conpliance

conpliance

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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.

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.

1.Human Rights and Workplace Environment

1Respect for Human Rights

We will always protect the human rights of every person involved in our business activities and respect the dignity and worth of each individual.

2Prohibition of Harassment

We will never tolerate acts of harassment in any form or on any basis (including sexual harassment, harassment of those providing childcare, nursing care or similar care, and power harassment).

3Health and Safety of Workplaces

We will comply with laws and regulations related to occupational health and safety, as we strive to maintain and improve workplace environments so that they allow employees to work safely and even more comfortably and productively.

4Safety and Disaster Readiness

We will implement various measures to prevent accidents such as fires. If there is a disaster, we will act rapidly and effectively to stop the spread of the disaster in accordance with operating procedures and manuals on disaster mitigation measures established at each business site.
2.Responsibility to Society and Stakeholders

5Disclosure of Corporate Information

We will provide timely and accurate disclosure of corporate information on matters such as management policies and the status of business activities in accordance with relevant laws and regulations. In addition, we will listen closely to the requests and opinions we receive from society and reflect this feedback in our business activities.

6Response to Anti-Social Forces

We will never have any relationships with anti-social forces or groups and will resolutely stand up to such entities.

7 Prohibition of Conduct that Creates Conflicts of Interest

We will never use our positions at work or information obtained in the course of our duties for personal gain or to engage in conduct that conflicts with the Company’s interests.

8Contributing to Society

We will remain aware of our role as a good corporate citizen as we seek to realize a sustainable society. With this in mind, we will engage proactively with society and conduct activities that contribute to it.

9Conserving the Environment

We will always remain mindful of our impact on the global environment and local communities as we conduct our business activities, contribute to the sustainable development of society, and fulfill our responsibilities to future generations.
3.Fair Trading and Competition

10Compliance with the Antimonopoly Act

We will conduct fair and lawful corporate activities in compliance with laws and regulations for maintaining competition and fair trading in the market, such as the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade (Antimonopoly Act) and the Act against Delay in Payment of Subcontract Proceeds, Etc. to Subcontractors (Subcontract Act).

11Prohibition of Unfair Competition

We will not engage in the unauthorized acquisition or use of the trade secrets of other companies or any conduct that would impair the business reputation of other companies.

12Entertainment and Gifts

In our relationships with suppliers and other business partners, we will maintain sound and fair relationships without providing or receiving entertainment or gifts in excess of accepted social norms and remaining in compliance with relevant laws and regulations as a matter of course.
4.Business Activities

13Drug Discovery Research

When engaging in research activities, we will actively pursue research activities in accordance with relevant laws, regulations, and internal rules, aiming to eradicate disease, improve the quality of people’s health and daily lives, and contribute to the future of healthcare.

14Export and Import

We will implement appropriate export and import procedures in compliance with export- and import-related laws, regulations, international treaties and other arrangements.

15Clinical Development

In the course of conducting clinical trials, we will respect the human rights of clinical trial subjects and secure their safety, as well as ensuring the quality and reliability of data, in accordance with relevant laws, regulations, and internal rules.

16Product Quality

Our top priority is to steadily supply high-quality products with an emphasis on efficacy and safety to patients around the world. We will provide a timely and appropriate supply of products in accordance with relevant laws, regulations, and internal rules.

17Management of Information about Matters such as Product Efficacy, Safety, and Quality

We will provide timely and accurate information about matters such as product efficacy, safety, and quality in accordance with relevant laws, regulations, and internal rules with the aim of ensuring proper use of the products manufactured and sold by the Company.

18Promotion Activities

When providing medical or pharmaceutical information to healthcare professionals, we will provide, gather, and communicate accurate information based on solid medical and pharmaceutical science in accordance with relevant laws, regulations, voluntary industry standards, and internal rules.
5.Information Management

19Respect for Intellectual Property

Recognizing that intellectual property is an important asset of the Company, we will take appropriate steps to protect our intellectual property. In addition, we will respect the intellectual property rights of others and will not engage in infringement or unauthorized use of them.

20Handling of Confidential Information

We recognize that confidential information, such as non-public information, know-how and customer information, is an important asset of the Company. Recognizing this, we will use and control this confidential information appropriately in accordance with relevant laws, regulations, and internal rules.

21Prohibition of Insider Trading

We will not commit acts that violate insider trading regulations or acts that could be suspected of violating such regulations.

22Handling of Personal Information

In order to protect the interests of individuals, we will appropriately handle the personal information of customers, patients, clinical trial subjects; donors of human cells, tissue and other biological samples; shareholders; and employees in accordance with relevant laws, regulations, and internal rules.

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.
Research and Development expenses include expenses incurred for research and surveys conducted under public regulations and various policies such as the Clinical Trials Act, and GCP/GVP/GPSP regulations under the Pharmaceucital and Medical Device Act. The funds provided will be disclosed as follows along with the annual total amount of each item. Payments made under agreements entered into through fiscal year 2017 will only be released on an "annual gross" basis.
(1)Specified clinical trials expenses - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(2)Research expenses based on ethical guidelines - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(3)Non-clinical research expenses - Total number of contracts and total amount paid for the year and a list of recipient facilities, etc.
(4)Clinical trial expenses - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(5)Post-marketing clinical trial expenses - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(6)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
(7)Post-marketing surveillance expenses - Names of recipient facilities, etc., number of contracts made for the applicable fiscal year, and total amount paid
(8)Other Costs - Annual Total 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
(* This section also includes information that is required to be released under the Clinical Trials Act.)
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
(* This section also includes information that is required to be released under the Clinical Trials Act.)
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