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30th Legislature(2017-2018)

Bill Text 30th Legislature


00 Enrolled HB 43                                                                                                          
01 Relating to prescribing, dispensing, and administering an investigational drug, biological                              
02 product, or device by physicians for patients who are terminally ill for the purpose of                                 
03 sustaining the patient's life; providing immunity related to manufacturing, distributing, or                            
04 providing investigational drugs, biological products, or devices; and relating to licensed health                       
05 care facility requirements.                                                                                             
06                           _______________                                                                               
07    * Section 1. AS 08.64.367 is amended by adding new subsections to read:                                              
08            (c)  A physician may not be subject to disciplinary action by the board for                                  
09       prescribing, dispensing, or administering an investigational drug, biological product,                            
10       or device, or providing related treatment, to a patient for the purpose of sustaining the                         
11       patient's life if the patient                                                                                     
12                 (1)  has a terminal illness;                                                                            
13                 (2)  is ineligible or unable to participate in a current clinical trial for the                         
01       investigational drug, biological product, or device;                                                              
02                 (3)  has considered, after consultation with the physician, all other                                   
03       treatment options currently approved by the United States Food and Drug                                           
04       Administration; and                                                                                               
05                 (4)  has given informed consent in writing for the use of the                                           
06       investigational drug, biological product, or device.                                                              
07            (d)  In this section,                                                                                        
08                 (1)  "investigational drug, biological product, or device" means a drug,                                
09       biological product, or device that has successfully completed Phase 1 studies of                                  
10 clinical trials for investigation and remains in ongoing clinical trials under Phase 2 or                               
11 Phase 3 or is in the new drug application process following Phase 3 of clinical trials,                                 
12 but has not been approved for general use by the United States Food and Drug                                            
13       Administration;                                                                                                   
14 (2)  "terminal illness" means a disease that, without life-sustaining                                                   
15 procedures, will result in death in the near future or a state of permanent                                             
16       unconsciousness from which recovery is unlikely.                                                                  
17    * Sec. 2. AS 09.65 is amended by adding a new section to read:                                                       
18 Sec. 09.65.325. Immunity relating to use or nonuse of investigational                                                   
19 drugs, biological products, and devices. (a) A person is not liable in an action for                                    
20 damages for the injury or death of a patient with a terminal illness resulting from the                                 
21 patient's use of an investigational drug, biological product, or device for the purpose of                              
22 sustaining the patient's life if the person, acting in good faith and with reasonable care,                             
23       is a                                                                                                              
24 (1)  physician or member of the medical team who prescribed,                                                            
25 dispensed, or administered the investigational drug, biological product, or device, or                                  
26 provided related treatment, to the patient and, before prescribing, dispensing, or                                      
27 administering the drug, product, or device, or providing related treatment, the                                         
28       physician or member of the medical team                                                                           
29 (A)  obtained the informed consent of the patient in writing after                                                      
30 presenting to the patient all treatment options currently approved by the United                                        
31 States Food and Drug Administration for treatment of the patient's terminal                                             
01            illness; and                                                                                                 
02                      (B)  provided to the patient written notice of the immunity                                        
03            provided under this section; or                                                                              
04 (2)  manufacturer, importer, or distributor of the investigational drug,                                                
05 biological product, or device and, before providing the drug, product, or device to the                                 
06 patient's physician, presented to the physician all treatment options currently approved                                
07 by the United States Food and Drug Administration for treatment of the patient's                                        
08 terminal illness and provided to the patient written notice of the immunity provided                                    
09       under this section.                                                                                               
10 (b)  A person, acting in good faith and with reasonable care, is not liable in an                                       
11       action for damages solely for declining to                                                                        
12 (1)  prescribe, dispense, or administer an investigational drug,                                                        
13       biological product, or device to a patient; or                                                                    
14 (2)  provide an investigational drug, biological product, or device to a                                                
15       patient's physician.                                                                                              
16 (c)  In this section, "investigational drug, biological product, or device" and                                         
17       "terminal illness" have the meanings given in AS 08.64.367.                                                       
18    * Sec. 3. AS 17.20.110 is amended by adding a new subsection to read:                                                
19 (b)  This section does not apply to a physician who prescribes or administers a                                         
20       new drug in accordance with the conditions set out in AS 08.64.367(c).                                            
21    * Sec. 4. AS 47.32.030 is amended by adding a new subsection to read:                                                
22 (d)  The department may not require a licensed entity to increase services for                                          
23 the sole purpose of accommodating a physician's practice of prescribing, dispensing,                                    
24 or administering an investigational drug, biological product, or device, or providing                                   
25 related treatment, to a patient. In this subsection, "investigational drug, biological                                  
26       product, or device" has the meaning given in AS 08.64.367.                                                        
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