Home Table of Contents

§ 10232.3. Definitions

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: December 11, 2017

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 65. Right-to-Try Act
Effective: December 11, 2017
35 P.S. § 10232.3
§ 10232.3. Definitions
Currentness
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 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 defined in section 802.1 of the act of July 19, 1979 (P.L. 130, No.48),1 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 Food and Drug Administration and remains under investigation in a clinical trial approved by the Food and Drug Administration.
“Physician.” As defined in section 2 of the act of December 20, 1985 (P.L. 457, No.112),2 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 eligible patient's medical record signed by the eligible patient and attested to by the eligible 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 eligible patient suffers.
(2) Attests to the fact that the eligible patient concurs with the eligible patient's treating physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the eligible patient's life.
(3) Identifies clearly the specific proposed investigational drug, biological product or medical device that the eligible 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 eligible 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 eligible 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 eligible patient understands that the eligible 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 eligible patient's estate, unless a contract between the eligible patient and the manufacturer of the investigational drug, biological product or medical device states otherwise.

Credits

2017, Oct. 11, P.L. 347, No. 33, § 3, effective in 60 days [Dec. 11, 2017].

Footnotes

1
35 P.S. § 448.802a.
2
63 P.S. § 422.2.
35 P.S. § 10232.3, PA ST 35 P.S. § 10232.3
Current through 2023 Regular Session Act 1. Some statute sections may be more current, see credits for details.
End of Document