|
REFERENCE TITLE: prescription medication; disclosure requirements |
|
State of Arizona House of Representatives Forty-ninth Legislature Second Regular Session 2010
|
|
HB 2705 |
|
|
|
Introduced by Representative Chabin
|
AN ACT
AMENDING title 36, Arizona Revised Statutes, by adding chapter 38; relating to prescription medication disclosure requirements.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Title 36, Arizona Revised Statutes, is amended by adding chapter 38, to read:
CHAPTER 38
PRESCRIPTION MEDICATION DISCLOSURE REQUIREMENTS
ARTICLE 1. GENERAL PROVISIONS
36‑3801. Definitions
In this chapter, unless the context otherwise requires:
1. "Bona fide clinical trial" means any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause and effect relationship between a medical intervention and a health outcome.
2. "Gift" means food, entertainment or travel, or a payment, honorarium, subscription, advance, service or product sample or anything of value, unless consideration of equal or greater value is received. Gift includes anything of value provided to a health care practitioner for less than market value.
3. "Health care practitioner" or "practitioner" means:
(a) A person who is licensed or certified pursuant to this title and who is authorized within that person's scope of practice to prescribe prescription drugs for any person.
(b) A partnership or corporation made up of health care practitioners.
(c) An officer, employee, agent or contractor of a health care practitioner or of a health care practitioner's partnership or corporation who is acting in the course and scope of that person's employment, agency or contract that is related to or supportive of the provision of health care to individuals.
4. "Labeler" means a person or entity that:
(a) Receives prescription drugs or biologics from a manufacturer or wholesaler.
(b) Repackages the drugs or biologics for later resale.
(c) Has a labeler code from the United States food and drug administration pursuant to 21 Code of Federal Regulations section 207.20.
5. "Manufacturer" means a person who is engaged in the manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, distributing or labeling of prescription drugs, biologics or medical devices.
6. "Marketing" means any of the following:
(a) Advertising, publicizing, promoting or selling a prescription drug, biologic or medical device through any medium or method, including electronic and Internet means.
(b) Activities undertaken for the purpose of influencing the market share of a prescription drug, biologic or medical device, or the prescribing patterns of a prescriber, a detailing visit or a personal appearance.
(c) Activities undertaken to evaluate or improve the effectiveness of a sales force.
(d) A brochure, media advertisement or announcement, poster or free sample of a prescription drug, biologic or medical device.
7. "Medical device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, that is:
(a) Recognized in the official national formulary or the United States pharmacopeia, or any supplement to the pharmacopeia.
(b) Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals.
(c) Intended to affect the structure or any function of the body of man or other animals, that does not achieve its primary intended purposes through chemical action in or on the body of man or other animals and that is not dependent on being metabolized for the achievement of its primary intended purposes.
8. "Person" means a business, individual, corporation, union, association, firm, partnership, committee or other organization or group of persons.
9. "Prescribed product" includes a drug or device as defined in the federal food, drug, and cosmetic act (21 United States Code section 321) and a biological product as defined in the public health service act (42 United States Code section 262).
10. "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.
(b) Offers continuing medical education credit, features multiple presenters on scientific research or is authorized by the sponsoring association to recommend or make policy.
11. "State health care program" means a program for which this state purchases pharmaceuticals, biologics or medical devices.
36‑3802. Gifts to health care practitioners; prohibition; exemptions
A. It is unlawful for any manufacturer or wholesale drug, biologic or medical device distributor who participates in a state health care program to offer or give any gift, fee, payment, subsidy or other economic benefit to a health care practitioner.
B. The following are excluded from the prohibition in subsection A of this section if they are disclosed pursuant to section 36‑3803:
1. Payment to the sponsor of a significant educational, scientific or policy-making conference or seminar if:
(a) The payment is not made directly to a health care practitioner.
(b) Funding is used solely for bona fide educational purposes.
(c) All activities are objective, free from industry influence and do not promote specific products.
2. Reasonable honoraria and payment of the reasonable expenses of a health care practitioner who serves on the faculty at a bona fide significant educational, scientific or policy-making conference or seminar if:
(a) There is an explicit contract with specific deliverables that are restricted to scientific issues and not marketing efforts.
(b) The content of the presentation, including slides and written materials, is determined by the health care practitioner.
3. Compensation for the substantial professional or consulting services of a practitioner in connection with a bona fide clinical trial if there is an explicit contract with specific deliverables that are restricted to scientific issues and not marketing efforts.
36‑3803. Disclosure of exempted gifts; fee
A. On or before July 1 of each year, a manufacturer of prescription drugs, biologics or medical devices that participates in a state health care program must disclose to the department of health services the value, nature, purpose and recipient of each gift, fee, payment, subsidy or other economic benefit that is not prohibited pursuant to section 36‑3802 and that is provided by the company, directly or through its agents, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or other person in this state who is authorized to prescribe, dispense or purchase prescription drugs, biologics or medical devices in this state. For each expenditure, the company must also identify the recipient and the recipient's address, credentials, institutional affiliation and state board or drug enforcement administration numbers.
B. Each company that is subject to the requirements of this section must also disclose to the department the name and address of the individual responsible for the company's compliance with this section, or if this information has been previously reported, any changes to the name or address of that individual.
C. Disclosure reports must be accompanied by payment of a fee prescribed by the department by rule to pay the costs of administering this section.
D. Disclosure reports submitted pursuant to this section are open to public inspection. The department shall make disclosure reports available and easily searchable on its website.
36‑3804. Advertising and marketing expenditure reporting;fee
A. On or before July 1 of each year, every manufacturer of prescription drugs, biologics or medical devices that participates in a state health care program must submit to the department of health services a report on advertising and marketing expenditures.
B. The report must be in the form and manner provided by the department and accompanied by a fee prescribed by the department by rule.
C. The annual report required by this section must include the following information as it pertains to marketing activities conducted in this state in a form that provides the value, nature, purpose and recipients of the expense:
1. Information on gifts disclosed pursuant to section 36‑3803.
2. All other expenses, whether direct or indirect, associated with advertising, marketing and promotion of prescription drugs, biologics and medical devices, including:
(a) Expenses associated with radio, television, magazines, newspapers, direct mail and telephone communications as they pertain to residents of this state, including a reasonable estimate of the value of expenses associated with advertising purchased for a regional or national market that includes advertising in this state.
(b) Any other expenses relating to the indirect promotion of prescription drugs, biologics and medical devices, including:
(i) Support of independent or continuing medical education programs, including payments to medical education companies.
(ii) Design, printing and production costs of patient education materials and disease management materials distributed in this state.
(iii) Consulting fees and expenses, participation in speakers' bureaus and honoraria or other payments for time while speaking at or attending meetings, lectures or conferences.
(iv) Writing articles or publications.
(v) Charitable grants, either directly or earmarked, even if unrestricted.
(vi) Product samples, if allowed.
(vii) Market research surveys or other activities undertaken in support of developing advertising or marketing strategies, or both.
(c) The aggregate cost of all employees or contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed in subdivisions (a) and (b) including all forms of payment to those employees. The cost reported under this subdivision must reflect only that portion of payment to employees or contractors that pertains to activities in this state or to recipients of the advertising or promotional activities who are residents of or are employed in this state.
D. Each company that is subject to this section must also disclose to the department the name and address of the individual who is responsible for the company's compliance with this section, or if this information has been previously reported, any changes to the name or address of that individual.
36‑3805. Report
On or before August 1 of each year, The department of health services shall submit a written report to the governor, the president of the senate and the speaker of the house of representatives and shall provide a copy of this report to the secretary of state. The report shall include information on the following:
1. Gifts required to be disclosed under section 36‑3803, in aggregate form and by selected types of prescribers or individual prescribers, as prioritized each year by the department, and analyzed to determine whether prescribing patterns by these prescribers of prescription drugs, biologics or medical devices reimbursed by the Arizona health care cost containment system administration or other state health care programs may reflect manufacturer influence.
2. All marketing activities, whether direct or indirect, including the scope of prescription drug, biologics and medical device marketing activities and expenses and their effect on the cost, utilization and delivery of health care services and any recommendations with regard to marketing activities of prescription drug, biologics and medical device manufacturers and labelers.
3. Violations and enforcement actions brought pursuant to this chapter.
36‑6806. Public records
A. The reports required to be submitted pursuant to sections 36‑3803 and 36‑3804, and the data and report compiled by the department of health services pursuant to section 36‑3805, are public records.
B. Notwithstanding any other law, information relating to the identity of health care practitioners and other recipients of gifts, payments and materials required to be reported pursuant to this chapter is not confidential information and is not a trade secret.
36-3807. Enforcement; injunctive relieve; civil penalty
The department of health services may bring an action for injunctive relief, costs and attorney fees and may impose a civil penalty of not more than ten thousand dollars for each violation of this chapter.
36‑3808. Prescriber education service; report; rules
A. The department of health services shall develop an evidence-based prescription education service designed to provide health care professionals who are licensed to prescribe or dispense prescribed products with information and education on the comparative efficacy, safety and cost‑effectiveness of commonly used prescribed products. In designing the service, the department shall consult with appropriate health care professionals or organizations knowledgeable about the practice of medicine and continuing medical education.
B. The education service developed pursuant to subsection A must include in-person outreach and education sessions to health care professionals in their place of work that are facilitated by qualified and appropriately trained clinician-educators. The education service sessions must be conducted on a one-to-one basis, whenever practicable, and must be available to health care professionals who participate in, contract with or are reimbursed by state health care programs. The education service may also provide education to other health care professionals free of charge if sufficient funding is available or for a fee prescribed by the department by rule.
C. The educational materials used by the education service must be based on a balanced and comprehensive review of evidence that is accepted in the practice of medicine, including scientific research that conforms to the generally accepted standards of experimental design, data collection, analysis and interpretation to provide unbiased continuing education on the comparative efficacy, safety and cost-effectiveness of medications. The education service may use materials that meet criteria developed by a medical school, academic medical center, school of pharmacy, medical society, research institute or other publicly sponsored prescriber education service.
D. The education service must establish:
1. Minimum clinical and educational qualifications for prescriber educators employed by or under contract with the service.
2. Required training for educators.
3. A code of conduct governing the behavior of educators in their interactions with health care professionals and establishing conflict of interest guidelines for educators and others involved in advising, developing and administering the service.
E. The department may seek grants and financial gifts from nonprofit charitable foundations to cover the planning, development and ongoing operation of the education service.
F. On or before January 1 of each year, the department shall submit a written report on the development of the education service to the governor, the president of the senate and the speaker of the house of representatives and shall provide a copy of this report to the secretary of state.
G. The department may adopt rules to enforce this section.
36‑3809. Program termination
The program established by this chapter ends on July 1, 2020 pursuant to section 41‑3102.