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ACTION ALERT: Withdraw C-51, strengthen Canada's drug approval processMay 22, 2008 As recently noted by the National Union of Public and General Employees (NUPGE), "The Harper government has introduced Bill C-51, an Act to amend the Food and Drugs Act, which dramatically reduces safety requirements for drug approval. The current system of drug approval requires prior evidence of a minimum of safety and efficacy. However, C-51 reverses existing process by bringing 'promising' new drugs onto the market and then monitoring their effectiveness. This practice will expose Canadians to new drugs before their potential dangers are known. C-51 would permit the speedy marketing of expensive new drugs – many of which have no therapeutic advantage over safer, cheaper drugs – before research on effectiveness and safety is completed.” They add, "Even post-marketing ‘surveillance’ to be done after new drugs are marketed will be carried out by the drug manufacturer involved, and thus will be biased in favour of the product being reviewed. For patients with rare diseases, who require access to groundbreaking new medications and can’t wait for a long approval process, a special access program already exists, one that does not include a general lowering of standards." We argue that 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 difficulty shrugging that off. Additionally, the CBC recently reported that, “Critics feel the bill will outlaw up to 60 per cent of natural health products currently sold in Canada, making many natural health products that have been sold in Canada for decades unavailable for purchase and penalizing parents who give herbs or supplements to their children. They also argue that the government could designate any natural health product a prescription drug, making it available by prescription only. They say these types of provisions will force small companies out of the market.” FOR MORE INFORMATION To read the Council of Canadians fact sheet on C-51, please go to http://canadians.org/integratethis/backgrounders/C51andtheSPP.pdf. To read our Integrate This! posting, go to http://www.canadians.org/integratethis/safety/2008/May-6.html. For additional background please read pages 164 to 168 of Maude Barlow’s book ‘Too Close for Comfort: Canada’s Future within Fortress North America’. To read NUPGE’s letter to Health Minister Clement, go to http://www.nupge.ca/publications/MiscPDFs/letter_clement_apr08.pdf. To read the CBC report ‘Criticism of natural health products Bill C-51 mounts’, go to http://www.cbc.ca/health/story/2008/05/09/bill-c51.html?ref=rss. TAKE ACTION Write federal Health Minister Tony Clement at Clement.T@parl.gc.ca to express your opposition to C-51. The Canadian Health Coalition is also asking Canadians to contact their MPs to voice their objections about C-51. You can access the action request by going to http://www.healthcoalition.ca/eC51.pdf. Brent Patterson, Director of Organizing and Campaigns, The Council of Canadians SEND YOUR LETTER NOW: |
