Monday, December 9, 2013

'Vanessa's Law' would let Ottawa pull dangerous drugs

New health legislation tabled in Parliament today would give the government more power to recall unsafe products and impose fines of up to $5 million a day for leaving unsafe products on shelves.

Tabled on behalf of federal Health Minister Rona Ambrose, the bill is being named Vanessa's Law to honour Conservative MP Terence Young's daughter. She died in 2000 after complications arose when she was taking Prepulsid, a drug she was prescribed.
If it becomes law, the bill would:
  • Require mandatory adverse drug reaction reporting by health-care institutions.
  • Allow the federal government to recall unsafe products.
  • Impose new penalties for unsafe products, including jail time and new fines up to $5 million a day. That's an increase from the current $5,000 a day.
  • Provide the courts with discretion to impose even stronger fines if violations were caused intentionally.
  • Compel drug companies to revise labels to clearly reflect health risk. 
  • Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.
Before the bill was tabled, Young sat down with CBC News and spoke about the need to make these changes, including greater penalties for drug company executives.

"If senior executives actually faced the threat of going to jail when they keep dangerous drugs on the market, things would change. So I would love to see that in a Canadian bill," Young said.

Ambrose said Vanessa's Law "would protect Canadians and help ensure no drug that is unsafe is left on the store shelves."

"Today we truly are changing the face of the pharmaceutical industry and the health-care system to make it more transparent, accountable and responsible, for not only the claims it makes [and] the labels it uses, but also the effects it has on Canadians," she said.

Is Health Canada prepared?

The bill would require health institutions such as hospitals to report all adverse drug reactions. Young said he wants doctors to be compelled to do the same, but that this bill is a good first step.

"This legislation is aimed at serious adverse drug reactions. The minor ones can be important, but it's the serious ones that are the problem," he said.

So much information, however, may be hard for the government to handle.

Dr. David Juurlink is in favour of forcing hospitals to report all adverse drug reactions. But the Sunnybrook Hospital researcher wonders what Health Canada will do with the information.

"How they are going to use this tsunami of new adverse drug reactions reports that they are presumably about to receive?" Juurlink said to CBC News.

Ambrose said she believes there are enough staff already at Health Canada to deal with the influx of new information.

http://www.cbc.ca/news/politics/vanessa-s-law-would-let-ottawa-pull-dangerous-drugs-1.2453785

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