Founded in 1997, BioMarin Pharmaceutical Inc. (“BioMarin” or the “Company”) develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions, focusing on product candidates that address currently unmet medical needs, suggest a clear-cut development profile and provide an opportunity to be first-to-market. It is our policy to conduct all aspects of our business in compliance with all applicable laws, as well as in accordance with the highest standards of ethical behavior.
BioMarin’s Global Compliance & Ethics program (the “Program”) is an enterprise-wide global initiative that addresses the seven elements discussed in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, as well as the tenets of the U.S. Federal Sentencing Guidelines and other applicable laws and regulations. The purpose of the Program is to prevent, detect and correct fraud, misconduct, and violations of company policies, procedures, and/or applicable laws and regulations. The Program applies to BioMarin Directors, officers, employees and, in certain situations, our agents, consultants, and independent contractors.
The Corporate Governance & Nominating Committee and Audit Committee of the BioMarin Board of Directors has ultimate authority to oversee the Program and Chief Compliance Officer (the “Compliance Officer”). The intent of the Board and Company officers is to set the tone for the ethical behavior expected of all Directors, officers, employees, and business partners.
The Compliance Officer has primary responsibility for strategic program planning related to the Program including ensuring that the Program’s training, policies and procedures, communications, auditing and monitoring, and corrective action processes are developed, in place, and modified as needed. The Compliance Officer reports to the Chief Executive Officer and to the BioMarin Board of Directors.
Policies and Procedures
BioMarin’s Global Code of Conduct & Business Ethics (the “Code”) and the Company’s various compliance policies, procedures, and/or processes are integrated across the organization with department specific procedures or guidance as needed. Among other things, our policies and procedures address the PhRMA Code and gifts to medical or health professionals. BioMarin Directors, officers, and employees are expected to comply with all of BioMarin’s global compliance policies, procedures, and processes.
The total value of all gifts, promotional materials of monetary value, meals, etc. that may be provided to any individual medical or healthcare professional during any calendar year shall not exceed $5,000.00. For the avoidance of doubt, the amounts paid for bona fide services provided to BioMarin and similar payments permitted under the PhRMA Code are excluded from this calculation. This annual limit shall be monitored and subject to periodic review by the Global Compliance & Ethics (“GCE”) department.
Education and Training
Education is a key element of our Program. Upon hire, all employees receive corporate compliance training on the Global Code of Conduct and Business Ethics and relevant compliance policies. Specialized training occurs in specific departments and across the Company for issues where compliance risks might be greater or where a need for additional training has been identified. The specialized training may include, but is not limited to, modules related to: data privacy, the prohibition of off-label promotion, and compliance generally. In addition, compliance leadership, trainers, and sales managers periodically address corporate compliance issues at regional and national sales meetings. Training is updated as needed for reasons that may include changes in the law, new risk areas, and changes to the PhRMA Code or other regionally specific codes or laws.
Our Program includes education and training of our Directors, officers, and employees on BioMarin’s Program and compliance related activities, risks, and laws.
BioMarin is committed to maintaining awareness of the Program through communication to its employees. BioMarin distributes communications to employees through a variety of methods including but not limited to all-hands meetings, Commercial team meetings, and company-wide or department-specific emails. BioMarin also maintains a toll-free hotline and website for reporting compliance concerns, as well as a process for investigating and documenting concerns. In the U.S., reporters can reach the hotline by calling +1 (866) 513-7198. Other countries’ access numbers, as well as the ability to report online, are available at www.BIOMARIN.ethicspoint.com.
BioMarin requires Directors, officers, and employees to promptly report suspected or actual violations of our Program and laws and regulations governing our business. Our toll-free hotline and website allow for anonymous reporting (except where prohibited by law) and is monitored by the Compliance Officer.
Auditing and Monitoring
As part of the Program, BioMarin will conduct auditing and monitoring activities designed to assess compliance with the Program policies, procedures, and processes, identify potential training needs, and identify policy, procedure, or process needs.
BioMarin is committed to an effective compliance Program. Accountability for compliance Program violations is required by the Code and other policy documentation.
Responding to Detected Offenses
The Program includes the investigation and response to identified or reported compliance issues. The response and level of investigation depends upon the reported or detected issue. The Compliance Officer oversees the investigation and any resulting corrective action that is determined necessary. Corrective action may range from taking appropriate disciplinary action, modifying policies, procedures or processes, employee education, or other action designed to prevent future violations.
BioMarin is committed to compliance and strives to maintain an active and effective Program.
BioMarin Pharmaceutical Inc.
Global Compliance & Ethics Program Declaration
Based upon our good faith understanding of the California Health and Safety Code sections 119400 and 119402, BioMarin declares that, as part of its continued efforts in the area of compliance, we have developed a comprehensive Global Compliance & Ethics Program for our commercial operations as required by the Code. To our knowledge, we are, in all material respects, in compliance with our Program. Copies of this declaration may be obtained by calling +1 (415) 506-6700.
June 30, 2022