Thank you very much, Madam Chair.
It's a pleasure to be here today before this committee to provide an overview of Canada's post-market activities for pharmaceuticals. In my opening remarks I will provide an overview of the main components of our program, the measures the department has recently implemented to enhance it, and the new strategies being considered to strengthen our safety system.
As the federal authority responsible for regulating health products and food, Health Canada plays a key role in protecting and improving the health and safety of Canadians.
Let me provide you with an overview of how we are regulating pharmaceutical products, which is the focus of the committee study.
I'll begin with the federal-provincial-territorial roles in pharmaceuticals.
As you know, all levels of government have a clear mutual interest in ensuring the safe and effective use of pharmaceutical products. The federal government is responsible for the regulatory oversight of the safety of pharmaceutical products made available to Canadians, and all governments also provide drug plan benefits to Canadians. In the case of the federal government, it's through the first nations and Inuit health branch for our first nations communities.
Before a pharmaceutical product is authorized for sale in Canada, the manufacturer must provide the department with scientific evidence of its safety, efficacy, and quality. Scientists then review the evidence to determine whether the risks associated with the product are acceptable in light of its potential benefits.
When the product is approved for sale, Health Canada conducts a number of important post-market activities, which this committee has identified in the terms of reference for the study. These include post-market surveillance and compliance and enforcement, as well as risk management activities and risk communication.
Post-market surveillance is the process of tracking pharmaceutical and other health products already approved on the market to access signals and safety trends once these products are in use by a wider population. It is the responsibility of the manufacturer to report serious adverse reactions.
Health Canada also encourages reporting from health care professionals and patients. Health Canada assesses the data and takes appropriate action if a serious health risk is identified or if the risks associated with the product outweigh its benefits. Such actions can range from issuing warnings to the public and the health care community to cancelling the market authorization of a product.
Regulators worldwide face new challenges in the regulation of health products, driven by changing trade patterns, increased globalization of the industry, rapidly evolving science, increased complexity of regulated products, and greater expectations from the public. Steps have been taken over the past several years to address some of the pressures and challenges facing our regulatory system. Through investments in the past, the efficiency and responsiveness of the drug review system has been substantially improved. Health Canada has cleared its submission backlogs and is now meeting internationally benchmarked performance targets for review of new drug submissions for pharmaceutical and biologic products without compromising its high standards of safety.
Following the high-profile safety issues related to COX-2 drugs and building on the recommendations made by the Standing Committee on Health in 2004, targeted measures have been implemented to strengthen the safety of pharmaceuticals and other health products through significantly enhanced funding.
I would like to thank the Standing Committee on Health for its past work on issues related to health products, particularly the 2004 “Opening the Medicine Cabinet” report, which helped guide our most recent work on strengthening and modernizing Canada's safety system for pharmaceuticals.
For your information, we've provided a kit with all the various reports that built on the work of the Standing Committee on Health over the past few years, which has more details about some of the information we're going to talk about this morning.
Improvements made in the past few years to strengthen post-market surveillance, which is of most interest to this committee, include enhanced clinical trial oversight, strengthened assessment and surveillance of marketed products, and strengthened compliance and enforcement.
We have increased our capacity to collect more and better information about the safety of products currently on the market, as well as our capacity to assess the information and to communicate the risk. For example, we have launched the MedEffect Canada website as a single window for timely safety information about health products. There are 17,000 subscribers to the MedEffect e-notice at this point. We are also distributing the Canadian Adverse Reaction Newsletter to approximately 67,000 physicians through the Canadian Medical Association Journal and to 25,000 pharmacists across Canada.
We have also opened two new regional adverse reaction offices, for a total of seven across the country, and have seen a 50% increase in the number of adverse reaction reports submitted to Health Canada since 2006.
While these investments were necessary to address immediate gaps in Canada's current safety system, the view was that Health Canada needed to fundamentally change the way it regulates health products, which is widely shared by stakeholders.
In the fall of 2006, Health Canada launched a broad review of its legislative regulatory and policy frameworks for health products, known as Blueprint for renewal. It articulates a number of orientations to modernize the regulatory system, including proposed strategies to strengthen the safety of pharmaceutical products throughout their life cycle.
We held national consultations with over 150 stakeholders on the blueprint document that you have in your kit. Strong support was expressed during these consultations for the proposed approaches to modernizing our system.
The blueprint outlines a number of gaps in the regulatory system. For example, we have legislation, the current Food and Drugs Act, that is outdated and was designed to address the realities of the 1950s, as opposed to the year 2007. The system is reactive, not always focused on the greatest risks, and uses blunt instruments that often result in a one-size-fits-all approach to regulating products. It focuses on pre-market and point-in-time approaches to assessing the safety of products, rather than looking at risks and benefits continuously across the product life cycle. The experience with COX-2 drugs has demonstrated the need to address these gaps, particularly in post-market authorities and capacity, to help prevent similar incidents from happening in the future.
The proposed food and consumer safety action plan that was announced by the Prime Minister in December 2007 and the related discussion paper that was released and posted on our website in mid-January, a couple of weeks ago, would fundamentally change the regulatory system for regulating pharmaceuticals and other health products so that it can be more responsive to rapid changes in the regulatory environment and better protect the health and safety of Canadians. This shift would be achieved through the implementation of a life cycle approach, an approach that is consistent with other leading regulators, such as the U.S. Food and Drug Administration and the European Medicines Agency.
With the proposed life cycle approach, a number of actions could be taken more proactively to prevent safety incidents, strengthen targeted oversight activities, and respond rapidly to incidents when they do occur, which sets the international standard for vigilance activities.
The successful implementation of the action plan would require legislative amendments to the Food and Drugs Act. Specifically, authority would be required to implement life cycle approaches to regulating health products, thus shifting the focus from pre-market review to one that continuously assesses a product's risks and benefits, both before and after it reaches the market, by putting conditions on the licence. It would provide a more modern and effective compliance and enforcement regime, including modern fines and penalties and the power to remove unsafe health products from the market. It would enable the department, in cooperation with the provinces and territories, to make it mandatory for hospitals to report on serious adverse drug reactions. And it would enhance the openness and transparency of Health Canada's regulatory activities to support greater public involvement in regulatory decision-making.
The implementation of a life cycle approach to regulating health products will provide information about the risk-benefit profile of a drug, based on its use in the real world. It will allow Health Canada to better respond to safety issues when they arise, therefore reducing negative consequences on the health of Canadians related to the use of unsafe products.
This concludes my opening remarks. I have colleagues with me who can provide details on some of the issues we've talked about. I leave it up to you to ask questions, or we can provide the details now, as you like.
