable Laws and Regulations.

Chapter 2 Definition of Terminologies

Article1The terms used in this Code are defined below.

  1. “All Policies” mean Global Policies and other Policies (including rules, detailed rules, and other items equivalent to Individual Entity Policies).
  2. “Applicable Laws and Regulations” mean all laws, cabinet orders, ministerial ordinances, municipal ordinances, rules, guidelines, policies, notifications, and other public norms related to the business activities of the ONO Group.
  3. “Employee(s)” means directors, officers, regular employees, contract employees, and other employees of the OPJP, including temporary staff and fixed-term employees.
  4. “HCP(s)” means Healthcare Professional(s), namely any member of the medical, dental, pharmacy or nursing professions, or any person who may prescribe, recommend, purchase, supply, sell or administer pharmaceutical products in the course of his or her duties.
  5. “JPMA” means the Japan Pharmaceutical Manufacturers Association.
  6. “OPJP” means Ono Pharmaceutical Co., Ltd.
  7. “Patient Organization(s)” means a patient group, a patient support group or such groups that are primarily composed of patients, their families, and their supporters; that represent the voice of patients, support patients and their families, and aim to improve the medical environment; and that, in principle, have roles and purposes defined in the articles of incorporation and by laws and a relevant rule of such patient group. However, presence or absence of corporate status and the form of their establishment are not considered.

Chapter 3 Scope

This Code applies to Employees.

Chapter 4 Basic Principle

Article 1Compliance Obligation

Employees shall comply with Applicable Laws and Regulations, this Code, and related All Policies with integrity.

Article 2Thorough Dissemination of the Code

  1. This Code shall be disclosed on the internal portal site to be known.
  2. The measures and implementation associated with compliance with this Code in each organization shall be determined by a responsible person of each organization.
  3. The Compliance Promotion Department shall serve as the consultation desk for this Code and promote compliance with this Code.

Article 3Ethics

In general, competition among corporations has a natural tendency to heat up to an immoderate extent, and it cannot be denied that this kind of conduct existed in drug promotion in the past. For this reason, numerous laws, regulations and industry self-regulations have been established today, beginning with the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” (hereinafter referred to as the “Pharmaceuticals and Medical Devices Act”) and the “Re-revision of the Standard for Adequate Advertisement of Pharmaceutical Products” (PSEHB Notification No. 0929-4, dated September 29, 2017; hereinafter referred to as the “Standard for Adequate Advertisement of Pharmaceutical Products”), the Guidelines for Provision of Sales Information, the “Fair Competition Code Concerning Restriction on Premium Offers in Ethical Pharmaceutical Drugs Marketing Industry” (hereinafter referred to as the “Fair Competition Code”), “Guideline for Preparation of Product Overview for Prescription Drug” (hereinafter referred to as the “Guideline for Product Overview Preparation”), and “Guidelines for the Certification of MRs.” As is generally known, drugs have the following characteristics.

  • Cannot be understood in essence by appearance alone.
  • Drugs have both effects and side effects, the occurrence of which differs from patient to patient.
  • Thus, drugs that are not accompanied by correct drug information cannot truly function as medicine.
  • Patients who require treatment are the only consumers.

It is because drugs have these characteristics that the abovementioned numerous laws, regulations and industry self-regulations are necessary.

At the same time, the environment surrounding pharmaceutical companies is becoming more diverse and complicated, and events that cannot be fully addressed by the philosophies and methods of the past are occurring one after another. In addition, society is calling on pharmaceutical companies to bring greater fairness and transparency to their relationships with HCPs. Under these conditions, disregard for the special nature of drugs could inflict significant damage on patients and the society, paving the way for health hazards or unnecessary use of drugs. It is clear that this would have dire consequences for OPJP itself, which would suffer a self-inflicted loss of credibility, extending to our products, the entire pharmaceutical industry, and the society at large. Needless to say, OPJP has nothing to gain – but much to lose – from such activities. Therefore, rather than seeing these laws, regulations and industry self-regulations as “things which are forced to be complied,” OPJP needs to perceive them as “reflections of the society’s expectations for pharmaceutical companies” and adopt a broader perspective to understand and own these regulations in the context of their social background and the purpose for which they are established.

It is easy to understand that corporate activities based on this sense of ethics establish a priceless foundation in the form of “public trust” towards drugs and pharmaceutical companies. This becomes even more evident if you examine pharmaceutical companies from the vantage point of an individual patient or a member of society. As a member of a community (be it a family, workplace, or region), everyone has a role that he or she is naturally expected to play. Society works on the assumption that each member performs a certain anticipated role. Any society will crumble if this premise does not hold.

The same applies to OPJP. From the standpoint of OPJP's drugs, it is clear that members of the society assume that high-quality drugs are being used properly when they receive healthcare, irrespective of whether or not there are laws, regulations and industry self-regulations in place. This is why it is particularly important for the pharmaceutical industry to perceive “corporate social responsibility” (CSR) as an important mission.

The character “rin” used as the first component of the Japanese word “rinri” (meaning “ethics”) signifies our mutual expectations with regard to human and social relationships. This means that OPJP is called upon to not only comply with laws, regulations and industry self-regulations but also adopt the stance of proactively responding to the society’s demands and expectations.

Article 4Fundamental Philosophy

Advances in medical and pharmaceutical science and improvements in public health depend on information-sharing interactions between the entire medical community, which comprises researchers, HCPs, patients, wholesalers, and OPJP. Integrity is essential to these interactions, and there must be confidence that decisions are made ethically and in the best interests of patients.

JPMA sets forth the basic principles of corporate behavior in the JPMA Code* to ensure appropriate interactions between the member companies and external stakeholders (hereinafter referred to as “stakeholders”).

The JPMA Code helps member companies accomplish their mission of making great contributions to public health in Japan and throughout the world while complying with a code of conduct based on high ethical standards. The Code’s standards of behavior apply to all interactions between member companies and stakeholders.

OPJP bears the responsibility to perform our corporate activities with high ethicality and transparency, and is called upon to promote activities based on the JPMA Code and this Code.

The criterion for judgment of OPJP’s own conduct must always be whether that conduct conforms to the spirit of the JPMA Code and this Code, regardless of whether the conduct in question is concretely described in the JPMA Code and this Code.

However, at times of major natural disaster or other emergency, it shall be necessary to adopt a flexible stance that gives highest priority to respect for human life.

Chapter 5 I-1 Ono Pharmaceutical Code of Practice

In view of the fact that OPJP engages in our corporate activities as a member of the life sciences industry, which operates under the public medical insurance system, OPJP shall conform to not only the Pharmaceuticals and Medical Devices Act, related laws and regulations, the “Standard for Adequate Advertisement of Pharmaceutical Products,” and the “Guidelines for Provision of Sales Information,” but also the industry self-regulations set forth in the “Fair Competition Code,” the “Code of Practice for Pharmaceutical Industry,” the “JPMA Charter of Corporate Behavior,” the “JPMA Compliance Program Guidelines,” etc., as well as maintain high ethical standards in all our conduct.

  1. Scope and Definition of Promotion ScopeThis Code applies not only to the promotion of prescription drugs but to all interactions among OPJP and researchers, HCPs, medical institutions, Patient Organizations, and wholesalers, etc. OPJP shall comply with the JPMA Code and this Code while respecting the IFPMA Code, the code of the organization with which JPMA has signed up as a member. Moreover, the criterion for judgment of OPJP’s own conduct must always be whether or not the conduct conforms to the spirit of this Code, regardless of whether or not the conduct in question is concretely described in this Code. Definition of PromotionThe word “promotion” as it is used here means “to engage with HCPs in the provision, collection, and communication of pharmaceutical product information for promoting the proper use and broader adoption of prescription drugs based on those interactions.” This includes all activities implemented by OPJP that may influence the prescribing decisions of HCPs.
  2. Responsibility of Top Management

    The top management of OPJP shall execute the following.

    With the awareness that acting in accordance with the “Basic Principles” is his or her own role, the top management shall set an example by implementing the provisions of this Code and making them known to all as he or she strives to maintain and improve the internal organization. The top-level manager shall perceive the conduct of all officers and Employees to be his or her own responsibility. When circumstances arise that run counter to the spirit of this Code, the top management shall take responsibility for resolving the problems, investigate and identify the cause, and take measures to prevent recurrence. Even in departments that are in charge of matters other than pharmaceutical products, top management shall observe the spirit of this Code in conducting corporate activities. Subsidiaries that manufacture and sell drugs in Japan shall also be required to comply with this Code. OPJP shall demonstrate our compliance with this Code to affiliates and subsidiaries that manufacture and market pharmaceuticals, whether in Japan or overseas, and seek their understanding of this Code.
  3. Fundamentals of Interaction Fundamentals of InteractionAdvances in medical and pharmaceutical sciences and improvements in public health depend on information-sharing interactions among the entire medical community, which comprises researchers, HCPs, Patient Organizations, wholesalers, and OPJP, and integrity is essential for these exchanges. The society relies upon pharmaceutical companies to make decisions ethically and in the best interests of patients when engaging in such interactions, and OPJP must always conduct ourselves in such a manner that the government, HCPs, and patients trust us to engage in ethical activities at all times. Transparency of InteractionsPharmaceutical companies are called upon to maintain a high sense of ethics as life sciences companies, and OPJP shall be accountable for interactions with researchers and HCPs and ensure that collaboration with Patient Organizations is conducted ethically and in good faith. OPJP shall maintain transparency in our corporate activities and properly discharge our accountability to the society in accordance with our own regulations based on the Medical Institutions Transparency Guidelines, Guidelines on Collaboration with Patient Organizations (hereinafter, “Patient Organization Collaboration Guidelines”), and the Patient Organization Transparency Guidelines.
  4. Interaction with HCPs

    In interactions with HCPs, OPJP shall give the highest priority to being of benefit to patients and contributing to the health and welfare of patients. With the goal of contributing to the development of medical and pharmaceutical science and the improvement of public health, OPJP's interactions shall focus on the provision of drug information, academic exchange on medical and pharmaceutical science, and support for research. When promoting industry-academia collaboration to further the development of medical and pharmaceutical science, OPJP shall make efforts to build relationships of trust with researchers, HCPs, and Patient Organizations while at the same time avoiding activities that could exert an inappropriate influence upon prescribing decisions.

  5. Prohibition on Preapproval Information Provision and Recommendation of Off-Label Uses

    OPJP shall not engage in promotion until approval for the drug is received in Japan. OPJP shall also refrain from endorsing off-label uses.

  6. Information Dissemination Activities

    As a life sciences company, OPJP shall provide scientific and objective information on drugs as needed. When providing information, OPJP shall strive to make the content and mode of expression easy for users to understand, while complying with the laws, regulations, and self-regulations.

    Advertisement of prescription drugs to the general public other than HCP is prohibited by the Pharmaceuticals and Medical Devices Act and the Standard for Adequate Advertisement of Pharmaceutical Products. This applies to information disseminated through press releases, disease education activities targeting the general public and patients, and provision of information to investors. OPJP shall conduct this scrutiny so that there will be no suspicion that such type of information dissemination constitutes the advertisement of prescription drugs or recommendations of unapproved drugs or off-label uses. Rules governing the dissemination of information to HCPs are set forth in “I-2. Ono Pharmaceutical Promotion Code for Prescription Drugs.”

    Promotional Materials (Including Digital Media)OPJP shall prepare promotional materials (including digital media; hereinafter referred to as “promotional materials”) in accordance with the related laws and self-regulations such as the Guideline for Product Overview Preparation. Social MediaOPJP shall bear all responsibility for content when utilizing digital communication via social media, etc. Accordingly, compliance with this Code must first be confirmed with related subsidiaries, affiliates, planning companies, agencies, officers and Employees.
  7. Holding of Seminars and Meetings

    OPJP can hold seminars for the purpose of providing information on medical and pharmaceutical science, as well as disease education information, etc. Moreover, OPJP can hold meetings, etc., of HCPs and others to obtain useful expert knowledge for their activities. When holding a seminar, meeting, etc. of HCPs and others, OPJP shall comply with the related laws and regulations, the Fair Competition Code, and “I-2 Ono Pharmaceutical Promotion Code for Prescription Drugs.”

  8. Fee for Services

    OPJP may engage researchers, HCPs, medical institutions, Patient Organizations, etc., for service arrangements such as research, clinical studies, post-marketing surveys, consultant and advisories, participation in the planning of meetings, chairing or lecturing at seminars, and training instructor duties, where such participation involves fees such as compensation. However, when making such arrangements for these services, OPJP must enter into a written agreement that fulfills all of the following criteria.

    A written agreement must be made to specify the purpose of the service to be provided and the basis for payment of those services. A legitimate need for the services must be clearly identified in advance. The service providers must be directly related to the identified need and must have the expertise necessary to provide the service. The number of people to be contracted must be reasonable to meet the specified need. The hiring must not be an inducement to prescribe, purchase, or recommend any specific drug. The compensation for the services is reasonable, reflects the fair value of the services provided, and is commensurate with the fair market value.

    In addition, when making service arrangements, internal rules, etc., of the service provider shall be respected; the related laws and regulations and the Fair Competition Code shall be complied with; and the compensation, expenses, etc., associated with the service arrangements shall be disclosed appropriately in accordance with OPJP’s guidelines based on the Medical Institutions Transparency Guidelines and the Patient Organizations Transparency Guidelines.

  9. Provision of Gifts, Cash, or Cash Equivalents

    OPJP shall not directly or indirectly provide researchers, HCPs, medical institutions, Patient Organizations, wholesalers, and stakeholders with the following gifts, cash, or cash equivalents.

    Gifts, cash, or cash equivalents that could exert inappropriate influence upon decision-making (including those that may affect the proper use of drugs) Gifts that undermine the dignity of pharmaceutical products Gifts, cash, or cash equivalents that are unlikely to meet with social understanding and acceptance
  10. Implementation of Study and Research Activities, as well as Post-Marketing Safety Management Operations and Post-Marketing Surveillance Studies and Research ActivitiesAt every phase, studies and research activities involved in epidemiological research, non-clinical studies, clinical research/clinical studies (clinical trials and post-marketing studies), etc., must have highly ethical and appropriate scientific objectives that conform to the laws and ethical guidelines. Moreover, information on R&D expenditures and public research subsidies shall be subject to disclosure under the “Medical Institutions Transparency Guidelines,” and OPJP shall bear appropriate accountability in accordance with the Guidelines.
    To ensure transparency of information on clinical studies, OPJP shall publicly disclose clinical study information in conformity with the “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases” (revised in 2018) and “Joint Position on the Publication of Clinical Trial Results in the Scientific Literature” (revised in 2017), which were jointly issued by JPMA, IFPMA, European Federation of Pharmaceutical Industries and Associations (EFPIA), and Pharmaceutical Research and Manufacturers of America (PhRMA).
    Additionally, to minimize harm from adverse reactions to pharmaceuticals, OPJP shall make efforts to develop safer, more effective drugs while promoting appropriate voluntary self-controls on the use of laboratory animals in drug development from the standpoint of animal welfare so that the R&D will be further improved.     Post-Marketing Safety Management Operations and Post-Marketing SurveillanceOPJP needs to have a proper understanding of the objectives behind the establishment of proper methods of use for post-launch drugs. Post-marketing safety management operations and post-marketing surveillance must be based on scientific evidence and conducted in compliance with laws, regulations, and self-regulations. These activities should never be used as tools of sales promotion.
  11. Collaboration with Patient Organizations

    In all types of collaboration with Patient Organizations, OPJP shall maintain a strong sense of ethics, act with integrity, and respect the independence of the Patient Organizations. Moreover, OPJP shall strive to promote sufficient mutual understanding of the objectives and content of the collaboration with the Patient Organizations. Therefore, when collaborating with Patient Organizations, OPJP shall establish regulations by referring to the “Patient Organization Collaboration Guidelines” and implement them faithfully.

    OPJP providing financial or other support to a Patient Organization shall make our involvement known to the public to foster a broad understanding of the fact that this support contributes to the activities and development of the Patient Organization while securing high ethical standards. For that purpose, OPJP shall establish our own guiding principles based on the “Patient Organizations Transparency Guidelines” and make the information public.

    OPJP shall ensure transparency of the activity items, funding, etc., in collaboration with Patient Organizations, by securing a written agreement or consent for the objectives and content of the support before collaboration, as well as by retaining records.

  12. Relationship with Wholesalers

    The relationship between pharmaceutical companies and wholesalers must be a fair business relationship that complies with the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade (hereinafter referred to as the “Antimonopoly Law”) and other laws, regulations, and self-regulations. Moreover, since this relationship is expected to ensure a greater degree of ethicality and transparency than similar relationships in other industries because its transactions take place under the public medical insurance system, OPJP shall establish and conform to our own standards in cases where cash, goods, food and drink, or the like is offered to wholesalers or accepted from them.

  13. Internal Procedure and Education

    OPJP shall establish and maintain appropriate internal procedures in order to comply with the related laws and regulations and the JPMA Code, and all officers and Employees must be required to undergo education appropriate to their role.

  14. Inquiries, Complaints, and Actions

    When there has been an inquiry or complaint about the JPMA Code and this Code, or when a code violation is suspected, for cases in which JPMA Code and this Code judged to have been breached, the Compliance Promotion Department shall take actions for improvements of the breaches.

  15. Activities Outside Japan Standards Applied to Activities Outside JapanEven in activities that take place overseas, OPJP shall respect this Code while conforming with the related laws and regulations of the relevant country, in addition to whatever pharmaceutical organization codes exist within the relevant country, or to the IFPMA Code in the absence of such codes. Provision of Information on Drugs OverseasOPJP shall, when providing medical information to overseas HCPs, provide globally consistent information, whether directly or indirectly through local agents, etc. On this occasion, in addition to the laws and regulations of the relevant country, if there is a code of a pharmaceutical industry in the relevant country, such code shall be followed; if there is no such code, the IFPMA Code shall be followed. Handling of Japanese HCPs Overseas and Foreign HCPs in JapanOPJP shall also comply with this Code when handling Japanese HCPs participating in seminars or scientific meetings overseas. When OPJP invites HCPs from overseas to seminars, etc., held in Japan, OPJP shall comply with the laws and regulations of the relevant country, in addition to the code of the pharmaceutical industry in the relevant country—or, if no such local code exists, to the IFPMA Code. Overseas Subsidiary Companies, Licensees and AgenciesWhen an overseas subsidiary of OPJP conducts activities in the relevant country, OPJP shall ensure that the overseas subsidiary adheres to the laws and regulations of the relevant country, in addition to any pharmaceutical organization codes existing within the relevant country, or to the IFPMA Code in the absence of such codes. When OPJP has an overseas licensee or agency conduct activities in the relevant country based on a licensing or agency agreement, OPJP shall ensure that the overseas licensee or agency adheres to the laws and regulations of the relevant country, in addition to any pharmaceutical organization codes existing within the relevant country, or to the IFPMA Code in the absence of such codes.
  16. Committee in Charge of the Guidelines for Provision of Sales Information

    The Compliance Promotion Department, as the department in charge of the Guidelines for Provision of Sales Information, will establish the review and supervisory committee to assist each department in complying with the guidelines.

Chapter 6 I-2 Ono Pharmaceutical Promotion Code for Prescription Drugs

The “Ono Pharmaceutical Promotion Code for Prescription Drugs” (hereinafter referred to as the “OPJP Promotion Code”) stipulates the responsibilities and fundamentals of promotional activities by all pharmaceutical companies when conducting promotional activities for prescription drugs, and it mandates that all officers and Employees of OPJP conduct their drug promotional activities in strict compliance therewith.

The word “promotion” means “to engage with HCPs in the provision, collection, and communication of pharmaceutical product information for promoting the proper use and adoption of prescription drugs based on those interactions.” OPJP must always judge whether our activities are in accordance with the spirit of the ONO-P Code, regardless of whether or not the Promotion Code contains concrete stipulations or descriptions that are relevant to the activities. Any and all violations of or deviations from the respective laws and regulations and acts that infringe upon the Standard for Adequate Advertisement of Pharmaceutical Products, the Guidelines for Provision of Sales Information, and the industry’s self-regulations for promotional activities of drugs shall be treated as breaches of this Code, even if such violations or deviations are not specifically mentioned in this Code.

The OPJP Promotion Code will be revised in accordance with the establishment, revision, and abolition of the IFPMA Code, laws and regulations, and voluntary codes, or changes in other regulations, environment, etc. surrounding promotion activities.

  1. Responsibilities of OPJP in Promotional Activities

    OPJP shall assume the responsibility for our promotional activities. In thorough recognition of this principle, OPJP shall be required to establish an in-house system to conduct appropriate promotional activities and ensure that all officers and Employees comply with it without exception.

    Although the OPJP Promotion Code obviously applies to promotional activities, it similarly applies to other activities that are regarded as promotion, irrespective of the name or any position of the organization that performs those activities.

    Continuously provide officers and Employees with the necessary training and education to support the proper use and adoption of drugs. Ensure that the evaluation/remuneration system for officers and Employees and others is not an inducement to unethical acts. Establish the internal systems necessary to comply with laws, regulations, and self-regulations.
  2. Fundamentals of Promotional Activities

    In promotional activities conducted by our officers and Employees, OPJP must be fully aware of both our social mission as persons who play a role in healthcare and their positions as officers and Employees who provide drug information as representatives of OPJP. Employees are called upon to perform the following duties in a sincere and honest manner:

    OPJP shall not engage in promotion until approval for the drug is received in Japan. Endorsement off-label uses shall also be refrained from endorsing off-label uses. Not only have the knowledge of the content of the digitized package inserts and risk management plans (hereinafter referred to as “RMP”), etc., for drugs sold by OPJP, but also strive to acquire familiarity with the medical and pharmaceutical science on which that information is based, as well as cultivate the ability to present such information correctly. Conduct promotional activities according to the rules and methods established by OPJP. Provide information on indications, dosage and administration, etc., in a fair and balanced manner in terms of efficacy and safety within the range approved as a drug and in a proper manner based on the most up-to-date scientific data. Collect and disseminate drug information as accurately and promptly as possible. OPJP shall not slander and/or defame competitors or competitors’ drugs. Maintain discipline when visiting a medical institution and abide by the rules of the institution. Strictly abide by laws and regulations and self-regulations and behave sensibly.
  3. Production and Use of Brochures and Advertisements, etc.

    In recognition of the fact that brochures, advertisements in medical journals, websites targeting HCPs, audiovisual materials such as slides and videos, and other promotional materials are important media for the dissemination of drug information, OPJP shall produce and use those materials in compliance with the Pharmaceuticals and Medical Devices Act, administrative notifications, and relevant self-regulations such as the Guideline for Product Overview Preparation. The statements contained therein shall be correct, fair, objective, and based on scientific data.

    OPJP shall appoint a person responsible for the management of prescription drug brochures, etc., and establish an in-house oversight system so that only promotional materials that have passed through a review are used.

  4. Holding of Seminars and Meetings

    Seminars held by OPJP for providing medical/pharmaceutical information, disease awareness information, etc., to HCPs shall be held on our own responsibility, and OPJP shall provide specialized academic and scientific information. Appropriate locales and venues for holding seminars and study meetings shall be selected depending on the purpose, and in principle they shall be within Japan. If food and drinks are offered in association with a seminar, they shall not be extravagant and not damage the dignity of pharmaceutical companies. Payments in cash or cash equivalents that are made in connection with holding a seminar shall be limited to travel expenses (transportation expenses, accommodation expenses, etc.) and compensation such as honoraria for the lecturer, and the compensation shall be within the range appropriate and reasonable to the value of service. Individuals accompanying the lecturer shall not receive travel expenses or participate in the social-gathering event. When providing premiums, etc., OPJP shall comply with the Fair Competition Code.

    In planning seminars for providing disease awareness information to ordinary consumers who are not HCP, special consideration shall be given to the Pharmaceuticals and Medical Devices Act and the Standard for Adequate Advertisement of Pharmaceutical Products.

    OPJP shall not use meetings as a vehicle for promotion, for example, when holding an advisory conference that invites HCPs and others or a meeting for clinical trials, etc., to obtain useful expert knowledge for our activities such as advisory at the time of formulating strategies for products.

  5. Supply and Management of Samples

    Samples are a means of providing drug information. There are two types of samples: “product samples,” which HCPs can use to confirm the external characteristics of prescription drugs, and “trial-use samples,” which physicians can use to confirm and evaluate the quality, efficacy, safety, and other pharmaceutical particulars of a drug before using it in clinical practice.

    Whichever type of sample is provided, it must be accompanied by the relevant prescription drug information, and only the minimum necessary amount should be provided. In particular, since “trial-use samples” are used in actual clinical practice, a strict system of management shall be constructed and appropriately implemented.

    (Note) Supply of samples shall be conducted in accordance with the separately established implementation standards.

  6. Relationship to the Fair Competition Code

    OPJP shall more proactively and rigorously comply with the Fair Competition Code. OPJP shall conduct ourselves according to high ethical standards without limiting ourselves to mere compliance with the Fair Competition Code.

Supplementary Provisions

This Code was adopted on March 1, 2013, and became effective on April 1, 2013.

Revision on November 1st, 2026

Other Policies