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Queen Rania Center for Entrepreneurship (QRCE) The Fourth Annual Conference on Technology Commercialization Amman , November 12-13, 2008 Dr. Amir H. Khoury www.amirkhoury.com “ Creating a New Intellectual Property Policy Regarding Access to Medicines & Technology Relating Thereto”
“ Limited List” approach: Counter to Doha Declaration
Each Member has right to grant compulsory licenses & freedom to determine grounds upon which such licenses are granted.
Countries cannot be expected to wait until a certain ailment has become ("sufficiently") widespread.
More logical/less costly if countries were to respond to health threats in a timely fashion (reducing costs of treatment; loss of human life).
“ TRIPS-Plus” Structure Undermines the Doha Declaration
Industrialized countries must stop exercising protective trade pressures to defend interests of multinationals.
APM widely recognized:
U.S. (2003) introduced Five-year President’s Emergency Plan for AIDS Relief (“PEPFAR” or “Emergency Plan”): Combat HIV/AIDS; provide funds to supply antiretroviral therapies; prevent new infections; establish support care.
“ Global ethics”? Increasingly rights-oriented world, little attention is placed on responsibility; All actors in global village must acknowledge/address responsibilities that necessarily correlate to existence of rights.
Property rights not in vacuum (“balanced against claims of humanity.”
“ Public goods” nature of pharmaceuticals (sui-generis creatures).
Medicines undisputedly commercial commodities, but a “common heritage of mankind.”
Development: Tackle economic & technological underdevelopment by adoption/ transplantation of norms of industrialized countries.
“ Center” dominated “Periphery”; e.g. patented medicines; effectively owned/ controlled by rich/industrialized countries (“Center”).
“ Periphery” prevented from attaining industrialization; remained consumer & supplier of raw materials (“passivity-dynamism”).
Increased compliance with IP laws serves to widen economic rift between “North” and “South.”
Throughout history, people/nations/countries have charted different paths of development; no single developmental path.
Despite apparent rift between CIPR & APM: Still possible to join two systems conceptually
Refines 2005 WTO protocol.
APM system would not stand counter to TRIPS: reflects “sprit” of Agreement (Art. 7):
Protection/enforcement of IPRs should contribute to promotion of technological innovation and to transfer & dissemination of technology, to mutual advantage of producers & users of technological knowledge and in a manner conducive to social & economic welfare, & to a balance of rights and obligations.
A workable APM mechanism into CIPR: Clear safeguards for needs of developing countries from within (Aristotelian “distributive justice” among nations re patented medicines).
Justifies burden placed on some member states/societies.
Given CIPR deficiencies in APM context: “efficiency” does not hold water (Doha Round) -- Overlooks allocation of entitlements & obligations among member states.
Art. 8 TRIPS: members formulating/amending their laws and regulations, may adopt measures necessary to protect public health.
Appropriate measures; consistent with provisions of Agreement, may be needed to prevent abuse of IPRs by right holders or resort to practices which unreasonably restrain trade or adversely affect international transfer of technology.
Art. 7 & 8 dormant! Tools for CIPR reformulation in APM context.
WIPO Dev. Agenda: More sustainable IP régime addressing public health; biodiversity; human rights.
WIPO entrusted with administration; allows for more effective rep. of developing countries (more democratic institution) (WIPO Art. 6).
“ Silent (Silenced) Majority,"
“ Forum shifting” merger/cooperation -- between WTO & WIPO; complement each other (IP administration, protection, enforcement).
Cooperation between WTO-WIPO already exists! Agreement aims to “establish a mutually supportive relationship”; “appropriate arrangements for cooperation” between them.
Empowering Local Industry through Accessibility of Research Data
Governments to apply TRIPS -- conducive to national public health.
Local pharmaceutical industry should be encouraged to expand its research activities, by relaxing prohibitions on using research data.
Sharing of data: Prevent local industries from making same mistakes (dead ends) as counterparts.
Data Exclusivity defense that has been advanced by TRIPS-Plus should be relaxed in order to accommodate needs of new pharmaceutical corporations in developing countries. Can be justified based TRIPS Article 39(3):
Members shall protect such data against disclosure, except where necessary to protect public, or unless steps are taken to ensure that data are protected against unfair commercial use.
Remedy practices that have been deemed to be anticompetitive.
Licenses subject to certain restrictions; slow & cumbersome (limited to cases where states failed to acquire a voluntary license based on “reasonable terms & conditions within a reasonable period of time.”
License contingent on “requirement to pay adequate remuneration in each case, taking into account economic value of the license.”
Require decisions relating to licenses to be “subject to judicial or other independent review by a distinct higher authority.”
Problematic for pharmaceutical preparations & esp. life threatening illness (speed & accessibility are imperative).
Core of proposal: Revised compulsory licensing model (beyond 2005 TRIPS protocol & new Art. 31bis on pharmaceuticals).
Compulsory Licensing: More Workable & Structured Mechanism, with Checks & Balances
If “Medical Emergency” declared? State allowed to produce/seek assistance in producing patented medicines. No need to acquire license (compulsory/otherwise) from patentee or notify WTO.
Licensing process: Not slow down production of relevant medication.
Patent owner entitled to retroactive compensation; would counterbalance his potential losses (contingent on showing by patentee that compulsory license was utilized without justification).
Beneficiary state invoking compulsory licensing is held accountable for royalties in amount equivalent to actual profits collected from sale of medication within its jurisdiction (0 profit= 0 royalty).
State unable to pay royalties? Seek assistance of funds (PEPFAR).