SENATE AMENDED
PRIOR PRINTER'S NO. 1420
PRINTER'S NO. 3956
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, RAVENSTAHL,
PETRI, MILNE, ZIMMERMAN, GABLER, COX, WATSON, GIBBONS, KORTZ
AND SANTARSIERO, MAY 4, 2015
SENATOR VANCE, PUBLIC HEALTH AND WELFARE, IN SENATE, AS AMENDED,
SEPTEMBER 28, 2016
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.
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(2) Patients who have a terminal illness do not have the
luxury of waiting until an investigational drug, biological
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 HEALTH CARE PROVIDER;
(ii) carefully considered all other treatment
options approved by the United States Food and Drug
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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 HEALTH CARE PROVIDER 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 LEGALLY AUTHORIZED REPRESENTATIVE has given
written, informed consent on the patient's behalf; and
(vi) documentation from the patient's treating
physician HEALTH CARE PROVIDER 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. "HEALTH CARE PROVIDER." A LICENSED HOSPITAL OR HEALTH CARE
FACILITY, MEDICAL EQUIPMENT SUPPLIER OR PERSON WHO IS LICENSED,
CERTIFIED OR OTHERWISE REGULATED TO PROVIDE HEALTH CARE SERVICES
UNDER THE LAWS OF THIS COMMONWEALTH, INCLUDING A PHYSICIAN,
PODIATRIST, OPTOMETRIST, PSYCHOLOGIST, PHYSICAL THERAPIST,
CERTIFIED NURSE PRACTITIONER, REGISTERED NURSE, NURSE MIDWIFE,
PHYSICIAN'S ASSISTANT, CHIROPRACTOR, DENTIST, PHARMACIST OR AN
INDIVIDUAL ACCREDITED OR CERTIFIED TO PROVIDE BEHAVIORAL HEALTH
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SERVICES.
"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.
"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 physician HEALTH CARE PROVIDER 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 HEALTH CARE PROVIDER 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
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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
HEALTH CARE PROVIDER'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
HEALTH CARE provider are not obligated to pay for THE USE OF
THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE OR 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
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
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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
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. NOTHING IN
THIS ACT SHALL BE CONSTRUED TO REQUIRE A HEALTH INSURER TO
PROVIDE COVERAGE FOR ANY HEALTH CARE SERVICES, INCLUDING
INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS OR DEVICES, THAT
WOULD NOT OTHERWISE BE A COVERED BENEFIT UNDER AN ELIGIBLE
PATIENT'S HEALTH INSURANCE POLICY.
Section 5. Unprofessional conduct.
(a) Physician HEALTH CARE PROVIDER immunity.--No physician
HEALTH CARE PROVIDER who in good faith recommends or
participates in the use of an investigational drug, biological
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product or device under this act shall be subject to criminal or
civil liability, nor shall a physician HEALTH CARE PROVIDER 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. ANY LAW OF THIS COMMONWEALTH RELATING TO LICENSURE.
(b) Physician HEALTH CARE PROVIDER licensure not affected.--
Notwithstanding any other law to the contrary, the State Board
of Medicine and the State Board of Osteopathic Medicine may not
NO LICENSURE BOARD MAY 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, BY A COMMONWEALTH LICENSURE BOARD based solely on the
individual's HEALTH CARE PROVIDER'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, 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
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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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