Fair Operating Practices

Being aware of our responsibilities as a pharmaceutical company dealing in pharmaceuticals upon which human lives depend, ONO PHARMACEUTICAL has the ONO PHARMACEUTICAL Codes of Conduct, which are its own codes of conduct, to ensure that it acts in compliance with laws and regulations and that it meets high ethical standards.

ONOfs Ethical System

Our ethical system consists of Ono Pharmaceutical Codes of Conduct, which serve as basic guidance for our corporate activities; the Compliance Program, which provides for standards of conduct for the activities; and the Codes of Practice, which are based on the pharmaceutical industry standards on promotion and other activities. In putting the ethical system into practice, we repeatedly remind our employees of their duties to ensure transparency in transactions and prevent fraud and corruption, and act in consideration of social situations at home and abroad. Being keenly aware of corporate ethics as a pharmaceutical company, we will continue to further strengthen our level of compliance in line with our ethical system.

Compliance Promotion Initiatives

œ Compliance Promotion System

To promote compliance, we have appointed a Corporate Ethics Officer and set up a Corporate Ethics Committee to examine and deliberate compliance-related issues and to plan and promote relevant training programs. We have internal and external contacts (refer to the chart below) for reporting and consultation on compliance issues as well as a system to ensure that informants can directly report to or consult with top management-that is, the Representative Director, the Corporate Ethics Officer, and the Corporate Auditors. Under this system, harassment and other compliance violations can be prevented and necessary measures can be taken to minimize any loss of credibility in the event of a compliance violation. Information related to the use of the system such as the name of the informer, the contents of the report, and privacy data will be strictly kept confidential and provided only to the interested persons who need it for investigation purposes. Anonymous reporting is allowed. No employees who have used this reporting system will suffer prejudicial treatment of any kind only for making the report.
We provide guidance to associated group companies in creating systems and rules to prevent the occurrence of noncompliance, and we strongly urge our affiliates and suppliers to do the same. In February 2015, we set up the ONO Hot Line, a 24-hour external contact service, thereby making efforts to enable employees throughout the group to report problems or consult without hesitation.

We provide the following training courses for employees to enhance their awareness of compliance. Every year we schedule a three-month period of intensive training during which we organize lectures given by the leaders of various departments, as well as training courses using an e-learning system, to improve employeesf familiarity with and understanding of compliance in general. In the event of a certain type of noncompliance, we also provide ad hoc training sessions to prevent the occurrence or recurrence of such noncompliance on a company-wide scale.
In particular, with regard to harassment, not only do we provide training courses for management staff, but we also have external lecturers hold sessions on harassment, thereby enhancing awareness of compliance.


œ Marketing

(Basic approach to marketing)

Our mission is to contribute improvement of the health and welfare of people around the world through research on and the development of innovative and highly-effective pharmaceuticals, the stable provision of high-quality pharmaceuticals, and appropriate information provision and collection. To this end, we have formulated the Pharmaceutical Promotion Code in the ONO Codes of Practice (hereinafter referred to as the gCodeh) as our action guidelines and we are proactively conducting promotion activities through collaboration between the Sales and Marketing Division, the Compliance Promotion Department, and the Safety and Quality Assurance Division, in order to realize optimal and patient-centered healthcare.

(Engagement in fair promotion activities)

For ONO PHARMACEUTICAL, gpromotionh does not mean just gsales promotion.h We define it as gproviding and conveying pharmaceutical information to medical workers so as to disseminate the appropriate use of pharmaceuticals based on such information.h Employees in the Sales and Marketing Division proactively carry out promotion activities, while always examining whether they are acting in accordance with the spirit of the Code regardless of whether there are any specific provision or description in the Code. Also, we comply with the Code and adhere to the JPMA (Japan Pharmaceutical Manufacturers Association) Code of Practice, as well as respecting the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) Code of Practice, which is a code established by an association in which the JPMA participates.

(Training to thoroughly inform fair promotion activities)

Compliance Promotion staff members visit sales branches in various places twice a year to provide MRs with compliance training sessions, aiming to disseminate and teach internal standards pertaining to the Code. Also, in the Sales and Marketing Division, joint meetings at the section chief level are held through collaboration with trade practice committees established under the Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry to share information and provide training. Furthermore, at meetings held by leaders in the Sales and Marketing Division, systems to improve familiarity with the aforementioned standards within the Division are developed.

œ Ethical Considerations

ONO always gives consideration to ethical treatment in various stages of research and development.
We conduct research using human specimens (blood, tissue, cells, genes, etc.) after strict deliberations on ethical and scientific acceptability. To this end, we have established internal ethical codes based on the basic guidelines specified by the Japanese government and set up the Research Using Human Specimens Ethics Committee composed of internal and external members as an advisory board.
To ensure that the lives of the animals are respected and proper consideration is made to animal welfare in research using laboratory animals, we have established the Institutional Animal Care and Use Committee that reviews whether all animal experimental protocols are prepared based on the principles of the 3Rs\Replacement (active use of alternative methods of experiment), Reduction (reducing the number of test animals), and Refinement (alleviation of pain)\in advance. The committee also implements self-inspections and assessments of the animal experiment processes. In recognition of these initiatives, Ono has earned the Center for Accreditation of Laboratory Animal Care and Use (CALAC) in the Japan Health Sciences Foundation (JHSF) accreditation as an animal testing facility.
Clinical trials, which are essential for verifying the safety and efficacy of investigational compounds, must be performed with respect for the rights of trial subjects. Clinical trials are closely monitored for patientsf safety and are stringently conducted under high ethical standards. We are committed to evaluating the real merit of investigational compounds by steadily applying essential and complete testing procedures that comply with the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices of Japan (Pharmaceutical and Medical Device Act) and other related legislation, as well as the global standards based on the spirit of the Declaration of Helsinki.

For more information, see the web pages below:

Considerations to ensure human rights during research


Ethical considerations in animal experiments


œ Fair and Transparent Business Activities

We conduct fair and transparent business activities, and provide training programs to repeatedly familiarize employees with their duties to prevent fraud and corruption.
We aim to contribute to healthcare all around the world and peoplefs health through continuous R&D activities and the stable supply of new drugs. To this end, we need to engage in collaborative activities-for example, providing support for patient organizations-and cooperate with research and medical institutions to help patients overcome disease and pain. To enhance the fairness and transparency of such collaborations and cooperation, it is important to ensure transparent relationships with our partners. We therefore disclose information on the costs of our assistance to medical institutions and patient organizations in accordance with our transparency guidelines, which are formulated in line with the relevant guidelines of the Japan Pharmaceutical Manufacturers Association (JPMA).
While compliance with laws related to fraud and corruption is attracting increasing attention on a global scale, we always act in consideration of the social situation in Japan and overseas. To this end, we established ONO PHARMACEUTICAL Bribery Prevention Global Policy and the Regulations on Bribery Prevention in April 2017 to clarify our bribery prevention system in a written form, and work to operate them in a strict manner.
To ensure that publicly funded research is conducted in compliance with the relevant guidelines established by the Japanese government, we have formulated the Action Guidelines for Publicly Funded Research and the Regulations on Publicly Funded Research, and apply them for even more appropriate use and management of public research funds.

See the ONO PHARMACEUTICAL Bribery Prevention Global Policy below for information on our bribery prevention system.

ONO PHARMACEUTICAL Bribery Prevention Global Policyi147KBj

For more information, see the web pages below:

Operation and management system of public research funds, and procurement policy


CSR Procurement

We have established a basic policy for procurement activities in terms of fairness, economic rationality, and environmental protection, and our procurement personnel are required to act in accordance with the policy. In addition, ONO clearly separates its purchase organization from other parts of the company and carries out regular internal audits of the purchase organization to confirm its transparency.

œ CSR Procurement Policy

ONO has established its policy for procurement activities based on the six CSR priority areas*.
* Corporate governance, innovative pharmaceutical products, human resources and human rights, the environment, fair operating practices, and society

Basic Ideas on Purchase Transactions
  1. Purchase transactions involve selecting and purchasing favorable goods and services on the basis of economic rationality.
  2. Purchase transactions are open to suppliers both at home and abroad and are conducted in a fair and transparent manner through a simple and easy-to-understand procedure.
  3. Purchase transactions play a key role in the activities of companies as part of their contribution to society as good citizens.
    Companies also give consideration to resource savings and environmental conservation in purchase transactions.

Basic Policy for Procurement Activities
  • (1) Compliance with relevant laws and regulations
    We will comply with relevant laws and regulations in Japan and other countries, and we will conduct fair transactions based on high ethical standards.
  • (2) Respect for human rights
    We will respect fundamental human rights and perform our duties without unjust discrimination.
  • (3) Economic rationality
    We will perform sufficient evaluations of the quality of goods and services and the management stability of suppliers, and we will select suppliers based on proper standards.
  • (4) Fair distribution of opportunities
    We will provide opportunities for all suppliers to compete in a fair and transparent manner.
  • (5) Consideration of the environment
    We will be conscious of the protection of resources and the conservation of the environment in our procurement activities.
  • (6) CSR procurement
    We will promote CSR activities in all of our procurement activities as part of our efforts to promote CSR activities throughout the ONO PHARMACEUTICAL Group.