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

Drug Shortages
Emergency Debate
Government Orders

March 12th, 2012 / 6:30 p.m.

NDP

Laurin Liu Rivière-des-Mille-Îles, QC

Mr. Speaker, I will be sharing my time with the member for Marc-Aurèle-Fortin.

I am pleased to take part in this emergency debate on Canada's drug shortage. Our official opposition health critic requested this debate, and I thank her for her initiative. In my opinion, this debate is necessary because of the Conservative government's negligence and the fact that a shortage of generic injectable drugs poses a real threat to public health.

Despite the government's reassuring statements, for the past three weeks, hospitals in Quebec and Canada have been dealing with the most severe injectable drug shortage ever. This crisis came about because the entire Canadian system depends on a single supplier, the Sandoz plant in Boucherville, for 90% of its generic injectable drugs. Sandoz manufactures 235 products, including morphine, anticoagulants, antibiotics and cancer drugs. Sandoz products are essential for palliative and intensive care, as well as surgery.

People in Rivière-des-Mille-Îles and residents of the lower Laurentians are worried about the shortage. Many of them depend on services provided by the Hôpital de Saint-Eustache, which is in my riding. Fortunately, facilities in the Laurentians have not yet been affected, but we know that some Quebec hospitals are coping with a shortage of drugs that are essential to critical and intensive care.

The situation is very disturbing. For example, at the Hôpital Maisonneuve-Rosemont, drug reserves have dwindled to a five- to seven-day supply—half of what they should be. Last week, some 80 surgeries were cancelled in the Outaouais. In the GTA, elective surgeries have been postponed or cancelled. In Alberta, some chemotherapy patients now have to go to pharmacies to get their own anti-nausea medication because they cannot get it intravenously at the hospital. Their pills can cost up to $13 each. The shortage of injectable opiates will hit intensive and palliative care patients particularly hard because they cannot take drugs by mouth.

The health care community is very worried. Myriam Sabourin, spokeswoman for the Agence de la santé et des services sociaux des Laurentides, admitted that if this situation continues, it could become a real problem. Ontario's health minister, Deb Matthews, said that patient safety is at significant risk. HealthPRO Canada, Canada's largest group purchasing organization, which is responsible for purchasing drugs for 255 institutions outside Quebec, estimates that the shortage could last for one year.

While this situation is critical, the Conservative government is wasting time trying to lay blame. It has blamed the provinces, which often tend to use a single supplier for their drugs. Clearly, this government has reached the height of hypocrisy. How can it criticize the provinces for trying to save some money using group purchasing, especially since this government just announced its unilateral decision to cap the indexing of health transfers?

Unlike this government, which is dragging its feet, the health ministers of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario and Quebec are showing leadership and holding weekly conference calls to establish supply priorities.

Not content to blame the provinces alone, the government has also tried to point the finger at Sandoz. The Minister of Health said that she is very concerned about how Sandoz has managed the situation. We are also concerned about how Sandoz has managed it, just as we are concerned about the lack of transparency of other companies in the pharmaceutical industry. But unlike the Conservatives, who want to deregulate everything, we believe that tighter regulations are needed, including a mandatory production reporting system.

The Conservative government has also tried to explain its disorganization by claiming that it could not have anticipated that a fire that took place on March 4 at the Sandoz facilities would stop production for over a week. Yet production problems at Sandoz date back to before the March 4 fire.

On February 16, the pharmaceutical company sent a letter to its clients announcing that it had to stop or temporarily suspend production of a number of its drugs, some of which are considered essential by Quebec hospitals.

This slowdown was the result of a warning from the U.S. Food and Drug Administration, which noted serious violations in the company's production standards. We should note however, that these violations should not affect products distributed in Canada. However, Sandoz has been working for the past two weeks on making the changes requested by the FDA, which has resulted in a significant slowdown in production. The March 4 fire obviously made things worse.

Nevertheless, our Canadian government has known, at least since February, that Sandoz would have difficulty meeting its commitments. Three weeks later, the Conservative government still has not come up with a credible solution and Sandoz still cannot say when it will be able to resume production.

In order to address the drug shortage, the Conservative government is trying to implement an expedited approval process for a number of drugs manufactured abroad that meet European or American standards. It generally takes at least three months for a drug to be approved by the Public Health Agency of Canada. The government hopes that expediting the approval process will make it possible to import substitutes.

Many observers are skeptical about this solution because the generic drug manufacturers are already working at capacity. Even if the federal government approves new products, the industry will not necessarily be able to manufacture them because they are already working full tilt.

Marc-André Gagnon, a professor of public policy at Carleton University and an expert on pharmaceutical programs, does not believe that this is an effective solution. Let me quote him.

We live in an era of just-in-time production...We must understand that the market for generic drugs is expanding. Thus, production is at full capacity at this time. Drugs cannot be stockpiled abroad in the event that a shortage occurs somewhere.

In short, the situation is precarious and it will take a long time to resolve the crisis because we lack the communication tools and the checks and balances for keeping the industry in line. The Liberal and Conservative governments refused to take action when they needed to. As a result, the provinces have come to realize, once again, that they must be self-reliant.

In closing, I would like to point out some of the solutions proposed by the NDP in recent years, which have been cited recently by the health community.

First, we think it is essential to implement a mandatory manufacturing reporting system so that the risk of stock shortages can be identified in advance. This proposal was reiterated by the Alberta and Ontario health ministers, the Canadian Cancer Society and doctors and administrators in hospitals across Canada.

We are also proposing that a special agency be given the mandate of monitoring the industry on an ongoing basis so that Health Canada can react more quickly when there is a potential drug shortage. I am very pleased to see that this proposal was recently mentioned by Diane Lamarre, president of the Ordre des pharmaciens du Québec.

Moreover, as the provincial ministers of health have proposed, the federal government should also approve certain suppliers, selected by the provinces, in order to address the drug shortage. To do this, the Conservative government must stop blaming others and agree to work with the provinces.

Finally, a longer-term vision must be developed. Drug shortages have become more frequent since 2008.

As doctors, pharmacists and some patient groups have called for, a broader investigation needs to be conducted into drug shortages. This investigation should focus on the transparency and business practices of pharmaceutical companies. It should also make recommendations in order to ensure that public authorities have all the tools they need to protect the common good.

I hope that the government will listen and will co-operate with stakeholders from the health care community and the provinces in order to resolve this recurring problem in the generic drug industry once and for all.

The federal government has a leadership role to play and must act in concert with the provinces to ensure that Canadians have all the drugs they need.

Lastly, I would like to thank all the employees of the House and all the pages who stayed in order to allow us to hold a debate on this very important subject.

I am ready to answer questions from my hon. colleagues.

Drug Shortages
Emergency Debate
Government Orders

6:40 p.m.

Simcoe—Grey
Ontario

Conservative

Kellie Leitch Parliamentary Secretary to the Minister of Human Resources and Skills Development and to the Minister of Labour

Mr. Speaker, my constituents in Simcoe—Grey have a clear idea of why there are drug shortages and understand that this is a global problem.

I would like to correct the member opposite on something that she said. I want to be very clear that there is not just one supplier of these medications. There is a challenge here because a choice was made by hospitals and provinces to choose to have a single company supply drugs. By way of example, midazolam, which may be one of those drugs that is talked about, has multiple suppliers, whether that be Apotex or Teva; and fentanyl has suppliers like Hospira Healthcare and Technilab Pharma. Let us understand that this is not a single, focused issue where there is one supplier, as the member opposite mentioned. There are multiple suppliers and there was a choice.

Why do the member and her party not want to work with us to make sure that we have a common interest in working together with industry and association partners to solve this problem for Canadians so that they have drugs available from multiple companies and multiple alternatives, as opposed to going on about how they want to focus on just one supplier?

Drug Shortages
Emergency Debate
Government Orders

6:40 p.m.

NDP

Laurin Liu Rivière-des-Mille-Îles, QC

Mr. Speaker, we have seen throughout this entire debate the government finger pointing, blaming the provinces for these problems and refusing to take a leadership role.

We on this side of the House have proposed some solutions and we will keep proposing them. These solutions have been supported by various groups across Canada and we hope that the government will pay close attention to them.

We proposed three simple solutions. First, we proposed that the government in co-operation with the provinces, territories and industry develop a nationwide strategy to anticipate, identify and manage shortages of essential medications. Second, we proposed that drug manufacturers be required to promptly report to Health Canada any disruptions or discontinuations of production. Furthermore, we would ask that the government expedite the review of regulatory submissions in order to make safe and effective medications available to the Canadian public.

Why is the government content to keep finger pointing? The NDP has proposed solutions. We propose that the government take a leadership role.

Drug Shortages
Emergency Debate
Government Orders

6:40 p.m.

NDP

Libby Davies Vancouver East, BC

Mr. Speaker, I really pick up on my colleague's comments, as we all feel a sense of frustration now. We came to this emergency debate with a real sense that we would not only talk about the real nature of the crisis facing Canadians around these drug shortages but also figure out what could be done. However, all we have heard all night is a shifting of the blame. Speaker after speaker on the government side has blamed everyone else, saying it is everyone else's problem. I do find that ironic, because even the Minister of Health said that she had written letters and done this and that. She seemed to express some frustration about what was going on. If the government had a plan, it has not been working and we are in a real mess.

I just want to offer that comment to my colleague, because she has hit the nail right on the head. This is not about blame but about figuring out what the heck we can do.

Drug Shortages
Emergency Debate
Government Orders

6:40 p.m.

NDP

Laurin Liu Rivière-des-Mille-Îles, QC

Mr. Speaker, as my colleague mentioned, we have seen a lack of leadership in the House tonight.

In a letter to the Minister of Health, the Canadian Anesthesiologists' Society called for the federal Department of Health to play a leadership role in developing nationwide strategies to “anticipate, identify and manage shortages of medically essential medications”, shortages that jeopardize patient health and safety in all parts of Canada.

We do hear a call from civil society and the provinces for the federal government to act. The government needs to stop passing the buck and take action right now.

Drug Shortages
Emergency Debate
Government Orders

6:45 p.m.

NDP

Alain Giguère Marc-Aurèle-Fortin, QC

Mr. Speaker, this problem has been around for a long time. We have this problem because our country, like many others, has surrendered an essential aspect of public health to pharmaceutical companies, particularly generic drug manufacturers.

Canada is not a third world country. It is perfectly capable of producing drugs. It has the people, the know-how and the natural resources to do so. It has everything it needs for a drug shortage to be unheard of, yet here we are with a drug shortage. That is because, for too long now, we have allowed an industry that clearly does not grasp its public health duty to call the shots. In a civilized country, as we like to think of ourselves, we do not let sick people suffer because of a lack of drugs. This important aspect has obviously been forgotten.

There are many people we can blame for this policy. The important thing is not laying blame, but solving a problem that starts with drug production. Blaming the people who provide medical services or who produce a particular drug will not solve the larger problem, which is the drug shortage.

We can point accusatory fingers at some, but will that help us, as a country, to address this public health challenge? The answer is no. Perhaps it is time to overcome certain federal-provincial quarrels and certain internal parliamentary politicking to tackle this problem more seriously.

We are dealing with a generic drug industry that will do everything it can in the fight to destroy a competitor's patent, that will do everything and invest everything in order to be able to produce a drug without the patent and without having taken part in the research. This industry tends to be very generous in marketing its products to doctors and pharmacists. This industry invests more money in PR and advertising than it does in production or in building facilities capable of producing these drugs. This industry cares a lot more about the bottom line than it does about the shared goals of public health. This is nothing new, and it is every private company's prerogative to try to maximize profits.

At times, this industry has gone too far. It was called to order by the Commissioner of Competition, who rightly said that generic drugs are being sold at unacceptable prices in Canada. In response to that situation, the service providers got together to make bulk purchases at a lesser cost in order to lower their overall drug budget. We cannot blame the hospitals and provincial governments for lowering their costs, especially when the federal government is cutting transfer payments for health. They are doing precisely what they are being asked to do: making a concerted effort to reduce their costs.

They are successfully staying within their drug budget, but now they are being criticized. Perhaps we need to be more consistent. We could continue to try to find who is responsible. We are all responsible. We did not work together to put an end to this situation.

The Parliamentary Secretary to the Minister of Human Resources and Skills Development said that it was time to work together to find a solution. That is a great idea, but we must find an effective solution that leads to concrete results, an observable change and a marked improvement. Essentially, the solution must put an end to drug shortages. We must develop a truly Canadian pharmaceutical industry that is able to respond to our country's needs. We must no longer depend on imports—rather like public charity from other countries—to address our drug shortages. We must attack the problem, not just draw attention to it. Everyone knows that there is a problem. We must find a solution.

It is true that the federal government is likely incapable of finding a miracle solution on its own. The federal government must co-operate with the provinces, hospitals and other who provide medical care. There must also be some co-operation with the pharmaceutical industry. I am sorry to say it and to insist so strongly, but the pharmaceutical industry must conduct a thorough review of its priorities.

The pharmaceutical industry's role is to manufacture drugs, not to pay for doctors or pharmacists to go on trips to Thailand. The industry's role is to produce inexpensive and effective drugs for all Canadians, not to have the biggest advertising budget. This is exactly where the problem lies. Their priorities are not compatible with the establishment of an effective public health care system.

Canada has the resources. It has the means. It is up to us to ensure that it has the intention. The intention of this government, of this Parliament, must be to guarantee public health, to ensure that Canadians will have absolutely guaranteed access to these drugs both now and in the future.

The NDP has proposed some solutions. Not only have we proposed solutions but we have also listened to the suggestions of other authorities: provincial governments, pharmaceutical industries, doctors' and pharmacists' associations, hospitals and even the government. The basic requisite is that these proposals must lead to solutions. The current solutions are no good. Asking these people who are too focused on profit to take care of public health is unacceptable. That is not their role; it is ours.

It goes without saying that I do not intend to abdicate this government's responsibility to private companies.

Drug Shortages
Emergency Debate
Government Orders

6:55 p.m.

Lotbinière—Chutes-de-la-Chaudière
Québec

Conservative

Jacques Gourde Parliamentary Secretary to the Minister of Public Works and Government Services

Mr. Speaker, I thank my colleague for his question and I also congratulate him for being open-minded about solutions.

My colleague has been in this chamber for more than 10 months. Could he explain how Quebec might perceive the intrusion into its jurisdictions when it comes to such a fragile and delicate matter as health?

Drug Shortages
Emergency Debate
Government Orders

6:55 p.m.

NDP

Alain Giguère Marc-Aurèle-Fortin, QC

Mr. Speaker, the government of Quebec has sole jurisdiction over the delivery of health care services to its people. The problem is not that services are inadequate, that services are not provided, or that we want to provide services instead of the province. The pharmaceutical industry is under federal jurisdiction, and we need to figure out how the Canadian government can ensure that the industry supplies drugs to people, governments and hospitals so that they can use them. That is the problem. It is not a matter of jurisdiction; it is a matter of production.

Drug Shortages
Emergency Debate
Government Orders

6:55 p.m.

NDP

Libby Davies Vancouver East, BC

Mr. Speaker, I would like to thank my colleague for his very thoughtful comments. He provided us with a larger picture of how these major drug companies have so much power and control. Government intervention in the public interest is required.

We have talked tonight about shortages for people who are facing serious surgeries, for people who need pain management and for people in palliative care. However, there are also other groups facing shortages. People with epilepsy have been facing crucial shortages in medications that prevent seizures for a period of time. Many people are worried about that. There are also people in the trans community who undergo surgery and need to take certain kinds of medications and hormones. They are also facing shortages. So we begin to see how widespread this is and the anxiety that it causes.

I know the member is fully aware of this. It reinforces the importance of the federal government to show some initiative here and to stop hiding and saying it is somebody else's problem. The federal government should actually think about what it can do and listen to the suggestions, including those from the member, that have been made in the debate here tonight.

Drug Shortages
Emergency Debate
Government Orders

6:55 p.m.

NDP

Alain Giguère Marc-Aurèle-Fortin, QC

Mr. Speaker, it can listen to the suggestions that we have made this evening and the entire House can listen to proposals from all the provinces, all the hospitals, all sorts of professionals and even people from this government. The main thing is that we have to succeed. That is what is important. We have to resolve the shortage problems now and forever.

Drug Shortages
Emergency Debate
Government Orders

6:55 p.m.

Simcoe—Grey
Ontario

Conservative

Kellie Leitch Parliamentary Secretary to the Minister of Human Resources and Skills Development and to the Minister of Labour

Mr. Speaker, we have heard again and again from the opposition members about the need for federal intervention into provincial and territorial jurisdiction, that only we can solve this supply problem. I would like to remind the member opposite that it is provinces and territories that sign the contracts with these companies like Sandoz because they know their jurisdictions and the patients who need to be taken care of. Does the member not believe that these decisions should be made by those people closest to care? Or does he think that we should be making those decisions in this House of Commons?

Drug Shortages
Emergency Debate
Government Orders

6:55 p.m.

NDP

Alain Giguère Marc-Aurèle-Fortin, QC

Mr. Speaker, with all due respect for the parliamentary secretary, the Patent Act is a federal act. Quality control for drugs is governed by federal legislation. It is as though she were saying that because we want to control the quality of manufacturing and investments in this industry, we want to take over a provincial responsibility. As far as I know, the provinces have never had this responsibility.

Drug Shortages
Emergency Debate
Government Orders

7 p.m.

Conservative

Wladyslaw Lizon Mississauga East—Cooksville, ON

Mr. Speaker, I would like to inform you that I will be splitting my time with the member for Lotbinière—Chutes-de-la-Chaudière.

When I rise in the House to address an issue I am pleased to do so, but not tonight. The very serious shortage of medically necessary drugs that has brought us to this emergency debate could have been mitigated if only Sandoz Canada had planned ahead and had been transparent with its customers. I must say that the more I learn about the company's behaviour, the angrier I get.

We can discuss every aspect of the drug shortage issue tonight. We understand that it is a complex global phenomenon with many causes.

We know of the serious work that our Minister of Health has done to bring purchasers and suppliers together to find a co-operative Canadian solution to this global challenge. These solutions are based on information sharing and solid contingency planning. They are direct, efficient solutions based on a clear and logical understanding of how the drug approval and supply system works in Canada. The minister's goal has been to help ensure that the right information gets into the right hands at the right time so that advance planning and notice can take place, alternative sources of supply can be found and treatment plans for patients can be adjusted if necessary.

I read the newspaper over the weekend. The warning system does not work well when the warning comes too late. Sandoz clearly did not warn the world about a looming shortage until it was too late to avoid it.

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. This product is not even produced for the Canadian market. Similar FDA findings were made at the 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.

As we all know, Sandoz is a virtual sole supplier of many medically necessary drugs for hospitals and clinics across the country. However, members now know that because of the painful events of the past few weeks, Sandoz was presumably aware of these facts in November. Nonetheless, before the middle of February, the company did not give full details of its plan to shut down its plant in Boucherville. This is especially concerning, considering it would have major supply consequences for all Canadians.

Following up on the FDA findings, Health Canada inspected the plant and found it to be compliant with our rules for safe, quality production. The department's officials held discussions with the company about how it planned to address the FDA findings, but never during those discussions were the full details or plans of the company's production cutback revealed, that is until February 15. That is 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 alternative sources of supply it had secured to make up shortfalls for customers, it said that it was starting to do that. So the company dropped a bombshell like this on the Canadian health care system and then said it was just starting to identify other suppliers. Sandoz did not even include an estimate of how long the shortages would last. It had to be asked.

The House has been aware of the work that the minister has done to encourage drug makers to be more transparent with customers and Canadians about drug shortages. Early last fall, she received a commitment from several professional and industry associations for a voluntary plan to provide more timely, accurate and comprehensive information about drug shortages to health care professionals and patients across Canada.

Sandoz Canada is a member of the Canadian Generic Pharmaceutical Association which contributed to the development of this plan. However, I have to say that the abject failure of Sandoz to date to provide clear, precise and timely information on the massive impact of its production cutbacks is completely contrary to the spirit and principles of the pledge made in the fall.

The information provided to Health Canada officials, the media and the public has been, at best, reactive, fragmented and incomplete. As a result of this information vacuum, health care providers across the country find themselves having to piece together the full scope and extent of the supply situation and scramble to maintain patient care. Hospitals and clinics, bulk drug purchases, provincial and territorial governments and Health Canada have had to poke and prod Sandoz at every turn. Supply pledges made by the company have frequently not been met by distributors. Sandoz has promised to provide updated supply information to health professionals, but their worried calls to Health Canada for help indicate that either the information or the supply, or both, are not getting through.

Then on Sunday, March 4, Health Canada became aware of a fire at the Boucherville plant through media reports. Health Canada also received an email from Sandoz on March 4 confirming there had been a fire. Health Canada urged Sandoz to go public with information about the fire, especially with its customers, the provinces and territories.

When it became clear that information was not forthcoming, at noon on March 6, Health Canada advised the provinces and territories of the fire. At the urging of Health Canada, and only after Health Canada had advised the provinces, Sandoz finally issued a press release on March 6. Only then did it publicly concede that the fire had forced the 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 to Health Canada submissions for alternative supplies to be assessed for safety and effectiveness.

Health Canada is expediting its authorization process during the shortage to help hospitals and doctors access alternative sources of supply.

Through the various networks supported by the health portfolio, we have been taking a leadership role by bringing together purchasers, provinces, territories, health care professionals and Sandoz to exchange the latest information on supply and to ensure that our collective efforts to address shortages are coordinated. Health Canada has a team of experts assigned to deal with shortage requests.

We are providing guidance to purchasers so they have a clear understanding of the safety information we require when a new source of supply is found. Through our co-operative relationship with other trusted regulators with high safety standards like Canada, such as the U.S. Food and Drug Administration and the European Medicines Agency, we have ready access to a wealth of information that will expedite our approval of foreign sources.

I want to assure Canadians that, notwithstanding these urgent circumstances, we will never compromise safety. The last thing anyone wants is for patients to be harmed by unsafe drugs authorized in a rush to fill supply gaps.

In Canada, the federal government has taken a leadership role in encouraging enhanced co-operation among all players in the drug approval and supply system. The Sandoz situation shows there is still a lot of work to do to improve information sharing and contingency planning by purchasers and suppliers. It is still our hope that this will happen. We believe that a voluntary purchaser-supplier solution is the most effective and efficient way to handle shortages. If necessary, the government will regulate mandatory advance notification in order to ensure Canadians get the information they need and deserve.

Drug Shortages
Emergency Debate
Government Orders

7:10 p.m.

NDP

Guy Caron Rimouski-Neigette—Témiscouata—Les Basques, QC

Mr. Speaker, I am pleased that my colleague opposite raised the issue of information, because lack of information was one of the major contributing factors to the problem we are dealing with now. I asked a question earlier, and I would like to ask it again because I have not really received an answer yet.

My colleague said that the voluntary reporting system for potential shortages works really well. The United States is bringing in a mandatory system. Companies will have to disclose when they expect a shortage of certain drugs. Congress is even talking about imposing fines of up to $1.8 million if companies do not announce a potential shortage at least six months in advance.

I would like to know how the member can justify a voluntary system that lets companies choose whether or not to announce a shortage, compared to a mandatory system that makes them responsible for advance notification and holds them accountable.

Drug Shortages
Emergency Debate
Government Orders

7:10 p.m.

Conservative

Wladyslaw Lizon Mississauga East—Cooksville, ON

Mr. Speaker, I do not know how many times during this debate it has been mentioned that we are dealing with provincial jurisdiction.

Health Canada is not involved in contracts with drug companies to buy drugs for hospitals, clinics or doctors. If the hon. member had listened to my speech, he would have heard the last sentence of my speech, which I will repeat. If necessary, the government will regulate mandatory advance notification in order to ensure Canadians get the information they need and deserve.