Bill C-523 (Historical)

Mandatory Disclosure of Drug Shortages Act

An Act to amend the Department of Health Act (disclosure of drug shortages)

This enactment amends the Department of Health Act to oblige drug suppliers to advise the Minister of any interruption or cessation of the production, distribution or importation of drugs and to oblige the Minister to prepare and implement an emergency response plan to address shortages of drugs.

Mandatory Disclosure of Drug Shortages Act

[Libby Davies, NDP, Vancouver East, BC]

Mr. Speaker, I would like to congratulate my colleague, the member for Saint-Bruno—Saint-Hubert, for bringing forward Bill C-523. It is a straightforward bill and one that is really needed. Basically, it would amend the Department of Health Act to oblige drug suppliers to advise the Minister of Health of any interruption or cessation of the production, distribution, or importation of drugs and oblige the minister to prepare and implement an emergency response plan to address drug shortages. It is straightforward and necessary.

In debate tonight, we have heard how serious the issue of drug shortages has been. There are thousands of patients and families across Canada who have suffered terrible anxiety, pain, and stress because they suddenly have found out that the prescription they require as a pain control measure or for epilepsy or a special condition is not available. It has had a huge impact on the medical community, pharmacists, doctors, anesthesiologists, and hospitals. By and large, the biggest impact on Canadians and what is causing the greatest anxiety and suffering is that their health and well-being have been compromised as a result of these shortages.

I am proud of the fact that the NDP has been monitoring and pushing for accountability on drug shortages ever since it became visible that there was a huge issue that was not being addressed by the federal government. In March of 2012, we brought forward a motion in the House of Commons for the government to, in co-operation with the provinces, territories and industries, develop a nationwide strategy to anticipate, identify and manage shortages of essential medications, require drug manufacturers to report promptly to Health Canada, and so on. It was adopted unanimously. It clearly laid out a course of action that needed to be taken. It was interesting that the government supported the motion in May of 2012.

We also tried to call for a review of that motion a year later to find out what progress had been made. We heard something in that regard from the parliamentary secretary tonight. A multi-stakeholder steering committee was set up with the provinces and health care organizations on purchases and supplies. We had a briefing in October of this year from Health Canada to find out how that work was going, and we still have significant concerns about drug shortages in Canada. As a result of that briefing in October of this year, I wrote to the Minister of Health on October 29 outlining some of the concerns we had.

Our major concern is that although the government has set up this multi-stakeholder steering committee and does involve the key players, there is still no system in place for accountability and to ensure that suppliers live up to their obligations. As we heard tonight, the system that has been put in place is basically a voluntary one, so there is no accountability to ensure it is being followed. As a result, it is left to regional purchasers such as hospitals, health authorities, and the provinces to chase after the suppliers to find out what problems there are and what they need to do.

The second concern I identified to the minister was that accountability should also extend to how the shortages were reported. I pointed out that there was only a voluntary system in place for companies to report shortages, and no consequences if they did not immediately report them, even in delays that would compromise patient health. This particular point is very much at the heart of my colleague's bill. We have been pressing for a required or mandatory reporting system. As we have heard, this is in place in the United States, New Zealand, and the European Union. It is a good practice and one we should be emulating.

The third issue that we have identified as a concern, as a result of hearing about the progress that has been made, is that there is no system in place that tracks systemic manufacturing violations. We know from Health Canada that it has identified approximately 46% of drug shortages are due to manufacturing issues, including safety violations, yet there has been no way to track which companies may be negligent in their production. In fact, Health Canada officials stated to us that they had not yet been able to address the root causes and the preventive measures that were required to address drug shortages. A system of accountability for manufacturing standards would also help in minimizing drug shortages.

Therefore, while I appreciate that the minister has taken some steps, frankly speaking, they are not adequate. They have not gone far enough. Out in the health community there is still an enormous amount of concern that we will face further shortages, that we will be scrambling as we did in 2012, that there will be yet another crisis. At the end of the day, it will be Canadians who are already in very difficult circumstances and who are already in many ways suffering, maybe in chronic pain, who will bear the brunt of a system that is not working properly.

The last comment I want to make is that we have studied this issue quite carefully. In fact, the parliamentary health committee had a study on drug shortages. The report issued by the committee was okay, it was adequate, but we felt it did not go far enough. Therefore, in the minority report from the NDP we made a number of recommendations, which I would like to refer to.

We urged the Minister of Health and the federal government to review the appropriate federal agency to assume responsibility for drug shortages notification website and to work with its provincial and territorial counterparts to set up and provide an investment for a public mandatory reporting system whereby drug companies would be required by law to report supply disruptions.

We also urged the Minister of Health and the government to convene an expert committee to identify critical drugs and require that any company marketing these critical drugs would have to give Health Canada a minimum of six months' warning of supply reductions.

Finally, there were other recommendations, but we also urged the Minister of Health and the federal government to convene a study to identify factors causing the drug shortages to determine if there were regulatory measures in addition to mandatory reporting that would identify and prevent drug shortages.

These are very extensive recommendations that we made.

I will finish with this. I was a bit aghast at the parliamentary secretary's comments earlier. On the one hand, she said that they were not going to support the bill because it sought to expand the role of the federal government and sought to expand the bureaucracy. She kind of trashed it. Then in the next breath she said that they would support mandatory reporting if it was needed. It seems to me that there is a contradiction. Conservatives supported the motion last year that came through the House as a result of an emergency debate.

Let us focus on the issue. Let us ensure that there is a system in place as outlined in this very good bill. It is very straightforward. Let us learn from what has happened in other jurisdictions and let us do a better job in Canada. We are not convinced the multi-stakeholder process that is in place now will actually do the job that is required. We urge members of the House to consider the bill and to support it when it comes to a second reading vote.

[Eve Adams, Conservative, Parliamentary Secretary to the Minister of Health]

Mr. Speaker, I rise today to speak to Bill C-523 and to take this opportunity to highlight our government's efforts to address drug shortages in Canada and to briefly outline why I believe this bill is not the right approach for Canadians.

Drug shortages are a global problem our government takes very seriously. Many of us have heard from our constituents about the impact drug shortages can have on patients and health care providers. Patients and their families need to be confident that they will have access to the drugs they need when they need them. This country's doctors need to know that when they write a prescription for a patient or make a request for a drug to be available during surgery that it will be available. Addressing these concerns, however, is no easy task.

Figuring out how best to address this issue has been a principle concern of our government and other key stakeholders across the health care system. That is why we are working with drug companies and the provinces and territories as part of a pan-Canadian strategy to manage and prevent shortages and to reduce their impact.

Our government recognizes that the only way to effectively prevent and manage drug shortages is through a multi-stakeholder approach. That is why we have called upon stakeholders across the drug supply chain to work together to take action.

In 2012, in partnership with the government of Alberta, we jointly launched the Multi-Stakeholder Steering Committee on Drug Shortages. This committee includes membership from industry, health professional associations, and governments. They are all working together on concrete measures to address three priority areas, including prevention of drug shortages, advanced notification and communication, and shortage mitigation and crisis management. I am pleased to say that this collaborative approach was endorsed by federal, provincial, and territorial ministers of health in 2012.

While this multi-stakeholder approach is relatively new, I am pleased to report that we have seen real progress in public notification of shortages on an industry-funded website; concrete tools to mitigate drug shortages across the supply chain; and coordinated action on recent drug shortages between the federal government, provinces, territories, and industry. Through our productive working relationship, industry has taken important steps to improve public notification of shortages and to provide Canadians, health care practitioners, and patients with the information they need on drug shortages.

However, Canada's drug supply system is changing and improving. It is also becoming more open and transparent.

In response to a call from the Minister of Health, industry launched drugshortages.ca in 2012. Through this site, industry has been working collaboratively and voluntarily to provide public notification of actual and anticipated drug shortages. The information available on this site is critical to helping all elements of the health care system adapt to potential supply disruptions before patient care is negatively impacted. Most importantly, this approach is working. Back in August, for example, one major company, Sandoz, voluntarily posted a number of upcoming drug shortages to this site, well in advance of an anticipated disruption.

We will continue to monitor and push industry to ensure timely and comprehensive posting on this website to build on the success we have seen thus far.

The multi-stakeholder approach has also resulted in the collaborative development of concrete tools to prevent and manage drug shortages across the supply chain. This September, two tools were announced by the Minister of Health, jointly with her Alberta counterpart, alongside industry and health professional association representatives from the committee. The first of these tools is a national protocol for the public notification of drug shortages. This protocol sets out clear expectations for how and when stakeholders across the supply chain share information in the event of a drug shortage. This protocol provides much-needed direction on roles and responsibilities and details on how to communicate to ensure that Canadians continue to receive the most up-to-date information on potential and actual drug shortages.

The second tool is a multi-stakeholder tool kit that identifies key measures that can be taken across the drug supply chain to prevent and reduce the impact of drug shortages. This tool kit provides a detailed outline of Canada's drug supply chain and the roles and responsibilities of key players in the event of a shortage.

Finally, the multi-stakeholder approach has resulted in unprecedented levels of collaboration and coordinated action on recent drug shortages among all levels of government and industry.

When these shortages are communicated or detected, stakeholders from across the health care system and drug supply chain are now coming together to identify the best available measures to address them. These improvements will help ensure that all stakeholders have access to the essential information necessary to support a robust supply of drugs in Canada.

The benefits and successes of our current multi-stakeholder approach to addressing drug shortages provide a useful background as to why I will not be supporting Bill C-523 and why our government will instead continue to support ongoing multi-stakeholder efforts.

This bill seeks to amend the Department of Health Act to require drug suppliers to notify the Minister of Health of any disruption in the supply of drugs and to impose fines for non-compliance.

Where Bill C-523 falls short is that it ignores the significant good will and positive momentum seen to date to address this important issue. In doing so, this bill prematurely concludes that mandatory notification is possible, enforceable, or would necessarily lead to a reduction in the frequency and duration of these shortages. I do not think this bill can achieve that.

This bill also fails to recognize the complexity of the supply chain and the distinct roles and responsibilities of its stakeholders in the event of a shortage. Industry's primary role in the event of a potential or actual drug shortage situation must be more than just providing notification. Our multi-stakeholder approach demands much more from industry than just notification. It demands that industry work collaboratively with stakeholders across the supply chain to review their manufacturing practices, find alternate products, and make the health and well-being of Canadians their principle concern.

Rather than focusing attention on all stakeholders and their different but complementary roles, Bill C-523 seeks to expand the role of the federal government. In doing so, this bill attempts to impose additional bureaucracy, burdensome oversight, and needless, unenforceable penalties. This ineffective, big government approach would not reduce drug shortages.

It is because of our efforts with all stakeholders that companies are providing advance notice of shortages online, including information about alternative treatments.

The lessons learned from the 2012 report of the Standing Committee on Health and from current multi-stakeholder efforts are that improved notification is only one component of a comprehensive strategy. We now know that this comprehensive approach to drug shortages requires an integrated focus on prevention, notification and communication, and mitigation and crisis management.

While our government will not support Bill C-523, we will continue to monitor this issue very closely. We are also open to considering a mandatory approach, if needed. Embarking upon such an approach at this time, however, would hinder the progress we have made so far.

Going forward, we will continue to expect greater transparency and accountability from industry. We will implement a new public register of manufacturers that have committed to advance notification and will publicly post letters to industry members who fail to comply.

However, let me be clear. If at any point it becomes clear that industry is not fulfilling its obligations to provide Canadians with timely, comprehensive, and reliable information on drug shortages, our government will not hesitate to bring forward a plan for stronger federal action.

In closing, Bill C-523 falls short of the strong, collaborative approach and action we have taken on drug shortages. It is an action Canadians expect and deserve from our government. We will continue to build on the successes we have seen so far, to draw on the strength of our partners, and to work together to prevent and manage drug shortages in Canada.

[Djaouida Sellah, NDP, Saint-Bruno—Saint-Hubert, QC]

moved that Bill C-523, An Act to amend the Department of Health Act (disclosure of drug shortages) be read the second time and referred to a committee.

Mr. Speaker, I am pleased to present Bill C-523, Mandatory Disclosure of Drug Shortages Act.

Drug shortages are a public health issue. Shortages have a significant impact on the health of Canadians, the practices of health care professionals and system costs.

The most important issue is that of patient health. Drug shortages are a danger to their health because they delay access to drugs and patients are given a less-effective drug with a greater risk of adverse effects. Drug shortages do not allow for a transition period, which is very important for patients on certain drugs.

Drug shortages are not a new problem, let alone a problem unique to Quebec or Canada. This is a global problem that has existed since the 1970s. However, the problem has become more pronounced in recent years. The number of shortages has exploded. Between 2005 and 2010, the number of shortages of FDA-approved drugs increased from 92 to 310.

The Régie de l'assurance maladie du Québec recorded 33 shortages in 2006, but 207 in 2010, before the major Sandoz episode in 2012. This crisis attracted a little more interest for this important public health issue.

Following this crisis, the NDP called for and got an emergency debate, but most importantly, we had a motion pass unanimously in March 2012. The motion read as follows:

That, in the opinion of this House, the government should: (a) in cooperation with provinces, territories and industry, develop a nationwide strategy to anticipate, identify, and manage shortages of essential medications; (b) require drug manufacturers to report promptly to Health Canada any planned disruption or discontinuation in production; and (c) expedite the review of regulatory submissions in order to make safe and effective medications available to the Canadian public.

What has been done since then to implement this motion? The Conservative government's database for voluntary reporting of drug shortages failed to ensure a transition period that is crucial to the health of Canadians. The government is leaving the health of Canadians in the hands of pharmaceutical companies, which are the only parties that decide when to report drug shortages.

More recently, the Minister of Health also announced the introduction of the multi-stakeholder toolkit and the protocol for the notification and communication of drug shortages, which:

...sets out clear expectations, principles and processes for how and when stakeholders across the supply chain share information in anticipation of or response to a drug shortage.

These are interesting and necessary tools, but they are far from sufficient. Neither the protocol nor the toolkit require manufacturers to provide accurate and timely information, and most importantly, no one is ultimately responsible for ensuring compliance with the protocol. This is not up to par—Canadians deserve better, and that is why I introduced this bill.

Moreover, in January 2013, Diane Lamarre, president of the Quebec order of pharmacists, stated that what the federal government had done so far was not enough.

Quebec's Minister of Health, Dr. Hébert, shared a similar sentiment when he said, “If the federal government was doing its job properly, shortages would be better prevented”.

The bill on mandatory disclosure of drug shortages addresses the need to introduce a transition period to ensure that the health of Canadians is protected.

The bill stipulates that the pharmaceutical company shall notify the minister of any planned or foreseeable interruption of the production, distribution or importation of a drug at least six months in advance. If a pharmaceutical company decides to cease producing, distributing or importing a drug, it must notify the minister at least 12 months in advance. The bill also stipulates that any companies found in violation of the act are liable to a fine.

Although we are talking about the regulatory framework for disclosing drug shortages, I am not suggesting that we reinvent the wheel.

Mandatory disclosure of drug shortages exists in the United States, New Zealand and in the European Union. Why not here in Canada? It has been called for by various groups, including the College of Family Physicians of Canada in a letter to the Prime Minister in 2011, and the Ordre des pharmaciens du Québec. Even officials at Health Canada have recommended to the minister that it be required.

Mandatory disclosure of drug shortages will have a direct positive impact on the practices of health professionals.

This bill has had many supporters. Some of the groups that support my initiative include: the National Association of Pharmacy Regulatory Authorities; the College of Family Physicians of Canada; the Ordre des pharmaciens du Québec, which adopted a resolution to support my bill; the Association des anesthésiologistes du Québec; the Newfoundland & Labrador Pharmacy Board; the Prince Edward Island Pharmacy Board; the Association des pharmaciens des établissements de santé du Québec; the Canadian Federation of Nurses Unions; and the College of Physicians and Surgeons of Alberta.

Drug shortages have a direct impact on the health of patients, first and foremost. These shortages undermine the health of Canadians and make it harder for our health system to run smoothly. The facts are overwhelming. Drug shortages have a significant impact on patient health and the work of health care professionals and put enormous pressure on health care costs.

The survey confirms that shortages are becoming increasingly common, as 78% of pharmacists said that they had difficulty sourcing a drug in their last shift at work. The survey also confirms the effects this has on the health care system, since 91% of hospital pharmacists agreed or strongly agreed that drug shortages are increasing costs to the health care system, and 76% of hospital pharmacists reported a significant impact on their workload.

The impact that drug shortages have on the patients is even more worrisome. According to a survey, 64% of doctors indicated that shortages of drugs had consequences for patients, and 78% of hospital pharmacists agreed or strongly agreed that the shortages adversely affect patients.

Furthermore, 91% of pharmacists said that their patients had been inconvenienced as a result of drug shortages. The impacts are greater in certain cases. For some, the consequences are limited to having to take—and pay for—a sometimes more expensive alternative drug.

For people with epilepsy, for example, the situation is more severe. When people suddenly stop taking anticonvulsants, seizures can become longer and more serious, and may require urgent care. They can sometimes even be fatal. Between 2009 and 2012 there were shortages for five different anticonvulsants, some of which were made by the same pharmaceutical company. These shortages forced some people to use a different preparation or, if available, another drug without the benefit of a transition period. That is unacceptable and it needs to change.

The Canadian Anesthesiologists' Society published the results of a survey of its members last June in the Canadian Journal of Anesthesia. The statistics are alarming. The sample included 60% of the society's members in all Canadian jurisdictions.

The survey revealed that 66% of respondents had experienced at least one shortage, forcing 49% of respondents to administer an inferior anesthetic. In addition, 8% of respondents witnessed drug errors caused by a shortage, 14% regarded drug shortages as having prolonged patients' recovery from anesthesia, and over 10% viewed shortages as resulting in an increased number of postoperative complications. That, however, is not the worst of it. The worst part is that, according to the survey, four respondents indicated that a shortage of anesthesia drugs and other essential drugs led to postoperative deaths. The drug shortage has become a human tragedy. We have to act now to put an end to that tragedy.

It is also clear that these shortages have had a significant impact on the work of health professionals. In the fall of 2012, the Canadian Medical Association, the Canadian Pharmacists Association and the Canadian Society of Hospital Pharmacists surveyed their members. That survey revealed alarming findings.

The survey confirmed that shortages are becoming increasingly frequent, with 78% of pharmacists stating that they had difficulty sourcing a drug in their last shift at work. The survey also confirmed that this situation is affecting the health system because 91% of hospital pharmacists agreed or strongly agreed that drug shortages are increasing costs to the health care system, and 76% of hospitals reported a significant impact on their workload.

We have wasted enough time. According to the Canadian Press, Health Canada did not choose mandatory reporting, in spite of the recommendations of the department's officials, because of the time required.

I will quote a Canadian Press article from December 27, 2012. Steve Outhouse, spokesperson for the former minister of health explained:

...a voluntary system was chosen because it would take too long for Health Canada to bring forward regulations mandating companies disclose production gaps.

More than a year later, nothing has been done to move in that direction. Because of this government's failure to take action, people are paying a high price.

I realize that mandatory reporting will not solve the problem of drug shortages. However, it is an indispensable tool that can help better manage the situation and provide patients and their health care providers with pertinent and complete information in order to better manage the consequences.

The United States, the European Union and New Zealand have all opted for mandatory reporting.

There is nothing revolutionary about this bill. It is based on what is happening around the world.

The financial penalities included in the bill are modelled on a proposal contained in a bill passed by the U.S. Congress. The principle is as follows: if the act is not enforced, there must be consequences.

It is important that we move towards mandatory disclosure. This is not a witch hunt against the pharmaceutical companies because I know they did a lot during the 2012 crisis. Sandoz, in particular, notified its clients of upcoming shortages. However, it is important to ensure that patients are safe and have access to the treatment they need in a timely manner.

I am asking all my colleagues and the government to support the bill because it is in the best interests of all Canadians.

[Michel Bédard]

I don't know if you're using the chart or the list, but Bill C-517 was discharged yesterday, so the next item is Bill C-523.

This bill would enact the mandatory disclosure of drug shortages act, so the manufacturer or importer of drugs would have to disclose any shortage in the future.

This bill does not concern questions outside of federal jurisdiction. It does not appear to be against the Constitution. There is no similar private member's bill on the order paper, and there is no similar government bill on the order paper.

[Djaouida Sellah, NDP, Saint-Bruno—Saint-Hubert, QC]

moved for leave to introduce C-523, An Act to amend the Department of Health Act (disclosure of drug shortages).

Mr. Speaker, I am very proud to introduce a bill concerning the disclosure of drug shortages.

Drug shortages are a major public health issue, one that is not limited to within Canada's borders. Canada has yet to require mandatory disclosure, even though it exists in other parts of the world such as the United States, New Zealand and the European Union. It has been called for by various groups, including the College of Family Physicians of Canada in a letter to the Prime Minister in 2011, and the Ordre des pharmaciens du Québec. Even officials at Health Canada have recommended to the minister that it be required.

I am very pleased to give the government the opportunity to do what must be done and pass the mandatory disclosure of drug shortages. I am asking the government to support this bill to make work easier for health care professionals, to avoid additional costs to the health care system and, above all, for the health and safety of Canadians.

(Motions deemed adopted, bill read the first time and printed)