PRINTER'S NO. 4046
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2643
Session of
2020
INTRODUCED BY ZABEL, HILL-EVANS, WEBSTER, FREEMAN, HOWARD,
YOUNGBLOOD, ULLMAN, T. DAVIS, MURT, HANBIDGE, RABB, FIEDLER,
VITALI, McCLINTON, DeLUCA, NEILSON AND DONATUCCI,
JUNE 29, 2020
REFERRED TO COMMITTEE ON HEALTH, JUNE 29, 2020
AN ACT
Providing for Pharmaceutical Manufacturing Prohibited Gifts Act.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Short title.
This act shall be known and may be cited as the
Pharmaceutical Manufacturer Prohibited Gifts Act.
Section 2. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Allowable expenditures." The term includes:
(1) Payment to the sponsor of a significant educational,
medical, scientific or policy-making conference or seminar,
provided:
(i) the payment is not made directly to a health
care professional or pharmacist;
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(ii) funding is used solely for bona fide
educational purposes, except that the sponsor may, in the
sponsor's discretion, apply some or all of the funding to
provide meals and other food for all conference
participants; and
(iii) all program content is objective, free from
industry control and does not promote specific products.
(2) Honoraria and payment of the expenses of a health
care professional who serves on the faculty at a bona fide
significant educational, medical, scientific or policy-making
conference or seminar, provided:
(i) there is an explicit contract with specific
deliverables that are restricted to medical issues, not
marketing activities; and
(ii) consistent with Federal law, the content of the
presentation, including slides and written materials, is
determined by the health care professional.
(3) For a bona fide clinical trial:
(i) gross compensation for the location or locations
involved;
(ii) direct salary support per principal
investigator and other health care professionals per
year; and
(iii) expenses paid on behalf of investigators or
other health care professionals paid to review the
clinical trial.
(4) A research project that constitutes a systematic
investigation, is designed to develop or contribute to
general knowledge and reasonably can be considered to be of
significant interest or value to scientists or health care
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professionals working in the particular field of inquiry,
including:
(i) gross compensation;
(ii) direct salary support per health care
professional; and
(iii) expenses paid on behalf of each health care
professional.
(5) Payment or reimbursement for the reasonable
expenses, including travel and lodging-related expenses,
necessary for technical training of individual health care
professionals on the use of a device if the commitment to
provide the expenses and the amounts or categories of
reasonable expenses to be paid are described in a written
agreement between the health care provider and the
manufacturer.
(6) Royalties and licensing fees paid to health care
providers in return for contractual rights to use or purchase
a patented or otherwise legally recognized discovery for
which the health care provider holds an ownership right.
(7) The payment of the reasonable expenses of an
individual related to the interview of the individual by a
manufacturer of prescribed products in connection with a bona
fide employment opportunity or for health care services on
behalf of an employee of the manufacturer.
(8) Sponsorship of an educational program offered by a
device manufacturer at a national or regional professional
society meeting at which programs accredited by the
Accreditation Council for Continuing Medical Education, or a
comparable professional accrediting entity, are also offered,
provided:
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(i) no payment is made directly to a health care
professional or pharmacist; and
(ii) the funding is used solely for bona fide
educational purposes, except that the manufacturer may
provide meals and other food for program participants.
(9) Items with a total combined retail value, in any
calendar year, of not more than $50.
(10) Other reasonable fees, payments, subsidies or other
economic benefits provided by a manufacturer of prescribed
products at fair market value.
"Bona fide clinical trial." An FDA-reviewed clinical trial
that constitutes research, as that term is defined in 45 CFR §
46.102 (relating to definitions), and reasonably can be
considered to be of interest to scientists or health care
professionals working in the particular field of inquiry.
"Clinical trial." Any study assessing the safety or efficacy
of prescribed products administered alone or in combination with
other prescribed products or other therapies, or assessing the
relative safety or efficacy of prescribed products in comparison
with other prescribed products or other therapies.
"Device." As defined in section 201 of the Federal Food,
Drug and Cosmetic Act (52 Stat. 1040, 21 U.S.C. § 301 et seq.).
"Free clinic." A health care facility operated by a
nonprofit private entity that:
(1) in providing health care, does not accept
reimbursement from any third-party payor, including
reimbursement from any insurance policy, health plan or
Federal or State health benefits program that is individually
determined;
(2) in providing health care, either:
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(i) does not impose charges on patients to whom
service is provided; or
(ii) imposes charges on patients according to the
patient's ability to pay;
(3) may accept patients' voluntary donations for health
care service provision; and
(4) is licensed or certified to provide health services
in accordance with the laws of this Commonwealth.
"Gift." Means:
(1) anything of value provided for free to a health care
provider; or
(2) except as provided for allowable expenditures, any
payment, food, entertainment, travel, subscription, advance,
service or anything else of value provided to a health care
provider, unless:
(i) it is an allowable expenditure; or
(ii) the health care provider reimburses the cost at
fair market value.
"Health benefit plan administrator." The person or entity
who sets formularies on behalf of an employer or health insurer.
"Health care professional." The following:
(1) A person who is authorized by law to prescribe or to
recommend prescribed products, who regularly practices in
this Commonwealth, and who either is licensed by the
Commonwealth to provide or is otherwise lawfully providing
health care in this Commonwealth.
(2) A partnership or corporation made up of the persons
described in paragraph (1).
(3) An officer, employee, agent or contractor of a
person described in paragraph (1) who is acting in the course
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and scope of employment, of an agency or of a contract
related to or supportive of the provision of health care to
individuals.
(4) The term shall not include a person described in
paragraph (1) who is employed solely by a manufacturer.
"Health care provider." A health care professional,
hospital, nursing home, pharmacist, health benefit plan
administrator or any other person authorized to dispense or
purchase for distribution prescribed products in this
Commonwealth. The term does not include a hospital foundation
that is organized as a nonprofit entity separate from a
hospital.
"Manufacturer." A pharmaceutical, biological product or
device manufacturer or any other person who is engaged in the
production, preparation, propagation, compounding, processing,
marketing, packaging, repacking, distributing or labeling of
prescribed products. The term does not include:
(1) a wholesale distributor of biological products or a
retailer or a pharmacist licensed under the act of September
27, 1961 (P.L.1700, No.699), known as the Pharmacy Act; or
(2) a manufacturer whose only prescribed products are
classified as Class I by the United States Food and Drug
Administration, are exempt from premarket notification under
section 510(k) of the Federal Food, Drug and Cosmetic Act (52
Stat. 1040, 21 U.S.C. § 301 et seq.) and are sold over-the-
counter without a prescription.
"Marketing." Includes promotion, detailing or any activity
that is intended to be used or is used to influence sales or
market share or to evaluate the effectiveness of a professional
sales force.
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"Pharmaceutical manufacturer." Any entity that is engaged in
the production, preparation, propagation, compounding,
conversion or processing of prescription drugs, whether directly
or indirectly by extraction from substances of natural origin,
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
distributor of prescription drugs, a retailer or a pharmacist
licensed under the Pharmacy Act.
"Prescribed product." A drug as defined in section 201 of
the Federal Food, Drug and Cosmetic Act, a compound drug or
drugs, a device as defined in this section, a biological product
as defined in section 351 of the Public Health Service Act, (58
Stat. 682, 42 U.S.C. § 201 et seq.), for human use or a
combination product as defined in 21 CFR § 3.2(e) (relating to
definitions). The term does not include prescription eyeglasses,
prescription sunglasses or other prescription eyewear.
"Regularly practices." To practice at least periodically
under contract with, as an employee of or as the owner of a
medical practice, health care facility, nursing home, hospital
or university located in this Commonwealth.
"Sample." A unit of a prescription drug, biological product
or device that is not intended to be sold and is intended to
promote the sale of the drug, product or device. The term
includes starter packs and coupons or other vouchers that enable
an individual to receive a prescribed product free of charge or
at a discounted price. The term does not include prescribed
products distributed free of charge or at a discounted price
under a manufacturer-sponsored or manufacturer-funded patient
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assistance program.
"Significant educational, scientific or policy-making
conference or seminar." An educational, scientific or policy-
making conference or seminar that:
(1) is accredited by the Accreditation Council for
Continuing Medical Education or a comparable organization or
is presented by an approved sponsor of continuing education,
provided that the sponsor is not a manufacturer of prescribed
products; and
(2) offers continuing education credit, features
multiple presenters on scientific research or is authorized
by the sponsor to recommend or make policy.
Section 3. Expenditures by manufacturers of prescribed
products.
(a) Prohibition.--A manufacturer of a prescribed product or
any wholesale distributor of devices, or any agent thereof, may
not offer or give any gift to a health care provider.
(b) Exception.--The prohibition under subsection (a) shall
not apply to any of the following:
(1) Samples of a prescribed product or reasonable
quantities of an over-the-counter drug, a nonprescription
device, an item of nonprescription durable medical equipment,
an item of medical food as defined in section 360ee(b)(3) of
the Federal Food, Drug and Cosmetic Act (52 Stat. 1040, 21
U.S.C. § 301 et seq.) or infant formula as defined in section
201(z) of the Federal Food, Drug, and Cosmetic Act, provided
to a health care provider for free distribution to patients.
(2) The loan of a device for a short-term trial period,
not to exceed 120 days, to permit evaluation of a device by a
health care provider or patient.
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(3) The provision of reasonable quantities of device
demonstration or evaluation units to a health care provider
to assess the appropriate use and function of the product and
determine whether and when to use or recommend the product in
the future.
(4) The provision, distribution, dissemination or
receipt of peer-reviewed academic, scientific or clinical
articles or journals and other items that serve a genuine
educational function provided to a health care provider for
the benefit of patients.
(5) Scholarship or other support for medical students,
residents or fellows to attend a significant educational,
scientific or policy-making conference or seminar of a
national, regional or specialty medical or other professional
association if the recipient of the scholarship or other
support is selected by the association.
(6) Rebates and discounts for prescribed products
provided in the normal course of business.
(7) Labels approved by the Food and Drug Administration
for prescribed products.
(8) The provision to a free clinic of financial
donations or of free:
(i) prescription drugs;
(ii) over-the-counter drugs;
(iii) devices;
(iv) biological products;
(v) combination products;
(vi) medical food;
(vii) infant formula; or
(viii) medical equipment or supplies.
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(9) Prescribed products distributed free of charge or at
a discounted price pursuant to a manufacturer-sponsored or
manufacturer-funded patient assistance program.
(10) Fellowship salary support provided to fellows
through grants from manufacturers of prescribed products,
provided:
(i) the grants are applied for by an academic
institution or hospital;
(ii) the institution or hospital selects the
recipient fellows;
(iii) the manufacturer imposes no further demands or
limits on the institution's, hospital's or fellow's use
of the funds; and
(iv) fellowships are not named for a manufacturer
and no individual recipient's fellowship is attributed to
a particular manufacturer of prescribed products.
(11) The provision of coffee or other snacks or
refreshments at a booth at a conference or seminar.
(c) Fee, payment, subsidy or other economic benefit
prohibited.--Except for allowable expenditures, no manufacturer
or other entity on behalf of a manufacturer shall provide any
fee, payment, subsidy or other economic benefit to a health care
provider in connection with the provider's participation in
research.
(d) Penalties.--The Attorney General or appropriate legal
authority may bring legal action for a violation of this act and
may impose on a manufacturer that violates the provisions of
this act a civil penalty of not more than $10,000 per violation.
Each unlawful gift shall constitute a separate violation. In any
action brought under this act, the Attorney General or
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appropriate legal authority shall have the same authority to
investigate and to obtain remedies as if the action were brought
under the act of December 17, 1968 (P.L.1224, No.387), known as
the Unfair Trade Practices and Consumer Protection Law.
Section 4. Effective date.
This act shall take effect in 60 days.
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