1.1 	A bill for an act
1.2 	relating to health; prohibiting the use of certain prescription information 
1.3 	for marketing purposes; amending Minnesota Statutes 2008, section 8.31, 
1.4 	subdivision 1; proposing coding for new law in Minnesota Statutes, chapter 151.
1.5 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.6 	Section 1. Minnesota Statutes 2008, section 8.31, subdivision 1, is amended to read:
1.7 		Subdivision 1.Investigate offenses against the provisions of certain designated 
1.8 	sections; assist in enforcement. The attorney general shall investigate violations of 
1.9 	the law of this state respecting unfair, discriminatory, and other unlawful practices in 
1.10 	business, commerce, or trade, and specifically, but not exclusively, section 151.60, the 
1.11 	Nonprofit Corporation Act (sections 317A.001 to 317A.909), the Act Against Unfair 
1.12 	Discrimination and Competition (sections 325D.01 to 325D.07), the Unlawful Trade 
1.13 	Practices Act (sections 325D.09 to 325D.16), the Antitrust Act (sections 325D.49 to 
1.14 	325D.66), section 325F.67 and other laws against false or fraudulent advertising, the 
1.15 	antidiscrimination acts contained in section 325D.67, the act against monopolization 
1.16 	of food products (section 325D.68), the act regulating telephone advertising services 
1.17 	(section 325E.39), the Prevention of Consumer Fraud Act (sections 325F.68 to 325F.70), 
1.18 	and chapter 53A regulating currency exchanges and assist in the enforcement of those 
1.19 	laws as in this section provided.  

1.20 	Sec. 2. [151.60] PRESCRIPTION RECORD PRIVACY.
1.21 		Subdivision 1.Definitions. For the purposes of this section, the terms defined in 
1.22 	this subdivision have the meanings given.
2.1 	(a) "Bona fide clinical trial" means any research project that prospectively 
2.2 	assigns human subjects to intervention and comparison groups to study the cause and 
2.3 	effect relationship between a medical intervention and a health outcome, has received 
2.4 	approval from an appropriate institutional review board, and has been registered at 
2.5 	ClinicalTrials.gov prior to commencement.
2.6 	(b) "Individual identifying information" means information that is derived from or 
2.7 	relates to a prescription for any prescribed product and directly or indirectly identifies a 
2.8 	practitioner or a patient in this state.
2.9 	(c) "Marketing" means any activity by an entity making or selling prescribed 
2.10 	products or the entity's agent that is intended to influence prescribing or purchasing 
2.11 	choices of the entity's products including, but not limited to:
2.12 	(1) advertising, publicizing, promoting, or sharing information about a product;
2.13 	(2) identifying individuals to receive a message promoting use of a particular 
2.14 	product including, but not limited to an advertisement, brochure, or contact by a sales 
2.15 	representative;
2.16 	(3) planning the substance of a sales representative visit or communication or the 
2.17 	substance of an advertisement or other promotional message or document;
2.18 	(4) identifying individuals to receive any form of gift, product sample, consultancy, 
2.19 	or any other item, service, compensation, or employment of value; or
2.20 	(5) advertising or promoting prescribed products directly to patients.
2.21 	(d) "Nonmarketing purposes" include, but are not limited to:
2.22 	(1) educational or quality assurance programs conducted by a health plan company 
2.23 	or a benefits management program to ensure compliance with an independently established 
2.24 	formulary based on evidence-based prescribing guidelines and cost-containment goals;
2.25 	(2) communication by a pharmacist about patient safety or generic substitution, or in 
2.26 	response to patient questions about a medication; or
2.27 	(3) safety warnings, adverse event reporting, labeling changes, or Risk Evaluation 
2.28 	and Management Strategy (REMS) compliance communications.
2.29 	(e) "Person" means a business, individual, corporation, union, association, firm, 
2.30 	partnership, committee, or other organization or group of persons.
2.31 	(f) "Pharmacy" means any individual or entity licensed or authorized under this 
2.32 	chapter to dispense prescribed products.
2.33 	(g) "Prescribed product" means a biological product as defined in section 351 of 
2.34 	the Public Health Service Act, United States Code, title 42, section 262, or a drug as 
2.35 	defined in section 201 of the federal Food, Drug, and Cosmetic Act, United States Code, 
2.36 	title 21, section 321.
3.1 	(h) "Regulated record" means information or documentation from a prescription 
3.2 	written by a practitioner doing business in this state or a prescription dispensed in this state.
3.3 		Subd. 2.Privacy provisions. (a) No person shall knowingly disclose or use 
3.4 	regulated records in this state that include prescription information containing individual 
3.5 	identifying information for the purpose of marketing a prescribed product.
3.6 	(b) A regulated record containing individual identifying information may be 
3.7 	transferred to another entity, including to another branch or subsidiary of the same entity, 
3.8 	if there is satisfactory assurance in writing that the recipient of the record will safeguard 
3.9 	the record from being disclosed or used in the state for any marketing purpose that 
3.10 	is prohibited under this section.
3.11 	(c) Regulated records containing individual identifying information may be 
3.12 	disclosed, sold, transferred, exchanged, or used for nonmarketing purposes.
3.13 	(d) This section does not prohibit conduct involving the collection, use, transfer, or 
3.14 	sale of regulated records for marketing purposes if:
3.15 	(1) the data are aggregated;
3.16 	(2) the data do not contain individually identifying information; and
3.17 	(3) there is no reasonable basis to believe that the data can be used to obtain 
3.18 	individually identifying information.
3.19 	(e) This section shall not prevent any person from disclosing regulated records to the 
3.20 	identified individual as long as the information does not include protected information 
3.21 	pertaining to any other person.
3.22 		Subd. 3.Consumer fraud. In addition to any other remedy provided by law, a 
3.23 	violation of this section shall constitute an unfair or deceptive act in trade or commerce and 
3.24 	an unfair method of competition and may be enforced under sections 325F.68 to 325F.70.
3.25 		Subd. 4.Exceptions. Nothing in this section shall be interpreted to regulate or 
3.26 	prohibit: 
3.27 	(1) conduct that takes place entirely outside of the state;
3.28 	(2) the content, time, place, or manner of any discussion between a practitioner 
3.29 	and a patient, a pharmacist and a patient, or a practitioner and any person representing a 
3.30 	prescription drug manufacturer;
3.31 	(3) the transmission of prescription information between a practitioner and a 
3.32 	licensed pharmacy;
3.33 	(4) the transfer of prescription information between licensed pharmacies; or
3.34 	(5) the transfer of prescription records that may occur in the event that the ownership 
3.35 	of a pharmacy is changed or transferred.
4.1 		Subd. 5.Report. Each pharmaceutical manufacturer, wholesale drug distributor, 
4.2 	or pharmacy licensed under this chapter shall submit to the board with their annual 
4.3 	registration or license renewal a statement on a form prescribed by the board indicating 
4.4 	that they have complied with and will continue to comply with this section. The statement 
4.5 	must be signed by the owner, president or chief executive officer of the manufacturer, 
4.6 	distributor, or pharmacy.
4.7 		Subd. 6.Severability. If any provision of this section or its application to any 
4.8 	person or circumstance is held invalid, the remainder of the section or the application of 
4.9 	the provisions to other persons or circumstances is not affected.