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The demands placed on pharmaceutical companies include guaranteeing constantly high ethical standards and transparency in the conduct of business; building two-way relationships of trust with external stakeholders such as researchers and medical professionals in the fields of medicine, dentistry and pharmacology, wholesalers and vendors, and patient groups; and working towards delivering optimal medical care through taking decisions ethically and from the standpoint of the patient.
2013 saw the Japan Pharmaceutical Manufacturers Association (hereafter: JPMA) fix its own Code of Practice in line with the aims of the IFPMA Code of Practice, covering all interactions held by member company executives and employees with researchers, medical professionals and patient groups.
As a standard against which to judge whether our own actions comply with the aims of this JPMA Code, we have fixed our Nippon Kayaku Code of Practice. We will duly respect this Code from a high ethical standpoint while promoting our corporate activities, ensuring greater transparency on the dissemination of compliance information and the corporate ethics which form the backbone of our business activities.
We voluntarily observe the Regulations for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, antitrust laws and related legislation, Presentation Activity Guidelines on Marketing Information for Prescription Drugs, the JPMA Code of Practice, and the Fair Competition Code for the Manufacture and Sale of Prescription Drugs. We have also fixed our Nippon Kayaku Pharmaceuticals Group Promotion Code for Prescription Drugs to ensure we present, gather and convey medical information via appropriate processes and in an accurate and prompt manner, and also promote the appropriate use of pharmaceutical drugs.
Nippon Kayaku’s Promotion Code has been drawn up as a set of internal company regulations which derive from the JPMA Code of Practice (in turn based on the IFPMA Code of Practice) and the Fair Marketing Activity Guidelines fixed to aid compliance with related laws and regulations.
We have also set up a Medical Information Supervision Department which has gained independence from both our Marketing & Sales and Medical Affairs divisions. This particular department is tasked with integrating all the ethical standards and information presentation guidelines pertinent to the medical work conducted across the entire company and group companies. It also conducts audit coaching, monitoring, and education and training activities related to the presentation of marketing information, so as to enable smoother management and administration overall.
In charge of training | Targeted at | Frequency | Covering |
---|---|---|---|
Medical Information Supervision Department | Pharmaceuticals Marketing Division | 12 times a year | Nippon Kayaku Code of Compliance; Marketing Information Presentation Activity Guidelines; Fair Competition Code |
Medical Information Supervision Department | Pharmaceuticals Marketing Division | Once a year | Types of internal company regulations (Self-checks and voluntary inspections) |
Medical Information Supervision Department | Pharmaceuticals Group | Once a year | Nippon Kayaku Code of Compliance |
Furthermore, our Marketing & Sales and Medical Affairs divisions and Medical Information Supervision Department are all audited annually by our Audit & Supervisory Board. The latter has been placed under the direct charge of the President, and, in line with internal auditing regulations, accepts no orders or directions from the various bodies it is tasked with auditing. It is therefore free to focus on scrutinizing and evaluating its subjects from the perspectives of legality and rationality, and uses the results to advise and make suggestions on information presentation, relevant improvements and increased rationality.
Progress in the fields of medicine, pharmaceutics and medical technology, and improvements in public health, are built upon our interactions with researchers and medical professionals, and our collaborations with bodies such as patient groups. That being the case, we must fulfil our duty of accountability when it comes to showing that these interactions and collaborations are indeed ethical and sincere. To that end have we fixed our Transparency Guidelines for Corporate Activities and Relations with Medical Institutions, as well as our Transparency Guidelines for Corporate Activities and Relations with Patient Groups. These serve as our own internal guidelines, based on which we upload annual information on corporate activity transparency to our company website.
As information materials are an extremely important method of conveying information on the appropriate use of prescription drugs, we must ensure their contents are scientifically-grounded and produced accurately, impartially and objectively. To achieve that end has Nippon Kayaku fixed its material examination procedures based on the Regulations for the Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (hereafter: laws on pharmaceuticals and medical devices etc.); the Presentation Activity Guidelines on Marketing Information for Prescription Drugs; the JPMA Code of Practice; and the Key Points on the Production of Outline Information on Prescription Drug Products. These are used by our screening committee comprised of various academics, including our internal medical doctors, to appropriately judge our materials. So that our presentations of marketing information do not deviate from the above-mentioned Presentation Activity Guidelines, we have set up an internal monitoring system to audit and offer appropriate guidance.
An understanding of the Nippon Kayaku Code of Practice is necessary for us to continue our corporate activities from a high ethical standpoint. We therefore support activities aimed at promoting understanding of the JPMA Code, establishing specific items of focus pertaining to the corporate activities of each division and workplace targeted for optimization, and periodically offering workplace-based education and training to all executives and staff.
Our Medical Division’s Code Compliance Committee (hereafter: this committee) has been set up to devise ways of promoting Medical Division compliance, and to establish Nippon Kayaku’s internal systems for observing the industry’s voluntary standards as laid down in: the laws on pharmaceuticals and medical devices; antitrust laws and related regulations; guidelines such as those pertaining to Presentation Activities on Marketing Information for Prescription Drugs; the Fair Competition Code for the Manufacture and Sale of Prescription Drugs; and the JPMA Code of Practice.
In order to promote Medical Division compliance does this committee aim to use the Nippon Kayaku Code of Practice to fix, revise, disseminate and instill knowledge of the necessary internal operating regulations and manuals pertaining to observation of related laws, regulations and voluntary standards during interactions with stakeholders.
In cases where serious code violations occur in matters related to medical laws and regulations, or presentation activities for prescription drug marketing information, this committee will respond to the circumstances, then explore and decide upon recurrence prevention measures. This committee will also fulfil the above functions in cases where a violation of either transparency guidelines or compliance guidelines is confirmed.
In instances where we present information to healthcare professionals overseas, invite Japan-based healthcare professionals to a lecture or conference overseas, or have an overseas subsidiary operating in a given country via a licensing or agency agreement, we continue to respect the Nippon Kayaku Code of Conduct and, in addition to local laws and regulations, observe any code that country’s pharmaceutical federation may have. In cases where no such code exists, we revert to following the IFPMA Code of Practice.
Nippon Kayaku’s medical business is aiming to “develop excellent pharmaceuticals and medical devices that provide new diagnostic and treatment opportunities, and stable supply of Biosimilars and generic drugs, contributing to people’s health.” Our quest to widen access to pharmaceutical drugs involves the following initiatives: