HF 491

1st Engrossment - 86th Legislature (2009 - 2010) Posted on 02/09/2010 01:37am

A bill for an act
relating to health; prohibiting the use of certain prescription information for
marketing purposes; imposing administrative penalties; amending Minnesota
Statutes 2008, section 151.50; proposing coding for new law in Minnesota
Statutes, chapter 151.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2008, section 151.50, is amended to read:

151.50 RULES.

The board shall adopt rules to carry out the purposes and enforce the provisions of
deleted text begin sections 151.42 to 151.51 deleted text end new text begin this chapter new text end . All rules adopted under this section shall conform
to wholesale drug distributor licensing guidelines formally adopted by the United States
Food and Drug Administration; and in case of conflict between a rule adopted by the
board and a Food and Drug Administration wholesale drug distributor guideline, the
latter shall control.

Sec. 2.

new text begin [151.60] PRESCRIPTION RECORD PRIVACY.
new text end

new text begin Subdivision 1. new text end

new text begin Intent; purpose. new text end

new text begin It is the intent of the legislature to safeguard the
confidentiality of prescribing information, protect the integrity of the doctor-patient
relationship, maintain the integrity and public trust in the medical profession, combat
vexatious and harassing sales practices, restrain undue influence exerted by pharmaceutical
industry marketing representatives over prescribing decisions, and further the state interest
in improving the quality and lowering the cost of health care. The purpose of this
legislation is to regulate the monitoring of prescribing practices only for commercial
marketing purposes by companies selling prescribed products. The intent is not to regulate
monitoring for other uses, such as quality control, research unrelated to marketing, or use
by governments or other entities not in the business of selling health care products.
new text end

new text begin Subd. 2. new text end

new text begin Definitions. new text end

new text begin For the purposes of this section, the terms defined in this
subdivision have the meanings given.
new text end

new text begin (a) "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, has received
approval from an appropriate institutional review board, and has been registered at
ClinicalTrials.gov prior to commencement.
new text end

new text begin (b) "Individual identifying information" means information, which directly or
indirectly identifies a practitioner or a patient in this state, where the information is derived
from or relates to a prescription for any prescribed product.
new text end

new text begin (c) "Marketing" means any activity by an entity making or selling prescribed
products or the entity's agent that is intended to influence prescribing or purchasing
choices of the entity's products including, but not limited to:
new text end

new text begin (1) advertising, publicizing, promoting, or sharing information about a product;
new text end

new text begin (2) identifying individuals to receive a message promoting use of a particular
product including, but not limited to, an advertisement, brochure, or contact by a sales
representative;
new text end

new text begin (3) planning the substance of a sales representative visit or communication or the
substance of an advertisement or other promotional message or document;
new text end

new text begin (4) evaluating or compensating sales representatives;
new text end

new text begin (5) identifying individuals to receive any form of gift, product sample, consultancy,
or any other item, service, compensation, or employment of value; or
new text end

new text begin (6) advertising or promoting prescribed products directly to patients.
new text end

new text begin (d) "Nonmarketing purposes" include, but are not limited to:
new text end

new text begin (1) educational or quality assurance programs conducted by a health plan company
or a benefits management program to ensure compliance with an independently established
formulary based on evidence-based prescribing guidelines and cost-containment goals;
new text end

new text begin (2) communication by a pharmacist about patient safety or generic substitution, or in
response to patient questions about a medication; or
new text end

new text begin (3) safety warnings, adverse event reporting, labeling changes, or Risk Evaluation
and Management Strategy (REMS) compliance communications.
new text end

new text begin (e) "Person" means a business, individual, corporation, union, association, firm,
partnership, committee, or other organization or group of persons.
new text end

new text begin (f) "Pharmacy" means any individual or entity licensed or authorized under this
chapter to dispense prescribed products.
new text end

new text begin (g) "Prescribed product" means a biological product as defined in section 351 of
the Public Health Service Act, United States Code, title 42, section 262, or a drug as
defined in section 201 of the federal Food, Drug, and Cosmetic Act, United States Code,
title 21, section 321.
new text end

new text begin (h) "Regulated record" means information or documentation from a prescription
written by a practitioner doing business in this state or a prescription dispensed in this state.
new text end

new text begin Subd. 3. new text end

new text begin Privacy provisions. new text end

new text begin (a) No person shall knowingly disclose or use
regulated records in this state that include prescription information containing individual
identifying information for the purpose of marketing a prescribed product.
new text end

new text begin (b) A regulated record containing individual identifying information may be
transferred to another entity, including to another branch or subsidiary of the same entity,
if there is satisfactory assurance in writing that the recipient of the record will safeguard
the record from being disclosed or used in the state for any marketing purpose that
is prohibited under this section.
new text end

new text begin (c) Regulated records containing individual identifying information may be
disclosed, sold, transferred, exchanged, or used for nonmarketing purposes.
new text end

new text begin (d) This section does not prohibit conduct involving the collection, use, transfer, or
sale of regulated records for marketing purposes if:
new text end

new text begin (1) the data are aggregated;
new text end

new text begin (2) the data do not contain individually identifying information; and
new text end

new text begin (3) there is no reasonable basis to believe that the data can be used to obtain
individually identifying information.
new text end

new text begin (e) This section shall not prevent any person from disclosing regulated records to the
identified individual as long as the information does not include protected information
pertaining to any other person.
new text end

new text begin Subd. 4. new text end

new text begin Enforcement. new text end

new text begin (a) Any person who knowingly fails to comply with the
requirements of this section by using or disclosing regulated records in a manner not
authorized under this section shall be subject to an administrative penalty of at least
$10,000 per violation and not more than $50,000 per violation, as assessed by the Board
of Pharmacy. Each disclosure of a regulated record shall constitute a violation.
new text end

new text begin (b) The Office of the Attorney General shall take necessary action to enforce
payment of penalties assessed under this subdivision.
new text end

new text begin Subd. 5. new text end

new text begin Consumer fraud. new text end

new text begin In addition to any other remedy provided by law, a
violation of this section shall be an unfair or deceptive act in trade or commerce and an
unfair method of competition and may be enforced under chapter 325F.
new text end

new text begin Subd. 6. new text end

new text begin No extraterritorial effect. new text end

new text begin Nothing in this section shall be interpreted to
regulate conduct that takes place entirely outside of the state.
new text end

new text begin Subd. 7. new text end

new text begin No effect on truthful speech of doctors or patients. new text end

new text begin Nothing in this
section shall be interpreted to regulate the content, time, place, or manner of any discussion
between a practitioner and their patient, or a practitioner and any person representing a
prescription drug manufacturer.
new text end

new text begin Subd. 8. new text end

new text begin Statement of compliance. new text end

new text begin Each pharmaceutical manufacturer, wholesale
drug distributor, or pharmacy licensed under this chapter shall submit to the board with
their annual registration or license renewal a statement on a form prescribed by the
board indicating that they have complied with and will continue to comply with this
section. The statement must be signed by owner, president, or chief executive owner of
the manufacturer, distributor, or pharmacy.
new text end

new text begin Subd. 9. new text end

new text begin Severability. new text end

new text begin If any provision of this section or its application to any
person or circumstance is held invalid, the remainder of the section or the application of
the provisions to other persons or circumstances is not affected.
new text end