00                            HOUSE BILL NO. 216                                                                          
01 "An Act relating to required disclosures for gene therapy products."                                                    
02 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA:                                                                
03    * Section 1. AS 18.13 is amended by adding a new section to read:                                                  
04                     Article 2. Gene Therapy Products.                                                                 
05 Sec. 18.13.100. Required disclosures. (a) An entity that makes a gene therapy                                         
06 product available in the state that could possibly affect, alter, or introduce genetic                                  
07 material or genetic change into the user of the product, individuals exposed to the                                     
08 product, or individuals exposed to others who have used the product, shall                                              
09 conspicuously label the product with the words "Potential Gene Therapy Product,"                                        
10       unless the product is commonly known to be a gene therapy product. The entity shall                               
11       take reasonable steps to ensure the potential purchaser or user of the product is made                            
12       aware of the presence of this label.                                                                              
13 (b)  Upon written request of a resident of this state, an entity that produces,                                         
14 sells, or distributes a product in this state with the capacity to expose the individual to                             
15 genetically modified material, including vaccines, gene therapies, drugs, and medical                                   

01 interventions, or a product manufacturer, government agency, or organization that has                                   
02 an interest in the production, sale, or distribution of a gene therapy product, shall                                   
03 provide all information, including all relevant reports, research, and knowledge,                                       
04 regarding the ways in which an individual who did not directly obtain or use the                                        
05 product may be exposed to the product or a component of the product. An entity is not                                   
06 required to disclose proprietary materials or information protected under state or                                      
07       federal intellectual property laws.                                                                               
08 (c)  An entity that makes a product available in the state that could transmit to                                       
09 or be absorbed into an individual in any way that could result in genetic modification                                  
10 shall obtain informed consent from all individuals who could be exposed to the                                          
11 product before exposure could occur. An entity unable to obtain informed consent                                        
12       under this subsection may not make the product available in the state.                                            
13            (d)  In this section,                                                                                        
14 (1)  "cosmetic" means articles and the components of articles intended                                                  
15 to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to                                
16 the human body or any part of the human body for cleansing, beautifying, promoting                                      
17       attractiveness, or altering the appearance;                                                                       
18                 (2)  "food" has the meaning given in AS 17.20.370;                                                      
19 (3)  "gene therapy product" means a product with capacity to alter,                                                     
20       interfere with, or otherwise act in a manner similar or equivalent to genes;                                      
21 (4)  "genetically modified" means the alteration of the genetic material                                                
22 of an individual through biotechnology or any other mechanism in a way that does not                                    
23       occur naturally or that does not occur at a natural rate;                                                         
24 (5)  "genetic change" is the measurable and irreversible alteration of a                                                
25       natural person's genes;                                                                                           
26 (6)  "product" means a food, cosmetic, or other substance intended to                                                   
27 be ingested, introduced into, or applied to the human body, or intended to induce                                       
28       physiological effects, and is made available for retail sale to the general public.