SYS-CON MEDIA Authors: Carmen Gonzalez, Sean Houghton, Glenn Rossman, Ignacio M. Llorente, Xenia von Wedel

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 are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
"ElasticBox is an enterprise company that makes it very easy for developers and IT ops to collaborate to develop, build and deploy applications on any cloud - private, public or hybrid," stated Monish Sharma, VP of Customer Success at ElasticBox, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happe...