Compliance

 California Statement of Compliance

California Health & Safety Code, Sections 119400 – 119402, (California Compliance Law) requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”) developed by the United States Department of Health and Human Services Office of Inspector General (OIG) and policies for compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) “Code on Interactions with Health Care Professionals” (PhRMA Code) within six months of any update or revision of the PhRMA Code.

HLS Therapeutics (USA), Inc. (HLS) has established a Compliance Program in accordance with the OIG Compliance Guidance and have policies in place to foster compliance with the PhRMA Code for their pharmaceutical businesses. For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, HLS has established a specific annual aggregate dollar limit of $2,500 on gifts, promotional materials, or items or activities that HLS may give or otherwise provide to an individual medical or healthcare professional in California. This cap is not an average or representative of a typical transaction, rather it is only intended to be an absolute maximum with respect to these specific items.

Without limitation, this cap does not include:

  • Sample Products to be Distributed to Patients
  • Fair Market Compensation for Legitimate Professional Services Rendered
  • Funding to Support Continuing Medical Education

Finally, the California Compliance Law requires pharmaceutical companies to make an annual written statement of their compliance with their own compliance program. HLS has designed and developed its Compliance Program, as well as associated monitoring mechanisms to ensure compliance therewith, to be adequate for the size and scope of its operations. HLS declares that to the best of its knowledge it is in compliance with the standards required by its own Compliance Program. As recognized by the OIG Compliance Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that HLS has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program.

2016A0609

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