S0003B0889A04391 AJM:EJH 11/20/15 #90 A04391
AMENDMENTS TO SENATE BILL NO. 3
Sponsor: REPRESENTATIVE BAKER
Printer's No. 889
Amend Bill, page 1, lines 1 through 16; pages 2 and 3, lines
1 through 30; page 4, line 1; by striking out all of said lines
on said pages and inserting
Providing for the use of investigational drugs, biological
products and devices by terminally ill patients.
Amend Bill, page 4, lines 4 through 30; pages 5 through 68,
lines 1 through 30; page 69, lines 1 through 27; by striking out
all of said lines on said pages and inserting
Section 1. Short title.
This act shall be known and may be cited as the Right-to-Try
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:
"Eligible patient." As follows:
(1) A person who has:
(i) a terminal illness, attested to by the patient's
treating physician;
(ii) carefully considered all other treatment
options approved by the United States 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 physician for an investigational drug,
biological product or device;
(v) given written, informed consent for the use of
the investigational drug, biological product or device
or, if the patient is a minor or lacks the mental
capacity to provide informed consent, a parent or legal
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guardian has given written, informed consent on the
patient's behalf; and
(vi) documentation from the patient's treating
physician that the patient meets the requirements of this
paragraph.
(2) A person with a qualifying medical condition who
seeks to use only an investigational cannabis product.
(3) The term does not include a person being treated as
an inpatient in any hospital.
"Hospital." As defined in section 802.1 of the act of July
19, 1979 (P.L.130, No.48), known as the Health Care Facilities
Act.
"Investigational cannabis product." A pharmaceutical product
which has been approved for study by the United States Food and
Drug Administration, but is not yet approved for general use by
the United States Food and Drug Administration, which contains a
derivative of cannabis.
"Investigational drug, biological product or device." A
drug, biological product or device that has successfully
completed phase one of a clinical trial but has not yet been
approved for general use by the United States Food and Drug
Administration and remains under investigation in a clinical
trial approved by the United States 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.
"Qualifying medical condition." As follows:
(1) Cancer.
(2) Epilepsy and seizures.
(3) Amyotrophic lateral sclerosis.
(4) Cachexia/wasting syndrome.
(5) Parkinson's disease.
(6) Traumatic brain injury and postconcussion syndrome.
(7) Multiple sclerosis.
(8) Spinocerebellar ataxia (SCA).
(9) HIV/AIDS.
(10) Glaucoma.
"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 signed by
the patient and attested to by the patient's treating 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 physician in believing that all
currently approved and conventionally recognized treatments
are unlikely to prolong the patient's life.
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(3) Clearly identifies the specific proposed
investigational drug, biological product or device or
investigational cannabis product that the patient is seeking
to use.
(4) Describes the potentially best and worst outcomes of
using the investigational drug, biological product or device
or investigational cannabis product 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 physician's knowledge of
the proposed treatment in conjunction with an awareness of
the patient's condition.
(5) Makes clear that the patient's health insurer and
provider are not obligated to pay for any care or treatment
consequent to the use of the investigational drug, biological
product or device or investigational cannabis product.
(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 device or
investigational cannabis product, 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 device or investigational cannabis
product states otherwise.
Section 3. Access.
(a) General rule.--A manufacturer of an investigational
drug, biological product or device or investigational cannabis
product may make available the manufacturer's investigational
drug, biological product or device or investigational cannabis
product to eligible patients in accordance with this act.
(b) Costs.--A manufacturer may:
(1) Provide an investigational drug, biological product
or device or investigational cannabis product 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 device or
investigational cannabis product.
(c) Insurers.--A health insurer may:
(1) In its discretion, provide coverage for the cost of
an investigational drug, biological product or device or
investigational cannabis product.
(2) Except as set forth in subsection (d), deny coverage
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to an eligible patient from the time the eligible patient
begins use of the investigational drug, biological product or
device or investigational cannabis product through a period
not to exceed six months from the time the investigational
drug, biological product or device or investigational
cannabis product is no longer used by the eligible patient.
(d) Limitation.--Coverage may not be denied for a
preexisting condition or in cases where coverage commenced prior
to the time the eligible patient begins use of the
investigational drug, biological product or device or
investigational cannabis product.
Section 4. Unprofessional conduct.
(a) Physician immunity.--No physician who in good faith
recommends or participates in the use of an investigational
drug, biological product or device or investigational cannabis
product under this act shall be subject to criminal or civil
liability, nor shall a physician be found to have committed an
act of unprofessional conduct under the act of October 5, 1978
(P.L.1109, No.261), known as the Osteopathic Medical Practice
Act, or the act of December 20, 1985 (P.L.457, No.112), known as
the Medical Practice Act of 1985.
(b) Physician licensure not affected.--Notwithstanding any
other law to the contrary, the State Board of Medicine and the
State Board of Osteopathic Medicine may not revoke, suspend or
otherwise take any action against an individual holding a
license issued under the Osteopathic Medical Practice Act or the
Medical Practice Act of 1985 based solely on the individual's
recommendations to an eligible patient regarding access to or
treatment with an investigational drug, biological product or
device or investigational cannabis product as long as the
recommendations are consistent with standards of care as set
forth by the manufacturer. Any action against an individual or
entity's Medicare certification based solely on recommendations
that a patient have access to an investigational drug,
biological product or device or investigational cannabis product
is prohibited.
Section 5. Construction.
Nothing in this act shall be construed as creating a private
cause of action against a manufacturer of an investigational
drug, biological product or device or investigational cannabis
product or against any other person or entity involved in the
care of an eligible patient using an investigational drug,
biological product or device or investigational cannabis product
for any injury suffered by the eligible patient resulting from
the investigational drug, biological product or device or
investigational cannabis product 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 6. Protection from prosecution.
In the prosecution for the unlawful possession of marijuana
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under the laws of this Commonwealth, it is an affirmative and
complete defense to the prosecution that the individual has a
qualifying illness and is using or possessing marijuana at the
recommendation of a physician to use cannabis or the individual
is the parent of a minor child with a terminal illness and is in
possession of marijuana for the benefit of the minor child who
has a recommendation of a physician to use cannabis.
Section 7. Effective date.
This act shall take effect in 60 days.
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