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PRIOR PRINTER'S NOS. 51, 1051
PRINTER'S NO. 1264
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
45
Session of
2017
INTRODUCED BY GODSHALL, BARRAR, BOBACK, V. BROWN, CALTAGIRONE,
CAUSER, D. COSTA, COX, DIAMOND, FRANKEL, GILLESPIE,
A. HARRIS, JAMES, W. KELLER, KINSEY, LONGIETTI, MARSHALL,
MILLARD, MOUL, MULLERY, MURT, NEILSON, O'BRIEN, ORTITAY,
PICKETT, QUIGLEY, READSHAW, SCHLOSSBERG, SIMMONS, TOEPEL,
WARD, WATSON, ZIMMERMAN, GABLER, KAUFFMAN, DeLUCA, D. MILLER,
WARREN, PHILLIPS-HILL, BARBIN AND FARRY, JANUARY 23, 2017
AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
APRIL 5, 2017
AN ACT
Providing for the use of investigational drugs, biological
products and MEDICAL devices by terminally ill patients.
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 Right-to-Try
Act.
Section 2. Legislative findings and intent.
(a) Findings and declarations.--The General Assembly finds
and declares as follows:
(1) The process of approval for investigational drugs,
biological products and MEDICAL devices in the United States
BY THE FEDERAL FOOD AND DRUG ADMINISTRATION protects future
patients from premature, ineffective and unsafe medications
and treatments over the long run, but the process often takes
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many years.
(2) Patients who have a terminal illness do not have the
luxury of waiting until an investigational drug, biological
product or MEDICAL device receives final approval from the
United States FEDERAL Food and Drug Administration.
(3) Patients who have a terminal illness have a
fundamental right to attempt to pursue the preservation of
their lives by accessing available investigational drugs,
biological products and MEDICAL devices.
(4) The use of available investigational drugs,
biological products and MEDICAL devices is a decision that
should be made by the patient with a terminal illness in
consultation with the patient's health care provider TREATING
PHYSICIAN and the patient's health care team, if applicable.
(5) The decision to use an investigational drug,
biological product or MEDICAL device should be made with full
awareness of the potential risks, benefits and consequences
to the patient and the patient's family.
(6) THE FEDERAL FOOD AND DRUG ADMINISTRATION RECENTLY,
IN JUNE 2016, IMPLEMENTED A MORE STREAMLINED PROCESS FOR
INDIVIDUAL PATIENT ACCESS TO INVESTIGATIONAL DRUGS AND
BIOLOGICAL PRODUCTS THROUGH ITS INDIVIDUAL PATIENT EXPANDED
ACCESS PROGRAM - FORM FDA 3926, WHICH MAY BE USEFUL IN SOME
SITUATIONS.
(b) Intent.--It is the intent of the General Assembly to
allow terminally ill patients to use potentially life-saving
investigational drugs, biological products and MEDICAL devices.
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
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context clearly indicates otherwise:
"Eligible patient." As follows:
(1) An individual who has:
(i) a terminal illness, attested to by the patient's
treating health care provider PHYSICIAN;
(ii) carefully considered all other treatment
options approved by the United States FEDERAL Food and
Drug Administration;
(iii) been unable to participate in a clinical trial
for the terminal illness that is located within 100 miles
of the patient's home address or has not been accepted to
the clinical trial within one week of completion of the
clinical trial application process;
(iv) received a recommendation from the patient's
treating health care provider PHYSICIAN for an
investigational drug, biological product or MEDICAL
device;
(v) given written, informed consent for the use of
the investigational drug, biological product or MEDICAL
device, or, if the patient is either a minor or lacks the
mental capacity to provide informed consent, a parent or
legally authorized representative has given written,
informed consent on the patient's behalf; and
(vi) documentation from the patient's treating
health care provider PHYSICIAN that the patient meets the
requirements of this paragraph.
(2) The term does not include an individual being
treated as an inpatient in any hospital.
"Health care provider." A licensed hospital or health care
facility, AS DEFINED IN SECTION 802.1 OF THE ACT OF JULY 19,
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1979 (P.L.130, NO.48), KNOWN AS THE HEALTH CARE FACILITIES ACT,
or A person who is licensed, certified or otherwise regulated to
provide health care services under the laws of this Commonwealth
as, INCLUDING, BUT NOT LIMITED TO, AS a physician, A certified
nurse practitioner or A physician's assistant.
"Investigational drug, biological product or MEDICAL device."
A drug, biological product or MEDICAL device that has
successfully completed phase one of a clinical trial but has not
yet been approved for general use by the United States FEDERAL
Food and Drug Administration and remains under investigation in
a clinical trial approved by the United States FEDERAL Food and
Drug Administration.
"PHYSICIAN." AS DEFINED IN SECTION 2 OF THE ACT OF DECEMBER
20, 1985 (P.L.457, NO.112), KNOWN AS THE MEDICAL PRACTICE ACT OF
1985.
"Terminal illness." A disease or condition that, without
life-sustaining procedures, will soon result in death or a state
of permanent unconsciousness from which recovery is unlikely.
"Written, informed consent." A written document placed in
the patient's medical record signed by the patient and attested
to by the patient's treating health care provider PHYSICIAN and
a witness that, at a minimum:
(1) Explains the currently approved products and
treatments for the disease or condition from which the
patient suffers.
(2) Attests to the fact that the patient concurs with
the patient's treating health care provider PHYSICIAN in
believing that all currently approved and conventionally
recognized treatments are unlikely to prolong the patient's
life.
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(3) Identifies clearly the specific proposed
investigational drug, biological product or MEDICAL device
that the patient is seeking to use.
(4) Describes the potentially best and worst outcomes of
using the investigational drug, biological product or MEDICAL
device with a realistic description of the most likely
outcome, including the possibility that new, unanticipated,
different or worse symptoms might result, and that death
could be hastened by the proposed treatment, based on the
health care provider's TREATING PHYSICIAN'S knowledge of the
proposed treatment and the patient's condition.
(5) Makes clear that the patient's health insurer and
health care provider are not obligated to pay for the use of
the investigational drug, biological product or MEDICAL
device or any care or treatments consequent to the use of the
investigational drug, biological product or MEDICAL device.
(6) Makes clear that the patient's eligibility for
hospice care may be withdrawn if the patient begins curative
treatment and care may be reinstated if the curative
treatment ends and the patient meets hospice eligibility
requirements.
(7) Makes clear that in-home health care may be denied
if treatment begins.
(8) States that the patient understands that the patient
is liable for all expenses consequent to the use of the
investigational drug, biological product or MEDICAL device,
and that this liability extends to the patient's estate,
unless a contract between the patient and the manufacturer of
the investigational drug, biological product or MEDICAL
device states otherwise.
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Section 4. Access.
(a) General rule.--A manufacturer of an investigational
drug, biological product or MEDICAL device may make available
the manufacturer's investigational drug, biological product or
MEDICAL device to eligible patients in accordance with this act.
(b) Costs.--A manufacturer may:
(1) Provide an investigational drug, biological product
or MEDICAL device to an eligible patient without receiving
compensation.
(2) Require an eligible patient to pay the costs of, or
the costs associated with, the manufacture of the
investigational drug, biological product or MEDICAL device.
(c) Insurers.--Nothing in this act may be construed to
require a health insurer to provide coverage for any health care
services, including investigational drugs, biological products
or MEDICAL devices, that would not otherwise be a covered
benefit under an eligible patient's health insurance policy.
Section 5. Unprofessional conduct.
(a) Health care provider immunity.--A health care provider
who in good faith recommends or participates in the use of an
investigational drug, biological product or MEDICAL device under
this act may not be subject to criminal or civil liability, nor
be found to have committed an act of unprofessional conduct
under any law of this Commonwealth relating to licensure.
(b) Health care provider licensure not affected.--
Notwithstanding any other law to the contrary, a licensure board
may not revoke, suspend or otherwise take any action against an
MAY NOT REVOKE, SUSPEND OR OTHERWISE TAKE ANY ACTION AGAINST:
(1) AN individual holding a license issued by a
Commonwealth licensure board based solely on the health care
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provider's recommendations to an eligible patient regarding
access to or treatment with an investigational drug,
biological product or MEDICAL device, as long as the
recommendations are consistent with medical standards of
care.; OR
(2) ANY OTHER LICENSEE OF THE COMMONWEALTH SOLELY FOR
PARTICIPATING IN THE USE OF AN INVESTIGATIONAL DRUG,
BIOLOGICAL PRODUCT OR MEDICAL DEVICE IN GOOD FAITH AND IN
ACCORDANCE WITH THE PROVISIONS OF THIS ACT.
Section 6. Construction.
Nothing in this act may be construed as creating a private
cause of action against a manufacturer of an investigational
drug, biological product or MEDICAL device, or against any other
person or entity involved in the care of an eligible patient
using an investigational drug, biological product or MEDICAL
device for any injury suffered by the eligible patient resulting
from the investigational drug, biological product or MEDICAL
device, as long as the manufacturer or other person or entity
acted in accordance with this act, except when the injury
results from a failure to exercise reasonable care.
Section 7. Effective date.
This act shall take effect in 60 days.
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