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{\author Peter Maybarduk User}{\operator Jaspreet}{\creatim\yr2009\mo2\dy27\hr12\min5}{\revtim\yr2009\mo2\dy27\hr12\min5}{\printim\yr2008\mo3\dy21\hr17\min27}{\version2}{\edmins1}{\nofpages5}{\nofwords1526}{\nofchars8699}{\*\company EI}{\nofcharsws10205}
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\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid3090046 Essential Action
\par P.O. Box 19405
\par Washington, D.C. 20036
\par 
\par March 21, 2008
\par }\pard \ltrpar\qr \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9441343 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid3090046 
\par }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9441343 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid3090046 Rachel S. Bae
\par Director for Intellectual Property and Innovation
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid15626146 Office of the United States Trade Representative
\par }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \cf1\insrsid9441343\charrsid15626146 600 17th Street, N.W.
\par }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9441343 {\rtlch\fcs1 \af0 \ltrch\fcs0 \cf1\insrsid9441343\charrsid15626146 Washington, DC 20508}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid9441343\charrsid15626146 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid3090046 
\par Re: Comments of Essential Action on the Proposal for an Anti-Counterfeiting Trade Agreement
\par 
\par Dear Director Bae, 
\par }\pard \ltrpar\qj \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9441343 {\rtlch\fcs1 \ab\ai\af0 \ltrch\fcs0 \b\i\insrsid9441343\charrsid3090046 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 Essential Action submits the following comments to the Office of the United States Trade Representative (USTR) concerning a proposed Anti-Counterfeiting Trade Agreement (ACTA).  
\par 
\par Essential Action is a project of Essential Information, a non-profit 501(c)
(3) organization based in Washington, D.C. We are concerned generally with protecting the public domain and the information commons. A key organizational area of focus is promoting access to medicines, including in the United States and especially in deve
l
oping countries. While we recognize that many other important issues are implicated by the proposed treaty, our comments focus particularly on concerns about the proposed ACTA in the context of the public health priority of ensuring access to safe and aff
ordable medicines to patients around the world, regardless of income or wealth.
\par 
\par }{\rtlch\fcs1 \ab\ai\af0 \ltrch\fcs0 \b\i\insrsid9441343\charrsid3090046 ACTA priorities}{\rtlch\fcs1 \ai\af0 \ltrch\fcs0 \i\insrsid9441343\charrsid3090046 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 
\par USTR\rquote s fact sheet and ACTA materials conflate patent, copyright and trademark infringement, \'93piracy\'94 a
nd counterfeiting. An agreement based on, or reflecting, such a conflation of distinct concepts is likely to be overly broad, proscribing behavior that cannot correctly be identified as counterfeiting and that is not necessarily detrimental to the public 
interest.  For example, commercially interested parties sometimes cast compulsory licensing for medicines -- legal under national legislation and World Trade Organization rules -- as patent theft or \'93piracy,\'94
 but no one can argue these practices bear any re
semblance to counterfeiting. At the same time, an agreement focused on patent, copyright and trademark infringement is likely to overlook important options to control counterfeiting, including by requiring companies to disclose knowledge of counterfeit pr
oducts.  
\par 
\par A multilateral counterfeiting treaty should concern itself specifically and uniquely with the dangers and harms posed to the public by counterfeit goods.  Paramount among these concerns is the proliferation of unsafe and ineffective products.  Su
b-standard drugs, for example, threaten patient health worldwide.  Notably, however, these dangers are not limited to counterfeit products: legitimate businesses, as well, commonly sell drugs with inappropriate amounts of the active ingredient, and a larg
e
 percentage of brand-name drugs sold in the United States use raw materials manufactured in India, China and other countries in factories that are inadequately inspected by the Food and Drug Administration.  The public interest in anti-counterfeiting, the
n
, is not as a subset of patent, copyright and trademark enforcement, but rather a subset of state actions to ensure product safety and efficacy. At least as regards medicines, this suggests counterfeiting should be considered in a broader framework than t
he ACTA proposes. 
\par 
\par Further, patents, trademarks and copyrights are private rights subject to private enforcement actions.  While provided for in public laws, it is generally the responsibility of private parties to identify alleged violations of patents, c
opyrights and trademarks and bring suit.  As proposed, ACTA would harness considerable public resources to strengthen the enforcement of these private rights.   This use of public means for private ends is not only tangential to the legitimate public goal
s of protecting consumers from unsafe and ineffective products, it may also come at significant financial cost to taxpayers.
\par 
\par }{\rtlch\fcs1 \ab\ai\af0 \ltrch\fcs0 \b\i\insrsid9441343\charrsid3090046 \'93Piracy\'94
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 
\par ACTA\rquote s use of the term \'93piracy\'94 also suggests an interest in capturing a much broader pattern of conduct than counterfeit
ing.  Piracy as a term is not technically descriptive, but is instead broadly applicable and useful in the art of persuasion.  Its inclusion in ACTA would open the agreement to abuse, and it should be eliminated.  Conduct ACTA intends to regulate or disco
urage should be described in precise terms.  
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904 
\par }{\rtlch\fcs1 \ab\ai\af0 \ltrch\fcs0 \b\i\insrsid9441343\charrsid3090046 International cooperation: sharing of information and disclosure
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid3090046 USTR seeks input concerning the sharing of information between parties and cooperation of law enforcement agencies.  Equally important is the sh
aring of counterfeiting information by legitimate private companies, which often have the first or most complete accounts of counterfeit products.   Without private companies disclosing their knowledge, agencies will be handicapped in their law enforcemen
t efforts. 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904 
\par For example, although pharmaceutical companies depend on law enforcement and public resources to }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 locate}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904 
 counterfeits and maintain consumer confidence in their brands, companies do not always disclose what they know about counterfeits in the mar
ket. Reportedly, the Pharmaceutical Security Institute (PSI), formed by fourteen pharmaceutical companies in 2002, recorded 76 cases of counterfeiting in 2004.  The FDA only knew of 58.}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\cs16\super\insrsid9441343\charrsid13198904 \chftn {\footnote \ltrpar \pard\plain \ltrpar\s15\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \cs16\fs20\super\insrsid9441343\charrsid3090046 \chftn }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  \'93Counterfeit medicines 
\endash  What are the problems?\'94 Pharma-Brief Special, BUKO Pharma-Kampagne, a member of Health Action International (2007) at 5.  
\par }}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904   PSI\rquote s counterfeiting database is}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343  considered the world\rquote s best, yet it}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid9441343\charrsid13198904  \'93is not accessible to the WHO, health authorities or the public.\'94}{\rtlch\fcs1 \af0 \ltrch\fcs0 \cs16\super\insrsid9441343\charrsid13198904 \chftn {\footnote \ltrpar \pard\plain \ltrpar
\s15\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 
\cs16\fs20\super\insrsid9441343\charrsid3090046 \chftn }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  \'93The global threat of counterfeit drugs: why industry and governments must communicate the dangers.\'94
  Robert Cockburn, Paul N. Newton, E. Kyeremateng Agyarko, Dora Akunyili, Nicholas J. White, Public Library of Science (PLoS) Medicine, April 2005, Volume 2, Issue 4, at 305.   
\par }}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904   Industry groups seem to favor general public awareness of the counterfeiting problem, which may lead to public assistance in enforcement, but }{\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid9441343 sometimes disfavor}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904  }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 public}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904  knowledge of}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \insrsid9441343  specific}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904  counterfeited products.  
\par 
\par For example, in 1995, GlaxoSmithKline allegedly asked the Ghanaian government not to alert the public of the presence of fake halofantrine antimalarial syrup in the market, for the sake of the company\rquote s reputation.}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\cs16\super\insrsid9441343\charrsid13198904 \chftn {\footnote \ltrpar \pard\plain \ltrpar\s15\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \cs16\fs20\super\insrsid9441343\charrsid3090046 \chftn }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  BUKO, }{\rtlch\fcs1 
\ai\af0\afs20 \ltrch\fcs0 \i\fs20\insrsid9441343\charrsid3090046 supra}{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046 , and PLoS, }{\rtlch\fcs1 \ai\af0\afs20 \ltrch\fcs0 \i\fs20\insrsid9441343\charrsid3090046 supra}{\rtlch\fcs1 
\af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046 .  GlaxoSmithKline also was reluctant to share information about fake syrup with the authors of the PLoS article.  
\par }}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904   In 2002 in Kansas City, BMS and Eli Lilly settled for $72 million }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 with the families of deceased}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid9441343\charrsid13198904  victims of counterfeit drugs, seemingly to avoid the precedent that drug companies could be held liable for }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 failing to}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\insrsid9441343\charrsid13198904  disseminat}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 e}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904  information about counterfeits.}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\cs16\super\insrsid9441343\charrsid13198904 \chftn {\footnote \ltrpar \pard\plain \ltrpar\s15\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \cs16\fs20\super\insrsid9441343\charrsid3090046 \chftn }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  PLoS, }{\rtlch\fcs1 
\ai\af0\afs20 \ltrch\fcs0 \i\fs20\insrsid9441343\charrsid3090046 supra}{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046 .  There are, of course, counterexamples.  \'93
In 2002, Johnson and Johnson issued 200,000 letters to health care professionals in the US warning them of fake Procrit\'85within one week of being notified of a severe counterfeit problem.\'94  PLoS. 
\par  }}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904     
\par }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 
\par }\pard \ltrpar\qj \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9441343 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904 
Governments should require companies to disclose any information they obtain about the existence of dangerous counterfeit products.  If the public is to incur expenses combating counterfeiting, the public should at least have a right to the best informati
on available so its enforcement activities are effective.  We are concerned that proposals for mandatory disclosure requirements are absent from the available materials on the ACTA.  
\par 
\par There are at least two existing proposals for statutory disclosure requirements.  Cockburn }{\rtlch\fcs1 \ai\af0 \ltrch\fcs0 \i\insrsid9441343\charrsid3090046 et al.}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904 
 propose a model based on the United Kingdom Civil Aviation Authority\rquote s reporting requirements for suspected unapproved aircraft parts.}{\rtlch\fcs1 \af0 \ltrch\fcs0 \cs16\super\insrsid9441343\charrsid13198904 \chftn {\footnote \ltrpar 
\pard\plain \ltrpar\s15\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 
\cs16\fs20\super\insrsid9441343\charrsid3090046 \chftn }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  PLoS, }{\rtlch\fcs1 \ai\af0\afs20 \ltrch\fcs0 \i\fs20\insrsid9441343\charrsid3090046 supra}{\rtlch\fcs1 \af0\afs20 
\ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  at 307.
\par }}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904   Companies would be required to report suspected counterfeits to regula
tory agencies.  The agency would then take responsibility for confirming the report and deciding whether and when to alert law enforcement and the public.  Meanwhile, legislation introduced by Representative Steve Israel (2}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\super\insrsid9441343\charrsid3090046 nd}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904  District of New York) proposed requiring drug companies to notify the FDA within two days of learning of a counterfeit threat.}{\rtlch\fcs1 \af0 
\ltrch\fcs0 \cs16\super\insrsid9441343\charrsid13198904 \chftn {\footnote \ltrpar \pard\plain \ltrpar\s15\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \cs16\fs20\super\insrsid9441343\charrsid3090046 \chftn }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  H.R. 2345, 109}{\rtlch\fcs1 
\af0\afs20 \ltrch\fcs0 \fs20\super\insrsid9441343\charrsid3090046 th}{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  Congress.  }}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904     
\par 
\par }{\rtlch\fcs1 \ab\ai\af0 \ltrch\fcs0 \b\i\insrsid9441343\charrsid3090046 Enforcement practices: public/private advisory groups
\par 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid3090046 USTR\rquote s ACTA fact sheet mentions provisions for advisory groups assi
sting in enforcement practices.  It is important that any such advisory groups consist of balanced memberships representing not only industry, but also consumers, and, in the case of medicines, generics firms as well as brand-name companies.  Overrepresen
tation of patent, copyright and trademark-dependent industries in anti-counterfeiting enforcement agencies could lead to enforcement priorities and expenses out of step with the public\rquote 
s interest in safe and effective products and a competitive marketplace.    }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904 
\par 
\par }{\rtlch\fcs1 \ab\ai\af0 \ltrch\fcs0 \b\i\insrsid9441343\charrsid3090046 Role of market forces
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904 
\par There is broad consensus that high prices of some legitimate products drive both supply and demand in markets for counterfeits.  For example, according to the World Health Organization, \'93When the prices of medicines become exce
ssively high and unaffordable, patients tend to look for cheaper sources.  Such situation [sic] encourages counterfeiters to produce cheaper counterfeit drugs. \'85
 When price differences exist between identical products, patients and consumers go for the cheaper ones.  This creates a greater incentive for counterfeiters to supply cheap counterfeit medicines.\'94}{\rtlch\fcs1 \af0 \ltrch\fcs0 
\cs16\super\insrsid9441343\charrsid3090046  }{\rtlch\fcs1 \af0 \ltrch\fcs0 \cs16\super\insrsid9441343\charrsid13198904 \chftn {\footnote \ltrpar \pard\plain \ltrpar\s15\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \cs16\fs20\super\insrsid9441343\charrsid3090046 \chftn }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 
\fs20\insrsid9441343\charrsid3090046  \'93}{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\cf1\insrsid9441343\charrsid3090046 What encourages counterfeiting of drugs?\'94}{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046 
  World Health Organization Counterfeits FAQ, available at: }{\field\flddirty{\*\fldinst {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\cf1\insrsid9441343\charrsid3090046  HYPERLINK "http://www.who.int/medicines/services/counterfeit/faqs/16/en/index.html" }{
\rtlch\fcs1 \af253\afs20 \ltrch\fcs0 \f253\fs20\cf1\insrsid13835692\charrsid3090046 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000004800000068007400740070003a002f002f007700770077002e00770068006f002e0069006e0074002f006d00650064006900630069006e00650073002f00730065007200760069006300650073002f0063006f0075006e007400650072006600650069007400
2f0066006100710073002f00310036002f0065006e002f0069006e006400650078002e00680074006d006c000000e0c9ea79f9bace118c8200aa004ba90b9000000068007400740070003a002f002f007700770077002e00770068006f002e0069006e0074002f006d00650064006900630069006e00650073002f00730065
007200760069006300650073002f0063006f0075006e0074006500720066006500690074002f0066006100710073002f00310036002f0065006e002f0069006e006400650078002e00680074006d006c00000000}}}{\fldrslt {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 
\cs17\fs20\ul\cf2\insrsid9441343\charrsid3090046 http://www.who.int/medicines/services/counterfeit/faqs/16/en/index.html}}}\sectd \linex0\endnhere\sectdefaultcl\sectrsid9441343\sftnbj {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 
\fs20\cf1\insrsid9441343\charrsid3090046 .}}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904   Despite a relatively well-controlled drug supply, high prices make the United States an especially attractive target. \'93
America has become the go-to market for counterfeiters because we pay the highest prices of anyone in the world,\'94 states Katherine Eban, author of \'93Dangerous Doses: How counterfeiters are contaminating America\rquote s drug supply.\'94}{\rtlch\fcs1 
\af0 \ltrch\fcs0 \cs16\super\insrsid9441343\charrsid13198904 \chftn {\footnote \ltrpar \pard\plain \ltrpar\s15\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046 
\par }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \cs16\fs20\super\insrsid9441343\charrsid3090046 \chftn }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  Harcourt (2005).  }}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904 
  Public Citizen commented to the FDA, \'93In our opinion, as the costs Americans pay for prescription drugs continue to skyrocket and as the disparity in these prices continues to grow in comparison to other countries the economic incentive
s for counterfeiting and selling substandard drugs increases proportionally.  This incentive is now greater than ever before.\'94}{\rtlch\fcs1 \af0 \ltrch\fcs0 \cs16\super\insrsid9441343\charrsid13198904 \chftn {\footnote \ltrpar \pard\plain \ltrpar
\s15\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 
\fs20\insrsid9441343\charrsid3090046 
\par }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \cs16\fs20\super\insrsid9441343\charrsid3090046 \chftn }{\rtlch\fcs1 \af0\afs20 \ltrch\fcs0 \fs20\insrsid9441343\charrsid3090046  \'93
Comments on the Final Rule implementing the Prescription Drug Marketing Act of 1987/PDUFA,\'94 Comments of Public Citizen\rquote s Health Research Group, October 27, 2000.  
\par }}}{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid13198904  
\par 
\par Patent regimes, which often allow exclusive rights holders to set high prices without fear of competition, create incentives both to innovate and to counterfeit.  The high cost of research and development is reflected in each consumer\rquote 
s purchase of a bottle of brand-name pills.  By contrast, a prize system, in which medicines could be sold at marginal cost, with innovators compensated through prizes rather than marketing monopolies, would create incentives only to 
innovate.  Counterfeiters would be forced to compete with low-price legitimate sales reflecting only the low overhead and manufacturing costs of each pill.  Incentives to trade in fakes would dwindle. There are other possible measures to reduce prices, an
d which would also reduce incentives to counterfeit.  
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 
\par A treaty focused on counterfeiting should not fail to address the role of the high prices for medicines in promoting counterfeiting. We recommend that this matter be discussed in the context of any tre
aty negotiation, and that any resulting treaty include provisions for a study and review of the interconnections between high price and counterfeiting, and possible measures to contain prices.
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343\charrsid3090046 
\par }{\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 Sincerely,
\par 
\par 
\par Peter Maybarduk
\par Staff Attorney
\par Essential Action
\par }\pard \ltrpar\ql \li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\rtlch\fcs1 \af0 \ltrch\fcs0 \insrsid9441343 
\par 
\par }}