Ethics & Compliance
Letter from Patrik Florencio, Amicus Chief Compliance & Risk Officer
Every company speaks of its dedication to ethics & compliance. Amicus is of course no exception – we are deeply committed to performance with integrity. Important sources of our strong commitment are the tone and direction from our CEO and Board, as well as the unusually strong bond and friendship between members of the Amicus leadership and executive teams which permeate the culture of our organization.
As colleagues, we respect and trust each other. As friends, we go the extra mile to support each other in our mutual corporate objectives. And this cuts across all departments. It is that support, and understanding that compliance is a shared responsibility, that makes Amicus so special and its commitment to ethics & compliance so meaningful.
Patrik Florencio, Amicus Chief Compliance & Risk Officer
Code of Conduct
Our Global Code of Conduct is our guide to performing with integrity around the world. It is founded on core principles and sets expectations for everyone who works at Amicus. The Code’s principles-based approach allows business decisions to be guided by our values, and by the rules set forth in our underlying policies and procedures.
The architecture of our Code is based on four core principles – a commitment to patients, to employees, to communities, and to shareholders. Having one set of values directing our behaviors across the globe allows us to act consistently on key matters regardless of context or country.
At Amicus, we demonstrate our integrity by never engaging in bribery or corrupt practices. This is vital to maintaining the trust of our employees, of the patients we serve, and of the customers and partners with whom we work. We do not solicit, accept, offer, promise, or pay bribes — whether directly or through a third party.
We further demonstrate our integrity by knowing the identity of our clients and others with whom we do business, and by adhering to global anti-bribery standards. Where we suspect criminal behavior, we take appropriate action.
Patient Organization Support
Patients and the advocacy organizations that represent them are at the heart of everything we do. It is the mothers, fathers, sons, and daughters – the real people who live with rare disease – who are the focus and beneficiaries of our work. To do that great and meaningful work we need to be great listeners and learners. We need to understand the true burdens of the individuals, families, and caregivers living with the rare diseases we seek to alleviate, and to grasp the medical needs of those rare disease communities. That understanding in turn informs and energizes everything we do. Such is the foundation and premise for our interactions with patient advocacy organizations. Annually, Amicus publishes a list of its financial support of European Patient Organizations. Although we are not a member of EFPIA, we follow the standards for such reports set out in the EFPIA code, which is implemented at the national level through the country-specific codes of EFPIA’s member associations.
Healthcare Practitioner (HCP) & Healthcare Organization (HCO) Disclosures
Amicus has a singular mission. To make medicines that improve the lives of patients living with rare disease. In the pursuit of this mission, we collaborate closely with HCPs and HCOs. Such interactions occur, for example, when we conduct clinical trials, gain critical medical insights regarding how our medicines are used and how we can improve them, and when we share up-to-date information about our research and products at scientific congresses. In all such interactions, we are committed to providing science-based, truthful, and non-misleading information about our products, and to paying no more than fair market value for needed and legitimate services. A growing number of countries around the world are adopting laws that require companies to make public the level of funding they provide to HCPs and HCOs, such as for research and consulting. Amicus is committed to complying with such transparency laws and with the transparency codes of the pharmaceutical industry associations of which it is a member.
CALIFORNIA DECLARATION OF COMPLIANCE
Amicus Therapeutics Inc. (“Amicus”) is committed to complying with all applicable laws, regulations and industry standards. Amicus has developed a Comprehensive Compliance Program in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the U.S. Department of Health and Human Services Office of Inspector General in April 2003 (OIG Guidance) and includes policies consistent with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code). For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, Amicus has established a specific annual aggregate dollar limit of $1,500 on gifts, promotional materials, or items or activities that Amicus may give or otherwise provide to an individual medical or healthcare professional in California on an annual basis from January 1st to December 31st. Such items or activities primarily include: medical reprints that provide an educational benefit or are related to the healthcare professional’s practice; modest meals associated with a substantive discussion of a Company product or a disease state; and other items or activities permitted under the PhRMA Code and/or the OIG Compliance Guidance. These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for healthcare professionals to assist in making clinical or other medical judgments. This limit may be revised from time to time, in which case the revised limit will be published in this section of the Company websites. This limit represents a spending cap, not a goal or average; in many cases, the amount spent per physician may be substantially less than the cap amount. The Company monitors interactions to help ensure compliance with the annual spending limits in California.
The annual limits do not include the following:
- Drug samples given to physicians and healthcare professionals
- Financial support for continuing medical education forums
- Financial support for health educational scholarships
- Payments for legitimate professionals services, and any meals or expenses associated with the provision of such services
- Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition
Based on a good faith understanding of the requirements of Section 119402 of the California Health & Safety Code, Amicus Therapeutics Inc. hereby declares that, to the best of its knowledge, its Comprehensive Compliance Program addresses the California statutory requirements for inclusion of policies addressing the OIG Guidance and PhMRA Code and limits on gifts and incentives to health professionals. Subject to the above, Amicus also hereby declares that it is in compliance with its Comprehensive Compliance Program.
Reporting a Concern
At Amicus, we believe that speaking up is crucial to our culture and to our long-term sustainability. It is a living example of our values. When something doesn’t seem right, speaking up shows integrity and the courage to do the right thing. It helps prevent mistakes and misconduct, while also promoting continuous improvement. It is because we care about our employees, patients, customers, and business partners that we take reporting concerns so seriously.
To report a concern, please click on the following link, which will take you to our EthicsPoint hotline site. Your report can be made on a totally confidential and anonymous basis. You have our guarantee that your comments will be heard.