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New drug licencing bill gambles with lives of Canadians

'Rushing new drugs to market as swiftly as possible.' - NUPGE President James Clancy

 

Ottawa (25 April 2008) - The Harper government is gambling with the lives of Canadians by introducing Bill C-51, a package of Food and Drug Act amendments that would open the door to the so-called "progressive licencing" of new medications in Canada.

"The Canadian public would be poorly protected if our drug approval policy is shifted to one with an increased reliance on research conducted by the drug manufacturers," says James Clancy, president of the 340,000-member National Union of Public and General Employees (NUPGE).

"And yet, that appears to be what your government is proposing," Clancy adds in a letter to Tony Clement, the federal health minister.

Big drug companies cannot be relied upon to produce unbiased research on drugs, as shown by the lengths that Merck and Co., went to minimize the death risk to patients taking Vioxx, Clancy noted. Not only did Merck under-report risks associated with Vioxx, it paid doctors to sign ghost written reports of clinical trials.

While the current drug approval system is not perfect, it tries to ensure "minimum" safety and effectiveness levels before new drugs are put on the market, Clancy said.

"The proposal for ‘progressive licensing’ sets this reasoning on its head. First 'promising' new drugs will be granted approval and then, once on the market, their safety will be appraised – primarily by those drug manufacturers who were responsible for bringing them to market in the first place," he noted.

Clancy said NUPGE supports measures to ensure effective unbiased monitoring of drugs that have been approved for the Canadian market.

"Indeed, we have long felt that the existing system inadequately tracked the possible harmful effects of post-approval drugs," he said.

"But strengthening the post-approval monitoring should go hand in hand with effective pre-approval testing and research. The National Union has long argued that the existing pre-approval system was too lax and that the threshold for approval was set too low.

"Unfortunately, it appears that your government has chosen to further weaken the pre-approval process in favour of rushing new drugs to market as swiftly as possible."

Clancy urged Clement to adopt three recommendations set out by the Canadian Health Coalition in hits paper, MORE FOR LESS: A National Pharmacare Strategy. Specifically, the government should:

  • Put safety and efficacy first when regulating drugs.
  • Create an accountable and transparent regulatory agency to approve drugs, one that is free of conflict of interest and receives no funding from the pharmaceutical industry.
  • Replace Health Canada’s Therapeutic Products Directorate with this new agency and ensure that it reports to the health minister and serves the public interest, including cost effectiveness for drugs. NUPGE

More information:
? NUPGE letter to Health Minister Tony Clement on Bill C-51
? MORE FOR LESS: A National Pharmacare Strategy