ࡱ> UWVB3( F/ 0|DTimes New RomanF0Wo 0TDBook AntiquaanF0Wo 0T DCG TimesquaanF0Wo 00DArial Unicode MS0Wo 0@DStarSymbolde MS0Wo 0 ` .  @n?" dd@  @@`` ld"V      !c $@uʚ;2Nʚ;g4]d]d0ppp@ <4!d!d 0LG<4dddd 0LG <4BdBd. 0LVN___PPT90(-Intellectual Property Negotiations Between the United States and Colombia, Peru and Equator for a Free Trade Agreement, Relating to Medicine /James Love CPTech Bogota, Colombia 21 July 2004 XBush Administration negotiating objectives of the United States in the area of medicinesYY$  What the US Wants: 1Patents Broader scope and lower standards of patentability Extended terms for delays in patent approval or drug registration Linkage between patents and drug registration Health Registration data Exclusive rights to rely upon data Narrowed limitations and exceptions Limits on parallel trade Narrow grounds for compulsory licenses TRIPS+ standards for compensation under compulsory licensing Dispute resolution for TRIPS+ measuresZZZ#Z$Z}Z'Z#$}'- u What the US Wants: 2High drug prices for innovative products Limits on government ability to negotiate lower drug prices (proposed in CAFTA) US oversight or regulation of drug reimbursement policies (Korea, Australia) Weaker Price Control Oversight (1993 agreement in Thailand)&))!2Words generally not found in USTR proposals on IPR33$kAnticompetitive Technology transfer Abuse of rights Access to medicine Doha Flexibility Neglected diseases$lL  nTraditional knowledge Genetic resources Biodiversity Public goods Open source Essential medicine Humanitarian  sEvery bilateral FTA under the TPA has including TRIPS plus measures that will result in higher prices for medicines6How to protect consumer interests in FTA negotiations? Basic strategies - IcInsist on more transparency Large pharmaceutical companies have deep access to texts, but the public who buys medicines does not Debate is limited Propose language which clarifies intent and objectives of agreements Get decent preamble Provisions regarding objectives and purposes are important, and public is harmed if left out of bilateral/regional FTAs\ZwZEZZwE_ TRIPS Article 7 - Objectives &#(#( c The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.$dc#c  <TRIPS  Article 8 - principles1. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement. 2. Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology. BT##1#(T 1  BProvisions regarding coherence with other international agreementsCC(fNothing in this agreement shall prevent a party from adopting limitations and exceptions that further the purposes of the: Universal Declaration of Human Rights Convention on the Rights of the Child the International Covenant on Economic, Social and Cultural Rights. United Nations Millennium Declaration Doha Declaration on TRIPS and Public Health Etc....P{ZZ{&"j#\"#Control of anticompetitive practice$$$aFrom TRIPS, Article 40 Nothing in this Agreement shall prevent Members from specifying in their legislation licensing practices or conditions that may in particular cases constitute an abuse of intellectual property rights having an adverse effect on competition in the relevant market. Member may adopt, consistently with the other provisions of this Agreement, appropriate measures to prevent or control such practices. From Chile/US FTA Nothing in this Chapter prevents a Party from adopting measures necessary to prevent anticompetitive practices . . from the abuse of the intellectual property rightsbZb&Paragraph 4: Doha Declaration on TRIPS''  ' 2 We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.23%Z 3 *Treatment of Doha Declaration is key issue++(EC is now referencing Doha Declaration in bilateral agreements Doha Declaration is referenced in US TPA law. Ask WHO to evaluate IPR provisions impact on Doha DeclarationResist specific provisionsPropose elimination or modification of provision in the following areas Patents Bilateral standards for scope, utility and novelty Extensions Linkage to registration Restrictions on Parallel trade DataNHV$HV$8Rights in data should not be stronger than patent rightsIn both cases, it should be appropriate override exclusive rights, subject to compensation It is not appropriate to accept a five year period during which governments cannot address abuses of intellectual property rights or protect public healthPCPTech recommends a compromise in the area of rules for health registration dataQQ Oppose exclusive rights approach. Propose system of compensatory liability, similar to that used for some agricultural chemicals in the US. Compensation based upon Disclosure of actual costs Reasonable share of costs, based upon global market shares Example -- $30 million in clinical trials costs, 0.3% share of global sales, $.09 million domestic share, allocated fairly among competitors. PZZ-['Change the dynamics of the negotiations((  Bring in new stakeholders in the US USTR takes advances narrow interests of big pharma sector Other US stakeholders can change US policy NGOs, other businesses, other government agencies, etc Propose different approaches to address legitimate concerns N$e7=$e7= P?R&D+ as a new paradigm for trade, to replace or moderate TRIPS+Propose a chapter on R&DCreating a committee on R&D, that can be expanded to other trading partners Propose an evaluation of the appropriate minimum levels of support for medical R&D  big approach  all medicines  small approach  neglected diseases, global public goods &[[@Suggestions for  small approachOffer to participate a global virtual consortium to support R&D for Vaccines for HIV and other infectious diseases Treatments for neglected diseases Global public goods, such as the Human Genome Project Support open access to publicly funded research6D0D0KIt is important to change the language and topics of the trade negotiationsLLNot about free ridding, but about appropriate sharing of costs and cooperation Not about protecting commercial interests, but about solving social problems that have a cross-border trade related aspect"Kerry strategyHope that agreements are not completed before election, or at least, not approved by the Congress before the election In any case, public health and public interest groups will ask for review of entire intellectual property rights chapters. Possible changes. Recent USTR letter on NAFTA and Canada s paragraph 6 proposal*>>For more information:n James Love email: james.love@cptech.org CPTech http:/www.cptech.org +1.202.387.8030, fax +1.202.234.5176oo*+ 0*/  ` ` ̙33` 333MMM` ff3333f` f` f` 3>?" dd@,|?" dd@   " @ ` n?" dd@   @@``PR    @ ` ` p>> f(    6y P  T Click to edit Master title style! !  0x|   RClick to edit Master text styles Second level Third level Fourth level Fifth level!     S  0 ``  >*  0 `   @*  0d `   @*H  0޽h ? ̙33 Default Design 0 zr` (    0,:X P    P*    0EX    X R*  d  c $ ?  X  0JX  @ X RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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Hlr"fOh+'0 `h  PowerPoint Presentation James LoveP James LoveP82eMicrosoft PowerPointon@[X@n@P_9oUGg  =K& &&#TNPP2OMii & TNPP &&TNPP    --- !---&G&wc ~@G  ~ ~ ~0- &Gy& --9qH@-- @Times New Roman  ~ ~ ~0- .H2 h+Intellectual Property Negotiations Between            . .E2 s)the United States and Colombia, Peru and              . .K2 O-Equator for a Free Trade Agreement, Relating       !    . .2 r to Medicine  &  .--1H--  .2 v{ James Love! . .2 CPTech. .2 DBogota . .2  , Colombia    . .2 .r 21 July 2004   .--"System !8 ~-&TNPP &՜.+,0    On-screen ShowCPTecheLs| Times New Roman Book Antiqua CG TimesArial Unicode MS StarSymbolDefault DesignIntellectual Property Negotiations Between the United States and Colombia, Peru and Equator for a Free Trade Agreement, Relating to MedicineYBush Administration negotiating objectives of the United States in the area of medicinesWhat the US Wants: 1What the US Wants: 23Words generally not found in USTR proposals on IPRtEvery bilateral FTA under the TPA has including TRIPS plus measures that will result in higher prices for medicines7How to protect consumer interests in FTA negotiations?Basic strategies - ITRIPS Article 7 - Objectives TRIPS Article 8 - principlesCProvisions regarding coherence with other international agreements$Control of anticompetitive practice'Paragraph 4: Doha Declaration on TRIPS+Treatment of Doha Declaration is key issueResist specific provisions9Rights in data should not be stronger than patent rightsQCPTech recommends a compromise in the area of rules for health registration data(Change the dynamics of the negotiationsPowerPoint Presentation@R&D+ as a new paradigm for trade, to replace or moderate TRIPS+Propose a chapter on R&D!Suggestions for small approachLIt is important to change the language and topics of the trade negotiationsKerry strategyFor more information:  Fonts UsedDesign Template Slide Titles"_(s James LoveJames Love  !"#$%&'()*+,-./0123456789;<=>?@ACDEFGHIKLMNOPQTRoot EntrydO)Current UserJSummaryInformation(:PowerPoint Document(LsDocumentSummaryInformation8BRoot EntrydO))EX@Current User#SummaryInformation(:PowerPoint Document(Ls  !"#$%&'()*+,-./0123456789;<=>?@ACDEFGHIT_(s