AMRYT COMPLIANCE INFORMATION

1. Compliance Reporting & Hotline Information

Questions, comments, and incidents pertaining to a suspected violation of Amryt policy, law or regulation, or ethical standards may be reported via the means listed below.  The web portal and telephone Helpline are supported by a third party, and are available 24 hours per day, 7 days per week.  Anonymity is available for all reporting methods where allowed by local law.

Do not use the Compliance resources to report issues pertaining to Human Resource complaints (e.g. harassment, bullying, employment matters), request medical information, to report Adverse Events, or to report Product Complaints.  Please see the information at the bottom of this page for assistance finding the proper recipient for such matters.

By Mail
Chief Compliance Officer
Amryt Pharma, plc
160 Federal Street
Floor 21
Boston, MA 02110

By email
Please direct any questions to compliance.us@amrytpharma.com

Report online
To report on line, please use this link: Online Reporting

By Phone
Please use this number to report to our third-party vendor (available 24/7/365)
(North America) 855-233-8089

2. Open Payments: US Federal Transparency Disclosures

Introduction

Close collaboration between Health Care Professionals (HCPs), Health Care Organizations (HCOs) and the pharmaceutical industry is a regular practice that allows drug developers’ access to the knowledge necessary to create lifesaving medicines. In turn, the HCP/HCO community has both the opportunity to influence options available to patients, and obtain knowledge regarding the latest care and treatment. Be it through clinical research, advisory boards, medical education programs, or collaboration on lifesaving medicines – sharing knowledge to improve the lives of patients is the cornerstone of all interactions.

Types of Payments

Amryt may choose to remunerate HCPs and HCOs by differing means, depending on the services provided, and the entity providing those services.  Types of payments may include any of the following:

  • Cash or cash equivalent
  • In-kind items or services
  • Stock, stock options, ownership interests, dividends, profits, or other return on investments
  • Any other form of payment or other transfer of value

Payments may be made for a variety of services, which CMS categorizes as the Nature of Payments.  Amryt has reported transfers of value for the following reasons (grouped by CMS-defined Natures):

  • Charitable Contributions
  • Compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program
  • Compensation for serving as faculty or as a speaker for a non-accredited and noncertified continuing education program
  • Consulting Fees
  • Current or Prospective Ownership or Investment Interests
  • Education
  • Food and Beverage
  • Grants
  • Research
  • Space Rental or Facility Fees
  • Travel & Lodging

Use of the CMS Open Payments Database

The Open Payments Data website can be accessed via the links within this section or directly at (https://openpaymentsdata.cms.gov/).  Users are encouraged to familiarize themselves with the CMS-provided system documentation, such as The Open Payments User Guide, or Using The Open Payments Search Tool: A Quick Guide. Users may obtain and query the full dataset, or use the online Search Tool (https://openpaymentsdata.cms.gov/search/) to view reported payments made to Covered Recipients.

Open Payments has provided the following instructions to assist users in searching the data:

  • For physician data, search from the home page:
    • Enter a First Name and/or Last Name in the search boxes, and click Search.
    • When the results screen appears, click on the Physician Name link you wish to review.
    • A profile screen will display summary level information, as well as specifics by payment type and year.
    • Use the Search Tool to search by additional criteria.
  • For teaching hospital or company data, use the Search Tool:
    • Choose the appropriate option for a Teaching Hospital or Company
    • Enter information in the search boxes (Hospital/Company name, city, state, zip/postal code) and click Search.
    • On the results screen, click on the link for the one you would like to review.
    • A profile screen will display summary level information, as well as specifics by payment type

THE OPEN PAYMENTS DATA AND SYSTEM ARE NOT OWNED, MAINTAINED, CONTROLLED, OR OTHERWISE ASSOCIATED, IN ANY WAY, WITH AMRYT PHARMA, ITS EMPLOYEES, OR AGENTS.  AMRYT ASSUMES NO LIABILITY FOR ANY DAMAGES THAT MAY RESULT FROM THE USE OF THE OPEN PAYMENTS DATA WEBSITE, AND / OR DATA CONTAINED THEREIN.

Additional US Transparency & Disclosure Reporting

  • State mandated disclosure requirements that are substantively similar or identical to those required by Open Payments are preempted. Amryt complies with all state requirements in which it conducts business.
  • Amryt has established a Comprehensive Compliance Program in compliance with the requirements of the California Health and Safe Code §§ 119400-119402.  The Compliance Program is in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers” from the United States Department of Health and Human Services Office of the Inspector General and includes policies consistent with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code).

    The purpose of the Compliance Program is to prevent and identify any potential violations of law or company policy.  Although the implementation of the program cannot guarantee that individual employees will not deviate from the policies and standards stated in the Compliance Program, Amryt has established procedures to investigate, take disciplinary action, and implement corrective measures as necessary.

    A copy of Amryt’s Comprehensive Compliance Program and this declaration can be obtained by emailing compliance.us@amrytpharma.com.
  • Section 6004 of the PPACA, Prescription Drug Sample Transparency, further amended the Social Security Act by adding section 1128H, Reporting Of Information Relating To Drug Samples, to Title XI. This sets forth the requirements and process for the disclosure of information pertaining to drug and product samples to the FDA, and entered effect on April 01, 2012. Amryt complies with all requirements under 1128H.
  • Pursuant to the Corporate Integrity Agreement implemented as part of Aegerion’s 2017 settlement with the United States and applicable states, a complete listing and description of grant support can be found below.

*Payments made during this year were by “Aegerion Pharmaceuticals, INC”. Aegerion was acquired by Amryt Pharma on September 25, 2019.

Please direct any questions to compliance.us@amrytpharma.com

3. PATIENT ORGANISATION TRANSPARENCY DISCLOSURES

In addition to partnering with HCPs and HCOs, Amryt also engages with patient organizations as they often provide a unique perspective and knowledge that assist us in furthering our goals of creating innovative new treatments. These interactions help us to improve the lives of our patients and are especially critical given the rare and orphan nature of many of the diseases we seek to treat.

In the spirit of acting responsibly and with integrity, we provide transparency of the financial support we provide to these patient organizations.  Further, to support our strong foundation of conducting business ethically, we are committed to respecting the independence of these organizations and their important work.

All financial support given to Patient Organizations in Europe can be accessed below.

*Payments made during this year were by “Aegerion Pharmaceuticals, INC”. Aegerion was acquired by Amryt Pharma on September 25, 2019.

4. GLOBAL TRANSPARENCY DISCLOSURES

All financial support given to HCPs and HCOs in Europe can be accessed below.

CountryReport DisclosureMethodological Notes

BELGIUM

REPORT 2019*
REPORT 2018*
METHODOLOGICAL NOTE 2019
METHODOLOGICAL NOTE 2018

FRANCE

REPORT 2019*
REPORT 2018*
N/A
N/A

GERMANY

REPORT 2019*
REPORT 2018*
METHODOLOGICAL NOTE 2019
METHODOLOGICAL NOTE 2018

UK

REPORT 2019*
REPORT 2018*
METHODOLOGICAL NOTE 2019
METHODOLOGICAL NOTE 2018

*Payments made during this year were by “Aegerion Pharmaceuticals, INC”. Aegerion was acquired by Amryt Pharma on September 25, 2019.