§ 4631a - Gifts by manufacturers of prescribed products
§ 4631a. Gifts by manufacturers of prescribed products
(a) As used in this section:
(1) "Allowable expenditures" means:
(A) Payment to the sponsor of a significant educational, medical, scientific, or policy-making conference or seminar, provided:
(i) the payment is not made directly to a health care provider;
(ii) funding is used solely for bona fide educational purposes; and
(iii) all program content is objective, free from industry control, and does not promote specific products.
(B) Honoraria and payment of the expenses of a health care professional who serves on the faculty at a bona fide significant educational, medical, scientific, or policy-making conference or seminar, provided:
(i) there is an explicit contract with specific deliverables which are restricted to medical issues, not marketing activities; and
(ii) the content of the presentation, including slides and written materials, is determined by the health care professional.
(C) For a bona fide clinical trial:
(i) gross compensation for the Vermont location or locations involved;
(ii) direct salary support per principal investigator and other health care professionals per year; and
(iii) expenses paid on behalf of investigators or other health care professionals paid to review the clinical trial.
(D) For a research project that constitutes a systematic investigation, is designed to develop or contribute to general knowledge, and reasonably can be considered to be of significant interest or value to scientists or health care professionals working in the particular field of inquiry:
(i) gross compensation;
(ii) direct salary support per health care professional; and
(iii) expenses paid on behalf of each health care professional.
(E) Payment or reimbursement for the reasonable expenses, including travel and lodging-related expenses, necessary for technical training of individual health care professionals on the use of a medical device if the commitment to provide such expenses and the amounts or categories of reasonable expenses to be paid are described in a written agreement between the health care provider and the manufacturer.
(F) Royalties and licensing fees paid to health care providers in return for contractual rights to use or purchase a patented or otherwise legally recognized discovery for which the health care provider holds an ownership right.
(G) Other reasonable fees, payments, subsidies, or other economic benefits provided by a manufacturer of prescribed products at fair market value.
(2) "Bona fide clinical trial" means an FDA-reviewed clinical trial that constitutes "research" as that term is defined in 45 C.F.R. § 46.102 and reasonably can be considered to be of interest to scientists or health care professionals working in the particular field of inquiry.
(3) "Clinical trial" means any study assessing the safety or efficacy of prescribed products administered alone or in combination with other prescribed products or other therapies, or assessing the relative safety or efficacy of prescribed products in comparison with other prescribed products or other therapies.
(4) "Gift" means:
(A) Anything of value provided to a health care provider for free; or
(B) Any payment, food, entertainment, travel, subscription, advance, service, or anything else of value provided to a health care provider, unless:
(i) it is an allowable expenditure as defined in subdivision (a)(1) of this section; or
(ii) the health care provider reimburses the cost at fair market value.
(5)(A) "Health care professional" means:
(i) a person who is authorized to prescribe or to recommend prescribed products and who either is licensed by this state to provide or is otherwise lawfully providing health care in this state; or
(ii) a partnership or corporation made up of the persons described in subdivision (i) of this subdivision (5)(A); or
(iii) an officer, employee, agent, or contractor of a person described in subdivision (i) of this subdivision (5)(A) who is acting in the course and scope of employment, of an agency, or of a contract related to or supportive of the provision of health care to individuals.
(B) The term shall not include a person described in subdivision (A) of this subdivision (5) who is employed solely by a manufacturer.
(6) "Health care provider" means a health care professional, a hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to dispense or purchase for distribution prescribed products in this state.
(7) "Manufacturer" means a pharmaceutical, biological product, or medical device manufacturer or any other person who is engaged in the production, preparation, propagation, compounding, processing, packaging, repacking, distributing, or labeling of prescribed products. The term does not include a wholesale distributor of biological products or a pharmacist licensed under chapter 36 of Title 26.
(8) "Marketing" shall include promotion, detailing, or any activity that is intended to be used or is used to influence sales or market share or to evaluate the effectiveness of a professional sales force.
(9) "Pharmaceutical manufacturer" means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, whether directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs. The term does not include a wholesale distributor of prescription drugs or a pharmacist licensed under chapter 36 of Title 26.
(10) "Prescribed product" means a drug or device as defined in section 201 of the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321, or a biological product as defined in section 351 of the Public Health Service Act, 42 U.S.C. § 262.
(11) "Significant educational, scientific, or policy-making conference or seminar" means an educational, scientific, or policy-making conference or seminar that:
(A) is accredited by the Accreditation Council for Continuing Medical Education or a comparable organization; and
(B) offers continuing medical education credit, features multiple presenters on scientific research, or is authorized by the sponsoring association to recommend or make policy.
(b)(1) It is unlawful for any manufacturer of a prescribed product or any wholesale distributor of medical devices, or any agent thereof, to offer or give any gift to a health care provider.
(2) The prohibition set forth in subdivision (1) of this subsection shall not apply to any of the following:
(A) Samples of a prescribed product provided to a health care provider for free distribution to patients.
(B) The loan of a medical device for a short-term trial period, not to exceed 90 days, to permit evaluation of a medical device by a health care provider or patient.
(C) The provision of reasonable quantities of medical device demonstration or evaluation units to a health care provider to assess the appropriate use and function of the product and determine whether and when to use or recommend the product in the future.
(D) The provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function provided to a health care provider for the benefit of patients.
(E) Scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association.
(F) Rebates and discounts for prescribed products provided in the normal course of business.
(G) Labels approved by the federal Food and Drug Administration for prescribed products.
(c) The attorney general may bring an action in Washington superior court for injunctive relief, costs, and attorney's fees and may impose on a manufacturer that violates this section a civil penalty of no more than $10,000.00 per violation. Each unlawful gift shall constitute a separate violation. (Added 2009, No. 59, § 3.)