Life Science Compliance Update

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January 15, 2018

Maine Updates Their Gift to Physicians Law Online

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Maine has posted a revised version of their gifts to physicians law which bans cash payments from pharmaceutical manufacturers, wholesalers agents for research, consulting, promotional speaking related payments but exempts educational materials, modest meals, prescription drug samples, honorarium at educational events and education-related funding to institutions.

We have previously written about the Maine Legislature passing a new law to prohibit gifts from industry to health care practitioners.

On November 1, 2017, the law went into effect and can now be found online for reference.

For a refresher, the law amends the Maine Pharmacy Act to prohibit a person engaged in the manufacture of prescription drugs or a person who buys prescription drugs for resale and distribution to persons other than consumers from giving a gift to an individual who is licensed, registered or otherwise authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of that individual's professional practice.

However, some significant changes seem to be made to the version listed on the Maine legislative site. Whereas previously there was a list of seven items specifically excluded from the bill, the final legislation does not include that same list.  Instead, the law prohibits manufacturers or wholesalers from offering or giving cash gifts in any amount of a gift for which reciprocity is expected or implied to a health care practitioner.

Further, the list of exceptions has shrunk to a handful. The exceptions include:

  • Giving noncash items of minimal value that will directly benefit the practitioner’s patients including:
    • Prescription drug samples for distribution to patients,
    • Educational materials
  • Modest meals and refreshments that are provided in connection with a meeting or presentation about the benefits, risks and appropriate uses of prescription drugs or medical devices, as long as the meeting or presentation occurs in a venue and manner conducive to informational communications;
  • Giving funding to an academic institution, residency program, or and fellowship program to support the participation of medical, nursing, physician assistant, veterinarian and pharmacy students, residents and fellows in professional meetings, including educational meetings, as long as the program identifies such funding recipients based on independent institutional criteria and the funds are distributed to recipients without specific attribution to sponsors;
  • Giving reasonable honoraria to a practitioner and making payment of reasonable expenses of a practitioner at a professional or educational conference or meeting.

We also recently reviewed the Maine Office of Professional and Occupational Regulation (OPOR) Regulatory Agenda to get a status update. The agenda notes that the Maine Board of Pharmacy expects to get involved in rule-making activity on the topic in 2017-2018.

From the Agenda,

Rulemaking activity is currently under consideration for purposes of implementing 2017 Public Law Chapter 249 to establish procedures and standards to Board-certify a pharmacist to prescribe naloxone hydrochloride and procedures and standards on the dispense naloxone hydrochloride (see chapter 40 below). The Board may consider rulemaking for purposes of implementing 2017 Public Law Chapter 267 on appropriateness of certain gifts extended by manufacturers or wholesale distributors to health care practitioners for which is major substantive rulemaking. In addition, the Board is expected to review rules overall streamlining, to ensure compliance with current laws, and to update rules by addressing outdated references, providing clarification of certain rules as necessary, and setting licensing requirements and operating standards for newly identified types of retail pharmacies.

While most of us like to be prepared and work hard to ensure full compliance with all laws, with no guidance or rule adoption of these laws, companies cannot be found in violation of the laws. Therefore, you still have time to comply while preparing your company for the laws once they take effect.

This change of language has no exemption for research or consulting. We encourage you to review the rules in their entirety to determine what changes if any, your company needs to take.

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