A. Introduction

BSN Medical Inc, Hydrofera LLC & Compression Solutions LLC (collectively called here “Essity Health & Medical US”) are medical device companies and part of Essity Group (“Essity”), a leading global hygiene and health company. 

This Compliance program declaration is provided in accordance with the requirements of California  Health & Safety Code §§ 119400-119402, which requires certain pharmaceutical and medical device companies doing business in California to make available their program for compliance with applicable federal and state laws and industry standards governing the marketing and advertising of their products.

Essity’s compliance program covers the seven elements of the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of Inspector General of the U.S. Department of Health and Human Services (the “OIG Guide”) in addition, the compliance program for Essity Health & Medical US is developed in accordance with the AdvaMed Code of Ethics which is substantially similar to the PhRMA Code, with respect to the standards for interactions between medical device manufacturers and healthcare professionals.   

The OIG Guide advises that effective compliance programs are comprised of seven elements. As described below, these elements form the basis of Essity’s Group compliance program to follow the standards regulating the marketing and promotion of its products and for the interactions with healthcare professionals. Contact details regarding the compliance program can be found on Essity’s website in the code of conduct section (www.essity.com) 

B. Overview of Essity’s Compliance Program

1. Written Policies and Procedures

Essity Health & Medical US has developed and distributed written compliance policies, procedures, and practices that guide the company and the conduct of employees in day-to-day commercial operations and that follow the applicable laws and regulations and standards governing the marketing and promotion of Essity’s Health & Medical US products. Among these standards are recognized industry codes of conduct including the Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code) published by the Advanced Medical Technology Association (AdvaMed). 

These policies include:

Policy on Business Meals

Essity Health & Medical US may occasionally offer a modest meal, consistent with the standards of the AdvaMed Code as part of a legitimate business purpose, such as an educational presentation. These modest meals should occur in modest venues conducive to the transfer of information and attendance by spouses or guests, is not permitted.

Policy on the Provision of Educational and Practice-Related Items

On occasion, company representatives may provide items that are designed primarily for the education of patients or HCPs, consistent with the standards of the AdvaMed Code.

In accordance with California Health & Safety Code §§119400 et seq., Essity Health & Medical US has established an annual spending limit of $2,500 USD for individual hospitality items, gratuities, and educational items directed to medical or healthcare professionals. The Company has an internal monitoring system in place to help ensure compliance with its annual spending limits.

Policy Prohibiting Entertainment and Gifts.

Essity Health & Medical US includes in its policy a prohibition to provide Entertainment (e.g. sporting events, theater, leisure travel, concerts, etc.) gifts, or promotional items to medical or healthcare providers.

2. Designed Compliance Officer

Essity Health & Medical US has appointed a Compliance Officer. The Compliance Officer has been empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management.

Essity has a Compliance Council that is Comprised of the Vice-president for Compliance & Ethics and members of the company’s executive team. The Vice-president for Compliance & Ethics has access to report directly to the Board of Directors.

3. Training and education

Essity Health & Medical US has an annual Health Care Compliance training process that includes testing of appropriate employees. The training covers applicable guidelines governing Essity’s compliance program. Essity regularly reviews and updates its training programs and identified additional areas of training on an "as needed" basis.

4. Lines of communication 

Essity encourages each employee to contribute and speak openly. To that end, Essity has adopted confidentiality, and non-retaliation policies. As part of its commitment to ethical and legal behavior, Essity requires its employees to report any actual or suspected violations of law or ethical standards so that they can be appropriately investigated and addressed. Employees can raise their concerns in several ways including their line manage, through the Human Resources, Legal, Compliance & Ethics Departments, or by calling Essity’s anonymous SpeakUp line.

5. Internal Monitoring and Auditing

Essity’s Compliance program includes activities to monitor and evaluate compliance with the Company’s policies and procedures. Essity’s approach includes monitoring based on identified and prioritized risk areas. Essity also has a wide variety of audits based on the annual audit plan, approved by the company’s BOD - Audit Committee.

6. Responding to Potential Violations

Adherence to the Code of Conduct is mandatory at Essity. Any violation of an employee’s obligations under the Code of Conduct can subject an employee to serious disciplinary measures, including possible termination of employment.  All employees have access to a whistleblowing system via phone or web where they can report violations of the Code of Conduct with the possibility to report anonymously.

7. Corrective Action Procedures

As part of the compliance program, Essity’s established a comprehensive internal investigation guideline to ensure that timely, complete, and objective investigations are conducted in response to allegations regarding the Essity’s Code of Conduct applicable policies. 

Essity is dedicated to the maintenance and ongoing assessment required of an effective compliance program. As changes are made to either the OIG Guidance or AdvaMed Code of Ethics, the Essity Health & Medical US Compliance Program must be updated with corresponding modifications within six months.

This Description is effective as of January 1, 2025. Essity will assess its Compliance program declaration at least annually, for the purpose of declaring compliance with California Health and Safety Codes §§ 119400-119402.

Declaration for California Compliance Law:

To the best of our knowledge as of this declaration, Essity Health & Medical US follows this Comprehensive Compliance Program, as described here, and with California Health & Safety Code sections 119400-119402 and with the established annual spending limits for reporting period of January 2024 – December 31 2024.