Fair Operating Practices

Being aware of responsibilities as a pharmaceutical company dealing in pharmaceuticals upon which human lives depend, ONO PHARMACEUTICAL has the Ono Pharmaceutical Code of Conduct to ensure that it acts in compliance with laws and regulations and that it meets high ethical standards. We thoroughly train all employees to ensure compliance and promote proper procurement activities in cooperation with suppliers.

ONO PHARMACEUTICALfs Compliance System

Our compliance system consists of the Ono Pharmaceutical Code of Conduct as basic guidelines for corporate activities, the Compliance Program as a behavioral standard for its activities, and the Code of Practice based on pharmaceutical industry standards related to promotional activities. In practicing the compliance system, we are repeatedly informing our employees about ensuring transparency, preventing fraud and corruption, constantly being conscious of domestic and international social conditions. We will continue to recognize our ethical philosophy as a pharmaceutical company and will make every effort to further improve compliance in line with our compliance system.

Compliance Promotion Initiatives

œ Compliance Promotion System

To promote compliance, we have appointed a Corporate Compliance Officer and set up a Corporate Committee. The Corporate Committee examines and deliberates on compliance-related issues, plans and promotes relevant training programs, and checks to what extent such compliant related matters are shared and understood within the company in cooperation with the internal auditing department. We have internal and external contacts (refer to the chart below) including a 24-hour external contact service named the ONO Hot Line, which was set up in 2015 for 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 Compliance Officer, and the Corporate Auditors. Under this system, compliance violations including harassment can be prevented, appropriate work environment can be ensured, and necessary measures can be taken to minimize any loss of credibility in the event of a compliance violation. We ensure that the matters including reporting personfs name, reported content, and his/her privacy are strictly kept confidential to other than those involved in the survey, and support anonymous reporting. In addition, we will never bring detriment to such a reporting person solely because of use of the system.
In particular, with regard to harassment, not only do we provide training courses for management staff, but we also include harassment and other issues in the sessions conducted by external lecturers, thereby enhancing awareness of compliance.
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. We also continue enhancing the system to make the contacts available in the entire group so that employees can report or consult without hesitation.

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.
In the past, inadequate safety monitoring performance for pharmaceuticals caused many chemical hazards. We periodically carry out education on chemical hazards for all employees so that we will not forget the patients' pain, the misery of chemical hazards, and the magnitude of corporate responsibility.

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

In order to conduct fair and transparent business activities, we repeatedly educate all employees every year so as to familiarize them with their duties to prevent fraud and corruption by providing e-learning opportunities and scheduling a special month-long period of intensive training during which we conduct training in each division.
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 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.

For the details of our system for preventing bribery and corruption, refer to the Ono Pharmaceutical Global Anti-Bribery and Corruption Policy (hereinafter the "Global Policy") below.

Ono Pharmaceutical Global Anti-Bribery and Corruption Policyi147KBj

No facilitation payment defined the Global Policy was exercised in FY 2017.

For more information, see the web pages below:

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


Responsible Promotion Activities

œBasic approach

We have formulated the Pharmaceutical Promotion Code in the ONO Codes of Practice (hereinafter referred to as the gCodeh) compliant with the JPMA Code of Practice as our action guidelines and are conducting responsible 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.

œEngagement in fair promotion activities

ONO PHARMACEUTICAL defines gpromotionh as gproviding and conveying pharmaceutical information to medical workers so as to disseminate the appropriate use of pharmaceuticals based on such information.h Employees involved promotions 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 specific provisions or descriptions in the Code. Also, we comply with the Code and adhere to the Promotion Code for Prescription Drugs defined by JPMA (Japan Pharmaceutical Manufacturers Association), 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.

œExamination system for promotional materials

The promotion of pharmaceuticals is required to provide accurate information in order to promote the appropriate use of and spread of pharmaceuticals. All materials used for such promotion are examined and approved by third parties after examination by the Compliance Promotion Department. The sales department is not supposed to be involved in this process at all.

œTraining to thoroughly inform fair promotion activities

We provide the following training courses for all employees involved in promotion 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.
As for 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 the Code. Also, in the Compliance Promotion Department and the Sales and Marketing Division, joint meetings at the section chief level are held in 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 attended by leaders from the Sales and Marketing Division, systems to improve familiarity with the aforementioned standards within the Division are developed.

œTraining for collecting safety information on pharmaceuticals

In MR activities, it is also important to collect safety information on the pharmaceuticals used and to provide useful information based on such collected information for the promotion of more appropriate use of pharmaceuticals. All employees involved in promotion activities participate in e-learning activities on the collection of information on side effects caused by our pharmaceuticals on the market every year and receive an educational booklet on matters such as the implementation of surveys on the pharmaceuticals manufactured and sold, so that they are aware of things to remember when collecting information.

Proper Procurement Activities

œ Basic policy for procurement activities

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) according to the three basic ideas, and its 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.

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.

œ Animal experiment outsourcing policy

When we outsource animal experiments, we ensure that the outsourcing contractor complies with the laws and standards of the relevant country concerning animal welfare. We also make every effort so that such an outsourcing contractor complies with our standards as much as possible. Please click here for our thoughts on ethical considerations in animal experiments.

œ Anti-bribery due diligence for third parties

Before appointing a third party such as a subcontractor or an agent, we perform due diligence using an Anti-bribery Check Sheet to see if there are any red flags. We have developed a process through which we submit the third partyfs replies to our detailed question sheet to the Corporate Compliance Officer to get his/her approval before appointing the third party in case we identify a red flag.