Healthcare Compliance based on the Chugai Code of Practice

In addition to compliance with laws and regulations when promoting healthcare compliance, Chugai strives to make proper and reasonable judgments, and take actions based on socially accepted norms and values demanded of pharmaceutical companies. Specifically, we established the “Chugai Code of Practice” to promote corporate activities based on high ethical standards, including promotional activities, for interaction between all of our officers and employees with researchers, healthcare professionals and patient groups.

Establishment of the “Chugai Code of Practice”

In 1988, the World Health Organization (WHO) established the “WHO Ethical criteria for medicinal drug promotion” for the purpose of supporting and encouraging the improvement of healthcare through the rational use of medicinal drugs.

Further, in 2012, the International Federation of Pharmaceutical Manufacturers’ Associations (IFPMA) announced its “IFPMA Code of Practice,” covering not only marketing activities, but also interactions with healthcare professionals, medical institutions and patient groups, as well as the promotion of pharmaceuticals. The “IFPMA Code of Practice” states in its Foreword, “There is no doubt that this industry brings great value to society in helping to improve global health, but we are deeply conscious we can never rest on our laurels. All who work in it, over two million employees, are properly held to higher standards than most because the very nature of our business requires us to win and retain patient trust. Trust is the lifeblood of our industry. It goes without saying that key ethical and safety values must be embedded within this highly regulated industry.”

In 2013, the Japan Pharmaceutical Manufacturers Association drew up the “JPMA Code of Practice” regarding interactions between all of the officers and employees of member companies with researchers, healthcare professionals and patient groups, grounded in the spirit of the “IFPMA Code of Practice.”

Chugai has established a basic policy on promotion activities for pharmaceuticals and interactions with medical institutions, healthcare professionals, and patient groups. It has also established a “Code of Practice,” a global policy that aims to constantly ensure high ethical standards and transparency in corporate activities, to be accountable, and to live up to the trust placed in us by society.

In Japan, we are a proactive participant in the Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry, the entity which issues the pharmaceutical industry’s voluntary guidelines, and in the Code Compliance Committee of the Japan Pharmaceutical Manufacturers Association. We have also established our own “Chugai Code of Practice” and promote ethical corporate behavior not only in our promotional activities but also in the interactions between all of our officers and employees with researchers, healthcare professionals and patient groups.

In addition, we have participated in numerous industry organizations, including the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), The Federation of Pharmaceutical Manufacturers’ Associations of JAPAN, The Japan Pharmaceutical Manufacturers Association, the Pharmaceutical Manufacturers’ Association of Tokyo, The European Federation of Pharmaceutical Industries and Associations (EFPIA) Japan, The Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry, Risk/Benefit Assessment of Drugs-Analysis & Response Council, and the Japan Pharmaceutical Information Center (JAPIC). We support the relevant codes and guidance stipulated by each organization.

Configuration and Management Organization of the “Chugai Code of Practice”

Under the responsibility of the Compliance Committee, Chugai manage and operate the “Chugai Code of Practice.” The “Chugai Code of Practice” clearly sets out the requirements for healthcare compliance such as objectives, definition of promotion, responsibilities of top management, basics of interactions, interactions with healthcare professionals, prohibition of providing information before approval and recommending off-label uses, outsourcing, provision of goods and money, study and research activities, dissemination of information, collaboration with patient organizations, relationships with ethical drug wholesalers, internal procedures and education, handling of cases of non-compliance with this code, and activities outside of Japan.

Initiatives related to Healthcare Compliance

Information Provision Activities for Pharmaceutical Products

In our activities to provide information on pharmaceuticals, we provide accurate and appropriate information essential to the selection and use of pharmaceuticals so that healthcare consumers and healthcare professionals can select and use pharmaceuticals. Misleading labeling and advertising of pharmaceuticals are regulated by Pharmaceutical and Medical Device Act and other applicable laws and regulations, the “Guidelines for Provision of Sales Information on Prescription Drugs” from the Ministry of Health, Labour and Welfare (MHLW), as well as applicable laws and regulations and pharmaceutical manufacturers’ associations codes of practice in each country. The information that we provide conforms to these regulations.

It is necessary for the proper use of pharmaceuticals and improvement of treatment techniques to properly work for collaboration with healthcare professionals and medical institutions. We will work to increase the transparency of our involvement in the collaborative activities, and properly disclose related payments for the purpose of increased social recognition and trust.

Continuing Education and Training for Employees

Continuing education and training is vital in the promotion of corporate activities that maintain high ethical standards. We provide education and training on the “Chugai Code of Practice” in addition to each country’s applicable laws and regulations and pharmaceutical manufacturers’ associations codes of practice every year, not only for the sales department, but also for officers and employees (including employees belonging to affiliated companies in Japan).

Compliance Risk Assessment

We examine healthcare compliance-related risk issues annually and draw up preventative measures against the occurrence of incidents, focusing on departments that interact with researchers, medical professionals, and patient groups. The following themes set out in the “Chugai Code of Practice” are to be examined as risk issues: Interactions with healthcare professionals, pre-approval information provision, prohibition of recommendation of off-label use, outsourcing, provision of goods and money, testing and research activities, information dissemination activities, collaboration with patient groups, and relationships with prescription drug wholesalers. The organizations responsible for healthcare compliance and risk work together in order to effectively follow-up on healthcare compliance promotion activities in each department.

Initiatives Related to the Creation and Provision of Materials with Pharmaceutical Information

The process of creating and providing materials with pharmaceutical information in the Chugai group is conducted in a proper and appropriate manner based on laws and regulations and industry standards for the purpose of ensuring the quality of information relating to pharmaceutical products.

The three themes described below are raised as basic policies.

  1. We shall design an organizational structure and guidelines/procedures for planning, creating, assessing, and providing materials with pharmaceutical information.
  2. We shall provide training to all employees handling pharmaceutical information to thoroughly disseminate the standards for creation, assessment, and approval of pharmaceutical information.
  3. We shall comply with applicable laws and industry standards when creating materials with pharmaceutical information, shall perform assessments, to be carried out by an organization independent from the planning and creation department, and shall provide pharmaceutical information in accordance with the promotion code and/or the code of practice applicable in respective countries.

Monitoring Compliance Status by Internal Audits

The compliance promotion system of the Chugai group is based on the concept of 3 Lines of Defense. The first line refers to each department or unit, as well as each organization in Japanese and overseas subsidiaries. We implement compliance initiatives autonomously while recognizing the compliance risks related to each respective operation. The second line refers to the Risk & Compliance Department and the Quality and Regulatory Compliance Unit, which support compliance risk management of the first line and take on the function of monitoring. At overseas subsidiaries, the Risk Compliance Officer takes on the function of the second line. The third line refers to the Audit Department, which assumes an auditing role from an independent standpoint to determine whether the first and second lines are properly fulfilling their respective roles and responsibilities.

Investigation and Corrective Actions in Response to Healthcare Compliance Violations

Based on the “Guidelines for Provision of Sales Information on Prescription Drugs” issued by the Ministry of Health, Labour and Welfare, Chugai has established “Guidelines for Provision of Sales Information on Prescription Drugs in Chugai.” If violations or deviations or spontaneous reports from the “Guidelines for Provision of Sales Information on Prescription Drugs in Chugai” are confirmed, we will respond in accordance with the “Standard operating procedure for complaints and recurrence prevention” and perform appropriate sales information provision activities. In addition, deviation cases related to the “JPMA Code of Practice” or “Fair Competition Code concerning Restriction on Premium Offers in Ethical Pharmaceutical Drugs Marketing Industry” shall be dealt with in the same manner based on the “Chugai Code of Practice.”

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