SENATE, No. 1239

SECTION 1. Chapter 112 of the general laws, as appearing in the 2004 Official Edition, is hereby amended by inserting at the end the following new section:-

“Section 227.  The department of public health, in consultation with the board of registration of pharmacy, shall promulgate regulations requiring the licensing of all pharmaceutical representatives.  As a prerequisite to such licensing, pharmaceutical representatives shall complete such training as may be deemed appropriate by the department.  As a prerequisite to the renewal of such license, pharmaceutical representatives shall complete continuing education as may be deemed appropriate by the department.  The fee for such license shall be $500 per year.  Revenue generated from this fee shall be divided in equal shares, 50 per cent to the office of attorney general, line item 0810-0000, for the investigation and prosecution of Medicaid fraud and other fraudulent drug pricing schemes disadvantaging the commonwealth or its citizens and 50 per cent to the board of registration in pharmacy, line item 4510-0722, to assist the board in implementing patient safety and medical error reduction programs.”

Section 1 of chapter 268B of the general laws, as appearing in the 2004 Official Edition, is hereby amended by inserting in paragraph “(g)”, line 39, after the word “entertainment”, the following words:- “meals, travel”; and by inserting after paragraph “(m)” the following new paragraphs:-

“(n) “pharmaceutical manufacturer agent”, a pharmaceutical marketer or any other person who for compensation or reward does any act to promote, oppose or influence the prescribing of a particular prescription drug or medical devise or category of prescription drugs or medical devices.  The term shall not include a licensed pharmacist, licensed physician or any other licensed healthcare professional with authority to prescribe prescription drugs who is acting within the ordinary scope of the practice for which he is licensed;

“(o) “pharmaceutical marketer”, a person who, while employed by or under contract to represent a pharmaceutical manufacturing company, engages in pharmaceutical detailing, promotional activities or other marketing of prescription drugs in this state to any physician, hospital, nursing home, pharmacist, health benefit plan administrator or any other person authorized to prescribe, dispense or purchase prescription drugs.  The term does not include a wholesale drug distributor licensed under section 37A of chapter 112, a representative of such a distributor who promotes or otherwise markets the services of the wholesale drug distributor in connection with a prescription drug, or a retail pharmacist registered under section 37 of chapter 112 if such person is not engaging in such practices under contract with a manufacturing company;”.

Section 1 of said chapter 268B is hereby further amended by deleting “(o)” and inserting in place thereof “(p)”; and by deleting “(p)” and inserting in place thereof “(q)”; and by deleting “(q)” and inserting in place thereof “(r)”; and by deleting “(r)” and inserting in place thereof “(s)”; and by deleting “(s)” and inserting in place thereof “(t)”.

Said chapter 268B is hereby amended by inserting after the words “Section 6” the following letter “(a)”; and by inserting at the end of section 6, after line 6, the following paragraph:-

“(b) No pharmaceutical manufacturer agent shall knowingly and willfully offer or give to a public official, and no public official shall knowingly or willfully solicit or accept from any pharmaceutical manufacturer agent, gifts of any value.  A person who violates this section shall be punished by a fine of not more than $5,000 or by imprisonment for not more than 2 years, or both.”

The general laws are hereby amended by adding after chapter 268B the following new chapter:-

Chapter 268C.  Physician and Pharmaceutical Manufacturer Conduct

Section 1.  As used in this chapter, the following words shall have the following meanings:-

"Gift", a payment, entertainment, meals, travel, honorarium, subscription, advance, services or anything of value, unless consideration of equal or greater value is received.  “Gift" shall not include anything of value received by inheritance, a gift received from a member of the physician’s immediate family or from a relative within the third degree of consanguinity of the physician or of the physician’s spouse or from the spouse of any such relative, or prescription drugs provided to a physician solely and exclusively for use by the physician’s patients.

"Immediate family", a spouse and any dependent children residing in the reporting person's household.

“Medical device”, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

            (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

            (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

            (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

            "Person", a business, individual, corporation, union, association, firm, partnership, committee, or other organization or group of persons.

“Pharmaceutical marketer”, a person who, while employed by or under contract to represent a pharmaceutical manufacturing company, engages in pharmaceutical detailing, promotional activities, or other marketing of prescription drugs in this state to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to prescribe, dispense, or purchase prescription drugs.  The term does not include a wholesale drug distributor licensed under section 36A of chapter 112, a representative of such a distributor who promotes or otherwise markets the services of the wholesale drug distributor in connection with a prescription drug, or a retail pharmacist registered under section 37 of chapter 112 if such person is not engaging in such practices under contract with a manufacturing company.

“Pharmaceutical manufacturing company”, any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs.  The term does not include a wholesale drug distributor licensed under section 36A of chapter 112 or a retail pharmacist registered under section 37 of chapter 112.

“Pharmaceutical manufacturer agent”, a pharmaceutical marketer or any other person who for compensation or reward does any act to promote, oppose or influence the prescribing of a particular prescription drug or medical device or category of prescription drugs or medical devices.  The term shall not include a licensed pharmacist, licensed physician or any other licensed health care professional with authority to prescribe prescription drugs who is acting within the ordinary scope of the practice for which he is licensed.

            “Physician”, a person licensed to practice medicine by the board of medicine pursuant to section 2 of chapter 112 who prescribes prescription drugs for any person, or the physician’s employees or agents.

“Prescription drugs”, any and all drugs upon which the manufacturer or distributor has placed or must, in compliance with federal law and regulations, place the following or a comparable warning: “Caution federal law prohibits dispensing without prescription.”

Section 2.  No pharmaceutical manufacturer agent shall knowingly and willfully offer or give to a physician or a member of a physician’s immediate family or a physician’s employee or agent or a health care facility or employee or agent of a health care facility, and no physician or a member of a physician’s immediate family or a physician’s employee or agent or health care facility or employee or agent of a health care facility shall knowingly and willfully solicit or accept from any pharmaceutical manufacturer agent, gifts of any value.

Section 3.  A person who violates this section shall be punished by a fine of not more than $5,000 or by imprisonment for not more than 2 years, or both.”