,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #ajjid  ,,9 ,,! ,,h\se ,,(         
,,repres5tatives  ,augu/ #ac1 #bjbf,ms4 
,hoyle ( ,oregon 7= h]self1 ,mr4        
,doggett1 ,ms4 ,/ansbury1 ,mr4 ,takano1 
,ms4 ,norton1 ,ms4 ,tlaib1 ,ms4         
,jayapal1 & ,mr4 ,cas>7 introduc$ !     
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to require p]sons :o und]take  
f$]ally fund$ rese>* & developm5t ( a   
biom$ical product or s]vice to ent] into
 reasonable pric+ agreem5ts ) !         
,secret>y ( ,heal? & ,human ,s]vices1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,af=dable ,pric+ = 
,taxpay]-,fund$ ,prescription ,drugs    
,act ( #bjbf4  #b4 ,reasonable price    
agreem5t  7a7 ,9 g5]al ,all ,f$]al      
ag5cies provid+ or receiv+ rese>* fund+1
 ?r\gh a grant1 contract1 coop]ative    
agreem5t1 or o!r agreem5t1 %all require 
9 su* agreem5t1 & 9 any lic5se ( !      
rights to a pat5t or regulatory te/ data
 = a biom$ical product or s]vice1 t !   

price ( any biom$ical product or s]vice 
develop$ ) ! b5efit ( su* rese>* be     
reasonable 7z det]m9$ by ! ,secret>y7   
unless ! ,secret>y waives su* reasonable
 price obligation "u subsection 7d74    
7b7 ,prohibition aga9/ *>g+ prices high]
 ?an 9 o!r l>ge economies ) high incomes
  7#a7 ,9 g5]al ,= purposes ( subsection
 7a71 any reasonable pric+ =mula %all   
ensure1 )\t prejudice to any o!r /&>ds  
or negotiat$ provisions = reasonable    
pric+1 t resid5ts ( ! ,unit$ ,/ates are 
n *>g$ m = ! biom$ical product or s]vice
 involv$ ?an ! ref]5ce price = c\ntries 
) l>ge economies & high incomes4  7#b7  
,ref]5ce price ,= purposes ( p>agraph   
7#a71 ! phrase ref]5ce price = c\ntries 
) l>ge economies & high incomes means-- 
7,a7 ! m$ian price *>g$ = ! biom$ical   
product or s]vice involv$ 9 ,canada & ! 
additional six ref]5ce c\ntries2 or     
7,b7 a modification to su* price t is   
adopt$ by regulation aft] provid+ notice
 & ! opportunity = ! public to comm5t1  
if ! ,secret>y det]m9es su* modification

 to be an appropriate & reasonable      
measure to protect ,unit$ ,/ates        
resid5ts f pay+ prices t are high] ?an  
prices 9 o!r c\ntries ) l>ge economies &
 high incomes4  7c7 ,additional         
requirem5ts  7#a7 ,9 g5]al ,9 c>ry+ out 
subsection 7a71 ! ,secret>y may         
promulgate by regulation additional     
requirem5ts to ensure t ! price = !     
biom$ical product or s]vice describ$ 9  
subsection 7a7 be reasonable4  7#b7     
,requirem5ts ,! additional requirem5ts  
"u p>agraph 7#a7 %all--  7,a7 address ! 
public int]e/ 9 ensur+ t publicly       
support$ innovations = biom$ical        
products & s]vices h reasonable prices2 
&  7,b7 take into acc\nt--  7i7 !       
importance ( provid+ robu/ inc5tives to 
inve/ 9 biom$ical rese>* & developm5t2 &
  7ii7 ! *all5ges ( adm9i/]+ agreem5ts  
describ$ 9 subsection 7a71 includ+ 9    
cases :]e ?ird p>ties control relevant  
intellectual prop]ty1 "k-h[1 or o!r     
assets4  7#c7 ,possible me*anisms ,!    
additional requirem5ts = reasonable     

pric+ au?oriz$ by p>agraph 7#a7 may     
include-- 7,a7 me*anisms to--  7i7 l[]  
prices or %ort5 exclusivity p]iods :5   
rev5ues exce$ t>gets2  7ii7 l[] prices t
 exce$ a /&>d ( co/ p] heal? b5efit     
a*iev$2 or  7iii7 l[] prices t con/itute
 significant b>ri]s to access or fiscal 
burd5s on pati5ts2 or  7,b7 a comb9ation
 ( me*anisms li/$ 9 subp>agraph 7,a7 or 
o!r me*anisms4  7d7 ,waiv]  7#a7 ,9     
g5]al ,! ,secret>y may waive "p or all (
 a reasonable pric+ obligation "u ?is   
section ^u a demon/ration t su* a waiv] 
is 9 ! public int]e/4 ,a decision to    
grant su* a waiv] %all set out !        
,secret>y's f9d+ t ! waiv] is 9 ! public
 int]e/4  7#b7 ,requir$ process ,no     
waiv] "u p>agraph 7#a7 %all take effect 
be=e--  7,a7 ! public is giv5 notice ( !
 propos$ waiv] & provid$ a reasonable   
opportunity to comm5t 9 writ+ & at a    
public he>+ on ! propos$ waiv]2 &  7,b7 
! ,secret>y publi%es an economic        
analysis to ju/ify ! waiv]4  7e7        
,transp>5cy  7#a7 ,report+ ,9 ord] to   

evaluate additional requirem5ts         
promulgat$ "u subsection 7c71 agreem5ts 
subject to subsection 7a7 %all include a
 requirem5t t ! manufactur] or o!r      
companies comm]cializ+ ! biom$ical      
product or s]vice involv$ report to !   
,secret>y 9 =mats det]m9$ by !          
,secret>y-- 7,a7 ! co/s ( ea* cl9ical   
trial und]tak5 to support ! ,f$]al      
regulatory approval ( ! biom$ical       
product or s]vice involv$2  7,b7        
subsidies ( ^? co/s by ! ,f$]al         
,gov]nm5t2 &  7,c7 ! annual rev5ues     
g5]at$ by ! biom$ical product or s]vice 
involv$1 by c\nty ( sale4  7#b7 ,public 
availability ,! ,secret>y %all make all 
reports "u p>agraph 7#a7 publicly       
available4  7f7 ,no effect on o!r       
requirem5ts ,! reasonable pric+         
requirem5ts impos$ "u ?is section are 9 
addition to any o!r requirem5ts to limit
 ! price ( biom$ical products or        
s]vices1 includ+ su* requirem5ts        
impos$--  7#a7 ?r\gh /&>ds or negotiat$ 
provisions on pric+ 9 contracts2 or     

7#b7 "u *apt] #ah ( title #ce1 ,unit$   
,/ates ,code1 to make ! b5efits (       
inv5tions fund$ by ! ,f$]al ,gov]nm5t   
available to ! public on reasonable     
t]ms4  7g7 ,def9itions ,9 ?is section3  
7#a7 ,! t]m biom$ical product or s]vice 
means a drug1 vacc9e1 m$ical device1    
diagno/ic te/1 assi/ive te*nology1 cell-
 or g5e-bas$ !rapy1 or o!r te*nology us$
 to provide heal? c>e4  7#b7 ,! t]m     
m$ical device has ! mean+ giv5 to ! t]m 
device 9 section #bja ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba74  7#c7 ,! t]m ,secret>y means !   
,secret>y ( ,heal? & ,human ,s]vices4   
7#d7 ,! t]m six ref]5ce c\ntries means !
 six c\ntries1 exclud+ ,canada1 t ov] ! 
previ\s ?ree cal5d> ye>s-- 7,a7 are     
memb] c\ntries ( ! ,organisation =      
,economic ,co-op]ation & ,developm5t2   
7,b7 h ! l>ge/ gross dome/ic products2 &
  7,c7 h a p] capita income t is at lea/
 #ej p]c5t ( ! av]age p] capita income (
 ! ,unit$ ,/ates4