The LumiraDx Group is committed to maintaining the highest level of ethical standards in the conduct of our business. The foundation of LumiraDx’s business conduct program is this: we will do business legally and ethically in all aspects of our global operations. We believe that integrity is the key to establishing and preserving our good reputation and the delivery of quality services to our customers.
LumiraDx has developed a comprehensive global compliance program (the “Program”). The Program reflects the seven elements of an effective compliance program as set forth in the “Compliance Program Guidance for Pharmaceutical Manufacturers” published in April 2003 by the Office of Inspector General, U.S. Department of Health and Human Service an as made applicable to the medical device industry (“OIG-HHS Guidance”). The Program also requires compliance with voluntary industry guidelines, including the MedTech Europe Code of Ethical Business Practice and the Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professionals.
In accordance with OIG-HHS Guidance, our Program includes the following:
1. Written Standards of Business Conduct
The LumiraDx Code of Conduct (the “Code”) aims to provide guidance to enable us to conduct business with the highest standards of ethics and integrity. All directors, officers and employees are required to observe not only the letter but also the spirit of the Code. LumiraDx employees read and certify adherence to the Code annually. LumiraDx also develops and distributes policies and procedures to supplement the Code and support the day-to-day activities of the business.
Our General Counsel serves as our chief compliance officer and is responsible for the development and enhancement of the Program (the “CCO”). The CCO reports compliance matters to the Chief Executive Officer, senior level leadership, and LumiraDx’s Board of Directors and committees. The CO reports directly to the Chief Executive Officer and leads a team of qualified legal and compliance professionals.
The CCO oversees regional Compliance Committees (each, a “Compliance Committee”). The Compliance Committee consists of senior-level leadership and is led by the CCO. The Compliance Committee was established to assist in the implementation of the compliance program. The Compliance Committee holds periodic meetings to discuss matters including the legal and regulatory environment, risk areas and best practices to ensure effective oversight of the Program. The Program includes dedicated legal and compliance support for each of LumiraDx’s businesses.
3. Effective Lines of Communication
We encourage our employees to ask questions, raise concerns, and report suspected or actual violations of our Code, policies, and procedures. Our employees have access to an anonymous web-based Ethics and Compliance Hotline, which is available 24 hours a day, seven days a week in multiple languages. Employees also may contact the CCO or Audit Committee directly. All allegations reported are thoroughly investigated and documented. Reports are handled as confidentially as possible.
4. Training and Education
LumiraDx employs a robust training program for directors, officers, and employees. LumiraDx mandates training on the Code and related policies and procedures, as well as targeted education and awareness programs that help foster a culture of compliance. LumiraDx training program includes other third parties and business partners, such as international distributors and agents. LumiraDx utilizes a variety of training platforms and mechanisms, including but not limited to interactive web-based modules and in person training sessions.
LumiraDx employees are expected to adhere to our Code and related policies and procedures. Failure to comply with the Code, or failure to report a violation, may result in disciplinary action up to and including termination of employment. The Code prohibits retaliation against any individual filing a good-faith complaint or for participating in the investigation of any such complaint.
6. Auditing and Monitoring
The CCO and Compliance Committee utilize results from internal audits and internal monitoring programs to assess the effectiveness of the Program. The CCO and Compliance Committee are committed to enhancing the Program to reflect the evolving needs of the business, as well as changing legal requirements and updated codes of ethics.
Results of investigations, audits, and monitoring are communicated to the CCO, Compliance Committee, and business leaders. The CCO partners with the business to implement corrective actions and make improvements to the Program.
Declaration for purposes of the California Act
In connection with its ongoing commitment to compliance, LumiraDx has developed the California Comprehensive Compliance Program pursuant to California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400-119402 (the “California Act”). Our California Program sets forth certain of our policies regarding relationships with California “medical or health professionals” as defined in the California Act.
In accordance with the California Act, LumiraDx has established a specific annual dollar limit of $2,500, which applies to promotional materials, items, and activities provided by an employee of relevant LumiraDx businesses to covered recipients in California.
To the best of its knowledge, LumiraDx declares that as of July 1, 2022, it is in all material respects in compliance with the requirements of the California Act.
To obtain a print version of this document, please contact LumiraDx’s customer service line at 1-888-586-4721.