Oklahoma § 63-3091.2 - Definitions

§ 63-3091.2. Definitions

For purposes of the Right to Try Act:

1. "Eligible patient" means a person who has:

a.

a terminal illness, attested to by the patient's

treating physician,

b.

considered all other treatment options currently

approved by the United States Food and Drug

Administration,

c.

been unable to participate in a clinical trial for the

terminal illness within one hundred (100) miles of the

patient's home address, or not been accepted to the

clinical trial within one (1) week of completion of

the clinical trial application process,

d.

received a recommendation from his or her physician

for the use of an investigational drug, biological

product or device,

e.

given written, informed consent for the use of the

investigational drug, biological product or device or,

if the patient is a minor or lacks the mental capacity

to provide informed consent, a parent or legal

guardian has given written, informed consent on the

patient's behalf, and

f.

documentation from his or her physician that he or she

meets the requirements of this paragraph.

"Eligible patient" does not include a person being treated as an

inpatient in a hospital licensed pursuant to the provisions of

Section 1-701 et seq. of Title 63 of the Oklahoma Statutes;

2. "Investigational drug, biological product or device" means 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 and

remains under investigation in a clinical trial approved by the

United States Food and Drug Administration;

3. "Terminal illness" means a disease that, without lifesustaining procedures, will soon result in death or a state of

permanent unconsciousness from which recovery is unlikely; and

Oklahoma Statutes - Title 63. Public Health and Safety

4. "Written, informed consent" means a written document signed

by the patient and attested to by the patient's physician and a

witness that, at a minimum:

a.

explains the currently approved products and

treatments for the disease or condition from which the

patient suffers,

b.

attests to the fact that the patient concurs with his

or her physician in believing that all currently

approved and conventionally recognized treatments are

unlikely to prolong the patient's life,

c.

clearly identifies the specific proposed

investigational drug, biological product or device

that the patient is seeking to use,

d.

describes the best and worst potential 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 physician's knowledge

of the proposed treatment in conjunction with an

awareness of the patient's condition,

e.

makes clear that the patient's health insurer and

provider are not obligated to pay for any care or

treatments consequent to the use of the

investigational drug, biological product or device,

f.

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,

g.

makes clear that in-home health care may be denied if

treatment begins, and

h.

states that the patient understands that he or she 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 drug, biological product or device

states otherwise.

Added by Laws 2015, c. 112, § 2, eff. Nov. 1, 2015.