PRINTER'S NO. 332
No. 320 Session of 2005
INTRODUCED BY STACK, STOUT, COSTA, LAVALLE, KITCHEN, O'PAKE,
WOZNIAK, RHOADES, TARTAGLIONE, KASUNIC, LOGAN, BOSCOLA AND
FERLO, FEBRUARY 18, 2005
REFERRED TO PUBLIC HEALTH AND WELFARE, FEBRUARY 18, 2005
AN ACT
1 Amending the act of July 8, 1986 (P.L.408, No.89), entitled, as
2 reenacted and amended, "An act providing for the creation of
3 the Health Care Cost Containment Council, for its powers and
4 duties, for health care cost containment through the
5 collection and dissemination of data, for public
6 accountability of health care costs and for health care for
7 the indigent; and making an appropriation," providing for the
8 definitions of "pharmaceutical marketer" and "pharmaceutical
9 manufacturing company"; providing for annual expense report
10 and for disclosure by pharmaceutical marketers; and imposing
11 penalties.
12 The General Assembly of the Commonwealth of Pennsylvania
13 hereby enacts as follows:
14 Section 1. Section 3 of the act of July 8, 1986 (P.L.408,
15 No.89), known as the Health Care Cost Containment Act, reenacted
16 and amended June 28, 1993 (P.L.146, No.34), is amended by adding
17 definitions to read:
18 Section 3. Definitions.
19 The following words and phrases when used in this act shall
20 have the meanings given to them in this section unless the
21 context clearly indicates otherwise:
22 * * *
1 "Pharmaceutical manufacturing company." Any entity which is
2 engaged in the production, preparation, propagation,
3 compounding, conversion or processing of prescription drugs,
4 either directly or indirectly by extraction from substances of
5 natural origin, or independently by means of chemical synthesis,
6 or by a combination of extraction and chemical synthesis, or any
7 entity engaged in the packaging, repackaging, labeling,
8 relabeling or distribution of prescription drugs. The term does
9 not include a wholesale drug distributor or pharmacist licensed
10 under the act of December 14, 1992 (P.L.1116, No.145), known as
11 the Wholesale Prescription Drug Distributors License Act.
12 "Pharmaceutical marketer." An individual who, while employed
13 by or under contract to represent a pharmaceutical manufacturing
14 company, engages in pharmaceutical detailing, promotional
15 activities or other marketing of prescription drugs in this
16 Commonwealth to any physician, hospital, nursing home,
17 pharmacist, health benefit plan administrator or any other
18 person authorized to prescribe, dispense or purchase
19 prescription drugs. The term does not include a wholesale drug
20 distributor or the distributor's representative who promotes or
21 otherwise markets the services of the wholesale drug distributor
22 in connection with a prescription drug.
23 * * *
24 Section 2. The act is amended by adding a section to read:
25 Section 16.1. Disclosure requirements for pharmaceutical
26 marketers.
27 (a) General rule.--On or before January 1, every
28 pharmaceutical manufacturing company shall prepare an annual
29 expense report that discloses to the council the value, nature
30 and purpose of any gift, fee, payment, subsidy or other economic
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1 benefit provided in connection with detailing, promotional or
2 other marketing activities by the company, directly or through
3 its pharmaceutical marketers, to any physician, hospital,
4 nursing home, pharmacist, health benefit plan administrator or
5 any other person in this Commonwealth authorized to prescribe,
6 dispense or purchase prescription drugs in this Commonwealth.
7 Disclosure shall be made on a form and in a manner prescribed by
8 the council. Disclosure by an annual expense report shall be
9 made on or before January 1 for the 12-month period ending the
10 preceding June 30. The council shall provide to the Office of
11 Attorney General complete access to the information required to
12 be disclosed under this subsection. The Office of Attorney
13 General shall report annually on the disclosures made under this
14 section to the Governor and the General Assembly on or before
15 March 1.
16 (b) Annual expense reports.--Annual expense reports as
17 required under subsection (a) shall contain the following
18 categories:
19 (1) A single aggregate good faith estimate of the total
20 amount spent for personnel and office expenses related to
21 marketing pharmaceutical drugs. This paragraph includes
22 salaries and other forms of compensation, benefits, vehicle
23 allowances, bonuses and reimbursable expenses. Reportable
24 personnel costs include costs for staff, research and
25 monitoring staff, consultants, lawyers, lobbyists,
26 publications and public relations staff, technical staff and
27 clerical and administrative support staff who engage in
28 marketing pharmaceutical drugs.
29 (2) The total costs for gifts, entertainment, meals,
30 transportation, lodging and receptions given to or provided
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1 to health care providers.
2 (3) In addition to reporting the totals required under
3 subsection (b), the annual expense report shall identify by
4 specialty and each occurrence any health care provider who
5 receives from a pharmaceutical company anything of value in
6 excess of $250.
7 (c) Exemptions.--The following shall be exempt from
8 disclosure:
9 (1) Free samples of prescription drugs intended to be
10 distributed to patients.
11 (2) The payment of reasonable compensation and
12 reimbursement of expenses in connection with bona fide
13 clinical trials. The term "clinical trial" means an approved
14 clinical trial conducted in connection with a research study
15 designed to answer specific questions about vaccines, new
16 therapies or new ways of using known treatments.
17 (3) Any gift, fee, payment, subsidy or other economic
18 benefit the value of which is less than $25.
19 (4) Scholarship or other support for medical students,
20 residents and fellows to attend a significant educational,
21 scientific or policymaking conference of a national, regional
22 or specialty medical or other professional association if the
23 recipient of the scholarship or other support is selected by
24 an association.
25 (d) Responsible individual.--Each company subject to the
26 provisions of this section shall also disclose to the council
27 annually on or before October 1 the name and address of the
28 individual responsible for the company's compliance with the
29 provisions of this section.
30 (e) Trade secret information.--The council and the Office of
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1 Attorney General shall keep confidential all trade secret
2 information. The disclosure form prescribed by the board shall
3 permit the company to identify any information that is a trade
4 secret.
5 (f) Penalties.--The Attorney General may bring an action in
6 the court of common pleas for injunctive relief, costs and
7 attorney fees, and impose on a pharmaceutical manufacturing
8 company that fails to disclose as required by this section a
9 civil penalty of no more than $10,000 per violation. Each
10 unlawful failure to disclose shall constitute a separate
11 violation.
12 Section 3. This act shall take effect in 60 days.
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