Welcome!

News Feed Item

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).

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
"We focus on SAP workloads because they are among the most powerful but somewhat challenging workloads out there to take into public cloud," explained Swen Conrad, CEO of Ocean9, Inc., in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"Outscale was founded in 2010, is based in France, is a strategic partner to Dassault Systémes and has done quite a bit of work with divisions of Dassault," explained Jackie Funk, Digital Marketing exec at Outscale, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We are still a relatively small software house and we are focusing on certain industries like FinTech, med tech, energy and utilities. We help our customers with their digital transformation," noted Piotr Stawinski, Founder and CEO of EARP Integration, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"I think DevOps is now a rambunctious teenager – it’s starting to get a mind of its own, wanting to get its own things but it still needs some adult supervision," explained Thomas Hooker, VP of marketing at CollabNet, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We've been engaging with a lot of customers including Panasonic, we've been involved with Cisco and now we're working with the U.S. government - the Department of Homeland Security," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We're here to tell the world about our cloud-scale infrastructure that we have at Juniper combined with the world-class security that we put into the cloud," explained Lisa Guess, VP of Systems Engineering at Juniper Networks, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
There is a huge demand for responsive, real-time mobile and web experiences, but current architectural patterns do not easily accommodate applications that respond to events in real time. Common solutions using message queues or HTTP long-polling quickly lead to resiliency, scalability and development velocity challenges. In his session at 21st Cloud Expo, Ryland Degnan, a Senior Software Engineer on the Netflix Edge Platform team, will discuss how by leveraging a reactive stream-based protocol,...
"With Digital Experience Monitoring what used to be a simple visit to a web page has exploded into app on phones, data from social media feeds, competitive benchmarking - these are all components that are only available because of some type of digital asset," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Your homes and cars can be automated and self-serviced. Why can't your storage? From simply asking questions to analyze and troubleshoot your infrastructure, to provisioning storage with snapshots, recovery and replication, your wildest sci-fi dream has come true. In his session at @DevOpsSummit at 20th Cloud Expo, Dan Florea, Director of Product Management at Tintri, provided a ChatOps demo where you can talk to your storage and manage it from anywhere, through Slack and similar services with...
"I'm here to leverage my secret sauce, which is using outsourced development and the company that I utilize is delaPlex Software and they've basically allowed me to win Fortune 500 companies," noted Justin Witz, CTO of FRA and PlanTools, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We want to show that our solution is far less expensive with a much better total cost of ownership so we announced several key features. One is called geo-distributed erasure coding, another is support for KVM and we introduced a new capability called Multi-Part," explained Tim Desai, Senior Product Marketing Manager at Hitachi Data Systems, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We provide IoT solutions. We provide the most compatible solutions for many applications. Our solutions are industry agnostic and also protocol agnostic," explained Richard Han, Head of Sales and Marketing and Engineering at Systena America, in this SYS-CON.tv interview at @ThingsExpo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"As we've gone out into the public cloud we've seen that over time we may have lost a few things - we've lost control, we've given up cost to a certain extent, and then security, flexibility," explained Steve Conner, VP of Sales at Cloudistics,in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We are an IT services solution provider and we sell software to support those solutions. Our focus and key areas are around security, enterprise monitoring, and continuous delivery optimization," noted John Balsavage, President of A&I Solutions, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
SYS-CON Events announced today that Calligo, an innovative cloud service provider offering mid-sized companies the highest levels of data privacy and security, has been named "Bronze Sponsor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Calligo offers unparalleled application performance guarantees, commercial flexibility and a personalised support service from its globally located cloud plat...