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) 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 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 Health Care Providers 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.

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 here.

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

AMRYT GRANTS DISCLOSURE

The table below contains information pertaining to Grants that are subject to disclosure pursuant to the CIA, including the name of the recipient, the name of the program funded, a brief description thereof, and the amount of the grant.

RecipientProgram NameProgram DescriptionGrant Amount
2019*
Mayo ClinicGenetics of Heart and Vascular DiseaseSupport for CME Education$10,000
National Lipid Association2019 Fall Clinical Lipid UpdateSupport for CME Education$25,000
2018*
Regents of the University of MichiganSupport for Lipodystrophy 2018A Satellite Symposium and SOLID Development$100,000
Mayo ClinicContinuing Medical EducationCME: Genetics of Heart and Vascular Disease$10,000
Endocrine SocietyENDO 2018Support for CME Lipid Sessions$35,000
National Lipid AssociationNLA AssessmentDevelopment and Implementation of NLA Assessment$102,162
2017*
American Heart AssociationScientific Sessions 2017Dedicated Track on Diabetes, Lipids, and Metabolic Syndrome$10,000
The Familial Hypercholesterolemia FoundationFH Global Summit SupportSupport for Japanese HCPs to attend 2017 FH Global Summit$14,000
The Familial Hypercholesterolemia FoundationFH Global Summit SupportSupport for Japanese HCPs to attend 2017 FH Global Summit$2,200

*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. Global Transparency Disclosures

In addition to partnering with healthcare professionals and healthcare organizations, 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.

RecipientCountryProgram DescriptionGrant Amount (Currency)
Association Robert Debré pour la Recherche MédicaleFranceSponsorship of PRISIS Day on 12 December 20198,000 EUR
EURORDIS – Rare Diseases EuropeFrance2019 Membership fees5,000 EUR
Associazione Italiana LipodistrofieItalyCompensation for delivery of a presentation (co-shared) during the EMEA Kick-off Meeting on 28 February 2019900 EUR
Teseo SrlItalyGrant funding for HCP training at Pisa Hospital on Theoretical-Practical Course on Lipodystrophy15,198 EUR
AELIP (International Association of Relatives and People Affected by Lipodystrophy)Spain2019 Support30,000 EUR
AELIP (International Association of Relatives and People Affected by Lipodystrophy)SpainSponsorship for the ECLIP meeting in Burgos, Spain, on 4 & 5 October 201910,000 EUR
AELIP (International Association of Relatives and People Affected by Lipodystrophy)SpainSponsorship for the organisation of “VII International Symposium of Lipodystrophies” in Burgos, Spain, on 5 October 20198,000 EUR
Genetic Alliance (RDUK)UK2019 Six-month membership fees5,500 GBP
Lipodystrophy UKUKCompensation for delivery of a presentation (co-shared) during the Satellite Symposium held at the annual 2019 ECE Congress1,025 GBP