compliance

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Outline

JCR Pharmaceuticals Co., Ltd. has established the standard for JCR compliance behavior based on the spirit of the company’s ethical code of practice. The standard contains behavioral guidelines that shall be looked up by all officers and employees sharing the values JCR deems important, so that they could ensure that individual behavior conforms to generally accepted mores.For the execution of business activities, this standard must be fully understood and observed and efforts made for its concrete implementation.

1.Basic Compliance

JCR is a life-related company that deals in various products serving for human health. Therefore, our corporate activities are executed with not only strict compliance with laws and regulations but also a high sense of probity so as to obtain the trust of all our customers.

2.Business Activities

(1)Research

In order to contribute to human health, improvement of the quality of life, and innovative medical treatment, we will tackle our research activities in accordance with the following plolicies:

  • We will keep in strict compliance with the laws and rules including Pharmaceutical Affairs Law and Good Laboratory Practice (GLP), and various guidelines including ICH for preclinical studies, as well as the criteria and applicable guidelines including Manufacturing Control and Quality Control Standards for Investigational Products, and Standards for Buildings and Facilities of Manufacturing Plants for Investigational Products (Investigational product GMP) in manufacturing investigational products.
  • We will treat lives and bodies of animals in a ethically allowable manner based on the spirit of animal welfare in conducting experiments using them.
  • We will keep in strict compliance with all applicable laws, regulations, guidelines, and rules in conducting researches using human-derived tissues/materials and human genes as well as respecting the dignity of life and human rights by due process of informed consent and protection of personal information.

(2)Development

  • We will carry out our clinical studies with strict adherence to scientific and ethical codes, not to mention the laws, regulations, and rules including Pharmaceutical Affairs Law and Good Clinical Practice (GCP), while also paying close attention to the notifications and guidelines from the regulatory authorities.
  • We will perform our clinical studies with strict adherence to all related laws, regulations, guidelines, and rules, and through the stringent process for acquiring informed consent and protection of personal information, accord respect to the dignity of life and human rights.
  • We will accurately record and preserve all necessary data with scientific objectivity, and prepare documents enabling objective and scientific assessment of efficacy and safety derived from the respective data in regard to the results of the clinical studies.

(3)Manufacturing

  • We will keep in strict compliance with the laws including Pharmaceutical Affairs Law and Good Manufacturing Practice (GMP) as well as the company’s criteria in the manufacture of its products, while ensuring appropriate quality control throughout all our manufacturing processes. Should any question be raised as to the quality of a product, we will take prompt measures including, where appropriate, recall of the product, as our first priority is on human health. We, furthermore, make our utmost efforts to investigate the cause and prevent its recurrence.
  • We will make a concerted effort to providing safe work environments that are accident and disaster-free as well as strengthen our production line in order to secure a stable supply of highly reliable products.

(4)Marketing

  • We will adopt fair business practices in sales and marketing in compliance with all applicable laws, regulations and ethical standards generally accepted in pharmaceutical industry.
  • We will take appropriate and faithful steps in responding to information required by customers and/or complaints of whatever nature.
  • In our advertisement and promotional activities, we will keep in strict compliance with applicable laws, regulations, and ethical standards generally accepted in pharmaceutical industry , and will always use fair and appropriate content and expressions which cannot be construed as fraudulent, exaggerated, discriminative, defamatory or otherwise abusive against human rights.

(5)Assurance of Reliability

  • We will control and supervise the quality, efficacy, and safety of our products pursuant to the Pharmaceutical Affairs Law to ensure proper use of these products.
  • We will actively collect, appropriately assess and promptly communicate information on our products to ensure their quality assurance.
  • We will immediately report any cases of suspected or actual adverse event or non-conformance information to the regulatory in accordance with applicable laws, notifications, and JCR’s internal rules, and will make every effort to pursue, investigate, and elucidate the cause.

(6)Business Administration

  • We will evaluate our employee performance in a fair and equitable manner and motivate each worker based on the predefined personnel management system.
  • We will keep our activities accountable pursuant to the Taxation Law, Commercial Law, and Securities and Exchange Act, and prepare accounting books and financial reports that correctly reflect our transactions.
  • We will control any invention conceived or developed by any employee in the course of his or her work and the patent right obtained thereon to be an important intellectual property vested to JCR in accordance with Regulations for Inventions by Employees.
  • We will not only comply with the regulations for a safe work environment and employees’ health, but also ensure the safety and health of all employees in the workplace by providing a good work environment, and vitalization of the workplace.

3.Individual Behavior

(1)Relationship with Customers
We will endeavor to understand how JCR is perceived by people and work to further contribute to human health. In addition, we will disclose appropriate and unbiased information at all times to maintain a dependable relationship with customers.
(2)Prohibition of Unfair Trade Practices
We will take fair business practices with medical institutions, distributors, and suppliers in compliance with applicable laws such as the Antimonopoly Law. We, among others, will never engage in inappropriate activities to induce others to deal with JCR such as the giving or promise of unlawful gifts, invitations to dinners and entertainments, or kickbacks to our customers.
(3)Prohibition of Insider Trading
We will not disclose important information yet to be published concerning our company or that of our customers which have been obtained in the course of our business activities in contravention of our Insider Trading Regulations, nor will purchase or sell stocks until such important information has been officially announced to the public.
(4)Protection of Information
We will strictly control and protect personal information collected for our business affairs in accordance with Personal Information Protection Regulations. We will also control and possess confidential documents and contracts and other legal instruments according to item in accordance with our related regulations.
(5)Prohibition of Sexual Harassment
We will never engage in sexual harassment in accordance with Sexual Harassment Prevention Regulations.

4.Transparency Guideline

JCR Pharmaceuticals “Transparency Guideline for the Relationships between Business Activities and Medical Institutions"

JCR Pharmaceuticals Co., Ltd. (hereinafter "the Company") has a corporate philosophy of "Contributing towards people’s healthcare through pharmaceuticals products". In addition to this corporate philosophy, the Company being a member of an industry related to people’s health where high ethical standards are demanded, we are committed to improving the transparency of relationships with medical institutions, etc., essential for research on medicine and pharmaceutical science, its practical applications, and the promotion of the proper use of pharmaceuticals, and gaining further higher trust from the society. We agree with the purpose of "Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" issued by the Japan Pharmaceutical Manufacturers Association and we have established our "Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" and publish information on monetary payments to medical professionals etc. on our website.

Information on monetary payments to medical institutions

(1)Publication means:
The monetary payments in the previous fiscal year are to be disclosed on our website, etc. after the settlement of accounts.
(2)Publication period:
From the fiscal year 2015, the information of the previous year will be disclosed. (Since the fiscal year 2015, we have been disclosing only the yearly number of items and the total amount of payment as fees for manuscript writing, etc. However, from the fiscal year 2018, we will disclose the information of the previous year according to the following guidelines.)
(3)Subjects and contents of publication:
A. Research and Development expenses etc.
We will disclose the total yearly amount of expenses for R&D purpose and costs of testing and investigation based on the ministerial ordinance by item as follows:
(1)Collaborative research expenses - Total yearly amount
(2)Outsourced research expenses - Total yearly amount
(3)Clinical trials expenses - Total yearly amount
(4)Post-marketing clinical trial expenses - Total yearly amount
(5)Expenses of case reporting on side effects and infections - Total yearly amount
(6)Post-marketing surveillance expenses - Total yearly amount
B. Academic research grants
As for donations, co-sponsorship expenses, etc. for promotion and fostering of academic research, we will disclose the recipients, the number of contributions a year, and amounts by item as follows:
(1)Scholarship donation - Number of cases and total amount a year
(2)General donations - Number of cases and total amount a year
(3)Academic conference donation - Amount paid for each conference
(4)Academic conference co-sponsorship expenses - Amount paid for each conference
C. Fees for manuscript writing, etc.
As for fees for lectures and manuscript writings to provide scientific information on diseases, medicine and pharmaceutical science, etc., we will disclose the name of organization, individual name, the number of cases a year, and total payment amounts by item as follows:
(1)Instructor's rewards - Number of cases and total amount paid a year for each recipient
(2)Fees for manuscript writing and review - Number of cases and total amount paid a year for each recipient
(3)Outsourcing expenses including consultation fee, etc. - Number of cases and total amount paid a year for each recipient
D. Information provision related expenses
As for expenses for the provision of information and materials on medicine and pharmaceutical science etc. intended for medical professionals, we will disclose the number of cases and total payment amounts a year for fees and expenses for lectures and explanatory meetings, and yearly payment amounts for fees for the provision of academic papers on medicine and pharmaceutical science, etc. (not including meetings for R&D purpose.)
(1)Lecture fees - Number of cases and total amount a year
(2)Explanatory meeting expenses - Number of cases and total amount a year
(3)Fees for the provision of academic papers on medicine and pharmaceutical science, etc. - Total yearly amount
E. Other costs
We will disclose the total yearly amount of expenses for hospitality to medical professionals as social courtesy.
Hospitality expenses, etc. - Total yearly amount
(4)Information on monetary payments to medical institutions

JCR Pharmaceuticals "Transparency Guideline for the Relation between Business Activities and Patient Organizations"

JCR Pharmaceuticals Co., Ltd. (hereinafter "the Company") has a corporate philosophy of "Contributing towards people’s healthcare through pharmaceuticals products". In order to contribute to people’s health, we are collaborate and cooperate with patient organizations representing the voice of patients and their families. As a member of an industry related to people’s health where high ethical standards are demanded and to gain understanding about our contribution to the activities of patient organizations, to increase the transparency of relationships with patient groups, we are committed to improving the transparency of relationships with patient organizations and gaining further higher trust from the society. We agree with the purpose of "Transparency Guideline for the Relation between Corporate Activities and Patient Organizations" issued by the Japan Pharmaceutical Manufacturers Association and we have established our "Transparency Guideline for the Relation between Corporate Activities and Patient Organizations" and publish information on monetary supports to patient organizations, etc. on our website.

Information on monetary payments to patient organizations

(1)Definition of patient organization(s)
In this guideline, the patient organization means a body (patient group, patient support organization, etc.) having a role and purpose principally defined in a constitution and constitutional rule, consisting mainly of patients, their families and their supporters, representing the patient's voice, supporting patients and their families, and aiming for the improvement of a care environment.
(2)Publication means:
The monetary payments in the previous fiscal year are to be disclosed on our website, etc. after the settlement of accounts.
(3)Publication period:
From the fiscal year 2015, the information of the previous year will be disclosed.
(4)Subjects and contents of publication:
A. Direct monetary payment
We will disclose direct payments to patient organizations for the purpose of supporting their activities.
(1)Donation and co-sponsorship expenses - Total yearly amount for each recipient
(2)Membership and supporting member expenses - Total yearly amount for each recipient
(3)Advertisement expenses - Total yearly amount for each recipient
B. Indirect monetary payment
We will disclose expenses paid to business entities for indirectly support to patient organizations.
(1)Expenses of lectures, explanatory meetings, workshops, etc. sponsored or co-sponsored by the Company - Total yearly amount and the name of indirectly involved patient organizations
(2)Outsourcing expenses paid to third parties - Total yearly amount and the name of indirectly involved patient organizations
C. Rewards to requests, etc.
We will disclose expenses paid as a consideration for manuscript writing and review, survey, and advice requested to patient organizations.
(1)Lecture fees - The name of the recipients and total payment amounts
(2)Fees for manuscript writing and review - Names of recipients and total payment amounts
(3)Survey expenses - Names of recipients and total payment amounts
(4)Outsourcing expenses including advisories - Names of recipients and total payment amounts
D. Voluntary service
We disclose information about assistance for lectures sponsored by patient organizations, etc., outsourcing of work related to the administration and management of patient organizations, and the temporary transfer or dispatch of our employees to patient organizations.
(1)Whether voluntary service was provided and names of patient organizations
(5)Information on monetary payments to patient organizations