An Act To Allow Terminally Ill Patients To Choose To Use Experimental Treatments
Maine Legislature, Session 127, LD 0180
Committee Amendment CA_A_H577 (House)

COMMITTEE AMENDMENT" A" to H.P. 138, L.D. 180, Bill, "An Act To Allow 
Terminally Ill Patients To Choose To Use Experimental Treatments" 
Amend the bill by striking out all of section 1 and inserting the following: 
'Sec. 1. 22 MRSA c. 602-A is enacted to read: 
CHAPTER 602-A 
ACCESS TO INVESTIGATIONAL TREATMENTS FOR TERMINALLY ILL 
PATIENTS 
§2671. Definitions 
As used in this chapter, unless the context otherwise indicates, the following terms 
have the following meanings. 
1. Eligible patient. "Eligible patient" means a person who has: 
A. Received a diagnosis of a terminal illness for which no standard treatment is 
effective and the diagnosis has been attested by the person's treating physician; 
B. Considered all treatment options approved by the United States Food and Drug 
Administration; 
C. Not been accepted into a clinical trial within one week of completion of the 
clinical trial application process; 
D. 
Received a recommendation from the person's treating physician for an 
investigational drug, biological product or device; 
E. Given written, informed consent for the use of the investigational drug, biological 
product or device under paragraph D or, if the person is a minor or lacks the mental 
capacity to provide informed consent, whose parent or legal guardian has given 
written, informed consent on the person's behalf; and 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A" to H.P. 138, L.D. 180 
F. 
Received documentation from the person's treating physician that the person 
meets all of the conditions in this subsection. 
2. 
Investigational drug, biological product or device. 
"Investigational drug, 
biological product or device" means a drug, biological product or device that has 
successfully completed Phase I of a United States Food and Drug Adrninistration-
approved clinical trial but has not yet been approved for general use by the United States 
Food and Drug Administration and remains under investigation in such a clinical trial. 
3. Terminal illness. "Terminal illness" means a disease or condition that, without 
life-sustaining measures, will soon result in death or in a state of permanent 
unconsciousness from which recovery is unlikely. 
4. Treating physician. "Treating physician" means a physician who has primary 
responsibility for the care of a patient and treatment of that patient's terminal illness. 
5. 
Written, informed consent. 
"Written, informed consent" means a written 
document signed by a patient or, if the patient is a minor or lacks the mental capacity to 
provide informed consent, a parent or legal guardian of the patient. The document must 
be attested by the patient's treating physician and a witness and include the following 
information: 
A. An explanation of the United States Food and Drug Administration-approved 
treatments for the disease or condition from which the patient suffers; 
B. A statement that the patient concurs with the patient's treating physician that all 
United States Food and Drug Administration-approved and standard treatments for 
the disease or condition from which the patient suffers are unlikely to prolong the 
patient's life; 
C. 
Clear identification of the specific investigational drug, biological product or 
device that the patient is seeking to use; and 
D. A description of the best and worst potential outcomes of using the investigational 
drug, biological product or device identified under paragraph C with a description of 
the most likely outcome. The description must include the possibility that new, 
unanticipated, different or worse symptoms might result and that death could be 
hastened by the proposed treatment. The description must be based on the treating 
physician's knowledge of the proposed treatment in conjunction with the treating 
physician's knowledge of the patient's overall medical condition. 
§2672. 
Availability of investigational drug, biological product or device by 
manufacturer 
A manufacturer of an investigational drug, biological product or device may make 
available the investigational drug, biological product or device to an eligible patient. 
1. Compensation. A manufacturer may provide an investigational drug, biological 
product or device to an eligible patient with or without receiving compensation. 
2. 
Costs. A manufacturer may require an eligible patient to pay the costs of 
manufacturing the dosage of an investigational drug, a biological product or a device 
dispensed to that eligible patient. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A" to H.P. 138, L.D. 180 
§2673. 
Action against health care practitioner or health care provider license 
prohibited 
A licensing board may not revoke, refuse to renew or suspend the license of or take 
any action against a health care practitioner as defined in Title 24, section 2502, 
subsection 1-A based solely on the health care practitioner'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. 
The licensing agency may not revoke, refuse to renew or suspend the license of or 
take any action against a health care provider as defined in Title 24, section 2502, 
subsection 2 based solely on the health care provider's involvement in the care of an 
eligible patient using an investigational drug, biological product or device. 
§2674. Officials, employees and agents of the State 
1. Violation. An official, employee or agent of the State may not block or attempt to 
block an eligible patient's access to an investigational drug, biological product or device. 
2. Medical standards of care. This section does not prohibit an official, employee 
or agent of the State from providing counseling, advice or a recommendation consistent 
with medical standards of care. 
§2675. No cause of action created 
This chapter does not create 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 the investigational drug, biological 
product or device for any harm done to the eligible patient resulting from the 
investigational drug, biological product or device if the manufacturer or other person or 
entity is complying in good faith with the provisions of this chapter and has exercised 
reasonable care. 
§2676. Clinical trial coverage 
This chapter does not affect the mandatory health care coverage for participation in 
clinical trials pursuant to Title 24-A, section 4310. 
§2677. Optional participation of health care practitioners and providers 
This chapter does not require a health care practitioner who is licensed in the State or 
a health care provider that is licensed in the State to provide any service related to an 
investigational drug, biological product or device.' 
SUMMARY 
This amendment does the following. 
1. 
It amends the definition of "eligible patient" in the bill by eliminating the 
condition that requires a patient to have been unable to participate in a clinical trial for 
treatment of the terminal illness within 100 miles of that person's home address. 
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COMMITTEE AMENDMENT "A" to H.P. 138, L.D. 180 
2. 
It amends the definition of "terminal illness" in the bill to provide that the 
condition need not reasonably be expected to result in death within 6 months but instead 
will soon result in death or in a state of permanent unconsciousness from which recovery 
is unlikely. 
3. It amends the definition of "written, informed consent" in the bill to remove 
certain requirements involving insurance implications, home health care services and 
hospice care and patient liability for certain expenses. 
4. It amends the provision that provides for the costs that are allowed to be charged 
by the manufacturer to ensure that the patient is being charged only for the costs of 
manufacturing the dosage of an investigational drug, a biological product or a device 
dispensed to that patient. 
5. It strikes the section dealing with insurance issues. 
6. It provides protection to health care providers who choose to provide care to an 
eligible patient using an investigational drug, biological product or device. 
7. 
It eliminates the penalty for blocking an eligible patient from access to an 
investigational drug, biological product or device. 
8. It makes it clear that the provision of services related to an investigational drug, 
biological product or device by health care practitioners and providers is optional. 
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COMMITTEE AMENDMENT