Mr. Speaker, I am happy to be here today to speak to Bill C-523, a bill that would undermine our current approach to mitigating drug shortages. Drug shortages are a global problem that our government takes very seriously. We have gone to great lengths to address the issue in a collaborative way, and we are making real progress in preventing, communicating and addressing drug shortages.
Bill C-523 would make it mandatory for drug suppliers to provide notification of any interruption to drug supply and would impose fines for non-compliance. It would increase the regulatory burden and even reduce our ability to prevent shortages.
Indeed, our government has been doing good work with drug companies, and the provinces and territories, as part of a pan-Canadian strategy to manage and prevent shortages and reduce their impact. As a result of our actions, the drug supply system is changing and improving. It is also becoming more open and transparent.
As my colleague, the hon. Parliamentary Secretary to the Minister of Health noted, the Minister of Health herself recently announced improved communication strategies to ensure that all players are working together and clearly understand their roles when problems do occur.
Make no mistake, it is a priority for our government to work with all key stakeholders to prevent and manage current and potential drug shortages. However, we cannot do this alone.
Drug supply chains involve many players, including drug companies, doctors, patients, pharmacists, group purchasing organizations and all levels of government. That is why we are committed to a drug shortage strategy based on collaboration. Each player in the drug supply system has a specific area of expertise as well as a unique set of responsibilities. By working closely with these players, we can take advantage of that expertise to prevent and manage shortages.
Our government has established productive relationships with these diverse players. Together we have been able to create important tools for addressing shortages, such as the protocol for the notification and communication of drug shortages, and the stakeholder toolkit, as announced by the Minister of Health earlier this year.
This protocol sets out clear expectations for how and when stakeholders will share information about drug shortages. It emphasizes that early warning is the key for the health care system to react to shortages. Stakeholders have agreed that all shortages, anticipated or actual, will be posted on the dedicated drug shortages website at drugshortages.ca.
The tool kit details the Canadian drug supply chain, clarifies the roles and responsibilities of all key players, and identifies the tools and the strategies available to prevent and address drug shortages. In creating the protocol and the tool kit, collaboration was absolutely essential.
I have already remarked on the complexity of the system and the many players involved in it. The only way for us to benefit from a stable drug supply system, a system that Canadians expect and deserve, is if all players do their part and work together toward the long-term solution.
The federal government's primary role in the drug system is to regulate the safety, quality, and efficacy of drugs and health products. However, we are also playing a strong and collaborative role with multiple jurisdictions and stakeholders to assist their efforts to anticipate, mitigate, and manage drug shortages. We have a strategy for dealing with shortages based on multi-stakeholder collaboration, and it is working. It takes advantage of diverse roles, responsibilities and expertise.
Bill C-523 would alter this completely, increase the regulatory burden for industry, and risk the positive momentum that we have built with diverse stakeholders. I urge all members of this House to maintain this goodwill, support our collaborative approach, and vote against the bill.
The bill is wrong for Canada because it undermines collaboration. It is also flawed because it prematurely assumes that mandatory notification is feasible and enforceable and would lead to a reduction in the frequency and duration of drug shortages.
Bill C-523 would impose a mandatory six-month advance notification for shortages and twelve-month notification whenever a manufacturer decides to stop making a drug, and it includes hefty fines for failures to notify.
The problem with these proposed regulations is that they fail to recognize important collaborative work that has been happening across the drug supply system. Given that stakeholders throughout the supply chain are currently willing to work with us, it is not clear how mandatory notification would improve our ability to address shortages at this time.
Because of our efforts, companies are providing advance notice of shortages online, including information on alternative treatments. Indeed, industry has been voluntarily posting potential and actual shortages on drugshortages.ca since March 2012.
One point I found particularly interesting is that under the voluntary notification in Canada, industry is publicly posting a wider range of shortages than is posted on websites for jurisdictions where notification is mandatory. It has to do with all of that collaboration that I discussed earlier. For example, public notification in the U.S. is limited only to medically necessary drugs with the greatest impact on public health. It is hard to see how this system would be an improvement over the current Canadian approach in which all anticipated and actual shortages are publicly posted.
Mandatory notification in Canada could threaten momentum and goodwill. Bill C-523 does not make any of these considerations. I simply cannot support a proposal to overhaul a voluntary system that is working increasingly well without any evidence that a mandatory prescriptive system would have a positive impact. If, for some reason, industry were to stop providing Canadians and health care providers with timely, comprehensive and unbiased information, then we would certainly have a reason to move forward with stronger federal action.
As mentioned earlier by the Parliamentary Secretary to the Minister of Health, our government would consider a mandatory approach if we failed to see continued success under our voluntary approach. With the current collaborative approach, mandatory notification would be a risky and unnecessary approach to an issue that this government is already very effectively addressing. Industry is in the best position to quickly inform health professionals when supply problems occur. It is the first to know when changes to manufacturing business practices occur that could lead to shortages.
In Canada, industry recognizes this, and, I repeat, is voluntarily posting shortages on drugshortages.ca. I encourage everybody to check that out. That means that Canadians and health care providers have easy, timely access to important information about which drugs are in shortage and can react accordingly. Transparency and communications around anticipated and actual drug shortages are key to enabling all relevant stakeholders to act accordingly.
We will continue to enhance transparency through initiatives like a new public register of manufacturers, which has committed to provide advance notification, and by publicizing instances where companies have failed to do so. For these measures to be successful, we must continue to recognize distinct roles and responsibilities so we can effectively limit the impact of drug shortages on Canadians.
As I mentioned earlier, the federal government's primary role in the drug supply system is regulating the safety, quality, and efficacy of drugs for the Canadian market. It is industry's responsibility to understand the need for their drugs and to provide public notification when it cannot meet such demand. It is encouraging to see that industry is effectively fulfilling that responsibility.
However, challenges remain, and we will continue to monitor the situation and to push industry along a collaborative path that is already showing progress. As I have said already, if stronger federal action is required, the government will take it. We recognize that all players in the drug supply system have distinct and important roles to play, and we are working closely with provinces, territories, and the industry.
This work has yielded progress, and our coordinated responses to drug shortages are encouraging. Recent supply disruptions saw government officials, both federal and provincial, collaborate closely with manufacturers to monitor and address those shortages. Going forward, we will continue this collaborative approach so that all players exercise their respective roles effectively and fulfill their important and complementary roles to one another. The government will do its part, and we expect others to do theirs.
In today's global marketplace, with a wide variety of drugs available to meet Canadians' health needs, a well-organized system is necessary to manage our drug supply. I assure everyone that thanks to our collaborative efforts, the Canadian drug supply is increasingly open, transparent, and well coordinated. Our collaborative approach protects patients by allowing all players to work together to prevent and manage shortages. We are going to continue to monitor this issue very closely to determine if a mandatory approach should be considered in the future.