Fair Operating Practices

Being aware of responsibilities as a pharmaceutical company dealing in pharmaceuticals upon which human lives depend, ONO PHARMACEUTICAL has its own codes of conduct to ensure that it acts in compliance with laws and regulations and that it meets high ethical standards. Recognizing that actions based not only on laws but also on social practices and norms underlie corporate ethics, ONO has been committed to instilling in its employees the importance of compliance with laws and internal and external rules. We thoroughly train all employees to ensure compliance and promote proper procurement activities in cooperation with suppliers.

ONO’s Ethical System

Our ethical system consists of the ONO PHARMACEUTICAL Codes of Conduct, which serve as basic guidance for our corporate activities; the Compliance Program, which provides standards of conduct for those activities; and the Codes of Practice, which are based on industry standards for promotional 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 we act in consideration of social situations at home and abroad. Being keenly aware of corporate ethics as a pharmaceutical company, we will continue to strengthen our level of compliance in line with our ethical system.


Compliance Promotion Initiatives

● Compliance Promotion System

To promote compliance, we have appointed a Corporate Ethics Officer and set up a Corporate Ethics Committee under the officer to examine and deliberate on compliance-related issues and to plan and promote relevant training programs.
We have internal and external contacts (refer to the chart below) 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 Ethics Officer, and the Corporate Auditors. Under this system, compliance violations can be prevented and necessary measures can be taken to minimize any loss of credibility in the event of a compliance violation.

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. A 24-hour ONO Hot Line was set up in February 2015 to enable group-wide employees to report or consult without hesitation.


● Compliance Education System

We provide the following training courses for employees to enhance their awareness of compliance:

  • (1) Every year we schedule a three-month period of training during which all employees are required to attend lectures given by the leaders of respective departments. At the same time, we provide training courses using an e-learning system to improve employees’ familiarity with and understanding of compliance in general. (Training on information security is provided separately.)
  • (2) We periodically provide training for relevant departments on the internal standards established based on laws and industry agreements. For example, in the Sales and Marketing Division, compliance promotion staff members visit each sales branch twice a year to provide MRs with compliance training on internal standards, particularly the Pharmaceutical Promotion Code in the ONO Codes of Practice.
  • (3) During job-level-specific training programs, sessions on harassment and other issues are held by external lecturers in order to educate employees during their career and enhance awareness of compliance.

● Ethical Considerations in Animal Experiments

ONO gives consideration to the ethical treatment of laboratory animals and human-derived biological specimens.

Considerations to ensure human rights during research


Ethical considerations in animal experiments


● Activities in the Development Phase

Ethical Considerations in Clinical Tests to Ensure Human Rights

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’ 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 Japan’s Pharmaceutical Affairs Act and other related legislation, as well as the ICH-GCP* based on the spirit of the Declaration of Helsinki.

*: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH)

● Fair and Transparent Business Activities

We conduct fair and transparent business activities.
We aim to contribute to healthcare all around the world and people’s 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).

● Efforts to Prevent Bribery and Other Fraud and Corruption

Compliance with laws related to bribery and other fraud and corruption is attracting increasing attention on a global scale in line with the establishment in various countries of relevant laws such as the Unfair Competition Prevention Act in Japan, the Foreign Corrupt Practices Act (FCPA) in the US, and the Bribery Act in the UK. In this context, ONO provides training programs to make employees fully aware of their duties to ensure transparency in transactions and prevent fraud and corruption, with a system based on a compliance program in its Codes of Conduct. We also organize training on FCPA, the Bribery Act, and other foreign anticorruption laws for relevant departments to repeatedly familiarize employees with the laws and ensure that they always act in consideration of the social situation in Japan and overseas.
As for publicly funded research, we formulated internal standard operating procedures in line with Japanese government guidelines for the appropriate use and management of such funds. In March 2016, we revised these procedures and upgraded them into two documents: the Action Guidelines for Publicly Funded Research and the Regulations on Publicly Funded Research. These took effect in April and are being applied for even more stringent use and management of public research funds.

⇒ System for the appropriate use and management of public research funds

CSR Procurement

We have established a basic policy-the Basic Ideas on Purchase Transactions-for procurement activities in terms of fairness, sound economic sense, and environmental protection. Our procurement personnel are required to act in accordance with the Purchase Transaction Rules based on the Basic Ideas on Purchase Transactions in order to perform fair and transparent procurement activities. 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.

● 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.