Company's Ethical Code of Practice / Transparency Guideline

Company's Ethical Code of Practice

These codes describe the standards that should be followed by executives and employees of JCR in business activities in and out of Japan.

Social Contributions

all business areas, activities must be performed under the philosophy, "We create treatments that go beyond rare disease to solve the world's most complex healthcare challenges". Particularly, research, development, manufacturing and marketing of pharmaceutical products should be performed as follows:

1. We conduct active and focused research and development to provide pharmaceuticals with superior safety and efficacy.
2. We conduct clinical studies with compliance to laws and regulations including GCP under each medical institution to protect subjects’ human rights.
3. We strive to establish the production line to produce high-quality products with prompt and strict quality controls to ensure quality, efficacy, and safety.
4. We strive to optimize the marketing of pharmaceuticals to contribute to saving medical resources. Also, we promptly transfer the safety information to medical front.

Compliance with Social Norms

We engage in business activities making contributions to local communities in addition to compliance with social order and laws as sensible corporate citizens.

Elimination of Antisocial Forces

We firmly confront antisocial forces that pose threats to civil society and make unjust and unlawful demands.

Protection of Human Rights

We respect employees’ human rights and individuality, and prepare employee-friendly work environment without any discrimination.

Business Activities with Consideration to Global Environment

We recognize that companies must make considerations for global environment as social responsibility, and actively engage in business activities with consideration to protection of global environment.

Transparency of Management

We make communications with not only stakeholders but also with wider society and disclose corporate information actively and fairly.

Information Management

We respect confidential documents and intellectual properties and protect our own rights. We also respect other companies’ rights.

Management in the Aim of Enhancing Corporate Value

For the management to promote research and development, we actively engage in rationalization and optimization of administrative structure.

Structurization of Corporate Ethics within the Company

Executives themselves must prepare and make efforts to raise awareness of company's ethical code of practice in all employees. In addition, all employees must recognize the company's ethical code of practice as their own responsibilities and make efforts to implement them.

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 "We create treatments that go beyond rare disease to solve the world's most complex healthcare challenges”. 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

Information on monetary payments to medical institutions(In Japanese)

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 "We create treatments that go beyond rare disease to solve the world's most complex healthcare challenges”". 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

Information on monetary payments to medical institutions(In Japanese)