PRINTER'S NO. 659
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
572
Session of
2017
INTRODUCED BY DINNIMAN, FONTANA, VULAKOVICH, MENSCH AND
RAFFERTY, APRIL 6, 2017
REFERRED TO HEALTH AND HUMAN SERVICES, APRIL 6, 2017
AN ACT
Providing for the use of investigational drugs, biological
products and devices by terminally ill patients under 18
years of age.
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 Right to Try for
Terminally Ill Children 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) The Commonwealth is committed to providing access to
life-saving treatments for its youngest and most vulnerable
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
populations. Patients under 18 years of age 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 under 18 years of age 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 parent or legal guardian of a patient under 18
years of age 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 under 18 years of age 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."
(1) A person who has:
(i) A terminal illness, attested to by the patient's
20170SB0572PN0659 - 2 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
treating health care provider.
(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 health care provider for an investigational
drug, biological product or device.
(v) A parent or legal guardian who has given
written, informed consent on the patient's behalf for the
use of the investigational drug, biological product or
device.
(vi) Documentation from the patient's treating
health care provider that the patient meets the
requirements of this paragraph.
(vii) Not yet attained 18 years of age.
(2) The term does not include a person being treated as
an inpatient in a hospital.
"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
20170SB0572PN0659 - 3 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
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 for patients under 18 years of age and remains
under investigation in a clinical trial approved by the United
States Food and Drug Administration.
"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 a
patient's medical record, signed by the patient's parent or
legal guardian on the patient's behalf and attested to by the
patient's treating 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's parent or
legal guardian concurs with the patient's treating 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 seeks 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,
20170SB0572PN0659 - 4 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
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 knowledge of the proposed treatment in conjunction
with an awareness of the patient's condition.
(5) 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.
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 provide an investigational
drug, biological product or device to an eligible patient
without receiving compensation.
(c) Health insurers.--
(1) Except as provided in paragraph (2), a health
insurer shall provide coverage for the cost of an
investigational drug, biological product or device.
(2) Coverage may not be denied for a preexisting
condition or in a case 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) Health care provider immunity.--No health care provider
who in good faith recommends or participates in the use of an
investigational drug, biological product or device under this
20170SB0572PN0659 - 5 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
act shall be subject to criminal or civil liability or 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, no Commonwealth
licensure board may revoke, suspend or otherwise take any action
against an individual holding a license issued by the
Commonwealth licensure board 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.
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.
20170SB0572PN0659 - 6 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25