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.

Financial Statement of Minister of Finance

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

Mr. Speaker, I will be sharing my time with the member for Rivière-du-Nord.

The Conservative government promised a balanced budget that would benefit all Canadians. Instead, it presented a budget filled with election goodies. In the past four years, we on this side of the House have gotten used to seeing propagandist bills. However, the fact that the Conservatives presented a completely populist budget just to win votes in the election this fall is simply mind-blowing.

The budget is balanced because the Conservatives scraped up money by draining the contingency reserve and selling shares. They are using House of Cards as their inspiration as they scrounge for loose change, the same way they took their statistics from Kijiji.

They are promising measures that will not take effect until much later on. However, income splitting will take effect immediately. This government is dishonest. Believe me when I say that Canadians are not fools. They understand that the Conservatives' promises are worthless, not to mention that the budget promises came late this year, just like spring.

I was elected to defend the interests of the people of Saint-Bruno—Saint-Hubert. I am obliged to tell them that this budget fails them. It is failing Quebeckers.

Let us talk about health. Health is being dealt a blow again this year. The government still has not understood the importance of investing in health. It does not understand that thousands of Quebeckers will not be able to pay for their health care costs, much like it does not understand that investing in health is investing in our country's economic future.

Treating a person over the age of 65 costs five times more than treating a person between the ages of 15 and 65. This government is failing our seniors, middle-class Canadians and the poorest members of our society, who will not have access to proper health care.

Quebeckers can only manage a hollow laugh because Canada must respect the Canada Health Act, which provides for universal health care. That means that all Canadians have the right to free public health care. However, how can the provinces apply these principles if cuts are being made to their funding?

The Conservative government is ignoring the provinces' desperate needs. It has refused to take Quebec's rapidly aging population into account when calculating health transfer amounts. Health transfers will no longer go up by 6% per year. They will be capped at 3%. This means a heavier burden for the provinces. The Conservatives are depriving the provinces of thousands of dollars. Canadians deserve better. They deserve a good health system.

Clearly the government does not understand a thing about health. It expects people to be happy with a few piddly programs when staff, nurses and doctors are in short supply and people are not getting the care they need at the right time.

Medical clinics are closing. Three clinics have already closed in my riding, Saint-Bruno—Saint-Hubert, and another will be closing this year. That is unacceptable. The federal government must adhere to the principles in the Canada Health Act. If the Conservative government is unable to maintain a formula that enables the provinces and territories to pay for universal access to quality care, it should let us take over. We on this side of the House will listen and sit down with the provinces to come up with solutions that fit.

The NDP has a plan to strengthen our health system because we all deserve access to quality care no matter where we live. In 2013, I introduced Bill C-523, which called for the mandatory reporting of drug shortages. The Conservative government voted against that bill, then last February, it announced that it would require drug companies to report drug shortages in advance.

I was delighted that the government had finally seen the light on such an important issue. However, I was very disappointed to find no sign of the announcement about drug shortages in the budget. There is nothing about that in the budget, and certainly no investment. Simply put, the government is dishonest. It makes big announcements, but that is all it knows how to do. There comes a time when you have to stop making promises and get out the chequebook.

Let us talk about infrastructure. Freight trains and oil cars go through Saint-Bruno—Saint-Hubert. The hon. member for Brossard—La Prairie and I have talked to our constituents, who have all said that they are very concerned about the lack of investment in rail safety. The Minister of Transport promised that the government would invest in enhancing safety, but where is that investment in budget 2015? Where are the promises of tangible measures to ensure the safe transportation of hazardous materials? Where is the increase in the number of inspectors? Unfortunately, I do not see any of that.

Nor is there anything about the Champlain Bridge. There are no details as to the cost of the toll or how this toll will affect the other bridges. We gathered more than 1,000 signatures in Saint-Bruno—Saint-Hubert alone from people denouncing this arbitrary measure. That is more than 1,000 locals who have spoken out against this toll, and thousands more if we include the south shore, but the government does not seem to think that what they have to say matters. My colleagues from the south shore and I are going to have to explain to our constituents why they are not important enough for the government to listen to them.

Let us talk about public transit. The government boasts about having good ideas in its budget to address public transit. The Conservatives' proposed measures for public transit are limited, and the provisions are so complicated that they will prevent funding from getting to the municipalities. The budget is out of step with what the south shore mayors want. They say that improving public transit, the light rail system, and extending the metro to Longueuil are priorities for the local economy and the shift toward sustainable development. What is more, the money for public transit will not be available for another two years, provided there is a contribution from the private sector.

Canadians expect budgets to address their priorities. They expect budgets to provide their children with the best possible start in life and create good jobs. The Conservative government is walking on thin ice. It is Quebeckers and middle-class workers who are paying the price.

Two words come to mind when I read the budget: “dishonesty” and “improvisation”.

Health

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

Mr. Speaker, the Conservatives' approach to drug shortages is a dismal failure. The worst part is that the Conservatives voted against my bill, Bill C-523, which sought to implement an emergency response plan to address this problem.

When Health Canada stops drug production for safety reasons, rather than finding another supplier, the government does nothing. Who ultimately pays the price? Canadians.

Why are the Conservatives ignoring this serious problem?

Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)

[Matthew Dubé, NDP, Chambly—Borduas, QC]

Mr. Speaker, first of all, I would like to mention that I will be sharing my time with my colleague from Churchill.

I would also like to take the time to acknowledge the courage of my colleague from Oakville, with whom I had the opportunity to work in committee. To my mind, the fact that he took the time to share his experience is not only very moving, but also very important. Personal experience plays an important role in our efforts to make progress on such a file. It goes beyond politics.

As my colleagues said, the NDP will support the bill at second reading. We recognize that it is a step in the right direction. In fact, a number of my colleagues said so this morning. We also recognize that it is important to send this bill to committee in order to hear from certain witnesses who may not have been adequately consulted. I am thinking of the Canadian Nurses Association, among others, which says that the front-line workers who face medical challenges in communities were not sufficiently consulted. It will be a good opportunity for us to hear what these people have to say and perhaps to propose amendments.

It must be said, unfortunately, that we have been waiting for this for a very long time. The introduction of this bill has been delayed a bit. As I was saying earlier, when I asked my colleague a question in 2011, I was on the Standing Committee on Public Accounts. We were studying the Auditor General's report, which raised the problem of drug safety and the fact that the time between Health Canada receiving the information and sharing it with the public takes too long. In some cases it took two years, which is far too long.

I remember some of the testimony we heard. There did not seem to be a very clear commitment from the government at that time. Nonetheless, we have to look on the bright side. It is better late than never. The bill has been introduced and we believe it is a step in the right direction. We have to acknowledge that.

In this matter, we have to address a number of aspects having to do with drug safety. We will talk about it further. This is an extremely important issue. In the case of food safety, there were some explosive issues, such as the XL Foods recall, for example. This issue has a direct impact on the daily safety of thousands of people in Canada.

When it comes to food and drugs, we want to make sure that people can look after their health safely. People take drugs to feel better, not to end up with more problems. It is very important to ensure that companies can be required to recall their ineffective drugs. We must also ensure that information is shared. That is very important. What we noticed, and continue to notice, is that there is an issue with transparency and the sharing of information.

For example, one suggestion that the NDP made with regard to this issue and this bill relates to the public disclosure of the results of clinical trials. We know that information is not always being made public or shared with Canadians. I think that is a major problem, given that people often do not know anything about the drugs they are taking. They just go to the doctor and get a prescription. They rely on the doctor's expertise and the often very basic information they may have.

This is even more important today because, with all the information that is available on the Internet, many people may try to find the information themselves. If the government gave them information from reliable sources such as the department, it could be very reassuring for them. Canadians would know that the information provided by the government was reliable, accurate and complete. There is still a lot of work to be done in this regard.

Speaking of information and transparency, this also relates to food safety. I do not really like to make this comparison, since we are talking about two different issues, but they are similar in that the government and the minister need to take some responsibility. For example, with respect to the XL Foods recall, the Americans were the ones who discovered the problem. This bill contains an extremely important element in this regard: it ensures that the minister can issue a recall even when the negative effects of the drug are discovered outside Canada.

The information sent to the United States or Europe, for example, shows that many drugs are used throughout the world. We must not limit ourselves to our own experience. We must benefit from the knowledge of others.

Once again, this bill is a step in the right direction. It is becoming a recurring theme for the government to use information that was discovered, seen and recognized in other places to make important decisions regarding the safety of drugs in Canada.

The work of my colleague from Saint-Bruno—Saint-Hubert also ties into this since she introduced Bill C-523, which deals with drug shortages. At first glance, drug shortages do not seem to have a direct impact on drug safety, but I would venture to say that they do.

It has to do with transparency and the dissemination of information. It is problematic when the public—and not just patients, but doctors as well—does not have full information about drug shortages, a problem that my colleague's bill aimed to fix, because other drugs are used, including some lesser-known ones that could pose certain risks. These drugs are used in emergencies but the individuals involved do not necessarily understand all of the side effects that can sometimes be negative.

We need to understand why it is important to make this improvement. I know that a government member could tell me that the Minister of Health showed some openness on this issue last week when she claimed she was prepared to look into drug shortages. However, our team and one of our NDP colleagues made a meaningful suggestion, and this suggestion could significantly improve Canada's entire pharmaceutical system.

The provincial governments are obviously responsible for ensuring that the health care system runs smoothly. People have a lot of concerns about drugs. They need to have good information and we need to ensure that our prescription system helps take care of Canadians and does not cause harmful side effects. The public is very concerned about this, and we must take measures such as the ones in this bill to protect the public.

Although we have some concerns and this bill has some flaws, all parties can agree that it is still a step in the right direction to improve our health care system. After all, our public health care system is one of the cornerstones of our society. Any step in the right direction to improve this system must be supported.

Drug Shortages

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

The third petition is about my Bill C-523 on the mandatory disclosure of drug shortages. The people who signed this petition have observed that the Government of Canada's voluntary approach has not reduced the impact of shortages on patients and health care professionals.

Purple Day

[Dany Morin, NDP, Chicoutimi—Le Fjord, QC]

Mr. Speaker, I am rising today to tell the House about Purple Day, which was created in 2008 by Cassidy Megan, from Nova Scotia, to combat the stigma faced by many people with epilepsy. Right now, 300,000 Canadians are living with epilepsy. While there is no cure, 70% of epilepsy cases are treatable. Unfortunately, drug shortages often mean that treatment is not available. Shortages of Clobazam, Zarontin and other drugs have had disastrous consequences for patients recently.

That is why I am supporting Bill C-523, introduced by my colleague from Saint-Bruno—Saint-Hubert, which would require manufacturers and distributors of pharmaceutical products to report any interruption in the drug supply chain. They would be subject to fines if they do not. This bill would also require the federal government to work with the provinces and territories to find solutions to the challenges posed by drug shortages. In recognition of Purple Day, I sincerely hope that my colleagues will come together and find solutions that will help those with epilepsy and their loved ones.

Mandatory Disclosure of Drug Shortages Act

[The Speaker, Conservative, Andrew Scheer]

The House will now proceed to the taking of the deferred recorded division on the motion at second reading stage of Bill C-523 under private members' business.

The House resumed from February 6 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.

[Paulina Ayala, NDP, Honoré-Mercier, QC]

Mr. Speaker, everyone knows that the serious drug shortages Canada is facing are jeopardizing our health care. Health Canada issues notices and warnings about medications.

Obviously, when health care is affected, our economy is as well. We can all agree that sick people and people who are not working cost a lot of money. A mom or dad who has to stay home when their child needs treatment because they could not get the right medication also costs a lot of money. Hospital costs are also affected. It is not good for anyone.

Who has to find the solution? Since health care is a provincial jurisdiction, some say that it should be up to them. That is not how it works. It is not that easy. It is true that provincial governments share part of the responsibility, especially with respect to supplies. When pharmaceutical companies are getting virtually exclusive contracts, competitors have less interest in manufacturing drugs, which therefore limits the choice of drugs.

However, the federal government must shoulder some responsibility too. Drug shortage problems have been growing since the mid-2000s. They affect both generic drugs and innovative drugs, which are more expensive and are not necessarily Canadian drugs. Those are drugs imported form pharmaceutical companies abroad. They are more expensive, of course.

That is why a number of countries, such as France and the United States, have introduced policies to reduce and control the magnitude of those shortages. There are many reasons for the shortages. It is not just because not enough drugs were produced. For instance, there have been cases where the raw materials went bad because the facilities of a pharmaceutical company were in bad shape. The drugs that were subsequently produced were not of good quality; they were actually dangerous. Therefore there can be many causes and quality control is very important.

In the past, we knew where the drugs came from. They often came from certain European countries. Now they can also come from emerging economies, where quality control is less rigorous than in North America or Europe. We must be careful. That is the federal government's responsibility. Emerging economies have supply problems. As a result, there is a significant increase in demand. Our population is aging and therefore needs more and more drugs. For some diseases, we can now find drugs that we did not have before, so demand has gone up. However, the main reason is that the population is increasingly aging. We must look after our seniors who have worked for us to be where we are today.

While demand has gone up, production has remained the same. Clearly, private companies want to make a profit. We all agree that they are not there as a charity.

Finally, since major patents have expired, pharmaceutical companies are focusing on producing new drugs that are more expensive instead of producing existing drugs that are just as effective and cheaper. That is also something to keep an eye on.

In 2011, the United States tried to find a solution to this problem. They required that all companies disclose all shortages. They also encouraged them to report any slowdown in production because these situations can be prevented.

It is up to the provincial governments and especially to us, federally elected members, to find a solution. I would like to address my colleagues now. It is up to us, as legislators, to pass the right laws. The health of Canadians is also our responsibility.

Clearly, I will be supporting my colleague's bill, Bill C-523, An Act to amend the Department of Health Act concerning the disclosure of drug shortages, which would oblige drug suppliers to advise the minister 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.

[Sadia Groguhé, NDP, Saint-Lambert, QC]

Thank you, Mr. Speaker.

I am pleased to speak to this issue and defend the proposal put forward by the member for Saint-Bruno—Saint-Hubert in Bill C-523, which addresses preventive disclosure of drug shortages by pharmaceutical companies.

This is an important public health issue that affects Canadians from all regions and all walks of life. This is also an opportunity to assert that the health of Canadians is not a free commodity and that public interest takes precedence over free enterprise in the drug industry.

We need to legislate this because, true to form, the Conservative government is watching the problem worsen, is saying it is acting in the interests of Canadians and is making a lot of noise. It gets riled up and then nothing happens. However, the statistics on drug shortages in Canada are stunning.

The working group on drug shortages found that the number of registered drug shortages rose from 92 in 2005 to 310 in 2010. That is an increase of over 300%. It is equivalent to six registered drug shortages per week.

In 2011, 250 drugs were on back order, representing a 40% increase over the previous year. It is clear that supply disruptions are on the rise and that more drugs are being affected.

Here is an analogy. This kind of problem in another industry would have no real impact on the lives of Canadians. If a person wants to buy a new car, but the dealer cannot deliver it on time, that person just goes and buys another make of car. That does not work for the drug industry.

According to the report of the working group on drug shortages that I quoted, drugs that are subject to shortages are essential, which means that they are used to treat or prevent serious health conditions and there are no substitutes. In other words, unlike dissatisfied customers, sick people cannot simply find substitutes for the drugs they need. That happens often, too often.

From January 2010 to August 2011, 93% of the 127 unforeseen shortages involved essential drugs and 41% were both essential and produced by a single manufacturer. This kind of breakdown in the supply chain has a significant impact on the health of all Canadians.

In 2012, the injection drug shortage caused at least 65 surgeries to be delayed. Doctors surveyed by the Canadian Medical Association, the Canadian Pharmacists Association and the hospital pharmacists association confirmed that drug shortages affected their patients' health.

It is important to understand that illnesses do not wait for the drugs that treat them to become available. When there is a shortage, illnesses continue to flourish, worsen and spread. No one is immune: rich or poor, young or old, Canadian or not. Illnesses spread if they are not treated, and that is that.

These interruptions in the supply chain also have an economic impact, first of all, because they drive up the cost of the health care system. A delay in treatment or surgical intervention causes the patient's condition to deteriorate. The longer we wait to treat that person, the harder and more costly it is. Some 91% of hospital physicians agree. These delays also cause an increase in the workload of health care providers.

All of these disruptions wind up being more costly for our health care system, and therefore our economy. Let us not forget that healthy employees are essential to keeping our businesses running smoothly.

A 2011 labour force survey conducted by Statistics Canada ranks health problems as the number one cause of absenteeism at work, apart from vacation. In 2011, every full-time employee lost on average eight working days because of sickness. That is a total of 105 million work days lost annually.

Canada is experiencing a labour shortage in certain sectors, which is threatening our competitiveness and our growth. Our businesses even have to call upon temporary foreign workers at times in order to meet their labour needs. Thus, it is important to tackle this public health problem immediately in order to improve the health of our workers and reduce absenteeism.

Has the government taken any sensible action to address the shortcomings in the drug supply chain? Absolutely not. It is hiding behind its usual ideology: the free market. Let it go; leave it alone; the market will take care of itself.

With that approach, it is putting the health of Canadians in the hands of pharmaceutical industries. It is forgetting that it alone has the possibility of anticipating the needs, and knowing the state of the supply and the capacity of the pharmaceutical industries to meet demand. The government refuses to ask them whether they will have the capacity to meet demand in the short, medium and long terms so that it can adjust. It prefers to rely on the goodwill of the industry. The Conservatives keep extolling the virtues of business, but here, they are not acting as good managers.

The NDP is a responsible party that understands the realities and challenges of public health. That is why we have developed a constructive approach. It is based on the need to inform and to anticipate the need for drugs in the country.

It is simple. We must introduce a mandatory reporting system that requires pharmaceutical companies to inform Health Canada of any potential shortage, as the College of Family Physicians of Canada is calling for.

The NDP wants to ensure that the health care professionals have access to the necessary information to take care of their patients and to make their work more efficient. For that, we must oblige the pharmaceutical industries to report any drug shortages. We must not rely on their goodwill.

Other developed countries do it and it works very well. In the United States, for example, Barack Obama's administration issued an executive order last October requiring all manufacturers to report shortages to the Food and Drug Administration.

It is time for the federal government to do its job and look after public health. Canadians' health is more important than the profits of the pharmaceutical industry. We must take appropriate action to guarantee that everyone has access to health care and medication. That is why I support the bill before us today.

[Élaine Michaud, NDP, Portneuf—Jacques-Cartier, QC]

Mr. Speaker, I am very proud to rise in the House today to support my colleague's bill, Bill C-523, An Act to amend the Department of Health Act (disclosure of drug shortages).

Before I begin, I would like to commend the initiative shown by the hon. member for Saint-Bruno—Saint-Hubert in tackling a public health problem that is very troubling and unfortunately has very serious consequences, namely, drug shortages. I also wish to congratulate her on her thoughtful work and consultations, and on everything she has done to prepare this bill. Given that she is a doctor, she is very familiar with and knowledgeable of the subject matter. She has introduced a bill that really tackles something that should be a priority for all governments, including the federal government and provincial governments.

My colleague's bill aims to amend the Department of Health Act in order to oblige drug suppliers to advise the minister of any interruption or cessation of the production, distribution or importation of drugs. If it passes, Bill C-523 will also oblige the minister to prepare and implement an emergency response plan to address shortages.

Drug shortages have been a problem in Canada for a long time. For over 40 years, drug shortages have been a growing and recurrent problem. In January 2012, the Sandoz plant closed temporarily, and the company had supply problems again in November of last year. That is a striking example of the disastrous consequences that a drug shortage can have for Canadian citizens.

When a major pharmaceutical manufacturer like Sandoz is having a hard time producing 36 drugs, 16 of which are completely out of stock, that obviously has a direct impact on people's quality of life and health. In fact, 91% of pharmacists report that their patients have been affected at some time by drug shortages. In light of these overwhelming statistics, the NDP believes that this is a very serious problem.

Drug shortages may require pharmacists to resort to alternative treatments or to delay providing a treatment to a patient because there is no pharmaceutical substitute. Sometimes, patients have adverse reactions to ingredients in what was supposed to be a similar drug. This is about chemicals that have a direct impact on how the body works. You cannot just substitute one drug for another and not expect any consequences. Consider drugs used to treat depression, anxiety and psychological conditions. It can take months or even years to find the right dosage or the right drug to treat various illnesses. If there is a shortage and one antidepressant has to be substituted for another, that can have a disastrous effect on people's health and their quality of life.

The NDP thinks these situations are totally unacceptable. Before being elected to the House of Commons, I used to work at the Régie de l'assurance maladie du Québec as an information officer. One of my main duties was to answer calls when people had questions about the public health insurance plan or even the public drug insurance plan that we are lucky to have in Quebec. The questions were on the cost of the drugs, their billing, or their insurance. Almost every day, I received calls from patients, often seniors unfortunately, who were dealing with a drug shortage. They had to try to find a substitute. Quite often, they had to pay extra money to find a drug that could give them temporary relief, with the risk of suffering side effects. Sometimes, there simply were no drugs available. People had to wait, sometimes at great risk to their lives.

In Quebec, we are quite lucky. The public drug insurance plan covers most of the prescription costs for people who do not have access to private insurance. When a person has to take a brand name drug instead of a generic drug, the extra cost is not covered by the public drug insurance plan. These extra charges come directly out of the pockets of people who have no other choice but to take the brand name drug. They have to rework their budget.

We are talking about seniors on the guaranteed income supplement who are barely making ends meet. They have to deal with drug shortages and maybe pay $50 or $60 more every month. This can easily total up to $100 for some medications.

I cannot imagine people in this same situation outside of Quebec. Some people have no drug coverage and have to pay the entire cost. It is a huge expense and the result of poor planning. No matter the reasons for drug shortages, the fact remains that people do not have any information or only have the information that the pharmaceutical company wants to give them. They are not able to predict them. Pharmacists, doctors and everyone working in the health system are directly affected by the shortages.

I will give another example. I spoke earlier about people with psychological or psychiatric problems. My colleague from Laval—Les Îles talked about people with epilepsy. That is another illness that is difficult to manage. It takes several attempts to find the right medication and the right dosage. If the patient has to skip a dose or change medications, the effects can be terrible. Someone who suffers from grand mal seizures has difficulty coping with the convulsions. If they change medications, the seizures can be more severe, more frequent and more violent. A seizure that lasts more than five minutes requires immediate hospitalization and can even result in death.

We really are talking about the tragic consequences of a lack of medication, even for a day. People who, like me, do not suffer from chronic conditions of that kind, cannot imagine the consequences. But my brother has epilepsy. I have seen the effect of the seizures, even with his medication. He has not had to deal with a drug shortage. I cannot imagine the impact on his daily life, and on my parents, if my family no longer had access to the medications he needs. That is so difficult to live with.

A government has a responsibility to act. We cannot just sweep this into the provinces' backyards, as the Conservative government is doing constantly. We have to take action. We have to do more than simply trust the pharmaceutical industry.

Have I heard anything more ridiculous than that? Not often, but it does not matter. They say that they have established a voluntary disclosure protocol. Wonderful. What additional information have we had since the protocol was established? Not a lot.

It makes absolutely no sense to entrust the lives of millions of Canadians to the good will of the pharmaceutical industry. This is the time for action.

My colleague is proposing to put a stop to the industry's dilly-dallying in disclosing drug shortages. The minister has to stop blaming the provinces for her own inaction and to shoulder her responsibilities for once. The voluntary disclosure protocol that the Conservatives have put in place does not require manufacturers to provide accurate information in a timely manner. They can provide information whenever they choose. No one has been identified to guarantee compliance with the protocol. Therefore we have to wonder what is the use of the protocol, other than providing more paperwork. For a government that does not like red tape, there seems to be a lot of it in their various initiatives, but unfortunately with no concrete results.

The first step in managing a problem like drug shortages would be to show some transparency, so that everyone concerned has a true picture of the situation. That is what my colleague's bill proposes and I congratulate her for her initiative.

Canadians need to have all the necessary information on drug shortages. We strongly believe that the public needs and has a right to all this information. Health care experts also have a right to that information. Pharmacists have a right to have the information as well, because they have to advise their customers. Some patients would like to have generic drugs and some would prefer something else. Pharmacists need to have up-to-date information to be able to advise the people who come to them with a real need.

We could look at what is being done elsewhere. In the United States, New Zealand and the European Union, they have all developed a mandatory disclosure system and have proven that system regulation can be a good thing. France did the same thing in the 1990s, and they have experienced fewer shortages than other western countries since that protocol took effect.

The Association des pharmaciens des établissements de santé du Québec, the Canadian Medical Association and the Cancer Society are all important health care agencies that have expressed their support for my colleague's Bill C-523.

I hope that all members of the House, regardless of their party, will support it as well.

[François Pilon, NDP, Laval—Les Îles, QC]

Mr. Speaker, I want to thank you for allowing me to speak to Bill C-523, An Act to amend the Department of Health Act (disclosure of drug shortages). Before I begin, I want to thank and congratulate my colleague from Saint-Bruno—Saint-Hubert for her hard work and her excellent bill.

This bill 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. It also obliges the minister to prepare and implement an emergency response plan to address shortages of drugs.

Drug shortages in Canada are a major public health problem and the federal government has a role to play in this. The drug shortage phenomenon is nothing new. This has been a recurring problem since the 1970s and there have been successive shortages under Liberal and Conservative governments without either taking action to solve this problem. Nonetheless, it is important to note that these shortages have increased in number and duration over the past few years.

The crisis in 2012, caused by the temporary shutdown of the Sandoz plant, one of the largest manufacturers of injectable drugs for hospitals, clearly showed the scale of this issue. The NDP actually used an opposition day at the time, March 14, 2012, and secured unanimous passage of a motion to resolve the issue. However, as on so many occasions before and since with this government, we have seen a lack of leadership and of will.

Just as with rail safety, air safety, the oil industry and the environment, this government has once again asked industry to regulate itself. We need only mention the many oil pipeline spills, the many railway accidents and the tainted meat scandal to demonstrate the ineffectiveness of industry self-regulation.

In fact, the only effective aspect of industry self-regulation is the effectiveness with which former Conservative members of Parliament have obtained jobs in sectors for which the Conservative government is promoting self-regulation. That could be the topic of another debate all by itself.

Let us return to the subject of the bill, drug shortages. Another reason why it is absolutely necessary to have legislation in this area, possibly the most important reason of all, is the safety of patients.

Drug shortages put patients at risk; they also require doctors, pharmacists and nurses to do extra work and ultimately lead to additional costs for all of us.

According to a survey by the Canadian Pharmacists Association, 91% of pharmacists stated that patients have been affected by drug shortages, either because of delays in treatment or because treatment was stopped, or because of the extra cost to purchase medication, extended hospital stays, procedures being delayed or cancelled, or because the original condition worsened.

In some cases, the impact may be minimal overall. However, in a number of cases, shortages can be catastrophic because the cost associated with medication can skyrocket and become too expensive for individuals who need to be on the drug.

Take a concrete case like epilepsy, where stopping medication sometimes has disastrous consequences. When someone stops taking antiepileptics or the medication is or must be changed suddenly, recurrent seizures can become more serious and longer than before. Prolonged attacks that last more than five minutes require emergency medical care and can even be fatal.

How does that tie in to the debate? Between 2009 and 2012, we experienced shortages of at least five different antiepileptic drugs. Some of them were made by a single pharmaceutical company.

These shortages have forced some people to use a different preparation, if available, or to switch medications without any transition, thus putting at risk the lives of all these people.

A government must protect its citizens. What did the government do? Once again, it shirked its responsibilities and blamed the provinces, its second favourite target after the official opposition. Indeed, the government said that, in its opinion, the provinces were responsible for changing their procurement policies.

However, that is not the opinion of the Quebec Minister of Health, Dr. Réjean Hébert, who unequivocally said the following, in the May 10, 2013, edition of L'actualité:

It is also Health Canada's responsibility to manage drug shortages. If the federal government was doing a better job, there would be fewer drug shortages.

It is high time that the federal government take responsibility. It can do so by voting for the bill we are debating today.

First and foremost, we are asking the government to adopt a system for the mandatory disclosure of drug shortages, as called for by the vast majority of patient and health professional groups. Canadians and their health professionals are entitled to have access to information that is crucial for public health.

That system is used in the United States, the European Union and New Zealand. France also adopted a system in the early 1990s and saw a significant drop in the number of shortages.

We are also urging the government to stop being so confrontational with the provinces and territories. We are asking it to work with them and with stakeholders to find a solution that will decrease the number of shortages and reduce their impact on patients and on our health care system.

According to statistics from the Régie de l'assurance maladie du Québec, the number of drug shortages rose from 33 in 2006 to 207 in 2010. That is unacceptable, dangerous and outrageous. It must be fixed right away. That is why we are asking everyone in the House to support the bill that was introduced by the hon. member for Saint-Bruno—Saint-Hubert.

I would like to conclude with a message for Canadians. The NDP believes that the health of Canadians is more important than profits for pharmaceutical companies. With this bill, we are taking the appropriate steps to ensure that Canadians will have access to the drugs they need, when they need them.

When it comes time to vote on this bill, we hope that the Conservative government, for once, will also put the interests of Canadians ahead of those of pharmaceutical companies.

[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.

[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.

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.

[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.