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May 6, 2008 A key initiative within the Security and Prosperity Partnership calls for the, "Identification and appropriate adoption of best practices in maintaining the safety, efficacy and quality of pharmaceutical products." Two milestones within this initiative are to, "Evaluate best practices related to pharmaceutical review processes," and "Examine the use of International Conference on Harmonization (ICH) guidelines and adopt best practices in maintaining the safety, efficacy and quality of medicines within the next 36 months (June 2008)." The Harper government's Bill C-51 would introduce the ‘progressive licensing' of new pharmaceutical products in Canada. Progressive licensing means an increased reliance on research conducted by the drug manufacturers themselves, fast-tracking the drug approval process, and the appraisal of the safety of drugs once they are on the market, again primarily by the drug companies themselves. The Globe and Mail reported on April 9 that, "A study published last month in the New England Journal of Medicine found that drugs approved quickly in the United States to meet government-imposed deadlines were significantly more likely to be subject to recalls and safety problems." That same article quotes Joel Lexchin, a health policy professor at York University and drug safety expert: "I think that's a pretty dangerous thing to be doing. This is part of a general trend in a lot of countries, at least with respect to the drug-approval system, [which] is deregulation, turning over more responsibility to the drug companies." The Edmonton Journal reported on April 9 that Canada will also be matching the U.S. penalty ceiling of $5 million for companies caught selling unsafe drugs. With profits last year of $8.144 billion, a company like Pfizer would have little difficult shrugging that off. Bill C-51 was introduced by the Harper government at the same time as Bill C-52, the Canadian Consumer Safety Act, which was also designed in collaboration with U.S. regulators as part of the regulatory cooperation framework announced at the 2007 SPP summit in Montebello, Quebec. Regulatory harmonization is a key priority of the North American Competitiveness Council, which praised SPP leaders for their progress at the time. “As one element of the [Regulatory Cooperation] Framework, governments agreed to develop and maintain an inventory of regulatory best practices from which regulators can draw upon as a resource,” claims an update on the official U.S. SPP website. “The establishment of this inventory will be an important milestone in advancing regulatory cooperation through the Framework.” A Food and Consumer Safety Action Plan, released earlier this year, explained the government’s new U.S.-style approach to food, drugs and consumer product safety. More information Click here to see the US process, which is similar to that proposed in Bill C-51. To read a letter that the National Union of Public and General Employees sent to Health Minister Tony Clement outlining their concerns with progressive licensing,” click here. The Canadian Health Coalition is asking Canadians to contact their MPs to voice their objections about C-51. You can access the action request by clicking here.
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