Ethics and Compliance

We can turn transformative breakthroughs into treatments because we have the right qualities and capabilities to deliver new drugs. This includes how we conduct ourselves as we go about our day-to-day work. We hold ourselves to the highest ethical standards. But this is more than merely following a code of conduct or following regulations, we practice these ethical values and behaviors every day. We know what is right and live by it.
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This ethical mindset is the driving principle behind every field in which we operate:

  • protecting a patient’s fundamental rights and ensuring transparency in our Research and Development processes

  • manufacturing drugs and engaging with the scientific community

  • respecting the environment and promoting social responsibility in the communities where we operate

These fundamental principles inform the documents that are central to how we do business.

Corporate Compliance Program

As part of Dompé’s commitment to compliance, a Corporate Compliance Program (CCP) has been established to help Dompé in meeting the compliance standards in accordance with the Compliance Program Guidance for Pharmaceuticals Manufacturers, developed by the Office of Inspector General (OIG) and requirements set forth by California Health and Safety Code §§ 119400-119402. Therefore, to the best of our knowledge and understanding of the legal requirements, Dompé declares we are in compliance with the requirements of California Health and Safety Code §§ 119400-119402.

Dompé’s CCP includes company policies, employee training on these policies, compliance mechanisms to foster open communications throughout Dompé, periodic audits to monitor compliance, investigations of alleged non-compliance and responses to detected offenses.

In Accordance with California Health and Safety Code, Dompé has established a specific annual dollar limit on gifts, promotional materials, items, or activities that Dompé may give or otherwise provide to an individual medical or health care professional located in the State of California, subject to permitted exclusions, at $3,000.00 per health care professional.

This declaration is made as of July 1, 2020. Dompé’s Code of Conduct can be found here

Transparency in Supply Chain

  • Dompé USA requires that entities in its product supply chain regularly certify that they do not engage in human trafficking and slavery, including employing slave labor brokers or third-party slave labor recruiters.

  • Our suppliers are expected to provide such certification annually. We have the right to audit all our suppliers of materials that are incorporated into our products and to conduct or use third parties to conduct announced audits of suppliers to assess compliance with this expectation. If we discover that a supplier is non complaint, we will require either corrective actions or will terminate outstanding orders.

  • We do not require independent certifications of compliance, but we reserve the right to obtain documentary evidence of compliance upon request.

  • We have internal policies and procedures that require our personnel employees to comply with our company standards, policies and procedure, including our Code of Conduct related to supplier workplace [https://www.dompe.com/who-we-are/responsibility/ethics-and-transparency]

  • We provide compliance training to all our employees and management, who have direct responsibility for supply chain management, training on human trafficking and slavery, particularly with respect to mitigating risks within the supply chains of products.

Transparency

Compliance with laws governing healthcare, professional ethics and our own procedures are the foundations of our activities.

In the US we have fully adopted the Pharmaceutical Research and Manufacturers of America (PhRMA) Code, and adhere to the Sunshine Act aka the National Physician Payment Transparency Program (Open Payments), a section of the Patient Protection and Affordable Care Act of 2010. It requires pharmaceutical and medical device companies report certain payments to the Federal government.

Outside the US, Dompé adheres to applicable laws and regulations.

SUNSHINE ACT

Learn more about the Center for medicare services (CMS) Open Payments a national disclosure program that promotes a transparent and accountable health care system.