Compliance

The Santen Group 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

The Santen Group 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 directors and employees, including contract and temporary staff.

Expanding understanding of the Santen Code of Practice

The Santen Group has published translations of the Santen Code of Practice, a concrete Code of Conduct in business activities, in 13 languages, to spread knowledge of the code to all Santen Group corporate executives and employees, who are becoming increasingly diverse in line with the progression of globalization. Every year, with the aim of promoting the "Santen Code of Practice," our president or chief compliance officer provides a message to all Santen executives and employees, and awareness activities are conducted in each country and region.

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, the Santen Group 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. The Global Compliance Policy came into effect in November 2019.

The Policy is aimed at ensuring that all Santen Group 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

The Santen Group has appointed a Chief Compliance Officer (CCO), a Compliance Committee, etc., to establish a system for promoting globalization-compatible compliance activities. The Santen Group also holds a Meeting of the Global Compliance Committee, which brings together executives in charge of regions and functional organizations, and a Global Compliance Working Committee, which is attended by in-house compliance administrators in charge of regions, regularly.

Preventive Measures against Corruption

The Santen Group 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 defines the ideal state of each employee's 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, the Santen Group provides employees with training by e-learning or other means continually, to facilitate each employee's understanding of the prevention of corruption including extortion, bribery and embezzlement.

The Santen Group was not involved in any incidents of corruption in FY2019.

Compliance Consulting & Reporting Desk

The Santen Group has made it easier for all employees, including contract and temporary staff to consult and report on suspicious actions 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 in nearly all of the countries where it conducts business 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.

Protection of Internal Whistle-Blowers

The Santen Group 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 -Whistleblowing System-"

In operating the whistleblowing system, Corporate Officers in charge of regions, for the purpose of preventing the occurrence of any penalty, act of retaliation including discriminatory treatment, or disadvantageous treatment including adverse impact on personnel performance evaluation, upon any whistleblower on the ground of his/her whistleblowing, shall take all necessary measures including the establishment of necessary internal rules and their dissemination among employees.

For example, in Japan, the Procedure Manual for Compliance Consultations and Reporting provides that internal whistle-blowers must not be treated in a disadvantageous manner, that if internal whistle-blowers are treated in a disadvantageous manner, such disadvantageous treatment must be ended, and that cooperators in reporting or investigations must also be protected in the same manner as whistle-blowers.

Protection of Personal Information

In April 2020, the Santen Group enacted a new Global Policy for Protection of Personal Information to comply with laws and ordinances on protection of personal information, which would be tightened in each country in the wake of the enforcement of the EU's General Data Protection Regulation (GDPR) in 2016. Based on the Policy, the Group has made global efforts to strengthen its system for protection of personal information. All Santen Group companies work together globally to raise employees' awareness of the Policy and implement it appropriately in order to ensure that personal information about patients, general consumers and employees is appropriately handled and protected.

In FY2019, there was no complaint concerning breaches of customer privacy, which Santen received from regulatory bodies.

Compliance Education

The Santen Group makes efforts to raise compliance awareness, by designating November as the Santen Code of Practice familiarization month, by providing employees with training and other measures. For example, as part of the awareness activity, we offer employees e-learning-based training of "bribery and corruption prevention" globally in FY2019. Additionally, Santen checks the levels of employees' understanding of and compliance with relevant regulations through regular employee opinion survey and internal audits.

In FY2019 there were no cases of major law violation by the Santen Group and no suits against the Group.

Maintaining an Appropriate Relationship with Healthcare Professionals or Patient Organizations and Ensuring Transparency

The Santen Group provides information materials, holds meetings and opinion-exchange opportunities for healthcare professionals or patient organizations, with the aim of promoting the appropriate use of pharmaceuticals among users and accurately understanding medical needs. We also provide assistance for research conducted at institutions including university hospitals as well as for patient organizations, for the purpose of promoting medical and pharmaceutical development. We not only comply with laws and regulations and self-imposed industry regulations, but also perform employee training so that all employees around the world can avoid compliance risks, and more, to ensure that our activities are conducted based on high ethical standards. The Santen Global Compliance Policy also stipulates relationships with healthcare professionals and external funding. The continuous scope of internal audits includes whether expenditures for healthcare professionals and other stakeholders are properly implemented.

Considerations for Animal Welfare in Research Activities

In pharmaceutical R&D, animal experiments need to be carried out to determine drug safety and efficacy. To respect the lives and welfare of animals used in our experiments, Santen reviews all animal experiments including those outsourced to external testers at the "Animal Care and Use Committee" in terms of the 4Rs in animal use: namely, "Reduction" in the number of animals used, "Replacement" of methods requiring the use of animals with alternative methods, "Refinement" of test procedures to minimize pain, and the "Responsibility" of testers and sponsors for consideration of animal welfare. In addition, to ensure that the 4Rs are observed, Santen has established internal regulations based on the "Act on the Welfare and Management of Animals," "Standards relating to the care and management of laboratory animals and relief of pain," and "Basic guidelines on the implementation of animal experimentation in facilities under the control of the Ministry of Health, Labour and Welfare (MHLW) of Japan." Based on these regulations, we educate and train employees who experiment animals, and check the conformance with national law and guidelines by ourselves. we periodically confirm care conditions.

These efforts of Santen were assessed by the Center for Accreditation of Laboratory Animal Care and Use, Japan Health Sciences Foundation (JHSF CALAC) (Note) , and were certified as compliant.

Note
Center for Accreditation of Laboratory Animal Care and Use, Japan Health Sciences Foundation (JHSF CALAC): JHSF CALAC is an external body that assesses/verifies whether scientifically appropriate animal experiments are conducted, while at the same time promoting voluntary management of animal experiments from the viewpoint of animal care, in animal experiments conducted at facilities under the control of MHLW.
Certification from JHSF CALAC