Mr. Speaker, I will be splitting my time with the member of Parliament for Brampton—Springdale.
As we debate the issue of drug shortages this evening, and in particular how shortages can be prevented, many people are asking why Canada has not learned from its international regulatory counterparts, in particular our neighbours to the south of the border.
I will take this opportunity to speak to the relative roles of Health Canada and the United States Food and Drug Administration in response to drug shortages. There is no magic bullet to resolving this issue. Health Canada has been in contact with international regulatory counterparts and studied their systems and there is no one clear solution to fixing this problem globally.
I will start by explaining more generally the role of Health Canada in comparison to what I know about the FDA. I will then provide some information about the specific issue of drug shortages and the relative and respective roles of the two organizations.
The Food and Drug Administration is the regulatory arm of the U.S. department of health and human services for food and health products, such as drugs and medical devices. The FDA is considered the American equivalent of the health products and food branch of Health Canada. The FDA is responsible for protecting the public by ensuring that human drugs, medical devices and other health products intended for human use are safe and effective. The FDA is responsible for conducting clinical trial reviews, conducting pre-market assessments of health products for market authorization, post-market surveillance of drugs and other health products, and the compliance and enforcement activities.
Although Health Canada has a broad mandate to help Canadians maintain and improve their health , while respecting individual choices and circumstances, its regulatory activities administered by the health products and food branch are quite similar to the activities of the U.S. FDA. More specifically, the primary role of Health Canada's health products and food branch is to ensure that health products sold in the Canadian market meet high standards with respect to safety, efficacy and quality. Like the FDA, this includes clinical trial review and assessments, pre-market assessments of applications for market authorizations or establishment of licences, post-market safety surveillance, and the range of compliance and enforcement activities.
The basis and principles of the scientific review process are generally accepted and similar worldwide within scientific communities. However, science is only part of the overall regulatory approach. There are differences in the laws in each country. There are differences in socio-economic factors, reimbursements and government funding structures, all of which influence the Canadian health care system landscape and, consequently, how Health Canada regulates.
With respect to drug shortages, it must be acknowledged that the supply chain is complex and typically involves many players to take a drug from raw material to retail sales. For this reason, it is not surprising that disruptions can occur in the supply chain that lead to shortages. In the past, these were largely seen as unfortunate but manageable issues that were dealt with by industry. Only in rare cases did they result in shortages on the market where patients were no longer able to access the recommended treatment. These situations are particularly challenging for patients as they can cause treatment delays or changes to a less effective alternative.
Within the last 10 years, there has been an increasing trend in the number of drug shortages. Both the U.S. FDA and Health Canada have studied the issue to better understand the root causes. The FDA has tracked a number of reported drug shortages in the system since 2005 and the number has increased steadily. The data they collected showed that shortages can arise for a variety of reasons, from manufacturing or capacity issues to shortages in raw materials, or regulatory decisions related to quality, safety or efficacy of a product.
Last year, Health Canada engaged the Canadian Agency for Drugs and Technologies in Health to examine the issue of drug shortages. The agency arrived at a conclusion similar to what was found in the data collected by the U.S. FDA: there is no one root cause for a drug shortage.
I will now speak in more detail to the respective roles of Health Canada and the FDA in responding to drug shortages, specifically in relation to shortage coordination, shortage notification, assistance to companies on regulatory activities and enforcement discretion.
The impacts of certain drug shortages are currently being experienced on the front lines. My colleagues are experiencing them across the province of Ontario and in other places across the country. Resolution of this issue is complex and ongoing.
Through outreach to health care professionals, international regulators and patient groups, Health Canada has been told that early notification of any anticipated or occurring drug shortage is key to assisting health care professionals respond to and manage drug shortages.
Both Health Canada and the FDA have taken action to see that companies are notifying health care professionals and the public of any problems that could lead to shortages. The FDA encourages voluntary reporting of any issues that can lead to a drug shortage and also has a narrow regulatory requirement for sole-source manufacturers of medically necessary drugs to inform it six months in advance of a temporary or permanent discontinuation. Health Canada also has a mandatory requirement for all manufacturers to notify it of discontinuations. With the implementation of the national drug monitoring system in 2012, as promised by industry and health care professional associations, Canada will have a voluntary system in one location for reporting all anticipated or occurring drug shortages.
As members will recall, it was the Minister of Health's action in 2011 that was the driving force behind the industry's commitment to post information on anticipated or occurring drug shortages. In a recent letter to Sandoz, the minister expressed her disappointment to the company for not following through on that pledge. However, even early communication and notification of drug shortages will not prevent all drug shortages, but it will allow health care professionals to better manage shortages when they occur.
When it comes to drug shortages, this is not where the role of the regulator ends. Health Canada and the FDA staff know the importance of being proactive in these shortage situations. When Health Canada becomes aware of a shortage that is impacting patients, the department does everything in its power to minimize the impact of shortages and to facilitate access to alternatives. This includes working closely with companies to resolve manufacturing and quality issues, ranging from simple fixes like enforcing the proper expiry date to correcting problems related to product sterility. The department will also work with manufacturers to see that submissions related to alternative suppliers and changes in manufacturing processes can be reviewed on a priority basis. These are important activities that can ensure the continuity of supply when companies fail to plan properly to prevent shortages.
Health Canada can also facilitate access to alternatives on an emergency basis by facilitating and working with foreign manufacturers to allow for temporary and limited importation of foreign versions of a drug. These activities are all very similar to the role played by the scientific and regulatory staff at the U.S. FDA. Regulators at Health Canada and at the FDA work with manufacturers as needed to ensure the information about shortages and alternative medications are made available to those who need them.
Both Health Canada and the U.S. FDA publish information on their respective sites about which products have been approved for sale by which company. These sites provide buyers with the information they need to diversify supply and seek alternatives. In addition, I would like to draw the members' attention to another drug shortages website that is maintained by the American Society of Health-System Pharmacists, an organization that is similar to our professional association of hospital pharmacists. The AHSP website is populated through voluntary reporting by industry and includes a comprehensive list of current and resolved shortages, information on available products and multiple resources for managing drug shortages. The two websites that Canadian industries are currently using to post shortages information on a regular basis are a step in the right direction to getting similar transparency here in Canada. It is expected that when industry and the health care professional associations deliver on their commitment for a national drug monitoring system in 2012, they will strive for functionality on par with this American site.
Our government would like to see a comprehensive national drug shortage monitoring system in place in the coming months that would provide early notification to those who need it as well as the best practices guidelines and information for managing shortages.
Our government understands the significance of this issue and the opportunities of learning from our international partners. In this case, we believe that Health Canada is taking steps very similar to our U.S. counterparts to improve communication and transparency in order to prevent and mitigate the impact of drug shortages.
