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

[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.

[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.

[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.

[The Acting Speaker, Conservative, Bruce Stanton]

Before I recognize the hon. member for Honoré-Mercier, I must inform her that I will have to interrupt her at 6:57 p.m. to allow time for the right of reply. The normal time for a speech is 10 minutes, but in this case, she will have about 7 minutes.

The hon. member for Honoré-Mercier.

[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.

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

Mr. Speaker, I would like to remind members that drug shortages are a major public health problem in which the federal government has a role to play.

This bill would give Canadians access to the same information that Europeans and Americans already have in terms of care. Drug shortages put patients at risk. They create more work for doctors, pharmacists and nurses in our healthcare system, and result in additional costs.

We need to switch to solution mode. In a letter to the industry, the Minister of Health has asked the industry to regulate itself. A new website is also available for voluntary reporting. These initiatives do not really help with planning, however, since the information is not always updated during a shortage.

Professor Jean-François Bussières looked at the drug shortages reported on the vendredipm.ca website—these are shortages from the Sigma purchasing group, which makes mandatory reporting of shortages part of its supply contracts. His study showed that 20% of all drug shortages reported on vendredipm.ca are not reported on the government's drug shortages website. This is ironic.

Having the industry require its suppliers to disclose any supply shortage to protect its production capacity seems normal to the Conservative government. It does not seem so keen to apply the same logic to pharmaceutical companies by requiring them to disclose drug shortages.

The minister spoke during the first part of the debate on my bill and said that it did not amend the right law. I would like to say something. The health of Canadians is more important to me than pharmaceutical companies' profits. It is the Minister of Health's responsibility to guarantee that Canadians have access to drugs at all times. Unless I am mistaken, the Department of Health Act, which I seek to amend, sets out the minister's prerogatives. That is why I am asking the minister to coordinate efforts to prevent any drug shortage, remedy it and develop and implement more emergency measures to address these shortages.

The federal government, which is content to deregulate a number of public safety measures, claims that the voluntary approach in this area is working. However, the facts tell another story. Drug shortages are not reported within a reasonable amount of time to allow for a transition period. The Conservatives pushed with all their might for a voluntary approach that has not worked in a number of sectors. The penuriesdemedicament.ca website and the protocol for the notification and communication of drug shortages include many aspects of my bill, including the disclosure of drug shortages, but not the legal obligation to do so.

There is a reason why a number of groups of health professionals, including the Ordre des pharmaciens du Québec, the College of Family Physicians of Canada and the Canadian Federation of Nurses Unions, are calling for this mandatory approach. We are behind here in Canada, because the United States and Europe, our largest economic partners, have already passed similar bills.

In closing, I call on the Conservative government to accept its responsibility to protect public health and to pass my bill concerning the disclosure of drug shortages.

I urge my Conservative colleagues not to vote against common sense.

[The Acting Speaker, Conservative, Bruce Stanton]

The question is on the motion. Is it the pleasure of the House to adopt the motion?

[Some hon. members]

Agreed.

No.

[The Acting Speaker, Conservative, Bruce Stanton]

All those in favour of the motion will please say yea.

[Some hon. members]

Yea.

[The Acting Speaker, Conservative, Bruce Stanton]

All those opposed will please say nay.

[Some hon. members]

Nay.

[The Acting Speaker, Conservative, Bruce Stanton]

In my opinion, the nays have it.

And five or more members having risen:

Pursuant to Standing Order 93, a recorded division stands deferred until Wednesday, February 12, 2014, immediately before the time provided for private members' business.