Regular Session 2017-2018 House Bill 0045 P.N. 2108

SENATE AMENDED

PRIOR PRINTER'S NOS. 51, 1051, 1264

PRINTER'S NO. 2108

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, FARRY AND KORTZ,

JANUARY 23, 2017

SENATOR BAKER, HEALTH AND HUMAN SERVICES, IN SENATE, AS AMENDED,

JUNE 21, 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

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

Federal Food and Drug Administration.

(3) Patients who have a terminal illness have a

fundamental right SHOULD BE ALLOWED 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 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.

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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) An individual who has:

(i) a terminal illness, attested to by the patient's

treating physician;

(ii) carefully considered all other treatment

options approved by the 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 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

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 health care facility, as

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defined in section 802.1 of the act of July 19, 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, 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 Federal Food and Drug

Administration and remains under investigation in a clinical

trial approved by the 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 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) Identifies clearly the specific proposed

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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

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.

Section 4. Access.

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(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 WHILE EXERCISING REASONABLE CARE 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:

(1) an individual holding a license issued by a

Commonwealth licensure board based solely on the health care

provider's recommendations to an eligible patient regarding

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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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