New drugs are taking too long to reach patients in Canada, report claimsBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b3440 (Published 25 August 2009) Cite this as: BMJ 2009;339:b3440
Patients in Canada are being denied swift access to new drugs, because the regulatory process is too slow, says a report from the Canadian think tank the Fraser Institute.
“It takes more than 14 months, on average, for Health Canada [the federal regulatory agency] to approve new medicines as safe and effective,” claims Brett Skinner, the institute’s director of health policy and author of the report.
“And while private insurers will immediately cover those medicines, the provinces can take up to another year to decide if they will pay for the same drugs,” he said. “For the third of Canadians who rely on provincial drug plans, this puts new medicines out of their reach for up to a year.” Some provinces decide not to cover the new drugs at all.
Mr Skinner believes that regulatory cooperation with other countries and replacing government drug programmes with subsidised access to private insurance would help speed up access.
But Mike McBane, executive director of the Canadian Health Coalition, a non-profit organisation that promotes Canada’s public health system, dismissed the report’s recommendations.
“[Most] new drugs offer no advantage over existing treatments; they are vastly more expensive; and they are, quite frankly, not on the market long enough to know if they’re safe or not,” he said. “We definitely should not automatically be assuming that every new drug that the companies want to market is a drug that a public drug plan should pay for.”
Performance based user fees would create a conflict of interest, he said, and would risk new drugs being too hastily approved, with a subsequent need to be withdrawn. Rofecoxib (Vioxx) was a case in point, he said: “We need to learn from that lesson. The drug approval system currently is broken, and the last thing you need is to speed it up.”
He called for much more rigorous examination of drugs coming up for approval and greater transparency in the clinical trial data supplied by industry. “We also need an independent drug safety board that investigates drugs that crash, just like when aeroplanes fall out of the sky. Right now if a drug crashes the only people who look at it are the people who approved it, and that’s a conflict of interest.”
Stephane Shank, senior adviser on media relations at Health Canada, said that it was important not to shorten the rigorous review process. “Our first priority is the health and safety of Canadians,” he said. Better regulatory performance was not just about timeliness but also about safety and transparency, he added.
The government had committed $C32m (£18m; €21m; $30m) to set up a drug safety and effectiveness network to carry out independent research on the safety of drugs already on the market, he said.
Cite this as: BMJ 2009;339:b3440
Access Delayed, Access Denied: Waiting For New Medicines in Canada is available at www.fraserinstitute.org.