Insmed

Global healthcare compliance

Ethics & Compliance Program

Every action and every decision is an opportunity to do the right thing

Rooted in integrity, our culture is guided by our values and our list of guiding principles. We operate with trust and respect in everything we do. Each of us is accountable for our actions, and we make decisions by putting patient needs first.

Our Global Healthcare Compliance Program incorporates:

  • General Compliance Program Guidance 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 culture is shaped by our words and actions

Ethical choices become the standard when integrity, honesty, and compliance guide our decision making. Our open-door communications approach is supported by training and awareness programs. Our global Speak-Up program provides an anonymous channel for reporting allegations of questionable or inappropriate activities to enable timely resolution.

Ethics & Compliance across Insmed

Our program includes written standards, risk assessment, and benchmarking to ensure best practice.

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 the Global Compliance Program, while local Compliance Committees are responsible 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 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, patients, and patient advocacy organizations.

View Our Code of Conduct

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 and based on regular risk assessments.

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.

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.

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.

Our Insmed Hotline can be reached at Insmed.ethicspoint.com or by dialing +1-844-539-2347.

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, industry standards, and industry best practices.

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 journals. 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 compliance@insmed.com.