Regular Session 2017-2018 House Bill 0045 P.N. 1264

PRIOR PRINTER'S NOS. 51, 1051

PRINTER'S NO. 1264

THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

No.

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.

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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