Minnesota Legislature
SF 3843
as introduced - 85th Legislature (2007 - 2008) Posted on 12/15/2009 12:00am
Current Version - as introduced
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A bill for an act
relating to health; preventing conflicts-of-interest, banning gifts from drug
manufacturers or distributors to physicians and formulary committee members;
amending Minnesota Statutes 2006, sections 151.461; 151.47, subdivision 1;
Minnesota Statutes 2007 Supplement, section 256B.0625, subdivision 13c;
proposing coding for new law in Minnesota Statutes, chapter 62J.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
Section 1.
new text begin
[62J.241] DISCLOSURE OF PAYMENTS TO PRACTITIONERS.
new text end
new text begin Subdivision 1. new text end
new text begin Disclosure required. new text end
new text begin
Each pharmaceutical manufacturer, wholesale
drug distributor, medical supply or device manufacturer or their agent shall file with
the commissioner of health an annual report that identifies all payments, honoraria,
reimbursement, or other compensation paid to practitioners, or sponsors of a medical
conference, professional meeting, or other educational program during the preceding
calendar year.
new text end
new text begin Subd. 2. new text end
new text begin Report format. new text end
new text begin
The format of the report shall be standardized and shall
include at a minimum the nature and value of any payments to a particular practitioner
during the year and shall identify the practitioner. Reports filed under this provision are
public data and must be made available on the department Web site in an easily accessible
and searchable format.
new text end
Sec. 2.
Minnesota Statutes 2006, section 151.461, is amended to read:
151.461 GIFTS TO PRACTITIONERS PROHIBITED.
It is unlawful for any new text begin pharmaceutical new text end manufacturernew text begin ,new text end deleted text begin ordeleted text end wholesale drug distributor,
new text begin medical supply or device manufacturer or distributer, new text end or any agent thereof, to offer or give
any gift deleted text begin of valuedeleted text end new text begin or to request another person to give a giftnew text end to a practitioner. deleted text begin A medical
device manufacturer that distributes drugs as an incidental part of its device business
shall not be considered a manufacturer, a wholesale drug distributor, or agent under this
section.deleted text end new text begin A practitioner may not accept a gift from a manufacturer or distributor or an agent
of either. new text end As used in this section, "gift" does not include:
(1) professional samples of a drugnew text begin or medical suppliesnew text end provided to a prescriber for
free distribution tonew text begin uninsured or low-incomenew text end patientsnew text begin , if there is evidence-based medicine
to support the clear superiority of the drug over less costly alternatives availablenew text end ;
deleted text begin
(2) items with a total combined retail value, in any calendar year, of not more than
$50;
deleted text end
deleted text begin (3) a paymentdeleted text end new text begin (2) an unrestricted grantnew text end to the sponsor of a medical conference,
professional meeting, or other educational program, providednew text begin that the grantor has no
influence on the content, presenters, or attendees at the event and providednew text end the payment is
deleted text begin not made directly to a practitioner and is useddeleted text end solely for bona fide educational purposesnew text begin
and is made to underwrite the conference, meeting, or program, is not meant to subsidize
any particular attendees, and is not tied to any particular practitioners attendancenew text end ;
deleted text begin (4)deleted text end new text begin (3)new text end reasonable honoraria and payment of the reasonable expenses of a practitioner
who serves on the faculty at a professional or educational conference or meetingnew text begin if the
honoraria for the speech or presentation does not exceed the standard hourly billing rate
of the practitionernew text end ;
deleted text begin (5)deleted text end new text begin (4)new text end compensation for the substantial professional or consulting services of a
practitioner in connection with a genuine new text begin clinical new text end research projectnew text begin if the compensation
does not exceed the standard hourly billing rate of the practitionernew text end ;
deleted text begin (6)deleted text end new text begin (5)new text end publications and educational materialsnew text begin , provided that the materials
were produced and published by the drug manufacturer or medical supply or device
manufacturernew text end ; or
deleted text begin (7)deleted text end new text begin (6)new text end salaries or other benefits paid to employees.new text begin If a practitioner who is currently
practicing in Minnesota is also an employee or agent of a drug manufacturer, wholesale
drug distributor, or medical supply or device manufacturer or distributor, the practitioner
must report the source, the amount, and the nature of the compensation received to the
Board of Medical Practice, and notify a patient of the employment relationship before
prescribing or recommending any medication or device from that manufacturer or
distributor to the patient.
new text end
new text begin
When a practitioner receives compensation under clause (3) or (4), the source,
the amount, and nature of the compensation must be reported to the Board of Medical
Practice, and the practitioner must notify a patient of the financial relationship before
prescribing any medication or device from that manufacturer or distributor to the patient.
new text end
new text begin
For purposes of this section, "practitioner" includes employees of the clinic or
facility where the practitioner works and includes family members of the practitioner.
new text end
Sec. 3.
Minnesota Statutes 2006, section 151.47, subdivision 1, is amended to read:
Subdivision 1.
Requirements.
All wholesale drug distributors are subject to the
requirements in paragraphs (a) to (f).
(a) No person or distribution outlet shall act as a wholesale drug distributor without
first obtaining a license from the board and paying the required fee.
(b) No license shall be issued or renewed for a wholesale drug distributor to operate
unless the applicant agrees to operate in a manner prescribed by federal and state law and
according to the rules adopted by the board.
(c) The board may require a separate license for each facility directly or indirectly
owned or operated by the same business entity within the state, or for a parent entity
with divisions, subsidiaries, or affiliate companies within the state, when operations
are conducted at more than one location and joint ownership and control exists among
all the entities.
(d) As a condition for receiving and retaining a wholesale drug distributor license
issued under sections 151.42 to 151.51, an applicant shall satisfy the board that it has
and will continuously maintain:
(1) adequate storage conditions and facilities;
(2) minimum liability and other insurance as may be required under any applicable
federal or state law;
(3) a viable security system that includes an after hours central alarm, or comparable
entry detection capability; restricted access to the premises; comprehensive employment
applicant screening; and safeguards against all forms of employee theft;
(4) a system of records describing all wholesale drug distributor activities set forth
in section 151.44 for at least the most recent two-year period, which shall be reasonably
accessible as defined by board regulations in any inspection authorized by the board;
(5) principals and persons, including officers, directors, primary shareholders,
and key management executives, who must at all times demonstrate and maintain their
capability of conducting business in conformity with sound financial practices as well
as state and federal law;
(6) complete, updated information, to be provided to the board as a condition for
obtaining and retaining a license, about each wholesale drug distributor to be licensed,
including all pertinent corporate licensee information, if applicable, or other ownership,
principal, key personnel, and facilities information found to be necessary by the board;
(7) written policies and procedures that assure reasonable wholesale drug distributor
preparation for, protection against, and handling of any facility security or operation
problems, including, but not limited to, those caused by natural disaster or government
emergency, inventory inaccuracies or product shipping and receiving, outdated product
or other unauthorized product control, appropriate disposition of returned goods, and
product recalls;
(8) sufficient inspection procedures for all incoming and outgoing product
shipments; and
(9) operations in compliance with all federal requirements applicable to wholesale
drug distribution.
(e) An agent or employee of any licensed wholesale drug distributor need not seek
licensure under this section.
deleted text begin
(f) A wholesale drug distributor shall file with the board an annual report, in a
form and on the date prescribed by the board, identifying all payments, honoraria,
reimbursement or other compensation authorized under section 151.461, clauses (3) to
(5), paid to practitioners in Minnesota during the preceding calendar year. The report
shall identify the nature and value of any payments totaling $100 or more, to a particular
practitioner during the year, and shall identify the practitioner. Reports filed under this
provision are public data.
deleted text end
Sec. 4.
Minnesota Statutes 2007 Supplement, section 256B.0625, subdivision 13c,
is amended to read:
Subd. 13c.
Formulary committee.
new text begin (a) new text end The commissioner, after receiving
recommendations from professional medical associations and professional pharmacy
associations, and consumer groups shall designate a Formulary Committee to carry
out duties as described in subdivisions 13 to 13g. The Formulary Committee shall be
comprised of four licensed physicians actively engaged in the practice of medicine in
Minnesota one of whom must be actively engaged in the treatment of persons with mental
illness; at least three licensed pharmacists actively engaged in the practice of pharmacy
in Minnesota; and one consumer representative; the remainder to be made up of health
care professionals who are licensed in their field and have recognized knowledge in the
clinically appropriate prescribing, dispensing, and monitoring of covered outpatient drugs.
Members of the Formulary Committee shall not be employed by the Department of Human
Services, but the committee shall be staffed by an employee of the department who shall
serve as an ex officio, nonvoting member of the committee. The department's medical
director shall also serve as an ex officio, nonvoting member for the committee. Committee
members shall serve three-year terms and may be reappointed by the commissioner. The
Formulary Committee shall meet at least quarterly. The commissioner may require more
frequent Formulary Committee meetings as needed. An honorarium of $100 per meeting
and reimbursement for mileage shall be paid to each committee member in attendance.
new text begin
(b) A member of the formulary committee may not accept a gift or any professional
samples from a drug manufacturer or wholesale drug distributor. A member of the
formulary committee may not be an employee or an agent of a drug manufacturer or
wholesale drug distributor. A formulary committee member may accept educational
materials related to pharmaceutical drugs if the educational materials are provided to
the formulary committee, which then provides the educational materials to members
of the committee, and provided that the materials were produced and published by the
drug manufacturer.
new text end