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House of Commons Hansard #94 of the 41st Parliament, 1st Session. (The original version is on Parliament's site.) The word of the day was drugs.

Topics

The House resumed from March 9 consideration of the motion in relation to the amendments made by the Senate to Bill C-10, An Act to enact the Justice for Victims of Terrorism Act and to amend the State Immunity Act, the Criminal Code, the Controlled Drugs and Substances Act, the Corrections and Conditional Release Act, the Youth Criminal Justice Act, the Immigration and Refugee Protection Act and other Acts.

Safe Streets and Communities ActGovernment Orders

3:05 p.m.

Conservative

The Speaker Conservative Andrew Scheer

The House will now proceed to the taking of the deferred recorded division on the amendment to the motion in relation to the Senate amendments to Bill C-10.

(The House divided on the amendment, which was negatived on the following division:)

Vote #155

Safe Streets and Communities ActGovernment Orders

3:10 p.m.

Conservative

The Speaker Conservative Andrew Scheer

I declare the amendment defeated.

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

Safe Streets and Communities ActGovernment Orders

3:15 p.m.

Some hon. members

Agreed.

No.

Safe Streets and Communities ActGovernment Orders

3:15 p.m.

Conservative

The Speaker Conservative Andrew Scheer

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

Safe Streets and Communities ActGovernment Orders

3:15 p.m.

Some hon. members

Yea.

Safe Streets and Communities ActGovernment Orders

3:15 p.m.

Conservative

The Speaker Conservative Andrew Scheer

All those opposed will please say nay.

Safe Streets and Communities ActGovernment Orders

3:15 p.m.

Some hon. members

Nay.

Safe Streets and Communities ActGovernment Orders

3:15 p.m.

Conservative

The Speaker Conservative Andrew Scheer

In my opinion, the yeas have it.

And five or more members having risen:

(The House divided on the motion, which was agreed to on the following division:)

Vote #156

Safe Streets and Communities ActGovernment Orders

3:20 p.m.

Conservative

The Speaker Conservative Andrew Scheer

I declare the motion carried.

Drug ShortagesEmergency DebateGovernment Orders

March 12th, 2012 / 3:25 p.m.

Conservative

The Speaker Conservative Andrew Scheer

The House will now proceed to the consideration of a motion to adjourn the House for the purpose of discussing a specific and important matter requiring urgent consideration, namely drug shortages.

Drug ShortagesEmergency DebateGovernment Orders

3:25 p.m.

NDP

Libby Davies NDP Vancouver East, BC

moved:

That the House do now adjourn.

Mr. Speaker, first of all, I would like to say that I will be sharing my time this evening with the hon. member for Beauharnois—Salaberry.

I would like to thank you, Mr. Speaker, for agreeing to my request to have an emergency debate on this very critical issue of drug shortages in Canada. I made the request on Friday and I am very glad that the House has an opportunity to discuss this very critical issue. Being in our ridings and our home communities over the weekend, I have no doubt that many members of Parliament probably heard from constituents how concerned they are about this escalating drug shortage in Canada.

We know that this shortage has been ongoing for a period of time, but in the last month or so it has become something that is now approaching a critical nature because of the closure of the Sandoz plant. We are also aware that this shortage is projected to last 12 to 18 months. Across the country many regions have had to change their prescription strategies to use replacements, often without experience about how they work, and to limit elective surgeries. As we gather information across the country and from ongoing news reports, we know now that pretty well every province and region is affected.

We need to put on the record that this shortage is having the most serious impact on patients in intensive care units and those who are dying and in need of pain management. We know that hospitals in Quebec are cancelling elective surgery and that hospitals in Ottawa are saying that they will probably have to do so in the next few weeks if their drug supplies are further depleted. We also know that in Alberta, Manitoba and B.C., they are also suggesting that they will have to do the same if the situation continues.

Although I am not a health expert, certainly from all of the information that we have before us, we know that injectable opiates are the main method of pain control for surgery, post-operative care and any hospital admission. With the hospitals running low on these drugs, they are now being forced to cancel elective surgeries and to save the medications for severely ill patients and those who need serious pain management.

We know, for example, that for patients in Alberta who are undergoing chemotherapy they are now being asked to buy their own anti-nausea drugs because the hospitals can no longer provide extra supplies. These drugs are very expensive. They can cost up to $13 a pill and it is good to know that the Province of Alberta has said it would reimburse the cost, but still it puts patients at a great hardship and disadvantage.

Right across the country there are stakeholders, health care interests, who are speaking out and I would like to read into the record some of what is being said about this crisis. For example, Dr. Rick Chisholm, president of the Canadian Anesthesiologists' Society, has been calling on the federal government to develop a national strategy to “anticipate, identify and manage shortages” of essential drugs.

We know that the Ontario Health Minister, Deb Matthews, has said that Ontario did not get any advance notice about the shortages. In fact, she pointed out that the provinces have no way of knowing when a supply is short because the federal government does not require drug companies to report gaps in supply.

We know that the Alberta Health Minister, Mr. Horne, has said that “We're not going to stand by and simply wait to hear from Sandoz”, the company that shut down, “or the federal government”.

We hear from a specialist nurse manager in Vancouver who specializes in pain management, who says that she cannot understand how the federal government has allowed the supply of all injectable opiates to be threatened.

The Cancer Control Society has pointed out that Health Canada is the regulator of drugs. It approves and certifies drugs for sale and monitors safety and regulates the way drug companies operate. It also points out that other countries have taken much more action to protect patients, including mandatory reporting and inquiries to address the root causes. It calls for a plan that must focus on the needs of patients.

We also know that the Canadian Medical Association did a survey more than a year ago where 74% of doctors surveyed said that they had encountered shortages of generic drugs, most commonly antibiotics.

We also know, and this is very concerning, that the Canadian Pain Society has reported that it is seeing an increase in people who are feeling suicidal because they are so worried about the lack of medication that they depend on every day. We are facing an incredibly serious situation.

There have been many reports over the years from the Canadian Pharmacists Association. The pharmacists have been sounding the alarm on this issue for a very long time and there have been media reports. Yet the response we have seem from the federal government has been, at best, completely inadequate and in fact really quite pathetic.

What has the federal government done? Well, it set up a voluntary reporting system. As we have heard from some of the provincial health ministers, setting up a voluntary system does nothing to require these companies to report information when they know they are going to have a shortage.

I think it is very interesting that in the United States, by contrast, in October 2011, President Obama issued an executive order directing the FDA to require drug manufacturers to provide adequate notice. In fact, there is currently legislation in the American Congress to require, not just ask, all companies to give six months' advance notice of potential shortages, punishable by civil fines for non-compliance that could reach $1.8 million under the proposed bill.

We can see that this problem is very widespread. It does not just involve Canada, but other countries have taken much more serious note of what is happening and are being proactive in intervening and ensuring that patients are not suffering.

It is very sad and disturbing, unfortunately, to see that the federal government and Health Canada have not taken such action in Canada. Therefore, I think it is very important to have this debate to hear the perspectives of different parties on the nature of the crisis and what we believe should be done.

I would suggest that the first issue we need to focus on is the need for Health Canada and the federal government to become much more involved in this issue. A voluntary committee is just not going to cut it. We know that provincial health ministers are now having daily calls to try to sort out this mess and the very real threat they face in deciding what to do in their individual jurisdictions and with the hospitals that depend on these now unavailable drugs.

I think it is imperative that Health Canada and the federal government acknowledge that they have not been proactive on this issue. Calling for voluntary measures to set up a website has not done anything to mitigate the crisis now before us. They need to take much stronger action.

We believe that there should be a review, an inquiry, about why these shortages exist and that we should put in place a mandatory reporting system. This is being done in other countries and is working for them. I think there needs to be a much better explanation from the drug companies about the problems they may encounter and if there are other factors at play such as mergers or a focus on marketing more expensive drugs, which, in effect, diminish the supply of generic drugs. This is a major issue that requires investigation.

It is an important first step to have this debate tonight to investigate what is going on and to say to the federal government that more has to be done. All of the stakeholders in Canada, some of whom I mentioned tonight, are calling for strong leadership and action by the federal government.

I hope that as a result of this debate tonight and the focus on this issue, we will see action and not see the health minister basically blame everyone else and in saying, oh well, it is the drug companies, it is the provinces, it is the territories and it is their problem. This is all of our problem; this is something that requires our attention.

We need to focus on the needs of patients. We need to make sure that people are not left in dire circumstances without proper pain management or the drugs they require because of a shortage that can be prevented and managed. We can put in place a plan that would work for people.

I look forward to the debate tonight and the various points of view that are offered.

Drug ShortagesEmergency DebateGovernment Orders

3:35 p.m.

Liberal

Bob Rae Liberal Toronto Centre, ON

Mr. Speaker, I want to congratulate my friend from Vancouver East for moving the motion and encouraging us all to address this question. All of us have been very troubled by it and have been raising it as an issue. My colleague from Vancouver Centre will be participating in the debate. We are all very concerned about it.

I would like to ask the hon. member the following. I still did not hear in her speech what she thinks are the actual causes of this shortage. There is obviously a huge market for a variety of products being produced by a variety of companies.

Is it that the companies do not feel they are getting sufficient payment for those products? Is it that they feel they can make more money by selling other products? If that is the case, would the member tell us, apart from a task force, and here I think we all recognize that something is required to get the discussion going, what she would envisage as a solution to ensure that the drugs, the painkillers and the supplies required by hospitals and doctors, will in fact be provided by the companies in question?

Drug ShortagesEmergency DebateGovernment Orders

3:35 p.m.

NDP

Libby Davies NDP Vancouver East, BC

Mr. Speaker, 10 minutes goes by very fast. I was barely able to touch on that very important issue. I do think this is why we need to have proper inquiry.

A number of reports, some of them American, have come out and given us some information on why these shortages are taking place. I did try to illuminate some of the causes or reasons.

Some of the drug companies say it is a problem with getting some raw materials, and so the production side and actually assembling what is needed is a problem. I think that needs to be investigated.

I do think there is an issue, and I have certainly been reading about this, with the increasing number of mergers of these drug companies in recent years. That means there are now fewer companies that are producing. Certainly the issue of sole-source supply is also a cause of concern and something that needs to be investigated. We saw this issue with the H1N1 vaccine when the federal government was scrambling to find an adequate supply.

There is also an issue, and there have been many queries and concerns about this, that this is so reliant on the marketplace. To me, this is in the public interest and it is imperative that the federal government intervene. When we leave it to market production and see mergers and issues with generic brands possibly being decreased in favour of more profitable brands, this is not serving the needs of patients.

These are all factors that contribute to the shortage that we are seeing and that need to be investigated with a proper reporting mechanism and a proper inquiry.

Drug ShortagesEmergency DebateGovernment Orders

3:35 p.m.

NDP

Pierre Nantel NDP Longueuil—Pierre-Boucher, QC

Mr. Speaker, I would like to congratulate my colleague on her speech.

She talked about the infamous H1N1 epidemic that the government had to place an emergency order for. This issue is especially important to me because the Sandoz plant is in my riding. Many of my friends and neighbours work at the plant, and I have met a lot of people who work there too. These people are feeling a lot of pressure from the whole country. I am talking about individuals, not the company. These people are under enormous pressure.

As a Canadian, I was astounded to find out that a single company was providing nearly 100% of certain drugs, narcotics, and 90% of injectable drugs. I cannot believe that a single provider has been allowed to have a monopoly on something so crucial. I would like my colleague to comment on that.

Drug ShortagesEmergency DebateGovernment Orders

3:35 p.m.

NDP

Libby Davies NDP Vancouver East, BC

Mr. Speaker, I think the issue at Sandoz, as my colleague has outlined, is something that has really made the situation very serious, but it is part of an overall shortage.

The whole issue of sole-source suppliers is something that does require a very thorough investigation. We do know that Canadian hospitals relied 100% on this one company for their injectable opiates, for examples, and they were not given adequate warning. In fact, we know that this company was initially warned by the U.S. Food and Drug Administration that they had to make upgrades, and yet this information was not properly communicated.

It does raise the question, just as we saw with the H1N1 vaccine, that the federal government as a major player has to be involved to ensure that these kinds of developments can be prevented. We could have prevented this. I am sure that the people at the plant want to get back to work and do the job they know needs to be done. However, if there is no system in place and no involvement by the federal government, then we have a disaster on our hands.

Drug ShortagesEmergency DebateGovernment Orders

3:40 p.m.

NDP

Anne Minh-Thu Quach NDP Beauharnois—Salaberry, QC

Mr. Speaker, I thank my hon. colleague from Vancouver East for taking the initiative with this evening's emergency debate on the drug shortage that Quebec is experiencing right now and that could affect the rest of Canada. As I rise here this evening to speak to this crucial issue, thousands of patients are wondering if their surgeries will go ahead as planned or if they will receive their cancer treatments.

Last week, dozens of surgeries in the Outaouais alone had to be postponed. At this time, Quebec hospitals are doing an inventory of their essential drugs in order to plan for possible shortages, and pharmacists are following the situation across Canada hour by hour. On voluntary disclosure websites that track drug availability, the list of drug shortages is now six pages long: pravastatin, fluconazole, dobutamine, feproz, amoxicillin and methotrexate, a drug used to treat leukemia that has been in short supply since last fall.

A number of health experts consider the current situation to be critical, but let us not forget, the current crisis is just the tip of the iceberg. Drug shortages have become more frequent over the past few years; since 2008, in fact. There are a number of reasons for this. There is the global shortage of molecules for producing drugs and the production shutdowns at certain companies for technical reasons or because of problems meeting quality and safety standards.

The situation at Sandoz in Boucherville, Quebec, falls into the last category. It was the United States Food and Drug Administration that criticized that pharmaceutical company's drug production methods, saying that the company did not satisfy American safety rules. The most troubling thing about this case is that the company knew for months that it had to make changes. The correspondence between the American agency and the company goes back to last November. Inspections were done in the summer of 2011. It was not until February 2012 that the information on the drug shortage at Sandoz was made public. Why did the company fail to inform the provincial and federal health authorities sooner? Did Health Canada know that the company was going to slow down production?

Obviously, the fire in the plant's roof did not help matters, but it is completely unacceptable that the governments, pharmacists, doctors and patients learned about the shortage at Sandoz so late in the game.

Let us not forget that Health Canada has a responsibility to ensure that the products offered on the Canadian market meet rigorous safety, effectiveness and quality standards. It is also the responsibility of the federal government to ensure that Canadians receive the health care they need. What is Health Canada doing to resolve the shortage problem? Not much for now. The federal government should show some leadership and work with the provinces to come up with a plan for the long term.

Currently, there are two websites for the voluntary disclosure of information about shortages. Pharmaceutical companies can use them to publish the names of their drugs for which production has slowed down or stopped. Unfortunately, the system is not reliable because there is also a shortage of information. Not all pharmaceutical companies contribute to updating the sites, and some refuse to disclose certain pieces of information.

Many stakeholders in the health care field are calling for better monitoring. Ontario's health minister, Deb Matthews, believes that there should be a mandatory drug information system. The Quebec order of pharmacists is calling for the same thing. The spokesperson for the Canadian Pharmacists Association, Jeff Morrison, called the existing system frustrating because it is up to drug companies to decide what information to share with the public. Today, the Canadian Cancer Society called on the federal government to fix the problem and released the following statement:

The Canadian Cancer Society believes that cancer patients must have access to high-quality, timely care no matter where they live in Canada. We are concerned and disheartened about reported drug shortages in Canada, including cancer drugs. For patients who are already going through a difficult time, not having access to appropriate drugs can be stressful and trying.

While the Society applauds the efforts being made by hospitals, doctors and pharmacists in dealing with this issue, we believe a national coordinated approach is needed to find effective solutions. Other countries have taken a more pro-active approach to drug shortages. The Society urges the Federal Minister of Health to provide leadership to address this critical healthcare issue...

When will the federal government take responsibility?

Ottawa cannot simply say that the supply issue falls under provincial jurisdiction, as we have been hearing for the past four or five days. Health Canada must work with the provinces and with the industry to find concrete solutions, particularly since this is a worldwide crisis and since closer co-operation with other regulatory bodies is vital to finding a sustainable solution right away.

But what is this government doing? It is in panic mode and so it finds a hasty solution by importing the injectable drugs that cannot currently be obtained on the Canadian market. This is a temporary and short-term solution that does nothing to resolve the problem in the long term. We must get to the root of the problem. One of the major causes of the drug shortage is the way the supply system operates in Canada. We should explain that bulk buying groups purchase drugs on behalf of hospitals. Clearly, buying in bulk reduces costs, which is a great benefit; however, the adverse effect of this way of doing things is that it considerably reduces the number of suppliers, as is the case with Sandoz in Quebec.

The drug shortage shows what can happen when we leave the market unsupervised and unregulated. Drugs are essential products upon which millions of Canadians depend. They are different from other goods. Dr. Peter Ellis, an oncologist at the Juravinski Hospital and Cancer Centre in Hamilton, believes that Health Canada must play a bigger role in this area. In his opinion, the only way to prevent future shortages is to better regulate the industry. This opinion is shared by SigmaSanté, the buying group that represents health institutions in the Montreal and Laval region.

While we wait for this government to finally realize that it is time to act, here are a few suggestions that may inspire the Minister of Health.

First, Health Canada could make a list of essential generic drugs. Before approving them, the department could require the pharmaceutical companies that produce the new versions of these drugs to commit to supplying them for five years.

Second, the federal government could ask companies for at least six months' notice—something like what is done in the United States—before they stop producing these drugs.

Third, Health Canada should always have a plan B because accidents can happen anywhere. A fire, contamination, a power outage—any of these things could have an effect on drug production.

Fourth, a government enterprise could also produce essential drugs to ensure a safe and continuous supply, as is currently done in Sweden.

The best solution is to enforce the regulations on an ongoing basis. We might wonder whether Health Canada has the means to do so. Need I remind the government that, last fall, the Auditor General sounded the alarm with regard to the drug verification process? He said:

The Department does not take timely action in its regulatory activities...In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information.

If problems were identified sooner, as they arose, then catastrophe could be averted and the problems addressed gradually. It is high time for Health Canada to take action. It is the federal government's responsibility to work with the provinces and with the industry to find solutions to the drug shortages.

I hope we will be able to reach conclusions and learn lessons from this crisis because this is about Canadians' health—the health of all patients who need drugs for their well-being.

I hope that the Conservatives opposite will follow suit and find solutions that are more sustainable than importing drugs from other countries. I hope that they will introduce more effective monitoring to ensure a sustainable, long-term plan so that people can get the care they need.

Drug ShortagesEmergency DebateGovernment Orders

3:50 p.m.

Conservative

Ron Cannan Conservative Kelowna—Lake Country, BC

Mr. Speaker, I would like to thank my hon. colleague across the way for her insightful comments this evening on a very important issue for all Canadians from coast to coast to coast.

I was advised of this issue last month. My daughter's fiancé is a pharmacist. The head pharmacist for the Interior Health Authority contacted my office. I immediately did some investigating. I realized that there was only one supplier in Canada for morphine and other drugs that are vital for surgeries across Canada. The more I investigated, the more I realized that it is the province's jurisdiction and it did not have a plan B. I was very surprised, just like all of us here. It is important that we all work together, take the high road and do not blame anybody. There is an issue within our Constitution that each province and territory is responsible for providing the necessary medication.

I would ask my hon. colleague this. In the future, as we move forward in finding a solution, does she think that the provinces, out of due diligence, should not go to a single-source supplier and allow for a plan B?

Drug ShortagesEmergency DebateGovernment Orders

3:50 p.m.

NDP

Anne Minh-Thu Quach NDP Beauharnois—Salaberry, QC

Mr. Speaker, I would like to thank the member opposite for his question about this issue, but I think that it is up to the federal government to ensure that all provinces have access to many kinds of drugs so that patients can get appropriate treatment.

When there is only one supplier, obviously a small technical glitch can quickly cause problems. It is up to the federal government to ensure compliance with regulations and effective monitoring so that we can identify places where there is a production slowdown or drug safety issue. The government would then be able to prevent this kind of catastrophe and shortage by working with the provinces. The government will not solve the problem by pointing at the provinces and saying that it is up to them to make sure they have the resources. Everyone will have to work together and work hard to find long-term solutions.

Drug ShortagesEmergency DebateGovernment Orders

3:50 p.m.

Liberal

Ted Hsu Liberal Kingston and the Islands, ON

Mr. Speaker, I would like to follow up on the question from the hon. member on the government side. It surprises me that in the drug market, where Canada imports most of its drugs from overseas, foreign regulations such as those of the United States Food and Drug Administration can affect production in Canada and in Quebec, which affects the supply of drugs in Ontario.

When the effects are all mixed up between Canada and foreign countries, and what happens in one province can affect another province, I find it amazing that we would leave the provinces to fend for themselves in a situation where it is clearly an international problem. With production in Asia and Europe, and raw materials coming from different places, and regulations in different countries affecting other countries, why should we leave this to the provinces to fend for themselves? Should the federal government not be making contacts with other countries, bringing this up in global health organizations, working with other countries, and using Canada's great reputation to lead the world in finding long-term solutions to this global problem?

Drug ShortagesEmergency DebateGovernment Orders

3:50 p.m.

NDP

Anne Minh-Thu Quach NDP Beauharnois—Salaberry, QC

Mr. Speaker, I thank my Liberal colleague for the question.

Indeed, the Government of Canada needs to show some leadership on this issue. This is not the first time Canada has experienced drug shortages. In Quebec alone, from January to June 2011, over 100 drugs were in short supply. This is a recurring problem that comes up every year.

The Conservative government has had the opportunity to deal with these situations. It could have—and still can—come up with lasting solutions. First of all, monitoring is not being done quickly enough right now. We heard from a number of health experts last Monday who told us that we need to act continuously along the way, and not wait for a crisis. Once a crisis hits, it is already too late. We absolutely must stay ahead of the curve and ensure that regular verifications are done. We also need a system that expands the number of suppliers. That could even be regulated. We have many options. In Sweden, the government has a public institution that supplies 2% of all drugs. That could ensure a consistent quantity of drugs on the market.

Drug ShortagesEmergency DebateGovernment Orders

3:55 p.m.

Nunavut Nunavut

Conservative

Leona Aglukkaq ConservativeMinister of Health and Minister of the Canadian Northern Economic Development Agency

Mr. Speaker, I rise before the House today to address a subject that is important to the health and well-being of Canadians. We know our health care system relies on a safe, secure and reliable supply chain for medicinal drugs and our country's doctors need to know that when they write prescriptions for patients or make requests for drugs to be available during surgery, that they will be there.

Health Canada is our country's regulator with regard to the safety, quality and effectiveness of the drugs available in Canada, but it is up to industry to produce drugs and it is up to the customers purchasing those drugs to ensure their suppliers will be able to fill their requests. That is the system we have created in conjunction with the provincial and territorial governments. Those are important facts that should not and cannot be lost in this debate. The circumstances that have led to the current situation have raised several red flags with regard to how some provinces have chosen to source their medicinal drugs. Unfortunately, the situation is more difficult than it might have been if Sandoz Canada had taken the steps we expect a drug manufacturer to take in these kinds of circumstances.

Last November, four months ago, Sandoz was notified by the U.S. FDA of concerns about production quality standards related to one product at its Boucherville plant and that product was not even produced for the Canadian market. Similar FDA findings were made about two Sandoz plants in the United States. It is important to note that at no time did the FDA find that the production issues were of such gravity to require Sandoz to cease production at any of these facilities. At no time before mid-February was notice given to anyone, neither Health Canada nor the country's customers, that this issue with just one product line at Boucherville would have such major supply consequences for all Canadians.

Following up on the FDA findings, my department inspected the plant and found it to be compliant with our rules for safe, quality production. My officials held discussions with the company about how it planned to address the FDA findings, but the size and scope of the company's production cutbacks was never revealed. That is, until February 15, when Sandoz simultaneously informed Health Canada and its customers that it was significantly cutting the output of medically necessary products from the plant. When the company was asked what alternate sources of supply it had secured to make up for the shortfall for its customers, it said that it was just starting to do that.

Sandoz made a decision to temporarily stop production of some products without first finding alternate sources for its customers who needed these drugs. Technically, its customers may be provincial or territorial governments and health authorities. It is the provincial and territorial governments that are responsible for the delivery of health care. They are the ones that deliver to Canadians in need of medical treatment. Ordinary people who are sick or in pain are the consumers and they are vulnerable. Sandoz has a responsibility to see that its customers are informed of anticipated shortages as soon as it becomes aware of the potential problems so Canadians are not left without an essential supply of its products.

Since December, there have been two public websites up and running that Sandoz could have used to post warnings of these anticipated shortages. It did not post that information until it was urged to do so by my officials at Health Canada. In a letter sent to Sandoz 10 days ago, I made it clear that I was disappointed with its lack of transparency and its failure to secure an alternate supply of drugs for which production was being interrupted. Hospitals and clinics, bulk drug purchasers, provincial and territorial governments and Health Canada have had to poke and prod Sandoz at every turn. Supply pledges made by this company have frequently not been met by distributors. Sandoz has promised to provide updated supply information to health professionals, but their worried calls to my department for help indicate that either the information or the supply, or both, are not getting through.

On Sunday, March 4, Health Canada became aware of a fire at the Boucherville plant through media reports. My department officials also received an email from Sandoz on March 4 confirming the facts. My officials urged Sandoz to go public with information about the fire, especially with their customers, again, the provinces and the territories.

When it became clear that information was not forthcoming, my officials advised the provinces and the territories of the fire, at noon on March 6. At the urging of my department, and only after we had advised the provinces, Sandoz finally issued a press release March 6. Only then did it publicly concede that the fire had forced a suspension of all production at the plant for at least a week. It took the company almost three weeks after the February 15 notification to deliver submissions for alternate supplies to my department in order that they be assessed for safety and effectiveness.

Sandoz is now scrambling to come up with a plan to solve the problem that interrupted production and created that shortage. Sandoz is also working to find alternative suppliers to make up for the shortfall from its production line.

I want to assure members of the House that our government is doing everything within its power to help minimize the impact of the shortage on hospitals and patients. We have been working around the clock to provide support to the provinces and the territories as they manage their drug supplies for their jurisdictions.

As I have mentioned, the current situation has highlighted the fact that there is over-dependence on the part of the provinces and the territories on a single supplier for essential drugs. The provinces and the territories cherish their independence when it comes to choosing suppliers. Provincial and territorial health authorities have set up bulk buying groups to purchase medically necessary drugs for patients. These groups sign supply contracts with drug makers. They determine who their supplier is, how many suppliers they need and establish penalties for non-delivery. In short, they are the ones that enter into contracts with industry. If they decide to enter into a contract with a sole provider, it would be beneficial to also have a backup plan.

There is ample evidence of more frequent drug shortages, but we have not seen a parallel increase in the sharing of shortage information or advanced planning on the part of drug purchasers or suppliers. Purchasers express surprise and frustration at shortages that have appeared to come out of the blue, but rather than seeking multiple sources as a cushion against supply interruptions, we have seen a great reliance by them on fewer suppliers. Producers do not appear to have done any real work to identify alternate sources in advance, even though they are fully aware of the global supply constraints.

While we respect their independence, we would advise against creating a supply chain that is reliant on just one supplier. Our advice has been, and continues to be, that provincial and territorial governments not become overreliant on one source of medicinal drugs.

What role does our government play? We are assisting the provinces and the territories by identifying approved Canadian suppliers for drugs if their current source should be unable to fill a request. When asked, we are fast-tracking approvals of products, including those produced abroad, without compromising our higher standards of safety. We are ensuring that all of the important players are in contact with one another and that they have the latest information about potential or current shortages.

We have also been working with companies and health stakeholders to increase the amount of information available to Canadians on potential and actual shortages. In fact, I initiated this last summer when I wrote to industry with a request to find an efficient way to inform those purchasing drugs of potential or upcoming shortages. In these situations there is no substitute for advance information to allow doctors and patients to adjust treatment.

To date, industry has started to respond and we have had some success on this front. Two websites are now being used to post such information. Industry and professional health care associations also need to do their part and continue to work on information sharing and ensuring they create stability in their supply chains to prevent drug shortages from occurring. When supplies are interrupted, hospitals, clinics and health professionals implement strategies to ensure the most efficient use of existing supplies and to minimize impact on patients. They keep patients advised of the supply situation in each facility and community and adjust treatment schedules and procedures, if needed.

Our approach on this has been to strongly encourage industry to be more open with information about shortages. If industry fails on this front, we will consider regulations that would require drug manufacturers and suppliers to provide information about potential shortages in a timely manner. Sandoz has committed to posting information for health professionals on current and potential drug shortages on its website, on the University of Saskatchewan Drug Information Services site and an equivalent French-language site. We expect Sandoz to keep providing information on what products may be in short supply. The timeliness and completeness of the information Sandoz provides will be closely monitored to determine if changes need to be made in the future to ensure Canadians have access to the information they need.

I have advised Sandoz that providing timely, accurate and comprehensive updates on the supply situation to its provincial and territorial customers is key and anything less is unacceptable. I was encouraged to hear about the letter that Sandoz sent out today in response to my letter to it, saying that it would respond to our call for transparency and sharing of details about drug shortages in the future a full 90 days in advance. I only wish there had been 90 days notice in this instance before the company had made changes to its level of production. I will choose to take Sandoz as its word, but will re-emphasize that millions of Canadians will be watching closely to see if it follows through. For information on any actual potential local impacts, we encourage Canadians to contact their local health care authorities or health care professionals. Health care professionals may wish to contact the company directly for more information.

As we work our way through the situation, the well-being of every patient and the health and safety of all Canadians will always be our priority if faced with an actual or potential drug shortage. Doctors, pharmacists and patients need enough advance notice from industry so treatment can be planned in accordance with the supply of medicines available.

My department is the driving force behind the posting of information on shortages by industry on the public website where Sandoz is now posting shortage information. This is an important first step in responding to my call for increased transparency on drug shortages, but I have also called on industry and health professional stakeholders to follow through on their pledge made in the fall of 2011 to create a national one-stop drug shortage monitoring and reporting system in 2012. The Sandoz situation has underlined the urgency of completing this work as soon as possible.

My department has a variety of tools available to help minimize the impact of any shortage. We will work to help maintain the supply of high-quality, safe and effective drugs by working closely with companies so they can quickly resolve any issues related to the manufacturing process, the quality of the products and any issue related to distribution. We are working with the manufacturers to ensure that any changes in the manufacturing process or location can be reviewed and authorized on a priority basis. That would also include any requests to supplement the supply from another manufacturer. We will be ensuring that all the necessary licensing requirements are met so there is always the assurance that drugs are safe and effective.

We are working with our international counterparts, such as the U.S. Food and Drug Administration, to identify additional sources of supply and to share information. We will also be making sure that the necessary information is available to the provinces and the territories for access to alternatives should there be an emergency. In other words, we will use all of the means at our disposal to help ease the impact of any shortage. Our response will be tailored to the situation as it arises.

Canadians can be assured that Health Canada is already fully engaged in our response to this situation, and we are equally ready to adapt our response as the situation evolves.

We also strongly encourage provincial and territorial health authorities to source drugs from multiple suppliers so that they are not vulnerable to production interruptions from a sole supplier.

It is also worth reminding members of the House that drug shortages are a worldwide preoccupation.

Members may recall the isotope shortage not so long ago. This is an example of how we had to collaborate with the provinces and the territories, as well as health care providers in order to find alternatives for imaging and tests that were much needed by cancer patients. There were a lot of positive lessons learned from that experience, and we are much better accustomed to finding alternatives.

Health professionals are equipped to recommend alternative drugs for patients when shortages do occur. Through our co-operative relationships with trusted regulators, such as the U.S. FDA and the European Medicines Agency with high safety standards like Canada, we have ready access to a wealth of information that will speed up our approval process for new sources.

We are expediting our authorization processes during the ongoing Sandoz shortage to help hospitals and doctors access alternative sources of safe supply. We will never compromise safety.

We have a team of experts assigned to deal with shortage requests. We are providing guidance to purchasers so that they have a clear understanding of the safety information we require when a new source of supply is found.

Overall, Health Canada's rules and regulations for authorizing drugs and manufacturing plants are designed to ensure that drugs sold in Canada are safe, effective and of high quality. Our safety standards are high because the health and safety of Canadians are what matter most.

Canadians deserve the maximum protection from drugs that are unsafe or do not work. We apply the same standards to all drugs, whether they are made in Canada or imported from another country.

Proof that a drug will improve the medical condition for which it is manufactured is required. We will authorize a drug only after we determine that the potential health benefits for patients outweigh the potential risk of using the drug.

We also require that drugs be packaged and distributed with information that will help doctors and patients make informed choices about their use. Drugs must be made by qualified, trained personnel and in a plant that is equipped to make and store the drugs according to the approved formula without contaminating it. A drug must also be tested for safety, effectiveness and quality before it leaves the plant, and it must be labelled correctly.

These are the standards to which we will adhere throughout any shortages, but working within the regulatory framework, we believe that we can help alleviate the shortages as they arise. We will help by sharing information between governments, health professionals and stakeholders. We will continue to work with manufacturers and stakeholders to share all relevant information on potential and actual shortages. Having a reliable source of information will give doctors and other health professionals the time and the opportunity to adapt according to the predicted supply disruptions.

When alternative supplies are identified, we will fast-track approval without compromising safety.

We will keep working with Sandoz to keep abreast of the production levels at the Boucherville plant so that we can interpret the impact any change might have on Canadians.

We will be making sure that all of the important players are in constant touch with one another and that they have the latest information about potential shortages.

There is nothing more important to this government than the health and well-being of Canadians. As we work our way through the current situation, we will also be looking to the future. We will be looking for ways to help the provinces and territories create a drug supply system that does not leave Canadians vulnerable because of changes on a single production line.

From now on drug suppliers and purchasers have to break with comfortable and profitable supply habits and assumptions. From now on we as a country cannot allow ourselves to remain in a position where the decisions of one drug maker can so seriously disrupt the entire health care system.

In fact, all of the players in our drug approval and supply system have to be sure that their thinking and planning is always with a goal that is in the best interests of the patients and their needs. Canadians deserve nothing less.

Drug ShortagesEmergency DebateGovernment Orders

4:15 p.m.

NDP

Libby Davies NDP Vancouver East, BC

Mr. Speaker, I thank the Minister of Health for being in the House tonight to participate in this very important debate. We certainly need to hear what the federal government is saying about this issue and what has happened over the last few months.

In listening to the minister's speech, I find it incredible that there is no recognition or acknowledgement that the lack of any plan has created this disaster. Does the minister believe that she and her government have properly served the needs of patients in responding to this crisis?

Will she acknowledge that these voluntary measures, the website and sending letters back and forth, simply have not worked? She has given a whole litany of complaints with the company. This is no small player. This is the federal government and the Minister of Health. Surely it raises the question that the lack of a proper reporting mechanism such as we see in other countries has contributed vastly to this crisis.

I would like her to respond to that and reflect on what has taken place over many months now. We were warned of these shortages a long time ago. I would like her to reflect on the so-called plan the government has which simply has not worked. Otherwise, we would not be having this debate tonight.