Compliance, Risk Management

Compliance

Otsuka Pharmaceutical Framework for Compliance

The Otsuka Group formulated its Global Code of Business Ethics to reflect its corporate philosophy, “Otsuka-people creating new products for better health worldwide.” As the core company of the Otsuka Group, Otsuka Pharmaceutical is fully committed to upholding this Global Code, and pursues compliance through the Otsuka Pharmaceutical Compliance Program and various related policies. The company defines compliance as meeting worldwide societal demands for a high level of ethics and transparency and executing business practices based on its corporate philosophy. In addition, the company recognizes that compliance is vital in earning the trust of all of its stakeholders, including patients and general consumers.

Otsuka Pharmaceutical Compliance Goals

Otsuka Pharmaceutical ceaselessly pursues innovation. The company’s approach to compliance emphasizes employee self-regulation to ensure that each employee is able to bring his or her sense of ethics and creativity into full play in the workplace.

The company is developing business operations around the world and has already globalized many of its operations. Otsuka Pharmaceutical is currently focused on compliance that incorporates a global perspective to fully accommodate its operations.

Spirit of Otsuka Pharmaceutical Compliance Program

The Basic Principles of the Otsuka Pharmaceutical Compliance Program stipulate the following:

(1)
In order to realize our corporate philosophy of “Otsuka-people creating new products for better health worldwide,” we expect that our corporate business activities will be conducted with a high sense of morality, in compliance not only with the law, but also with bioethics standards.
(2)
Starting with Japan, we wish to be a sound company and sound businesspeople that will be accepted in every country and community throughout the world. In order to achieve this, we shall comply with the laws and regulations of each country, and the rules of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) while also acting in accordance with the social customs applicable in each community.
(3)
We shall strive to fulfill our corporate social responsibility (CSR), including when we outsource research, development, manufacturing, or sales to Otsuka Group companies or to third parties, through the manufacture and sale of our pharmaceuticals and food products and our support for the arts and culture.

In addition, we have outlined a compliance program with 28 stipulations on matters ranging from environmental conservation initiatives and prohibition of unfair trade practices, to protection of personal information, clinical trials, and provision of medical information.

Education and Training on Compliance

Otsuka Pharmaceutical conducts annual compliance training for executives and employees in leadership positions. Training sessions for general employees are set up by division, with employees attending lectures at least once a year. Combined, these add up to about 50 training sessions provided by the company each year. The company not only has in place codes of conduct and compliance programs, but also provides the education and training that employees need to conscientiously maintain compliance and consistently improve compliance processes at the company.

Risk Management

Otsuka Pharmaceutical has identified fundamental items related to risk management and developed risk management procedures to prevent and/or minimize loss. The company has also formed a risk management committee with the authority to make decisions on risk management matters.

Otsuka Pharmaceutical’s risk management system addresses natural disasters, accidents, incidents, outbreaks of disease, and IT-related trouble. In addition, the company is focused on developing risk management systems to minimize the effect of negative events arising from business management or operations that could result in the loss of or damage to the company’s intellectual property rights, failure to fulfill environmental responsibilities, compliance issues, or loss of financial assets, as well as company or group physical and economic assets or credit.

Ensuring Business Continuity in Times of Emergency

Otsuka Pharmaceutical has a business continuity plan (BCP) to minimize damage to business assets, to ensure the continuity of its core businesses, and to facilitate the quick restoration of business in times of natural disaster, terrorism, accidents, outbreaks of disease, and IT-related trouble. In August 2012, Otsuka Pharmaceutical became the first Japanese pharmaceutical company to acquire third party certification in the ISO 22301 international standard for business continuity management (BCM) systems, for the manufacturing and stable supply of products for medical-related businesses. In 2013, the company expanded the scope of its program to acquire ISO 22301 certification to the manufacturing and stable supply of beverages and food products. Acquisition of ISO 22301 certification is a mark that an organization effectively institutes and manages business continuity through PDCA management that includes education, training and internal audits related to action plans for ensuring the continuity and/or restoration of business even during times of natural disaster, epidemics, and other emergencies.

BCMS Certification

Scope of ISO 22301 Certification Registration
Manufacturing and stable supply of pharmaceuticals, beverages and food products

Certified Sites (as of April 30, 2014)
Otsuka Pharmaceutical Co., Ltd.: Tokyo Headquarters, Tokushima Headquarters, Osaka Headquarters, Tokushima Factory, Second Tokushima Factory, Tokushima Itano Factory, Tokushima Wajiki Factory, Takasaki Factory, Fukuroi Factory, Saga Factory

Otsuka Pharmaceutical will continue to improve its business continuity capabilities, working to educate employees and conducting drills and exercises for diverse risks. These efforts will enhance the company’s business continuity management and anticipation of risks, and further raise employee awareness.