SF 1044

1st Engrossment - 86th Legislature (2009 - 2010) Posted on 02/09/2010 02:18am

A bill for an act
relating to health; prohibiting the use of certain prescription information
for marketing purposes; amending Minnesota Statutes 2008, section 8.31,
subdivision 1; 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 8.31, subdivision 1, is amended to read:

Subdivision 1.

Investigate offenses against the provisions of certain designated
sections; assist in enforcement.

The attorney general shall investigate violations of
the law of this state respecting unfair, discriminatory, and other unlawful practices in
business, commerce, or trade, and specifically, but not exclusively, new text begin section 151.60, new text end the
Nonprofit Corporation Act (sections 317A.001 to 317A.909), the Act Against Unfair
Discrimination and Competition (sections 325D.01 to 325D.07), the Unlawful Trade
Practices Act (sections 325D.09 to 325D.16), the Antitrust Act (sections 325D.49 to
325D.66), section 325F.67 and other laws against false or fraudulent advertising, the
antidiscrimination acts contained in section 325D.67, the act against monopolization
of food products (section 325D.68), the act regulating telephone advertising services
(section 325E.39), the Prevention of Consumer Fraud Act (sections 325F.68 to 325F.70),
and chapter 53A regulating currency exchanges and assist in the enforcement of those
laws as in this section provided.

Sec. 2.

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

new text begin Subdivision 1. 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 that is derived from or
relates to a prescription for any prescribed product and directly or indirectly identifies a
practitioner or a patient in this state.
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) 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 (5) 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. 2. 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. 3. 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 constitute an unfair or deceptive act in trade or commerce and
an unfair method of competition and may be enforced under sections 325F.68 to 325F.70.
new text end

new text begin Subd. 4. new text end

new text begin Exceptions. new text end

new text begin Nothing in this section shall be interpreted to regulate or
prohibit:
new text end

new text begin (1) conduct that takes place entirely outside of the state;
new text end

new text begin (2) the content, time, place, or manner of any discussion between a practitioner
and a patient, a pharmacist and a patient, or a practitioner and any person representing a
prescription drug manufacturer;
new text end

new text begin (3) the transmission of prescription information between a practitioner and a
licensed pharmacy;
new text end

new text begin (4) the transfer of prescription information between licensed pharmacies; or
new text end

new text begin (5) the transfer of prescription records that may occur in the event that the ownership
of a pharmacy is changed or transferred.
new text end

new text begin Subd. 5. new text end

new text begin Report. 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 the owner, president or chief executive officer of the manufacturer,
distributor, or pharmacy.
new text end

new text begin Subd. 6. 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