PRINTER'S NO. 1420
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1104
Session of
2015
INTRODUCED BY GODSHALL, BOBACK, MILLARD, JAMES, MURT, D. COSTA,
O'BRIEN, PASHINSKI, BARRAR, MARSHALL, KOTIK, QUIGLEY, HARHAI,
BARBIN, DeLUCA, LEWIS, COHEN, ROZZI, CAUSER AND RAVENSTAHL,
MAY 4, 2015
REFERRED TO COMMITTEE ON HEALTH, MAY 4, 2015
AN ACT
Providing for the use of investigational drugs, biological
products and 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 devices in the United States protects
future patients from premature, ineffective and unsafe
medications and treatments over the long run, but the process
often takes many years.
(2) Patients who have a terminal illness do not have the
luxury of waiting until an investigational drug, biological
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product or device receives final approval from the United
States 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 devices.
(4) The use of available investigational drugs,
biological products and devices is a decision that should be
made by the patient with a terminal illness in consultation
with the patient's health care provider and the patient's
health care team, if applicable.
(5) The decision to use an investigational drug,
biological product or device should be made with full
awareness of the potential risks, benefits and consequences
to the patient and the patient's family.
(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 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
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
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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
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) 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 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
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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 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.
(3) Clearly identifies the specific proposed
investigational drug, biological product or device that the
patient is seeking to use.
(4) Describes the potentially best and worst outcomes of
using the investigational drug, biological product or 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 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 treatments
consequent to the use of the investigational drug, biological
product or device.
(6) Makes clear that the patient's eligibility for
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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, 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 states
otherwise.
Section 4. Access.
(a) General rule.--A manufacturer of an investigational
drug, biological product or device may make available the
manufacturer's investigational drug, biological product or
device to eligible patients in accordance with this act.
(b) Costs.--A manufacturer may:
(1) Provide an investigational drug, biological product
or 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 device.
(c) Insurers.--A health insurer may:
(1) In its discretion, provide coverage for the cost of
an investigational drug, biological product or device.
(2) Except as set forth in subsection (d), deny coverage
to an eligible patient from the time the eligible patient
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begins use of the investigational drug, biological product or
device through a period not to exceed six months from the
time the investigational drug, biological product or device
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.
Section 5. 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 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, as long as the recommendations are consistent with
medical standards of care. Any action against an individual or
entity's Medicare certification based solely on recommendations
that a patient have access to an investigational drug,
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biological product or device is prohibited.
Section 6. 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 against any other person
or entity involved in the care of an eligible patient using an
investigational drug, biological product or device for any
injury suffered by the eligible patient resulting from the
investigational drug, biological product or 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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