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

[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.

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

Mr. Speaker, this private member's bill would propose creating an entirely new layer of bureaucracy charged with the near-Herculean task of having to monitor mandatory reporting.

I do not understand how the member opposite believes that this would achieve anything. The United States has mandatory reporting and it has never once been able to levy a fine. Could the member explain this?

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

Mr. Speaker, I thank my colleague opposite for asking the question. I feel it is a relevant question.

In fact, the bill will not have a financial or administrative impact. When the reporting is not mandatory, the consequences are more costly. We know that human lives have been lost.

In terms of the penalties in the United States, I will say that the penalty was still in force when I introduced the bill. However, it has subsequently been withdrawn.

[Libby Davies, NDP, Vancouver East, BC]

Mr. Speaker, in response to what the parliamentary secretary said, I wonder if she has thought about the fact that in the U.S. the FDA does not have to monitor the fines because it has a mandatory system. It is because of the mandatory system that there is reporting. The Americans have not actually had to use the fines. They are there as a penalty, but in talking with officials at Health Canada, my understanding is that the mandatory system in the U.S. has meant that they have not even had to use the fines. It is actually a positive thing, but maybe she has not thought about that.

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

Mr. Speaker, I thank my colleague, the NDP health critic. I know that she is working very hard on the health portfolio.

In the United States, as in New Zealand and Europe, everyone chose the mandatory system over the voluntary system. Here, we deplore the fact that the government gives companies the option to report drug shortages or not. In fact, the poll indicated the effects quite well. Human lives have even been lost.

The United States may have withdrawn the fines, but they were there initially. The approach is mandatory, not voluntary.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

Mr. Speaker, in fact this private member's bill also appears to attempt to amend the wrong act. Pharmaceuticals are already regulated under the Food and Drugs Act, yet this bill proposes to amend the Department of Health Act. The word “drug” only appears once in the entire Department of Health Act, and when it does appear, it is because it is referencing the Food and Drugs Act.

I would ask why the member opposite proposes to amend an entirely different act from the one in which pharmaceuticals are actually governed.

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

Mr. Speaker, I do not intend to amend the bill, but I am asking that the mandatory reporting of drug shortages be included. I want to see it in the bill.

I know that my colleagues opposite might not agree, but, as I said and I repeat, I am totally open to amendments being made in committee. What matters to me is that we are already starting to see the mandatory approach.

[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.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Mr. Speaker, the Liberal Party will be supporting the bill. We think it is timely.

I listened to my hon. colleague, the parliamentary secretary, use terms like “needless”. This bill, which intends to deal in a real way with drug shortages, is not needless at all. I will tell members why later on.

The parliamentary secretary talked about bureaucratic big government. I do not think this is bureaucratic and big government. In fact, it is bureaucracy that is standing in the way of the kinds of processes we need to get drugs out into the community as soon as possible.

We should not be referring to Sandoz in any positive light. It was Sandoz that cost communities for intravenous anesthetics in the hospitals. It was a huge problem for everyone. It catapulted this problem onto the front pages of the newspapers and onto centre stage.

However, this is not something new. The college of pharmacists and the Canadian Pharmacists Association identified this problem in 2010, saying that about 90% of pharmacists had a difficult time filling prescriptions, because they could not find the drugs they needed. At that time, about 58% of physicians said that they actually could not find the drugs they needed and had to look for substitutions.

That was in 2010. We, as Liberals, had a round table with all the stakeholders and came up with a good sense of the situation in Canada. We knew that this was not just a Canadian problem. This is also linked to global shortages of drugs in terms of raw materials, et cetera.

We also watched the United States deal with this problem in a different way than Canada did. The Food and Drug Administration in the United States identified the problem back in 2010, just as Canada did. The President created a group of 11 extra people within the Food and Drug Administration to work solely on drug shortages. They were to identify upcoming shortages before they actually occurred, look for alternatives for those drugs at an early stage so that patients could get them when they needed them, and look at whether there was collusion at all in the drug industry with regard to shortages.

We know that a lot of these shortages are from generic companies. Many of the drugs we are talking about are old tried and true drugs that have been in the pharmacopoeia for physicians, patients, and pharmacists for the last 30 years. Now they are no longer being made, in many instances, because they are not profitable, and they cannot find the raw materials, et cetera.

It is not a needless problem or a needless intervention the parliamentary secretary referred to.

Here is what has happened since 2010, when pharmacists and doctors identified this problem. In 2012, since the government has taken the steps the parliamentary secretary talked about, the situation has worsened. Now 95% of pharmacists say that they have trouble trying to get the drugs that are prescribed, and 68% of physicians, an increase from 52%, are now saying that this is a problem for them in treating their patients.

What happens when patients cannot get a drug that has been working for them and is being prescribed? First, physicians have to find an alternative. That is very difficult to do if one does not know in advance. For people who understand about drugs and about patient care, they will know that they cannot suddenly, even if they could find an alternative, switch a drug right away in a day. One has to be weaned from the drug. One has find out if the alternative will work for the patient. The patient may get side effects from that alternative. In the meantime, what happens when patients cannot get access to the drugs they need is that they get very sick and go to the ER. That is a cost to the system. That also makes them enter hospital for a period of time while they try being put on a new drug without consequences. That takes up hospital beds. We find that it backs up the system. Patients can get worse in terms of the progression of illnesses.

We see that this is a real problem in terms of patient care. It is not just something on a piece of paper. The pharmacists and doctors are flagging this as a real problem for patient care.

We are suggesting that we do something about it, in spite of the voluntary reporting system. No one is suggesting that it is not done in good faith. In an ideal world, all drug companies would say that they think they are going to have shortages and that they will happen in six months, and they will flag them early. However, they do not.

This is not an ideal world. It has shown over three years that the system of voluntary reporting has not worked. It is time to go into a mandatory system. It is time to identify beforehand. It is time to look at what the United States has been doing successfully with this drug shortage problem, listen to it and maybe learn something.

Do we listen to best practices? No, but we should look at them. We should see that at the end of the day, this is not about the industry. This is about patient care. This is about people having access to the drugs they need when they need them.

Let me give the House an example. Hospital pharmacists and people who are treating patients for terminal illness and for certain cancers have found that some of the chemotherapy treatment obviously has side effects. The drugs to treat those side effects are now no longer easily available. The other drugs that they might used have far more side effects than they would want in a patient who has cancer or a terminal illness. Again, we are finding that people are unable to use the substitutions.

Epilepsy is another example. If people do not have the drugs that they have been taking for many years, which have been out there in the marketplace for a long time and have worked for many epileptics, and if they cannot find them, they have to go on to newer drugs that may or may not work for them and that may have many side effects for them, causing them to get sicker. By the way, if they do not get the drug and they have to wait for two weeks, the problem for patients is that they can start going back into epileptic seizures, when they had been controlled for 20 or 30 years.

This is an issue of patient care. The government does not have to continue with the voluntary measures that it has used and that have been shown to not work. We are talking about evidence here. If we had it for three years and it is making things worse, fix it. What is the big problem? I do not believe that if the United States is able to get industry to work with government and mandate certain things without industry getting mad at it, the government has taken a strong step forward. People there obviously give a hoot about their patients and what happens to their citizens.

The problem here is that we have to get on top of this. We have to be proactive about it. We have to mandate getting it out there. Many drugs, and I could go down an extensive list of drugs right now, are in short supply and will never flag on time. Timeliness is an issue, not simply mandating reporting. The thing about timeliness is that it gives the doctor and the pharmacist the ability to find a new and alternative drug, to search around and see if they can find that drug to tide the patient over while they are trying the new drug. This is an essential component of patient care. It is important for patients. For those here who have family members who are ill, especially with chronic diseases, or family members with acute diseases who cannot find immediate care for themselves, this is a real problem.

The government should stop doing the job thing and the ideological thing and look at actual outcomes. It should look at whether the situation it has had for three years is working and move forward to have a better system to emulate the practice in the United States. It is not a bad thing to emulate good practices. The government should emulate the practice of the United States Food and Drug Administration and what Mr. Obama has done. Let us take care of Canadian patients.

This is what we intend to do. This is why this bill has come forward. This is why we, as Liberals who flagged it and came up with similar ideas in the beginning, will support the bill. It is a good bill, it is a solid bill, and it will help patients in the long run.

[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.

[Ted Opitz, Conservative, Etobicoke Centre, ON]

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.

[The Acting Speaker, Conservative, Bruce Stanton]

The time provided for the consideration of private members' business has now expired, and the order is dropped to the bottom of the order of precedence on the Order Paper.

The House resumed from November 19, 2013, consideration of the motion 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.

[Wayne Easter, Liberal, Malpeque, PE]

Mr. Speaker, indeed, I am pleased to speak on Bill C-523, presented as a private member's bill from the NDP. The Liberals have actually been calling for the Conservative government to implement mandatory reporting of drug shortages since 2011, and with luck, we will finally see this move forward.

This legislation is quite simple in that it mandates that a supplier, be it a manufacturer, wholesaler, distributor, or importer of drugs, notify the Minister of Health of any planned interruption of the production, distribution, or importation of a drug at least six months in advance. Failure to do this would be punishable via summary conviction and a fine of not more than $1.8 million. Any unexpected interruption would have to be reported to the minister as soon as possible or the supplier would face a summary conviction and fine of not more than $10,000 per day from the day the offence is committed, up to a maximum of $1.8 million.

Moreover, under the terms of this legislation, if a supplier is planning to cease production, distribution, or importation, the minister must be informed at least 12 months in advance or face a summary conviction and fine of not more than $1.8 million.

The minister must develop a plan—and this is important—in conjunction with the provinces and territories to prevent and address drug shortages, inform patients and health care providers, and prepare and implement any emergency response plan to address any shortage of a drug. I said that is important because the record of the government, in terms of doing anything in a co-operative way with the provinces, is that this seems almost foreign to it. This might all sound complicated, but in reality, the bill is simply calling on industry to keep government informed when a specific drug might become scarce, so appropriate planning can be undertaken.

Why was the bill proposed in the first place? Simply put, it was proposed in response to the ongoing shortage of medically necessary drugs across Canada. In the past, the Conservatives have asked drug companies to collect and post information regarding pending shortages on public websites to help health care professionals adjust treatment plans in a timely fashion. However, this is a voluntary reporting system and does not compel drug companies to disclose any information. As the case last year with Sandoz Canada has shown us, this can lead to significant harm to the health of Canadians who depend on necessary medication. We need to address this to prevent problems in the future. Many MPs in their own constituencies have had constituents come in to talk about shortages of drugs, which may have affected their health.

In the fall of 2011, following the Liberal round table on drug shortages, we recommended that Health Canada should establish a team within Health Canada to anticipate, identify, and manage drug shortages, similar to the 11-person team established by U.S. President Obama at the U.S. FDA. The government has not shown any such leadership, however.

Canada's government must institute a mandatory drug shortage reporting system, which would require manufacturers to list unavailable medications and to develop early warning systems that could highlight potential drug shortages, so health ministers, medical professionals, and patients would be notified as soon as possible. It is the responsible and prudent thing to do. Ensuring a safe supply of essential drugs is a key responsibility of the federal government, but it is a responsibility that the Conservative government has not taken seriously.

Shortages of essential drugs needed for common health issues and procedures are not a new problem, nor is the problem limited to Canada. It is a global problem that demands real action. For nearly three years, community hospitals, clinics, and pharmacies across Canada have been experiencing serious shortages in common medications, including those used for cancer care, heart problems, epilepsy, pain control, and surgical procedures. The federal government has had plenty of warning about the situation but has consistently failed to take action.

Members do not have to take my word for it. The Canadian Pharmacists Association sounded the alarm on shortages three years ago. It noted that 90% of pharmacists face drug shortages each week when filling prescriptions and that these shortages have become worse over time. The Canadian Pharmacists Association asked for the health committee to study the issue urgently and to ensure that this issue is on the agenda of the World Health Assembly meeting in May.

For our part, on two separate occasions at the health committee, August 2011 and again in November, the Liberals demanded that an investigation be launched into the shortages. However, all of these warnings yielded nothing but silence from the government. Members know how these committees work. They go in camera, they are basically shut down, government members vote against the motion, and the public does not know what happened.

As I have already mentioned, in the fall of 2011, the Liberals held a round table on drug shortages with drug experts from across the country. The recommendations that emerged from this were clear. Strong federal action was required to address current and future drug shortages.

In the face of these concerns, the Conservatives have done next to nothing. Their wilful disengagement and abandonment of meaningful responsibility for the shortages has worsened the problem. Rather than real action, the Conservatives brought in a toothless, voluntary drug shortage reporting system, which does not force pharmaceutical companies to report drug shortages, as is required in countries like France and the United States. In its first test case with Sandoz Canada, the voluntary system utterly failed to provide provincial health authorities with advanced warning of a shortage. The company's drug production problems were known months before, but provinces were only notified in late February, leaving the provinces no time to create contingency plans. The previous minister of health herself admitted that the voluntary reporting system was a flop.

The Liberals believe that a mandatory national drug shortage reporting system is required, and today we are backing up that belief with our votes. This reporting system should require drug manufacturers to list unavailable medications and to develop early warning systems that could highlight potential drug shortages, so that health ministers, medical professionals, and patients are notified as soon as possible. The provinces are asking for this and health stakeholders are asking for this, yet the Conservatives ignore their calls and continue to support a failed system that is putting Canadian lives at risk.

I call on members opposite. The backbench members opposite are not members of the executive council. They can act independently, on their own. They do not need to take direction from the departments and from cabinet. They can stand up for citizens on their own. I hold those backbench members responsible for the fact that some of my constituents are seeing drug shortages. It is because the government failed to act and the backbenchers failed to stand up in their own right for their constituents.

In conclusion, the government's approach has clearly been reckless and shortsighted. However, hope is not lost. If members would stand up and do the right thing and support Bill C-523, we would at least have somewhat of a start in dealing with this problem.

[Christine Moore, NDP, Abitibi—Témiscamingue, QC]

Mr. Speaker, I am very pleased to speak to Bill C-523, which was moved by my colleague, the hon. member for Saint-Bruno—Saint-Hubert. This bill would reform the Department of Health Act to deal more effectively with drug shortages.

I would like to mention that I am a nurse by training and that in order to maintain my credentials, I work approximately twice a month in an emergency room and intensive care ward. Critical specialized drugs are used in those places to keep people alive, and that is why I feel it is crucial that we deal more effectively with the issue of drug shortages. Shortages do a lot to complicate matters in a hospital.

Hospitals are already grappling with many issues, such as the fact that there are not enough beds or staff. They are dealing with many problems. Combine those problems with drug shortages and it becomes much more complicated to administer care. This can even lead to operations being cancelled.

Recently, there was a shortage of injection drugs. As a result, non-urgent surgeries were cancelled so as not to deplete supplies of drugs used for those operations in case there were truly urgent cases in which lives depended on those drugs.

The federal government's failure to take action on this issue is having a direct impact on people. People are not getting their surgeries, they are having problems, and their treatment can be out of whack if they change drugs while waiting for a shortage to end.

For example, treating people with psychiatric and mental health conditions is a delicate balancing act, and there is an art to finding the right combination of different classes of drugs to help them and prevent their psychiatric symptoms from recurring. If one of those drugs is taken out of the equation or a substitute is introduced, that can throw off the balance. It can even trigger a psychotic episode. The government needs to understand the critical impact that drug shortages can have on the overall health of patients.

The federal government's failure to act on this matter has forced the provinces to manage it in the end. It becomes very complicated.

This reform is based on two main features: the mandatory disclosure by suppliers of a planned or foreseeable drug shortage and the implementation of an emergency response plan to address shortages.

Drug shortages are a public health issue. Furthermore, this problem is not limited to Canada. It is a global problem. When a company experiences a shortage, its impact will be felt around the world.

In practical terms, the United States has adopted mandatory reporting of drug shortages. That is what this bill calls for. This legislative framework has produced clear results: 195 shortages were avoided in 2011 and 2012 alone. The Food and Drug Administration, or FDA, centralizes the information going around about drug shortages and develops an action plan accordingly. It is ready to take action. Ever since the FDA imposed that requirement, the number of shortages that have been avoided rose constantly between 2005 and 2010. Every year, the number of shortages that have been avoided has gone up. Over those five years, approximately 100 drug shortages were avoided. As I just said, in 2011-12, 195 were avoided.

It is incredible how what is basically simple legislation can actually solve or avoid problems that could be critical for people's health.

Many countries have plans and have tackled the problem of dealing with drug shortages. Health Canada should make changes to its regulations based on U.S. and European practices in order to take effective action to deal with the causes and consequences of drug shortages.

By examining the current Department of Health Act, we see that it is the cause of two failures. First of all, it is a public health problem in that patients do not have access to the drugs they need for their treatment. That manifests itself in different ways, as I noted earlier with the psychiatry example.

A more expensive alternative drug can be purchased. It may have a financial impact on patients. It can worsen their health if their symptoms can no longer be managed. In some cases and with certain drugs, it can unfortunately result in the patient's death.

Accordingly, the minister's inaction on preventing drug shortages and the consequences that entails, can cause death. That is something quite tangible and we cannot stand idly by. We cannot ignore this problem.

What is more, this creates budgetary problems. A drug shortage creates extra costs for our health care system. The supplier network has to be changed and the patients have to be contacted again to be given new treatments, for instance. Switching a person to a new drug sometimes requires extra monitoring or blood samples to be taken in order to adjust the treatment. If a patient is denied an antihypertensive and a substitute has to be found because of the shortage, then his blood pressure needs to be taken. He will need to be monitored by a nurse for a certain period of time to ensure that the substitute drugs truly suit him and are treating the symptoms.

We go from having a patient whose condition was under control because he was taking drugs, to having patients who need to be monitored to ensure that their conditions are still under control. This creates rather significant extra costs to the health care system. Most of the cost created by the shortage is borne by the provinces.

Bill C-523 recognizes this doubly dysfunctional system and aims to provide a solution to the problem of drug shortages. It would legally require suppliers to disclose any planned or foreseeable drug shortages, as I mentioned earlier. That is not too complicated for a company to do. It knows when it could end up with a drug shortage because demand has increased or because there are problems with its production line. Therefore, it is not too complicated for companies to inform the government. It would not be a heavy administrative burden. It is rather simple. Health Canada would then quickly pass along the information to hospitals and the provinces, so that they can take appropriate action.

The bill also calls for an action plan. We know how serious the consequences can be for patients. Having an action plan is a priority. We cannot remain silent.

Lastly, we had an emergency debate about the last drug shortage because the government did not have an action plan. It is not prepared for these situations. It is unacceptable that it is not prepared to take action for our health care system or to combat drug shortages. It shows a lack of concern for the health of all Canadians.

That is why it is very important for us to address this issue and pass this bill, so that we can take action for the sake of patients and Canadians.