Compliance

Santen not only complies with laws and ordinances but also engages in sensible corporate conduct based on sound moral values.

Santen Code of Practice as a Code of Conduct

Santen believes it is important for our employees to not only comply with laws and regulations, but also to act in accordance with a high standard of ethics befitting workers at Santen, and to truly earn customers' trust, based on an understanding of the spirit behind Santen's Values. We have established the Santen Code of Practice as our code of conduct for all corporate executives and employees, including contract and temporary staff.

Expanding understanding of the Santen Code of Practice

Santen has published translations of the Santen Code of Practice, a Code of Conduct, in 13 languages and conducted awareness activities on countries or regions basis, to spread knowledge of the code to all Santen corporate executives and employees, who are becoming increasingly diverse in line with the progression of globalization. Also, with the aim of promoting the "Santen Code of Practice," our president or chief compliance officer continuously provides a message to all Santen executives and employees, and the management takes the initiative in conducting management based on compliance.

Santen Global Compliance Policy

Business activities in the healthcare industry involve frequent interactions with government employees and healthcare professionals in all settings, including research and development, manufacturing and sales. Due to this business structure, controls on inappropriate conduct, such as corruption and bribery, have been tightened, and increasingly strict laws and regulations have been adopted. This situation requires companies in the healthcare industry to ensure high transparency in their corporate activities.

Against this background, to define the rules that employees must comply with, Santen formulated a new Global Compliance Policy based on the Code of Practice of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which has members from among many pharmaceutical manufacturers around the world. "Santen Global Compliance Policy" came into effect in November 2019.

The Policy is aimed at ensuring that all Santen Group corporate executives and employees observe laws and ordinances and act in a highly ethical and sincere manner, and consequently contribute to a better quality of life (QOL) for all patients.

Global Compliance System

Santen has appointed a Chief Compliance Officer and established a Compliance Committee consisting of executives in charge of each region and function. This committee promotes a variety of compliance measures globally, including dissemination of the basic philosophy and regulations, fostering a corporate culture of compliance, and responding to compliance issues. We have also appointed compliance administrators to assist in global promotion activities in each region, and regularly hold compliance officer meetings to discuss methods for promoting decisions made by the Compliance Committee and measures for dealing with issues, and to support promotion activities on a global basis.

Preventive Measures against Corruption

Santen joined the United Nations Global Compact in October 2017 and works against corruption including extortion, bribery and embezzlement. We prohibit employees from committing such as act of bribery by clearly declaring, "We do not engage in any conduct regarded as bribery or corruption, whether directly or through a third party, that would violate the applicable laws and regulations of the relevant country, including those applicable to other countries," in the Santen Code of Practice, which is the code of conduct.. We maintain sound and normal relationships with political and governmental bodies, and, when making political donations, observe the applicable laws and regulations, such as the Political Funds Control Act, as well as appropriately controlling such donations based on in-house regulations. The Santen Code of Practice also provides that we shall refuse any demands from antisocial entities in a resolute manner. Moreover, Santen provides employees with training by e-learning or other means continually, to facilitate each corporate executives and employee's understanding of the prevention of corruption including extortion, bribery and embezzlement.

Santen was not involved in any incidents of corruption in FY2020.

Compliance Consulting & Reporting Desk

Santen has made it easier for all corporate executives and employees, including contract and temporary staff to consult and report on suspicious cases and questions related to compliance by establishing in-house consulting and reporting desks that respond in various languages in its operating countries and regional bases. Additionally, Santen has established external helplines that receive reports anonymously with the cooperation of external third-parties, such as lawyers. Incoming consultations and reports are appropriately investigated and addressed in a sincere manner, and reports are relayed to the Board of Directors regularly.

The number of consultations and reports in 2020 was 23.

Protection of Internal Whistle-Blowers

Santen Compliance Rules provide that the Group must take appropriate measures to protect internal whistle-blowers in each area where it operates.

Extract from "Compliance Rules -Compliance Violations, Whistleblowing System-"

In operating the whistleblowing system described in the preceding paragraph, Santen group companies shall not permit any disadvantageous treatment upon any whistleblower on the ground of his/her whistleblowing such as imposing any penalty, act of retaliation including discriminatory treatment, or adverse impact on personnel performance evaluation. Heads of Functional Divisions, Heads of Regional Business and the Presidents of Santen group companies shall, in their organization or business, take all necessary measures to materialize the above ban on disadvantageous treatment including raising awareness on such ban and the establishment of necessary internal rules.

In Japan, for example, the "Consultation and Reporting Procedure" stipulates the protection of whistleblowers, and stipulates that no disadvantageous treatment shall be imposed on whistleblowers, that if disadvantageous treatment is confirmed, such conduct shall be suspended, and that whistleblowers and research collaborators shall be protected in the same manner as whistleblowers.

Protection of Personal Information

With the enactment of the EU-based GDPR (General Data Protection Regulation) in 2016, Santen formulated a new "Global Data Privacy Policy" in order to comply with stricter laws and regulations on the protection of personal information in each country. The new policy was enacted in April 2020. In order to properly handle and protect the personal information of patients, consumers and employees, we are working together globally to strengthen our personal information protection system, including disseminating this information to all corporate executives and employees.

At Santen, there were no breaches of client data reported to regulators in FY2020.

Compliance Education

Santen makes efforts to raise compliance awareness, by designating November as the Santen Code of Practice familiarization month, by providing all corporate executives and employees with training and other measures. For example, as part of the awareness activity, we offer employees e-learning-based training of "overview of healthcare compliance" globally in FY2020. In addition, employees sign and certify for understanding and complying with the Santen Global Compliance Policy when joining the company.

In FY2020 there were no cases of major law violation by the Santen Group and no suits against the Group.