.................... moves to amend H. F. No. 491 as follows:
Delete everything after the enacting clause and insert:
"Section 1. Minnesota Statutes 2008, section 151.50, is amended to read:
The board shall adopt rules to carry out the purposes and enforce the provisions of
151.51 this chapter
. 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. [151.60] PRESCRIPTION RECORD PRIVACY.
1.12 Subdivision 1. Intent; purpose. It is the intent of the legislature to safeguard the
1.13confidentiality of prescribing information, protect the integrity of the doctor-patient
1.14relationship, maintain the integrity and public trust in the medical profession, combat
1.15vexatious and harassing sales practices, restrain undue influence exerted by pharmaceutical
1.16industry marketing representatives over prescribing decisions, and further the state interest
1.17in improving the quality and lowering the cost of health care. The purpose of this
1.18legislation is to regulate the monitoring of prescribing practices only for commercial
1.19marketing purposes by companies selling prescribed products. The intent is not to regulate
1.20monitoring for other uses, such as quality control, research unrelated to marketing, or use
1.21by governments or other entities not in the business of selling health care products.
1.22 Subd. 2. Definitions. For the purposes of this section, the terms defined in this
1.23subdivision have the meanings given.
1.24(a) "Bona fide clinical trial" means any research project that prospectively
1.25assigns human subjects to intervention and comparison groups to study the cause and
1.26effect relationship between a medical intervention and a health outcome, has received
2.1approval from an appropriate institutional review board, and has been registered at
2.2ClinicalTrials.gov prior to commencement.
2.3(b) "Individual identifying information" means information, which directly or
2.4indirectly identifies a practitioner or a patient in this state, where the information is derived
2.5from or relates to a prescription for any prescribed product.
2.6(c) "Marketing" means any activity by an entity making or selling prescribed
2.7products or the entity's agent that is intended to influence prescribing or purchasing
2.8choices of the entity's products including, but not limited to:
2.9(1) advertising, publicizing, promoting, or sharing information about a product;
2.10(2) identifying individuals to receive a message promoting use of a particular
2.11product including, but not limited to an advertisement, brochure, or contact by a sales
2.13(3) planning the substance of a sales representative visit or communication or the
2.14substance of an advertisement or other promotional message or document;
2.15(4) evaluating or compensating sales representatives;
2.16(5) identifying individuals to receive any form of gift, product sample, consultancy,
2.17or any other item, service, compensation, or employment of value; or
2.18(6) advertising or promoting prescribed products directly to patients.
2.19(d) "Nonmarketing purposes" include, but are not limited to:
2.20(1) educational or quality assurance programs conducted by a health plan company
2.21or a benefits management program to ensure compliance with an independently established
2.22formulary based on evidence-based prescribing guidelines and cost-containment goals;
2.23(2) communication by a pharmacist about patient safety or generic substitution, or in
2.24response to patient questions about a medication; or
2.25(3) safety warnings, adverse event reporting, labeling changes, or Risk Evaluation
2.26and Management Strategy (REMS) compliance communications.
2.27(e) "Person" means a business, individual, corporation, union, association, firm,
2.28partnership, committee, or other organization or group of persons.
2.29(f) "Pharmacy" means any individual or entity licensed or authorized under this
2.30chapter to dispense prescribed products.
2.31(g) "Prescribed product" means a biological product as defined in section 351 of
2.32the Public Health Service Act, United States Code, title 42, section 262, or a drug as
2.33defined in section 201 of the federal Food, Drug, and Cosmetic Act, United States Code,
2.34title 21, section 321.
2.35(h) "Regulated record" means information or documentation from a prescription
2.36written by a practitioner doing business in this state or a prescription dispensed in this state.
3.1 Subd. 3. Privacy provisions. (a) No person shall knowingly disclose or use
3.2regulated records in this state that include prescription information containing individual
3.3identifying information for the purpose of marketing a prescribed product.
3.4(b) A regulated record containing individual identifying information may be
3.5transferred to another entity, including to another branch or subsidiary of the same entity,
3.6if there is satisfactory assurance in writing that the recipient of the record will safeguard
3.7the record from being disclosed or used in the state for any marketing purpose that
3.8is prohibited under this section.
3.9(c) Regulated records containing individual identifying information may be
3.10disclosed, sold, transferred, exchanged, or used for nonmarketing purposes.
3.11(d) This section does not prohibit conduct involving the collection, use, transfer, or
3.12sale of regulated records for marketing purposes if:
3.13(1) the data are aggregated;
3.14(2) the data does not contain individually identifying information; and
3.15(3) there is no reasonable basis to believe that the data can be used to obtain
3.16individually identifying information.
3.17(e) This section shall not prevent any person from disclosing regulated records to the
3.18identified individual as long as the information does not include protected information
3.19pertaining to any other person.
3.20 Subd. 4. Enforcement. (a) Any person who knowingly fails to comply with the
3.21requirements of this section by using or disclosing regulated records in a manner not
3.22authorized under this section shall be subject to an administrative penalty of at least
3.23$10,000 per violation and not more than $50,000 per violation, as assessed by the Board
3.24of Pharmacy. Each disclosure of a regulated record shall constitute a violation.
3.25(b) The Office of the Attorney General shall take necessary action to enforce
3.26payment of penalties assessed under this subdivision.
3.27 Subd. 5. Consumer fraud. In addition to any other remedy provided by law, a
3.28violation of this section shall be an unfair or deceptive act in trade or commerce and an
3.29unfair method of competition and may be enforced under chapter 325F.
3.30 Subd. 6. No extraterritorial effect. Nothing in this section shall be interpreted to
3.31regulate conduct that takes place entirely outside of the state.
3.32 Subd. 7. No effect on truthful speech of doctors or patients. Nothing in this
3.33section shall be interpreted to regulate the content, time, place, or manner of any discussion
3.34between a practitioner and their patient, or a practitioner and any person representing a
3.35prescription drug manufacturer.
4.1 Subd. 8. Report. Each pharmaceutical manufacturer, wholesale drug distributor,
4.2or pharmacy licensed under this chapter shall submit to the board with their annual
4.3registration or license renewal a statement on a form prescribed by the board indicating
4.4that they have complied with and will continue to comply with this section. The statement
4.5must be signed by owner, president or chief executive owner of the manufacturer,
4.6distributor, or pharmacy.
4.7 Subd. 9. Severability. If any provision of this section or its application to any
4.8person or circumstance is held invalid, the remainder of the section or the application of
4.9the provisions to other persons or circumstances is not affected.
Delete the title and insert:
relating to health; prohibiting the use of certain prescription information for
marketing purposes; amending Minnesota Statutes 2008, section 151.50;
proposing coding for new law in Minnesota Statutes, chapter 151."