Section 1. Amend Title 16 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows:

Chapter 25A. The Delaware "Right to Try" Act

§2501A.Findings.

(a) The process of approval for investigational drugs, biological products and devices in the United
States often takes many years.

(b) Patients who have a terminal illness do not have the luxury of waiting until an investigational drug, biological product or device receives final approval.

(c) The standards of the United States Food and Drug Administration for the use of investigational drugs, biological products and devices may deny the benefits of potentially life-saving treatments to terminally ill patients.

(d) The State of Delaware recognizes that patients who have a terminal illness have a fundamental right to attempt to pursue the preservation of their own life by accessing available investigational drugs, biological products and devices.

(e) 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 his or her treating physician.

§2502A.Definitions.

In this Chapter the following definitions shall apply:

(1) "Eligible patient" means a person who meets all of the following:

a.Has a terminal illness, attested to by the patient's treating physician.

b.As determined by the patient's treating physician, has no comparable or satisfactory treatment

optionsthat are approved by the United States Food and Drug Administration and available to diagnose, monitor or treat the person's illness or condition.

c.Has received a prescription or recommendation by their treating physician for an

investigational drug, biological product or device.

d.Has given informed consent in writing for the use of the investigational drug, biological

product or device.In the case that the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian may provide informed consent on the patient's behalf.

e.Has obtained documentation from their treating physician stating that he or she meets the

eligibility requirements.

(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 been approved for general use by the United States Food and Drug Administration.Additionally, the drug must currently be under investigation in an FDA clinical trial.

(3) "Terminal illness" means an advanced stage of an illness with a terminal prognosis that will lead to

death within 12 months and has no known cure.

(4) "Informed consent in writing" means a written document signed by the patient and attested to by the

patient's treating physician and a witness that, at a minimum:

a.Explains the currently approved products and treatments for the illness or condition from

which the patient suffers.

b.Attests to the fact that the patient concurs with his or her treating 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 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 treating 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 insurance provider is 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.

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.

§2503A.Availability of Investigational Drugs, Biological Products or Devices

(a) 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 under this Chapter.

(b) 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 associated with, the manufacture of the

investigational drug, biological product or device.

(c) This section does not require that a manufacturer make available an investigational drug, biological product or device to an eligible patient.

§2504A.Health Insurance Coverage for Investigational Drugs, Biological Products or Devices

(a) A health insurance provider may choose to provide coverage for the cost of the investigational drug, biological product or device.

(b) Nothing in this section shall be construed to require a health insurance provider to provide coverage for the cost of any investigational drug, biological product or device.

§2505A.Action Against Physician License Prohibited

(a) Notwithstanding any provision of law to the contrary, no state agency or regulatory board shall revoke, fail to renew, or take any action against a physician's license issued under Title 24 based solely on a physician's recommendation to an eligible patient regarding prescription for, or treatment with, an investigational drug, biological product or device.

§506A.Liability

(a) Except in the case of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, dispenses, or administers an investigational drug, biological product or device to an eligible patient in accordance with this Chapter shall not be liable in any action under state law for any loss, damage, or injury arising out of, relating to, or resulting from:

(1) The design, development, clinical testing and investigation, manufacturing, labeling,

distribution, sale, purchase, donation, dispensing, prescription, administration or use of the drug or device.

(2) The safety or effectiveness of the drug or device.

§2507A.Prevention of State Interference

(a) An official, employee, or agent of this state shall not block or attempt to block an eligible patient's access to an investigational drug, biological product or device. Counseling, advice, or a recommendation consistent with medical standards of care from a licensed health care provider is not a violation of this Chapter.

SPONSOR:	Sen. Bonini & Sen. Peterson & Rep. Bennett
	Sens. Cloutier, Hocker, Lawson, Pettyjohn, Richardson, Simpson; Reps. Dukes, Hudson, Miro, Ramone, Spiegelman, Wilson