That's the concern after the government moved yesterday to meet intense pressure to get new drugs on the market faster while maintaining rigorous safety requirements. But health experts warned that Canadians could be exposed to meds that are approved too quickly to ensure safety,The Globe and Mail reports.
Canada introduced sweeping changes to the way drugs are approved and monitored so safety checks will be required before and after they reach the market. Under the new rules, drugmakers will have to prove only that the benefit of their product outweighs the harm. In the old system, the federal government proved a drug was safe before it was approved for public use, the paper writes. But Health Minister Tony Clement insists the rules won't water down safety requirements for new drugs, and the continued monitoring will improve the government's ability to spot problems.
"I can assure you we are not going to change our standards or change our stringent review. Our work is going to remain as intense," he tells the paper. And he insists that, while the government is focused on meeting demands to speed access to new drugs, Health Canada's new "progressive licensing" or "life-cycle" approach to drug approvals and monitoring will make safety requirements more stringent. Although the government has not yet outlined how the post-approval assessment would work.
But health experts warn the new system could reduce safety standards and endanger Canadians. Countries that have adopted similar systems have seen a significant increase in drug recalls and serious side effects. "I think that's a pretty dangerous thing to be doing," Joel Lexchin, a health policy professor at York University and drug safety expert, tells the paper. "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."
One of the major concerns is that the legislation changes the safety threshold for the approval of new drugs, Michael McBane, national co-ordinator of the Canadian Health Coalition, tells the paper. That "radical shift" puts the onus of proof on industry. "That represents a lowering of safety standards - changing health-protection laws to move away from precaution in favor of risk management," he says. The changes could make it easier for drugs to be approved quickly because they won't have to meet as high a demand for safety evidence, he adds. "The new law says we won't know if (drugs) are safe because we're doing it before safety information is completed (with) focus on post-market surveillance."
Health Canada's concept paper on progressive licensing, which was released last year, says there may be room for drugs to make it onto the market without the type of evidence usually required. The paper states that clinical data on some drugs, including breakthrough medicines or treatments for rare diseases, may be limited before they are approved. The paper says progressive licensing would allow them onto the market, where federal health officials would closely monitor their safety, The Globe and Mail writes.
But even if the government has good intentions to maintain high levels of premarket safety checks, the new framework, combined with growing pressure on governments to speed up drug approvals, could put consumers at risk, one clinical pharmacologist tells the paper.
Although the government says safety reviews won't become less rigorous, "they do imply they'll be speeding up the process," says Jim Wright, professor in the anesthesiology, pharmacology and therapeutics department at the University of British Columbia. "When something is fast-tracked, there's pressure on the reviewer to do things faster and most likely that's going to be putting pressure on them to not request further information that's needed."
But even if drugs aren't approved any faster, the proposed new system is unlikely to help the government monitor drugs once they hit the market, Wright says. That's because reports of side effects or regular safety updates submitted by drug companies to the government are not enough to identify underlying patterns of problems, the paper writes.