Insmed is committed to establishing and maintaining an effective Global Healthcare Compliance Program, which incorporates elements outlined in:
- Compliance Program Guidance for the Pharmaceutical Manufacturers issued by the U.S. Office of Inspector General (OIG), Department of Health and Human Services
- A Resource Guide to the U.S. Foreign Corrupt Practices Act issued by the U.S. Department of Justice
- Code on Interactions with Healthcare Professionals issued by the Pharmaceutical Research and Manufacturers of America (PhRMA)
- Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals issued by the European Federation of Pharmaceutical Industries and Associations
- Code of Practice issued by the Japan Pharmaceutical Manufacturers Association
Our Global Healthcare Compliance Program is one of the key components of our commitment to the highest standards of corporate conduct. Our Global Healthcare Compliance Program is designed to:
- Prevent, detect, and correct violations of law, regulations and company policies and procedures
- Establish compliance-related policies and procedures for business operations
- Develop training and other programs designed to educate employees regarding applicable policies, procedures and standards
- Implement a mechanism for reporting allegations of questionable or inappropriate activities to enable timely investigation and resolution
- Take appropriate corrective action to prevent recurrence of misconduct
Leadership and Structure
Insmed has established the Global Healthcare Compliance group, led by our Chief Compliance Officer with a dedicated compliance team to support the company’s culture of compliance for its business activities. The Chief Compliance Officer has overall responsibility for developing and implementing policies, procedures, and practices designed to ensure compliance with applicable healthcare program requirements.
The development and distribution of written standards of conduct, policies, procedures, and guiding principles is integral to the Compliance Program. Insmed has developed a Code of Conduct that describes our organizational principles and values. Additionally, the Code of Conduct provides policy and standards for conducting business and sets forth the expectations for reporting instances of possible noncompliance.
In addition to the Code of Conduct, Insmed has written policies and procedures governing our general business activities as well as those activities related to the marketing and sales of our products and our interactions with healthcare professionals, healthcare organizations and patients.
Insmed’s Executive Committee is comprised of members of senior management and led by the Chief Executive Officer. Healthcare Compliance and Risk Committees are a regular agenda item.
Another critical element to our Global Healthcare Compliance Program is the education and training of our employees on their ethical and legal obligations regarding healthcare compliance related topics. Our Global Healthcare Compliance Program incorporates training on Insmed’s policies, processes and standards. Insmed will regularly review and update training programs and identify additional areas of training on an as needed basis.
Risk Assessment, Auditing and Monitoring
Insmed’s Global Healthcare Compliance Program includes conducting risk assessments which drive monitoring, auditing, and ongoing evaluation to ensure compliance with the company’s policies and procedures. The extent and frequency of auditing and monitoring activities is guided by assessing risk and varies according to a variety of factors including changes in business activities, changes in regulatory requirements, and other considerations. The results of monitoring and/or auditing reviews may be used as a basis for improving upon existing policies/procedures or adopting new ones and for the development or modification of training or business practices.
Third-Party Due Diligence
Insmed engages in risk-based compliance third-party due diligence. This includes the qualifications of the third party, including business reputation and any relationship with foreign officials. Payment arrangements are also evaluated to ensure appropriate compensation which is not used as a basis for bribery or corruption.
Procedures for Reporting Violations
Insmed has an open-door policy and encourages open communication amongst our colleagues. We encourage reporting of potential instances of noncompliance and have a policy of non-retaliation. Our Code of Conduct and policies require employees to report any known or suspected violations of law, regulations, company policies or procedures. To support this effort, Insmed has established several vehicles for reporting including an external reporting hotline to facilitate confidential, anonymous reporting. Additionally, Insmed investigates all reports and prohibits retaliation against any person who, in good faith, reports known or suspected compliance issues.
Investigations, Sanctions and Corrective Actions
In the event that Insmed becomes aware of any alleged violations of law, regulation, policy or procedure, we investigate the circumstances surrounding the alleged noncompliance to determine whether a violation has occurred. While each substantiated violation will be evaluated on a case-by-case basis, where appropriate Insmed will use corrective actions consistent with company policy, up to and including termination.
Insmed evaluates its comprehensive compliance program on an ongoing basis for improvements, addressing gaps or issues found through investigation, monitoring and auditing, and in response to changes in laws, regulations and industry standards.
Annual Dollar Limits on Gifts or Incentives Provided to Medical or Healthcare Professionals in California
As required by, and in accordance with the definitions set forth in, California SB 1765, Insmed has established an annual dollar limit to healthcare professionals in California for certain promotional activities. This annual dollar limit is $2,000 per such individual and may be revised from time to time. It includes occasional meals and snacks, meals provided in connection with an Insmed speaker program and any educational items, such as medically related textbooks or journal. It does not include grants for medical education, professional service or consulting fees, patient education materials and approved scientific reprints. Insmed follows a calendar year reporting cycle for purposes of making its annual declarations under California Health and Safety Code Sections 119400 – 119402. The annual declaration is made on or around July 1 each year for covered activities occurring in the preceding calendar year.
A copy of this Compliance Program and the declaration of compliance may be obtained by contacting firstname.lastname@example.org.