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It is incumbent upon pharmaceutical companies to consistently ensure high standards of ethics and transparency in their business activities, to establish relationships of trust with external stakeholders including medical, dental and pharmaceutical researchers and healthcare professionals, wholesalers, patient groups, etc., and to make efforts to ensure that optimal and ethical medical care is provided from the standpoint of patients.
In 2013, the Japan Pharmaceutical Manufacturers Association (JPMA) established the JPMA Code of Practice for all officers and employees of its member companies to follow in interacting with researchers, healthcare professionals, patient groups, etc., in line with the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice.
Nippon Kayaku established the Nippon Kayaku Code of Practice as a standard against which its officers and employees can determine whether their own acts are in keeping with the JPMA Code of Practice. By thus underscoring and firmly sharing our commitment to corporate ethics and compliance, which are the foundation of our business activities, we proceed with our business with a highly ethical mindset in adherence to the code.
The progress of medicine, pharmacy and medical engineering and enhancement of public health are built on our interactions with researchers and healthcare professionals and collaborations with patient groups and other bodies. We need to be accountable for such interactions and collaborations, ensuring that they are conducted ethically and in good faith. To this end, we annually disclose any funding we provide in relation to these acts on our website to ensure transparency of corporate activity information based on our own guidelines created in line with JPMA’s “Guidelines for Transparency of Relationship between Pharmaceutical Companies and Medical Institutions, etc.” and “Guidelines for Transparency of Relationship between Corporate Activities and Patient Organizations.”
Information materials play an extremely important role in providing pharmaceutical information to ensure the appropriate use of prescription drugs. Their contents must therefore be based on scientific evidence and created and used in an accurate, fair and objective manner. For this reason, Nippon Kayaku has set forth a Review Procedure in compliance with such laws and regulations as the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter, “Pharmaceuticals and Medical Devices Act”), Guidelines for Provision of Sales Information on Prescription Drugs, JPMA Code of Practice and Guideline for Preparation of Product Overview for Prescription Drug, and tasks the Review Committee, which is comprised of expert committee members including in-house medical doctors, with conducting appropriate reviews. In addition, our internal monitoring system keeps activities for the provision of sales information in check and provides instructions to make sure that they do not deviate from the Guidelines for Provision of Sales Information on Prescription Drugs.
To execute ongoing corporate activities with a highly ethical mindset, it is imperative that all our officers and employees become versed in the Nippon Kayaku Code of Practice. In support of JPMA’s initiative to promote understanding of its code, we set concrete goals to be pursued by each group and workplace with the aim of optimizing our corporate activities, and regularly implement education and training tailored for each business site.
Nippon Kayaku has in place Code & Compliance Committee, Pharmaceuticals Group (hereinafter, “the Committee”) as a body for promoting compliance within Pharmaceuticals Group, and for building an internal system to ensure our compliance with related laws including the Pharmaceuticals and Medical Devices Act and Antimonopoly Act, government guidelines including the Guidelines for Provision of Sales Information on Prescription Drugs and voluntary industry standards including the Fair Competition Code concerning Restriction on Premium Offers in Ethical Pharmaceutical Drugs Marketing Industry and JPMA Code of Practice.
While striving to promote compliance within the, the Committee, pursuant to the Nippon Kayaku Code of Practice, aims to establish and revise the internal operating rules and procedures required for ensuring that our officers and employees comply with related laws and voluntary standards in their interactions with stakeholders, and to make sure that the rules and procedures are widely embraced by all and embedded in the corporate culture.
In the event that a serious violation of any law related to pharmaceuticals, the Guidelines for Provision of Sales Information on Prescription Drugs or any important code occurs, the Committee responds to the incident and discusses and determines measures to prevent recurrence. Moreover, when a violation of any code including the Guidelines for Transparency or noncompliance is identified, the Committee holds a meeting to discuss and determine measures to prevent recurrence.
When providing pharmaceutical information to healthcare professionals overseas or inviting healthcare professionals in Japan to attend lectures and conferences held overseas, or when a subsidiary in an overseas country assigns its non-Japanese licensees or agents to engage in activities in the applicable country based on a licensing or agency agreement, all individuals involved are expected to respect the Nippon Kayaku Code of Practice, and comply with the relevant laws of the applicable country and its pharmaceutical industry association code if there is one, or the IFPMA Code of Practice if there is not.