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

As a life-related company that deals in various products for human health, we conduct our corporate activities sincerely, not only with strict compliance with laws and regulations but also a highly ethical perspective so as to obtain the trust of all our stakeholders.

(1)Responsibility to Society and Stakeholders
We will constantly consider society’s and stakeholders’ expectations of JCR, and strive to contribute further to human health.
We will comply not only with laws and regulations, industry rules, and internal regulations, but also take care to act sincerely and responsibly at all times, even in situations not covered by laws and regulations or rules, to ensure that JCR and ourselves to do not lose trust.
We will maintain sound relationships with society and stakeholders by providing prompt disclosure of appropriate and fair information at all times.
(2)Fair Trading and Competition
In our relationships with medical institutions, distributors, and suppliers, we will conduct fair business activities in accordance with laws and regulations, such as the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade and Unfair Competition Prevention Act.
We will conduct business activities in compliance with the Act against Unjustifiable Premiums and Misleading Representations and the industry’s own rules, such as the rules on fair competition for ethical pharmaceuticals and the rules on fair competition for medical devices. We will not act unjustly to attract business through measures such as offering customers improper gifts, invitations to dinner or entertainment, kickbacks, or rebates.
We will observe the National Public Services Ethics Act and the ethics code, and will not attempt to bribe public officials.
(3)Prohibition of Insider Trading
In accordance with the JCR’s internal rules, we will not disclose important information about JCR or its business partners having become privy to such information in the course of our duties. Moreover, we will not buy or sell any related shares until such information has been disclosed publicly. Furthermore, we will not allow third parties to buy or sell shares using such information.
When buying or selling JCR’s shares, we will make a prior application in line with the JCR’s internal rules, including for purchases or sales by cohabiting relatives.
(4)Information Management
We will rigorously store, manage and handle personal information collected through our business operations in accordance with laws and regulations, agreements, and internal regulations.
We understand the importance of protecting intellectual property and take particular care not to disclose such property prior to public disclosure through patent procedures, either intentionally or unintentionally. Moreover, we respect the valid intellectual property rights of others.
We rigorously manage confidential documents and agreements in accordance with relevant internal regulations. Moreover, we handle the confidential information of business partners based on confidentiality agreements only within the scope of the agreement.
(5)Human Rights and Working Environments
As we conduct our duties, we will respect the human rights and humanity of all people inside and outside the company.
We will comply with laws and regulations related to health and safety, as well as internal regulations, and maintain safe, healthy working environments.
We will respect diversity, and aim to create a comfortable working environment. Accordingly, we will comply with laws such as the Act on Securing, Etc. of Equal Opportunity and Treatment between Men and Women in Employment and internal regulations, and refrain from behavior that detracts from the working environment, such as harassment or discrimination.
We will not subject whistleblowers to retaliation or disadvantageous treatment.

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:
For payments on new agreements made from fiscal 2018 onward, we will make the following disclosures. For clinical funding in “collaborative research expenses” and “outsourced research expenses,” we will disclose the names of recipient facilities, etc., number of contracts made for the applicable fiscal year and amount paid, while for non-clinical funding, disclosure will include the total number of contracts and total amount paid for the year and a list of all recipient facilities, etc. For “clinical trial expenses,” “post-marketing clinical trial expenses,” “expenses of case reporting on adverse reactions and infections” and “post-marketing surveillance expenses,” we will disclose the names of recipient facilities, etc., number of contracts made for the applicable fiscal year and amount paid.
(1)Collaborative research expenses (Clinical) - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(Non-clinical) - Total number of contracts and total amount paid for the year and a list of recipient facilities, etc.
(2)Outsourced research expenses (Clinical) - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(Non-clinical) - Total number of contracts and total amount paid for the year and a list of recipient facilities, etc.
(3)Clinical trials expenses - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(4)Post-marketing clinical trial expenses - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(5)Expenses of case reporting on adverse reactions and infections - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(6)Post-marketing surveillance expenses - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
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