Compliance

The Santen Group develops and operates a system for complying with laws and regulations as well as the business practices of the countries/regions in which we operate for every employee to act according to a high standard of ethics.

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 temporary or part-time 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, including temporary or part-time staff, and awareness activities are conducted in each country and region. In 2017, we set February and July as "Santen Code of Practice Awareness Month," and launched a worldwide campaign to promote understanding of the code among all Santen employees.

Global Compliance System

In October 2016, Santen appointed a Chief Compliance Officer, a Compliance Committee, etc., to establish a system for promoting globalization-compatible compliance activities. Santen 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 and functional organizations, twice a year. Based on the decision made at the committee, we promote global compliance activities. Previously, we have set compliance-related consultation/complaint systems in each region/country, and we launched worldwide campaigns to promote understanding of the "Santen Code of Practice" among all Santen employees in both February and July, 2017.

Compliance Consulting & Reporting Desk

To ensure compliance, the Santen Group wants all employees not only to observe laws and regulations, but also to act in accordance with a specific code of conduct in their business activities, which Santen stipulates in the "Santen Code of Practice" as the standards of responsibility required for workers at Santen.

We also have compliance-related consultation/complaint systems available in each country/region in their respective language(s), to encourage our employees to consult with or report to us or ask questions regarding suspected acts of non-compliance. In addition to maintaining the strict confidentiality of whistleblowers, our internal rules, established according to the Whistle-Blower Protection Act as well as related guidelines, call for the protection of whistleblowers from any disadvantages. Our "outside helpline" service, provided by third parties, including outside lawyers, is available anonymously in almost every country.

Compliance Education

The Santen Group makes efforts to raise compliance awareness, by clarifying desirable conduct, as well as the necessity of compliance, in the Santen Code of Practice as a concrete Code of Conduct in our business activities; providing employees with training; and other measures.

In Japan, to facilitate employees' understanding of compliance, Santen provides training for all new employees and all newly appointed managerial staff members. Additionally, Santen checks the levels of employees' understanding of and compliance with relevant regulations through regular employee opinion survey and internal audits. Santen provided training on "Enforcement of stricter compliance," "Understanding of regulations on bribery prevention," "Spread of information on contacts for advice and reporting on compliance," "Security export control," and other topics in FY2017 to deepen employees' understanding of the rules and procedures to be followed. Santen also provides training for each division or section, on "Avoidance of conflict of interest," "Prevention of insider trading," the "Act against Delay in Payment of Subcontract Proceeds, etc. to Subcontractors," the "Act against Unjustifiable Premiums and Misleading Representations" and other topics, according to the contents of the participants' duties.

In FY2017 there were no cases of major law violation by the Santen Group and no suits against the Group.

Preventive Measures against Corruption

The Santen Group strictly prohibits employees from committing any act of bribery or corruption 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 Code of Conduct 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 Code of Conduct also provides that we shall refuse any demands from antisocial entities.

Moreover, the Santen Group provides employees with corruption prevention training by e-learning or other means on a regular basis, to facilitate each employee's understanding of the prevention of corruption of all kinds, including forceful demands, bribery, and conflicts of interest.

The Santen Group was not involved in any incidents of corruption in FY2017.

Maintaining an Appropriate Relationship with Healthcare Professionals and Patient Organizations to Ensure Transparency

The Santen Group presents meetings and opinion-exchange opportunities to healthcare professionals and 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 regulations of the industry, but also establish in-house guidelines and perform continual training and inspection, to ensure that our activities are conducted based on high ethical standards.

In Japan, we have established a donation committee led by our corporate officer in charge of CSR, with the aim of reviewing the validity of donations made. Furthermore, whenever donations are made, our organization independent of our sales and R&D departments checks and records the details of the donations and discloses these annual results on our website.

Appropriate Promotion

The Santen Group declares in the Santen Code of Practice: "We promptly provide accurate and reliable information on quality, efficacy, safety and other matters of pharmaceuticals and related products as part of our fair sales and marketing activities, in order to promote the optimal use of pharmaceuticals and related products." With regard to advertising and promotion, we formulate guidelines, such as promotion codes, by division or by country, and provide employees with education.

In Japan, we have established the Assessment Committee for Prescription Medicine Information Outlines and Advertisements, which assesses whether the product information outlines, advertisements, production promotion materials, and other materials that we use serve the purpose of promoting the appropriate use of the product, and use only those advertisements and materials that receive approval from the Committee. In other countries and territories too, we have defined the necessary procedures in compliance with the legal and voluntary regulations there.

In FY2017, there were no incidents of violations concerning advertising or promotion by the Santen Group.

Supporting the Industry's Voluntarily Established Codes

The Santen Group supports the IFPMA Code of Practice of the International Federation of Pharmaceutical Manufacturers & Associations, to which R&D-oriented pharmaceutical companies belong, and engage in conduct in compliance with codes voluntarily established by the industrial organization in the relevant country or territory, including the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

In Japan, we belong to the Japan Pharmaceutical Manufacturers Association (JPMA), and observe the JPMA Code of Practice (hereinafter "JPMA Code"), which provides the standards of conduct for all executives and employees of member companies with regard to their relationships with researchers, medical experts, patient associations, etc. Every November, which we have defined as the "Month for Facilitating Understanding of the Codes of Practice," the President gives a message to the employees recommending that they reconfirm the background and purposes of laws and regulations, the JPMA Code, and other rules, and engage in honest conduct.

Ensuring Protection of Personal Information

To appropriately treat and protect the personal information of patients, general consumers and employees, the Santen Group has devised a Policy toward the Protection of Personal Information and a compliance program on the protection of personal information, and strives to spread necessary knowledge to all Santen Group executives and employees through training and to operate the policy and program appropriately.

In FY2017, to appropriately respond to the revised Act on Protection of Personal Information, which came into effect in Japan in May in the same year, we revised our in-house regulations, and drew contracts for legitimate transfers of personal information among our group companies both in Japan and abroad. In addition, to comply with the General Data Protection Regulation (GDPR), a new regulation on the protection of personal information in the EU, which became effective in May 2018, we also formulated in-house regulations for our group companies in Europe, revised our privacy policy, and drew contracts among our group companies for legitimate transfers of personal data from Europe to outside Europe.

There were no privacy violation cases by the Santen Group in FY2017.

Information Security Measures

The Santen Group implements measures against the risks of information leakage, including formulating internal regulations, including the Basic Policy for Information Security and Information Security Corporate Principles and Rules, and developing and operating a system for information security based on these regulations, in order to properly protect and manage information. In response to the globalization of our businesses, Santen reformulated the Regulations on Information Security in May 2016 by expanding their scope to overseas group companies. In May 2018, we established a section dedicated to information security in a global scope, and put the section into operation. We also implement other information security measures, such as providing our employees with information security education, and carrying out assessment of physical security.