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EBM does not acknowledge the relevance of emerging paradigms in health and illness Richardson 2002 ; . EBM asserts that study findings are "rigorous" only after sequential series of "significant" outcomes have been obtained from identical study designs using identical statistical methods. EBM assumes that averaged results of systematic reviews or meta-analyses of several studies can be validly applied to individuals, providing clinically pertinent guidance in treatment planning Churchill 1999.
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Although Canada's intellectual property situation was strengthened by its compliance with the ruling of the World trade Organization WTO ; on patent protection, its failure to enforce its protection for data exclusivity remains a cause for serious concern. Price controls, regulatory delays, and restrictions on formulary listing also hamper PhRMA member companies' ability to do business in Canada. In October 2001, the Health Minister approached a generic company about producing infringing copies of a patented medicine effective against anthrax. This failure to follow Patent Act requirements was subsequently reversed and we welcomed subsequent public statements by a number of Ministers about the Government's commitment to respecting Canadian law, specifically the Patent Act. For these reasons, PhRMA requests that Canada be included in the 2003 "Special 301" Priority Watch list, and that the U.S. Government continue to seek assurances that the problems described herein are quickly and effectively resolved. Intellectual Property Protection After patent protection improved in 1992, several PhRMA member companies made significant investments in Canada. However, Canada's industrial property regime was found lacking in two WTO cases in 2000. Canada agreed to amend its practices and related regulations in the area of allowing generic manufacturers to stockpile pharmaceuticals before patent expiration, and amended its patent law in July 2001 to provide 20-year patent protection to patents filed before October 1, 1989, and which took less than three years to obtain. Unfortunately, Canada continues in some areas to fall short of the requirements of the Trade Related Intellectual Property Agreement TRIPS ; . PhRMA remains seriously concerned by the failure of Canadian regulatory authorities to provide effective enforcement for provisions relating to data exclusivity, as required by TRIPS Article 39.3. Although Canada has statutory data protection, judicial decisions have rendered those protections meaningless. Canadian authorities allow parties other than the right holder to effectively gain marketing approval in direct reliance of protected confidential data. This violates TRIPS Article 39.3 as it eliminates the TRIPS requirement to prevent "unfair commercial use" of protected data. We urge the United States to move data protection to the top of the bilateral commercial agenda with Canada. Other Obligations Canada is required under both TRIPS and the North American Free Trade Agreement NAFTA ; to ensure effective enforcement of the standards of patent protection provided for in those Agreements and macrodantin. AREA DRUGS & THERAPEUTICS COMMITTEE : 11TH JUNE 2001 ACTION BY The Committee would be kept advised of developments. NOTED.

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