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Study Comparing Canada and Europe Debunks the Myth That Faster Drug Approvals Will Increase Safety Risks: Canadian Health Policy Institute (CHPI)

TORONTO, ON--(Marketwired - August 22, 2014) - New research published by the Canadian Health Policy Institute (CHPI) finds that though regulatory approvals for new drugs in Europe are faster versus Canada, the rate of discontinuations of new drugs for safety reasons is the same in both jurisdictions. The findings mean that the added drug approval delay in Canada achieves no extra assurance of safety, but instead imposes an unnecessary cost on Canadian patients who are forced to forego the potential health benefits that could be gained from earlier access to new drugs.

The study authored by Dr. Nigel Rawson (Ph.D.) compared drug approval delays in Canada versus Europe, and the rates of discontinuations of new drug products from the market for a safety reason over a 10-year period (2003-2012) using data from Health Canada and the European Medicines Agency.

Rawson found that over the 10-year period from 2003 to 2012, 186 new drugs were approved by Health Canada compared with 189 by the European Medicines Agency. The median approval delay for the new drugs approved in Canada was 391 days compared with 338 days for new drugs approved in Europe. However, the rate of discontinuation of these new drugs for safety reasons was 1.6% in both jurisdictions.

A comparison of jurisdictional experience between consecutive five-year periods showed that the Canadian median review time exceeded the European median by more than 100 days in drugs approved between 2003 and 2007 (503 days versus 349 days), but between 2008 and 2012, the Canadian median delay was only 15 days longer than the European median (353 days versus 338 days).

Despite longer approval times in Canada during the period, the rate of discontinuation in drugs approved in the 2003-07 period among products with a minimum of 18 months of post-approval time was virtually the same in Canada (2.2%) and Europe (2.1%). Just as importantly, despite the speeding up of review times in Canada in 2008-12, none of the drugs approved during this period in either jurisdiction had been discontinued for a safety reason as of the end of June 2014, at which time they had a minimum of 18 months post-approval time.

The study concludes that contrary to the suggestion that decreasing drug review times increases the risk of safety issues, the evidence shows that faster drug approval times in Canada were associated with a reduction in the rate of drugs discontinued for safety reasons versus the previous period (falling from 2.2% in 2003-07 to 0% in 2008-12). In addition, despite Europe having faster drug approval times than Canada throughout the decade, the rate of discontinuation for safety reasons was no higher in Europe than in Canada in any period.

This means that the added drug approval delay in Canada achieved no extra assurance of safety but imposed a cost on Canadian patients who were forced to forego the potential health benefits that could have been gained from earlier access to new drugs.

Open Access Permission

CHPI grants open access permission to republish this news release in whole or in part for use in news articles including a reference to Canadian Health Policy Institute (CHPI) as the publisher. Please include all hyper-linked text where possible.

Get the Study

The study, Do faster drug approvals increase safety risks? Evidence from Canada and Europe 2003-2012, was published at CHPI's free access online journal, Canadian Health Policy and can be downloaded at: www.canadianhealthpolicy.com or www.chpi.ca

Get the Open Access Commentary

A supporting commentary is appended (below) to this news release. CHPI grants open access permission to republish this commentary on the condition that it is published in its entirety without editing and with full attribution to the author. Please include all hyper-linked text where possible.

About CHPI

Canadian Health Policy Institute (CHPI) is a non-profit think-tank funded by independent research grants and unrestricted operating grants from public sector, private sector and non-profit sector sources. CHPI is dedicated to conducting, publishing and communicating evidence-based socio-economic research on health system performance and health policy issues that are important to Canadians.

COMMENTARY

(635 words including title and author credit)

Faster approval of new drugs does not compromise safety

Before any new drug can be sold in Canada, it must be approved as safe and effective by Health Canada. Research shows that the wait for new drug approval in Canada has tended to be longer than in other jurisdictions. However, Health Canada's performance has been improving in recent years and the regulatory delays affecting access to new drugs have shortened substantially in Canada. Some experts have been critical of Health Canada's efforts to achieve more timely regulatory approval of new drugs and have argued that shorter review times will result in lower quality assurance for drug safety.

I examined this concern in a recent study that was published by the Canadian Health Policy Institute (CHPI). The study compared drug approval delays in Canada versus Europe, and the rates of discontinuations of new drug products from the market for a safety reason over a 10-year period (2003-2012) using data from Health Canada and the European Medicines Agency.

The data show that though regulatory approvals for new drugs in Europe are faster versus Canada, the rate of discontinuations of new drugs for safety reasons is the same in both jurisdictions. The findings mean that the added drug approval delay in Canada achieves no extra assurance of safety, but instead imposes an unnecessary cost on Canadian patients who are forced to forego the potential health benefits that could be gained from earlier access to new drugs.

Over the 10-year period from 2003 to 2012, 186 new drugs were approved by Health Canada compared with 189 by the European Medicines Agency. The median approval delay for the new drugs approved in Canada was 391 days compared with 338 days for new drugs approved in Europe. However, the rate of discontinuation of these new drugs for safety reasons was 1.6% in both jurisdictions.

A comparison of jurisdictional experience between consecutive five-year periods showed that the Canadian median review time exceeded the European median by more than 100 days in drugs approved between 2003 and 2007 (503 days versus 349 days), but between 2008 and 2012, the Canadian median delay was only 15 days longer than the European median (353 days versus 338 days).

Despite longer approval times in Canada during the period, the rate of discontinuation in drugs approved in the 2003-07 period among products with a minimum of 18 months of post-approval time was virtually the same in Canada (2.2%) and Europe (2.1%). Just as importantly, despite the speeding up of review times in Canada in 2008-12, none of the drugs approved during this period in either jurisdiction had been discontinued for a safety reason as of the end of June 2014, at which time they had a minimum of 18 months post-approval time.

Contrary to the suggestion that decreasing drug review times increases the risk of safety issues, the evidence shows that as drug approval times in Canada grew shorter there was a reduction in the rate of drugs discontinued for safety reasons versus the previous period (falling from 2.2% in 2003-07 to 0% in 2008-12).

In addition, despite Europe having faster drug approval times than Canada throughout the decade, the rate of discontinuation for safety reasons was no higher in Europe than in Canada in any period.

European and Canadian experience shows that a slower regulatory approval process does not necessarily improve drug safety. Policy-makers need to balance safety concerns against the knowledge that any delay to accessing new drugs also imposes a potential cost on patients in lost health benefits. The evidence shows that by speeding up its approval process, Health Canada has in effect reduced these hidden costs and unintended consequences.

Dr. Nigel SB Rawson, Ph.D. is President of Eastlake Research Group in Oakville, Ontario and an affiliated scholar with Canadian Health Policy Institute (CHPI).

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