An Act To Restrict Gifts to Health Care Practitioners from Pharmaceutical and Medical Device Manufacturers
Maine Legislature, Session 124, LD 1262
Committee: Health and Human Services
Sponsors: TREAT, MARTIN, MILLER, PERRY, WEBSTER, SIMPSON
Amends: 22 MRSA §2697, 22 MRSA §2698-A, 22 MRSA §2698-C, 22 MRSA §2700-A

MAINE STATE LEGISLATURE 
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124th MAINE·LEGISLATURE 
FIRST P...EGULAR SESSION-2009 
Legislative Document 
No. 1262 
H.P.881 
House of Representatives, March 31, 2009 
An Act To Restrict Gifts to Health Care Practitioners from 
Pharmaceutical and Medical Device Manufacturers 
Reference to the Committee on Health and Human Services suggested and order~d printed. 
Presented by Representative TREAT of Hallowell. 
?I/l-~ 1n· 17!1I£;:fdt2fi14{ 
MILLICENT M. MacFARLAND 
Clerk 
Cosponsored by Representatives: MARTIN of Eagle Lake, MILLER of Somerville, PERCY.of 
Phippsburg, PERRY of Calais, STUCKEY ofPOliland, WEBSTER of Freeport; Senator: 
SIMPSON of Androscoggin. 
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l'rinlcJ tIn rt:cyded pilpt:r 
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Be it enacted by the People of the State of Maine as follows: 
Sec. 1. 22 MRSA §2697, s'ub-§l, as enacted by PL 1999, c. 786, Pt. A, §3, is 
amended to read: 
1. Definitions. As used in this subchapter, unless the contt:xt othenw.ist:, indi~ates;, 
the following terms have the following meanings. 
A. 
"Labeler" means an entity or person that receives IP-rescription drugs from a 
manufacturer or wholesaler and repackages those drugs, f<Dr later retail sale and that 
has a labeler code from the federal F God and Drug Administration under 21 Code of 
Federal Regulations, 207.26 (1999):. 
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A-I. "Health care practitione!" means a person who is licensed in the State to, 
provide health care and prescribe prescription drugs, including an organization 
consisting of persons licensed in the State to provide health care and prescribe 
prescription drugs and an employee, agent or contractor of a person licensed to 
provide health care in the State and to prescribe prescription drugs. 
B. 
"Manufacturer" means a manufacturer of person who manufactures, prepares, 
propagates, compounds, processes, packages, repackages, distributes or labels 
prescription drugs and includes a subsidiary or affiliate of a manufacturer. 
C. 
"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 recognized in the official United States 
Pharmacopeia and National Formulary or accessory issued by the United States 
Pharmacopeial Convention and is intended: 
(1) For use' in the diagnosis of disease or other conditions or in the cure, 
mitigation, treatment or prevention of disease in a human being or animal; or 
(2) To affect the structure or any function of the body of a human being or 
animal and does not achieve its primary intended purpose by being metabolized 
or through chemical action within or on the body of the human being or animal. 
D. "Prescription drugs" means pharmaceuticals, biologics or medical devices. 
E. "State health care program" means a health care program for which the State 
purchases prescription,drugs, including but not limited to Medicaid. 
Sec. 2. 22 MRSA §2698-A, as amended by PL 2005, c. 286, § § 1 and 2, is further 
amended to read: 
§2698-A. Marketing costs 
A manufacturer or labeler of prescription drugs dispensed in this State that employs, 
directs or utilizes marketing repres'entatives in this State shall report marketing costs for 
prescription drugs in this State as provided in this section. 
1. Purposes. Marketing costs for prescription drugs in this State must be reported to 
the department for the purposes, of assisting this State in }ts role as a purchaser of 
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prescription drugs and an administrator of prescription drug prograrns, enabling this State 
to determine the scope of prescription drug marketing costs and their effect on the cost, 
utilization and delivery of health care services and furthering the role of this State as 
guardian of the public interest. 
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2. Definitions. As used in this section, unless the context otherwise indicates, the 
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following terms have the following meanings. 
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"Labeler" has the same meaning as provided in section .2697, subsection 1 . 
B. 
"Manufacturer" has the same meaning as provided in section 2697, subsection 1. 
C. 
"Marketing" means advertising and promotional activities,· including, but 'not 
limited to, the activities described in subsection 4. an activity undertaken or materials 
or products made available to a health care practitioner or to the general public 
related to the transfer of prescription drugs from the manufacturer or seller to the 
consumer or buyer, including: 
(1) Advertising, publicizing, promoting or selling through any media or method 
including electronic and Internet means; . 
(2) A detailing visit or a personal appearance for the purpose of influencing the 
market share or the prescribing patterns of a health care practitioner; 
(3) Activities undertaken to evaluate or improve the effectiveness 0f a saks 
force; or 
(4) A brochure, media advertisement or announcement, poster or free sample of 
a prescription drug. 
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3. Manner of reporting. Beginning in 2007, by July 1 sf each year, a manufacturer 
or labeler of prescription drugs that directly or indirectly distributes prescription drugs for 
dispensation to. residents of this State or participates in a state health care program shall 
file a report with the department in the fonn and manner provided by the department. 
The department shall require an Internet-based form that allows theinfonnation required 
by this subsection to be searched online by a consumer. The report must be accompanied 
by payment of a fee, as set by the depariment in rule, to support. the work of the 
department under this section. 
4. Content of annual report by manufacturer 01' labeler. The:annual report filed 
under subsection 3 must include the following infonnation for each .. calendar year, 
beginning with calendar year 2006, as it pertains to marketing activitics conducted within 
this State in a fonn that provides the value, nature, purpose and recipienLofthe expense: 
A. Allexperises, whether direct or indirect, associated with ad"rertiSing, marlrettng 
and direct promotion of prescription drugs through radio, tekvisiOl1, magazines, 
ne\vspapers, dircct mail and telephone communications as thcy:pcrtain to residents of 
this State, cxcept for e]cpenses associated 'lAth advertising purchasnd::foLaTegional or 
national market that includes advertising \vitlnn the State;~ 
(1) Advertising, marketing and direct promotion of-prescription;drugs through 
radio, 
television, 
magazines, 
newspapers, 
direct .q.mail·· ... :.mId .·telephone 
conununications as they pertain to residents of this State,.inclnBiiw:a::reasonable 
20. 
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estimate of the value of expenses associated with advertising purchased for a 
regional or national market that includes advertising within the State; 
(2) The indirect promotion of prescription drugs, including: 
(a) 
Support of anindepencient or continuing medical education program 
including payment to a medical education company; 
(b) Design, printing and production costs of patient education and disease 
management materials distributed within the State; 
(6) Consulting fees and expenses, participation in a speakers' bureau and 
honoraria or other payment for time whiiespeaking at or attending a meeting, 
lecture or conference; 
(d) Writing an article or publication; 
(e) A charitable grant, given either directly or through an earmark, even if 
unrestricted; 
(f) A product sample; and 
(g) A market research· survey or other activity undertaken in support of 
developing advertising or market strategies; and 
(3) Information reported under section 2698-C, subsectio~ 4; 
B. With regard to all persons and entities licensed to provide health care in this State, 
includIng health care professionals and persons employed by them in this State, 
carriers licensed under Title 24 or Title 24-A, health plans and benefits managers, 
. pharmacies, hospitals, nursing facilities, clinics and other entities licerised to provide 
health care under this Title, the following information: 
(1) 
All expenses associated with educational or informational progrmns, 
materials and seminars and remuneration for promoting or participating in 
educational or informational sessions, regardless of whether the manufacturer or 
labeler provides the educational or informatiorial sessions or materials; 
(2) 
All expenses associated with food, entertainment, gifts received in a 
calendar year that are valued in the aggregate at more than $25 and anything 
provided to a health care professional for less than market value; 
(3) All expenses associated with trips and travel; and 
(4) All expenses associated with product samples, eJwept for samples that vlill 
be distributed free of chare-a to patients; and 
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 
paragraphs A and B, including all forms of payment to those employees. The cost 
reported under this paragraph must reflect only that portion of payment to employees 
or contractors that pertains to activities within this State or to recipients of the 
advertising or promotional activities who are residents of or are employed in this 
State. 
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A person subject to tIlis subsection shall report to the department the name and address of 
the individual responsible for the person's compliance with this subsection or, if this 
information has already been reported to the department, a change to the name or address 
of the individual responsible for the person's compliance with this subsection. 
The 
individual named in this paragraph as responsible for the person's compliance with this 
subsection shall certify that the report required under tIlis section is complete and 
accurate. 
5. 
Exceptions. 
The following marketing expenses are not subject to the 
requirements of this section: 
A. Expenses of $25 or less; 
B. Reasonable compensation and reimbursement for expenses in connection with a 
bona fide clinical trial of a new vaccine, therapy or treatment; and 
C. 
Scholarships and reimbursement of expenses for attending a significant 
educational, scientific, medical or policy-making conference or .senlinar of a national, 
regional or specialty medical or other professional association if the recipient of the 
scholarship is chosen by the association sponsoring the conference or senlinar. 
6. Department reports. Beginning in 2007, by fu November 30th each year, the 
department shall provide an annual report, providing infonnation in aggregate fonn, on 
prescription drug marketing expenses to the Legislature and the Attorney General. By 
January 1, 2008 and every 2 years after that date, the department shall provide a report to 
the Legislature and the Attorney General, providing infonnation in aggregate fonn, 
containing the raw data and an analysis of the data subnlitted to the department under 
subsection 4, including the scope of prescription drug marketing activities and e)(penses 
and their effect on' the cost, ut,ilization and. delivery of health care services and any 
recommendations with regard to marketing activities of prescription drug manufacturers 
and labelers.~ 
A. Information disclosed under section 2698-C, subsection 4, which must be: 
(1) Presented on a per health care practitioner basis; 
(2Y Organized by selected types of health care practitioner as prioritized each 
year by the department; and 
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(3) 
Analyzed to deternline whether prescribing patterns by the health care 
practitioners of prescription drugs reimbursed by a state health care program may 
reflect manufacturer influence; 
B. The scope of prescription drug marketing and expenses and their effect on the 
cost, use and delivery of health care services and any recommendations with regard 
. to marketing by manufacturers and labelers; and 
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C. Information on violations and enforcement action under this section. 
The department must post a report required by this subsection on a publicly accessible 
portion of the department's 'website. 
7. Confidentiality; public information. Notwithstanding any provision of law to 
the contrary, information subnlitted to the department pursuant to this section is not 
confidential and is Heta public record as defined in Title 1, section 402, subsection 3. 
Disclosure may be made by the department to a eontraetor providing serviees to the 
department undfilr this seetion; however, that diselosure does not ehange the. eonfidential 
status of the inforrhation. Data eompiled in aggregate foRn by the department for the 
purposes of reporting required by this seetion is a publie reeord as defined in Title 1, 
seetion 402, subseetion 3, as long as it does not reveal trade infonnation that is proteeted 
bv state or federaiiav/. 
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8. Penalty. This section may be enforced in a civil action brought by the Attorney 
. General. A manufacturer or labeler that fails to provide a report as required by this . 
section commits a civil violation for which a fine of $1 ,000 plus costs and attorney's fees 
may be adjudged. 
9. Rulemaldng. The department ffiall may adopt rules to implement this section.· 
Rules adopted pursuant to this section are routirie technical rules as defi11ed in Title 5, 
chapter 375, subchapter 2-A. 
Sec. 3. 22 MRSA §2698-C is enacted to read: 
§2698-C. Gifts to practitioners 
1. Definitions. As used in this section, the following terms have the following 
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meanings. 
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A. 
"Bona fide clinical trial" means a research project that prospectively assigns 
human subj ects . to intervention and comparison groups to study the cause and effect 
relationship between a medical intervention and a health outcome. 
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B. "Gift" means anything of value provided to a health care practitioner for less than 
market value, including a payment, . food, enteliainment, travel, honorarium, 
subscription, advance or service, unless consideration of equal or greater value is 
received. "Gift" does not mean a product sample. 
C.· "Significant educational, sCientific, medical or policy-making conference or 
seminar " means an educational, scientific or policy-making conference or seminar 
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that offers continuing medical education credit, features multiple presenters on 
scientific research or is authorized by the sponsoring association to recommend or 
make policy and is accredited by the Accreditation Council for Continuing. Medical 
Education or a successor organization. 
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2. Gifts prohibited. Except for a gift under subsection 3 or a product sample under 
subsection 5, a manufacturer or wholesale prescription drug distributor who participates 
in a state health care program may not offer or give a gift, fee, payment, subsidy or other 
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economic benefit to a health care practitioner. 
3. . Exemptions. 
The following gifts are excluded from the prohibition under 
subsection 2: 
'A. Payment to a sponsor of a significant educational, scientific, medical or policy-
making conference or seminar at which: 
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(I) The payment is not made directly to a health care practitioner; 
(2) Funding is used solely for educational purposes; and 
(3) All activities are objective, free from industry influence and do not promote 
specific products; 
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B. Reasonable honoraria and payment of the reasonable expenses of a health care 
practitioner who serves on the faculty at a significant educatiomil, scientific, medical 
or policy~making conference or seminar at which: 
(1) There is ·an exWl'icit contract that is. restricted' to scientific issues and not 
marketing effoFts; arrd: 
(2) 1ffu:e content of the presentation, including slides and wFitten materials, IS 
detemrined by the health care practitioner; and 
C. Compensation for substantial professional or consulting services of a health care 
practitioner in connection with a bona fide clinical trial as long as there is an explicit 
contract that is restricted to scientific issues and not marketing efforts. 
4. Disclosure. By July 1st of each year beginning in 2010, a manufactUrer that 
. participates in a state health care program shall disclose to the department the value, 
nature, purpose and recipient of a gift,· fee, payment, -subsidy, product sample or other 
economic benefit under subsection 3 or subsection 5 that is provided by the manufacturer, 
directly or indirectly through an . agent, to a health care pnictitioner, hosjJital, nursing 
home, pharmacist, health benefit plan administrator or any other person in the State 
authorized to prescribe, dispense or purchase prescription drugs .. For each gift, fee, 
payment, subsidy, product sample or other economic benefit disclosed under this 
subsection, the manufacturer shall identify the recipient's name, address, credentials, 
institutional affiliation and any governmental registration, license or identification 
number. 
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5. Product sample. A· product sample may be dispensed by a manufacturer under 
the following conditions: 
A. The product sample must be donated generally to a health care facility, not to an 
individual, and accepted and dispensed centrally; 
B. 
Product sample dispensing must meet standards for inventory control, drug 
interaction and dosage screening, labeling and documentation as required by the 
department; and 
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C. A health care practitioner or a member of the practitioner's staff or family who is 
not a patient ofthe health care facility may not use a product sample. 
Sec. 4. 22 MRSA §2700-A, sub-§l, ~-2 is enacted to read: 
B-2. "Prescription drugs" means pharmaceuticals, biologics or medical· devices. 
Sec. 5. 22 MRSA §2700-A, sub-§4, as amended by PL 2007, c .. 327, §2, IS 
further amended to read: 
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4. Fees. Beginning April 1,2006, each manufacturer of prescription drugs that are 
provided to Maine residents through the MaineCare program under section 3174-G or the 
elderly low-cost drug program under section 254-D shall pay a fee of $1 ,000 per calendar 
year to the State. Fees collected under this subsection must be used to cover the cost of 
overseeing implementation of this section, including but not limited to maintaining links 
to publicly accessible websites to which manufacturers are posting clinical trial 
information under subsection 3 and other relevant sites, assessing whether and the extent 
to which Maine residents have been harmed by the use of a particular drug and 
undertaking the public education initiative under subsection 5 and the prescription drug 
academic detailing program under section 2685. One half of the annual revenues from 
this subsection must be allocated to and used for the academic detailing program under 
section 2685. Revenues received under this subsection, with the exception of funding 
designated for the academic detailing program under section 2685, must be deposited into 
an Other Special Revenue Funds account to be used for the purposes of this subsection .. 
The department may increase the fee under this subsection to cover the department's 
reasonable cost of administering this section. 
SUMMARY 
This bill: 
1. Prohibits most gifts and payments to 
health care practitjoners from 
pharmaceutical and medical device manufacturers; 
2. 
Includes medical devices in the definition of "prescription drug" for the purposes 
of requirements involving a pharmaceutical manufacturer's giving of gifts to health care 
pracHtioners and reporting marketing expenses; 
3. 
Establishes requirements· for pharmaceutical manufacturers' giving sample 
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products to health care practitioners; 
4. Requires the Department of Health and Human Services to report a 
pharmaceutical manufacturer's gifts and payments per health care practitioner instead of 
in the aggregate; 
5. Limits the confidentiality of pharmaceutical manufacturers' reporting information 
to trade information protected by state and federal law; 
6. 
Requires the Department of Health and Human Services to post the department's 
annual report regarding a pharmaceutical manufacturer's marketing expenses on a 
publicly accessible portion of the department's website; and 
7. Allows the Department of Health and Human Services to raise the fees of 
pharmaceutical manufacturers to cover reasonable costs of the department. 
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