Regular Session 2017-2018 House Bill 0045 P.N. 0051

PRINTER'S NO. 51

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 AND DeLUCA,

JANUARY 23, 2017

REFERRED TO COMMITTEE ON HUMAN SERVICES, JANUARY 23, 2017

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

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) An individual who has:

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

treating 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 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 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 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, 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

services.

"Investigational drug, biological product or device." A

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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.

"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 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 in believing that

all currently approved and conventionally recognized

treatments are unlikely to prolong the patient's life.

(3) Identifies clearly 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 health care

provider's knowledge of the proposed treatment and the

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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

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

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the costs associated with, the manufacture of the

investigational drug, biological product or device.

Nothing in this act may 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) 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 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

individual holding a license issued by a Commonwealth licensure

board based solely on the 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.

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 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

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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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