Basic Ideas on Ethical Marketing Practices
In addition to establishing our code in the Company and Japan Daiichi Sankyo and overseas Group companies in accordance with the industry code of each country and territory in which we operate based on the International Federation of Pharmaceutical Manufacturers & Associations Code of Practice (“IFPMA Code”), we established the “Daiichi Sankyo Group Global Marketing Code of Conduct” on October 1, 2016, as the Group’s common global policy with the aim of maintaining a high level of standard when interacting with healthcare professionals, medical institutions, and patient organizations as well as promoting pharmaceutical products.
In this policy, we clearly state that relationships between each Group company and healthcare professionals must be maintained for the purpose of improving the quality of healthcare, with a focus on providing information on pharmaceutical products to healthcare professionals, providing scientific and educational information, and supporting medical research and education.
In line with the revision of the IFPMA Code in January 2019, we revised the policy, prohibiting the provision of gifts and promotional aids to healthcare professionals, etc. We also prohibit the provision of entertainment, cash, and other personal gifts and stipulates stricter terms and conditions of contract in cases where we pay remuneration to healthcare professionals as well as the appropriateness of the remuneration. In this way, we promote appropriate marketing practices in accordance with the IFPMA Code.
Strengthening of the Review System for Sales Promotion Materials
We conduct strict reviews of sales promotion materials for our pharmaceutical products in accordance with laws, regulations, and industry codes of the countries in which we operate.
In Japan, the Medical Drug Information Review Meeting, which includes third-party external committee members who became independent from the Company’s Sales & Marketing Division and Medical Affairs Division, reviews all materials for provision of sales information and such for domestic products within Japan, while the Direct To Consumer (“DTC”) Advertisement Review Meeting reviews all DTC materials (Review Meeting Secretariat: Code Compliance Group of the Japan Legal Affairs Department). Materials that have been reviewed expire in two years, and to extend the period, they need to be reviewed again. The Review Meeting Secretariat also checks the content of in-house trainings provided to sales representatives, etc.
At the Review Meeting Secretariat, in addition to reviewing sales promotion materials, we also provide training to those who are responsible for creating such materials, those who are responsible for the products, those who are responsible for training materials, etc., on the material creation procedure several times each year (or as required) to further increase their awareness and improve their expertise.
In the United States, we have developed various company policies and procedures to ensure that product advertisements for Daiichi Sankyo, Inc. (“DSI”) are in compliance with applicable codes of conduct, and other applicable laws and regulations, including those of the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and the Food and Drug Administration (“FDA”). Pharmaceutical advertising is intended to facilitate informed communication between patients and healthcare professionals regarding treatment options. Pharmaceutical advertising materials must be supported by actual evidence and consistent with labeling approved by the FDA, and the content must be accurate and must not mislead users. DSI has established a process to ensure that these requirements are met. Specifically, committees within DSI review and approve such materials in accordance with our review process, which includes medical and legal reviews. After approval, the materials are permitted to be used only up to one year or as otherwise established/extended by policy and procedure. At DSI, appropriate training is provided to all colleagues involved in the creation and use of such promotional materials.
Compliance with the Guidelines about Sales Dissemination of Information Campaign
In compliance with the “Guidelines for Provision of Sales Information on Prescription Drugs” that came into effect on April 1, 2019 in Japan (issued by the Ministry of Health, Labour and Welfare), the Company has appointed the Legal Affairs Department in Japan as the department responsible for supervising the activities to provide sales information and established the Supervisory Committee on provision of sales information on prescription drugs. This Supervisory Committee supervises and provides guidance on the statuses of reviewing materials, preparing and storing operational records, implementing monitoring, addressing inappropriate sales dissemination of information campaign, etc., at the Company. We periodically provide training to the Company’s employees so that they are fully aware of the precautions when providing information on investigational and off-label products and they may carry out provision of sales information on prescription drugs properly. We also provide a page on our corporate website for feedback on provision of sales information on prescription drugs.