The federal government is about to overhaul the way drugs are regulated in Canada to give consumers faster access to breakthrough treatments, but some medical experts and political critics are worried the changes will turn Canadians into guinea pigs for new drugs that haven't been adequately tested.
A new regulatory system, outlined in a broad package of changes to consumer product and food regulations announced last December, would allow certain drugs to be quickly approved for sale without the safety evidence that is normally required.
The changes are designed to update Canada's aging drug regulation system to allow faster access to new blockbuster pharmaceuticals and let health officials evaluate potential risks throughout a drug's lifespan, instead of focusing on safety mainly before they're approved.
But without massive changes in the way health officials monitor drugs once they hit the market, the new system could pose serious risks to consumers, said David Juurlink, clinical pharmacologist and drug safety researcher at Toronto's Sunnybrook Health Sciences Centre.
"I suppose it's laudable to want to get new drugs on the market sooner, but I think we have to be very, very aware of the fact the faster we bring something to market, the less we will know about its risks and benefits. That has got to be a bad thing," he said.
Others say it's a mistake to even consider reducing the level of safety evidence required before a new drug is approved, focusing instead on assessing safety once drugs are already on the market.
"I question the need for relaxing premarket standards when currently they're not catching a significant portion of the drugs with risks," said Mary Wiktorowicz, chairwoman of the school of health policy and management at Toronto's York University.
Recent high-profile examples of drugs - such as Vioxx and Avandia - that had to be pulled from the market even after going through rigorous premarket tests, highlight the need for thorough trials both before and after drugs are available to the public, said Judy Wasylycia-Leis, health critic for the federal New Democratic Party.
"I would like to see a much more rigorous process at the front end," she said. "We're putting drugs on the market that aren't fully tested and for which there may be serious problems and we're putting peoples' lives at risk."
Health Canada first floated the idea of adopting a progressive licensing system about a year ago and has been consulting with experts and the industry in recent months. But the new system could take effect very soon under the recent legislative package.
Many of the details outlining the specifics for the operation of new system and the type of evidence that would be required before drugs hit the market won't be made public until federal regulations are published in coming weeks. Health Canada officials declined requests seeking information on the changes.
But in documents posted on its website, Health Canada said the new system would require increased safety monitoring, changes to help improve reporting of problems experienced by patients and greater transparency, such as public disclosure of clinical drug trials that companies submit to the government.
The changes are a step toward making necessary improvements to the drug safety monitoring system and aligning Canada with similar developments in other countries, said Michael Paterson, a scientist at the Institute for Clinical Evaluative Sciences.
Although the new system calls for greater scrutiny, Ms. Wasylycia-Leis said the government must establish an independent body to review drugs in order for it to work.
"We can't have this system of set standards on paper and then let the industry see if they're safe or not. That's like putting the fox in charge of the hen house."
Experts say other measures that must be adopted to ensure a move to progressive licensing doesn't compromise safety include public disclosure of the rationale for approving new drugs, establishing public registries to address the difficulty of tracking adverse reactions to drugs, and setting a requirement for continuing, large clinical trials once the drugs hit the market.
Regardless of the safeguards that are put in place, reducing the safety evidence required before new drugs are approved will make it very difficult to monitor and catch problems before it's too late, said Jim Wright, professor in the anesthesiology, pharmacology and therapeutics department at the University of British Columbia.
"It's very difficult to pick up things after [the drug] is on the market. That's not what we want," he said. "I think it sounds to me like it's moving toward a less rigorous review. That's the whole issue."
