Debates of March 12th, 2012

Drug Shortages

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

Mr. Speaker, this is the most severe drug shortage that our country has ever experienced. The current shortage is having serious consequences. Among other things, surgeries had to be cancelled in some hospitals in Quebec, many pharmacists, health professionals, as well as managers and administrative employees in hospitals are working extremely hard to find alternative drugs and new suppliers. Health professionals do not know whether they will be able to give the treatments required and patients are unsure whether they will be able to receive treatment.

And these are only the direct and visible effects of the current shortage. What I find even more fascinating is the government's reaction; once again, it is improvising. The government seems surprised by the shortage. I am prepared to admit that the unfortunate events that occurred at the Sandoz facility, which is located very near my riding, could not have been predicted. However, a possible drug shortage created by the temporary closure of a generic drug factory, regardless of where it is found and what drugs it manufactures, is a much more predictable situation.

We do not have to look very far back in history to see that the current phenomenon is not an isolated or unique event. It is a recurrent trend. I can list some problems that have occurred in just the past few months.

In August 2011, as a result of the temporary closure of the Ben Venue Laboratories factory, there was a shortage of about a dozen drugs in Canada, some of which are used to treat cancer and have no substitutes. The situation was the same as that at Sandoz. In December, we learned of a shortage of misoprostol, a drug used in obstetrics to reduce post-partum hemorrhaging. There is no substitute for misoprostol available on the market and, according to an article in La Presse, the drug will not be available until 2013.

Last October, the media reported a recurrent shortage of some anti-epileptic drugs. For many drugs, a shortage means that a new supplier or an equivalent drug must be found. Things are not that simple in the case of certain anti-epileptic drugs. Many of these drugs are not very profitable and thus are not manufactured by very many factories. So, when production is temporarily stopped, there are few or no alternate suppliers.

Over the past few years, some patients have been told at the their local pharmacy that their medication was out of stock. What adds to the problem is that, for patients who take anti-epileptic drugs, it is very dangerous to suddenly change medications. Change must be made gradually in order to ensure the patient's safety. The problem is that, without a mandatory reporting system for drug shortages, it is difficult for patients to transition smoothly to new drugs when their regular drugs are not available.

I have brought these facts before the House in order to make two very specific points. First, the drug shortage has real and concrete impacts on Canadians, and we should be concerned. Second, I wanted to show that the current drug shortage was a foreseeable situation but that the government ignored the warning signs.

Speaking through its mouthpiece, the Minister of Health, the government seemed so proud of its plan when the NDP questioned it during a Standing Committee on Health meeting. Today we see that the plan is completely ineffective and inadequate. I hope that the minister sees that she should have done more and that earlier shortages should have raised a red flag.

I would like to add that the Canadian Medical Association consulted its members on this subject in January 2011. The results of the consultation were very interesting. Three out of four respondents said that they had had problems with drug shortages in the previous year. Two-thirds of respondents said that the shortages caused what they considered to be serious consequences for patients.

Once again, Canadian patients are paying for the Conservatives' bad health care decisions. What is of even greater concern is the fact that patients are living in fear, wondering whether the surgery they have already been waiting a year to have will be postponed once again because of the minister's complacency. They are the ones who go to the pharmacy hoping that they will not have to run all over town to get their prescriptions.

Today, the drug shortage in hospitals has led to this emergency debate, and we must examine the problem. However, we must never forget all the Canadians who need their medications on a daily basis.

According to the Canadian Medical Association survey, the majority of drugs that are in short supply are once again, first and foremost, antibiotics such as penicillin, anti-depressants and antihypertensives. These drugs are used on a daily basis by thousands of Canadians and a shortage creates uncertainty that should not exist.

The events of the past few weeks with respect to Sandoz have highlighted a problem that has existed for quite some time.

We must now find a solution to guarantee that Canadians can have the care they deserve and to which they are entitled. We must find a solution to guarantee the supply of drugs for our hospitals and our patients.

In closing, I would simply like to say that the drug shortage is a public health problem.

We need to make people the focus of our actions and our deliberations. We need to act immediately, for the people.

[Kellie Leitch, Conservative, Parliamentary Secretary to the Minister of Human Resources and Skills Development and to the Minister of Labour]

Mr. Speaker, does the member know who has jurisdiction for health care services in our country?

My patients and my clinic knew that the provinces had jurisdiction. I, as a physician, know who has jurisdiction for health care services in this country, and that is the provinces. This clarity of responsibility is something that helps make our health care system run so well, the clarity that the provinces have responsibility for health care services.

Does the member opposite know who has responsibility for this jurisdiction? Will she work with us to ensure that we, as a federal government, are working with our provincial partners to ensure we are dealing with these issues as opposed to her approach today?

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

Mr. Speaker, I want to thank the member opposite for the question.

I think we are talking about a drug problem, not health care delivery. I realize that health care is a provincial and territorial jurisdiction, but we are talking about the Conservative government's lack of leadership with regard to forecasting shortages and coming up with proposals for imposing mandatory reporting requirements on the pharmaceutical companies. If that were already the case, we would not be here this evening having this debate.

[Joy Smith, Conservative, Kildonan—St. Paul, MB]

Mr. Speaker, I know that each province has its jurisdiction. Clearly, the provinces are in charge of ensuring they get the manufacturers they want. Sandoz was a sole source for a lot of the provinces. Therefore, Quebec, Manitoba and Saskatchewan made those decisions.

Is the member suggesting that the federal government should impose its will on the provinces and take over the provinces jurisdictions?

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

Mr. Speaker, I want to thank my colleague and chair of the Standing Committee on Health for her question.

I never said or mentioned today—neither I nor my colleagues on this side of the House who spoke before me—that we need to impose anything on the provinces. We are just asking the federal government to work with the provinces and territories to find common solutions for Canada as a whole.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Mr. Speaker, I have been hearing all night the concept that most people in the House, other than the Conservatives, do not seem to understand jurisdictions. As a physician, I know that the province is responsible for where health care is delivered and who delivers it and it ensures it complies with the principles of the Canada Health Act, for which the federal government is responsible. The act discusses issues like universality, portability, accessibility and that people should have the same quality of health care no matter where they are in the country.

This is not about the delivery of health care. The provinces may have a responsibility in certain instances for providing pharmacare to people who cannot afford to buy their drugs and for various jurisdictions within the provinces and to make the decision on what that is. However, a t the end of the day, the people who provide health care for the well-being of Canadians happen to be physicians. The hon. member is a physician.

In her speech, the Minister of Health said that there was nothing more important than the health and well-being of Canadians. She should know that the core issue here is how we ensure the health and well-being of Canadians under the Canada Health Act?

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

Mr. Speaker, I thank my hon. colleague, Ms. Fry, who like me, is a member of the Standing Committee on Health. You put your finger exactly on the sore spot, if you will. If the minister were really thinking about the well-being of Canadians, she could have done something about this crisis today.

As you know, my dear colleague, the drug shortage is having a very serious impact on patients in intensive care and on terminally-ill people whose pain can only be eased with opiates. On the list of drugs produced by Sandoz, unfortunately, there is a shortage of injectable opiates—

[The Speaker, Andrew Scheer]

Order. I must interrupt the hon. member and remind her that it is not the practice of the House to use proper names and that she must address her questions and comments to the Chair, and not directly to her colleagues.

Resuming debate, the hon. Parliamentary Secretary to the Minister of Human Resources and Skills Development and to the Minister of Labour.

[Kellie Leitch, Conservative, Parliamentary Secretary to the Minister of Human Resources and Skills Development and to the Minister of Labour]

Mr. Speaker, I will be splitting my time with the member of Parliament for Brampton—Springdale.

As we debate the issue of drug shortages this evening, and in particular how shortages can be prevented, many people are asking why Canada has not learned from its international regulatory counterparts, in particular our neighbours to the south of the border.

I will take this opportunity to speak to the relative roles of Health Canada and the United States Food and Drug Administration in response to drug shortages. There is no magic bullet to resolving this issue. Health Canada has been in contact with international regulatory counterparts and studied their systems and there is no one clear solution to fixing this problem globally.

I will start by explaining more generally the role of Health Canada in comparison to what I know about the FDA. I will then provide some information about the specific issue of drug shortages and the relative and respective roles of the two organizations.

The Food and Drug Administration is the regulatory arm of the U.S. department of health and human services for food and health products, such as drugs and medical devices. The FDA is considered the American equivalent of the health products and food branch of Health Canada. The FDA is responsible for protecting the public by ensuring that human drugs, medical devices and other health products intended for human use are safe and effective. The FDA is responsible for conducting clinical trial reviews, conducting pre-market assessments of health products for market authorization, post-market surveillance of drugs and other health products, and the compliance and enforcement activities.

Although Health Canada has a broad mandate to help Canadians maintain and improve their health , while respecting individual choices and circumstances, its regulatory activities administered by the health products and food branch are quite similar to the activities of the U.S. FDA. More specifically, the primary role of Health Canada's health products and food branch is to ensure that health products sold in the Canadian market meet high standards with respect to safety, efficacy and quality. Like the FDA, this includes clinical trial review and assessments, pre-market assessments of applications for market authorizations or establishment of licences, post-market safety surveillance, and the range of compliance and enforcement activities.

The basis and principles of the scientific review process are generally accepted and similar worldwide within scientific communities. However, science is only part of the overall regulatory approach. There are differences in the laws in each country. There are differences in socio-economic factors, reimbursements and government funding structures, all of which influence the Canadian health care system landscape and, consequently, how Health Canada regulates.

With respect to drug shortages, it must be acknowledged that the supply chain is complex and typically involves many players to take a drug from raw material to retail sales. For this reason, it is not surprising that disruptions can occur in the supply chain that lead to shortages. In the past, these were largely seen as unfortunate but manageable issues that were dealt with by industry. Only in rare cases did they result in shortages on the market where patients were no longer able to access the recommended treatment. These situations are particularly challenging for patients as they can cause treatment delays or changes to a less effective alternative.

Within the last 10 years, there has been an increasing trend in the number of drug shortages. Both the U.S. FDA and Health Canada have studied the issue to better understand the root causes. The FDA has tracked a number of reported drug shortages in the system since 2005 and the number has increased steadily. The data they collected showed that shortages can arise for a variety of reasons, from manufacturing or capacity issues to shortages in raw materials, or regulatory decisions related to quality, safety or efficacy of a product.

Last year, Health Canada engaged the Canadian Agency for Drugs and Technologies in Health to examine the issue of drug shortages. The agency arrived at a conclusion similar to what was found in the data collected by the U.S. FDA: there is no one root cause for a drug shortage.

I will now speak in more detail to the respective roles of Health Canada and the FDA in responding to drug shortages, specifically in relation to shortage coordination, shortage notification, assistance to companies on regulatory activities and enforcement discretion.

The impacts of certain drug shortages are currently being experienced on the front lines. My colleagues are experiencing them across the province of Ontario and in other places across the country. Resolution of this issue is complex and ongoing.

Through outreach to health care professionals, international regulators and patient groups, Health Canada has been told that early notification of any anticipated or occurring drug shortage is key to assisting health care professionals respond to and manage drug shortages.

Both Health Canada and the FDA have taken action to see that companies are notifying health care professionals and the public of any problems that could lead to shortages. The FDA encourages voluntary reporting of any issues that can lead to a drug shortage and also has a narrow regulatory requirement for sole-source manufacturers of medically necessary drugs to inform it six months in advance of a temporary or permanent discontinuation. Health Canada also has a mandatory requirement for all manufacturers to notify it of discontinuations. With the implementation of the national drug monitoring system in 2012, as promised by industry and health care professional associations, Canada will have a voluntary system in one location for reporting all anticipated or occurring drug shortages.

As members will recall, it was the Minister of Health's action in 2011 that was the driving force behind the industry's commitment to post information on anticipated or occurring drug shortages. In a recent letter to Sandoz, the minister expressed her disappointment to the company for not following through on that pledge. However, even early communication and notification of drug shortages will not prevent all drug shortages, but it will allow health care professionals to better manage shortages when they occur.

When it comes to drug shortages, this is not where the role of the regulator ends. Health Canada and the FDA staff know the importance of being proactive in these shortage situations. When Health Canada becomes aware of a shortage that is impacting patients, the department does everything in its power to minimize the impact of shortages and to facilitate access to alternatives. This includes working closely with companies to resolve manufacturing and quality issues, ranging from simple fixes like enforcing the proper expiry date to correcting problems related to product sterility. The department will also work with manufacturers to see that submissions related to alternative suppliers and changes in manufacturing processes can be reviewed on a priority basis. These are important activities that can ensure the continuity of supply when companies fail to plan properly to prevent shortages.

Health Canada can also facilitate access to alternatives on an emergency basis by facilitating and working with foreign manufacturers to allow for temporary and limited importation of foreign versions of a drug. These activities are all very similar to the role played by the scientific and regulatory staff at the U.S. FDA. Regulators at Health Canada and at the FDA work with manufacturers as needed to ensure the information about shortages and alternative medications are made available to those who need them.

Both Health Canada and the U.S. FDA publish information on their respective sites about which products have been approved for sale by which company. These sites provide buyers with the information they need to diversify supply and seek alternatives. In addition, I would like to draw the members' attention to another drug shortages website that is maintained by the American Society of Health-System Pharmacists, an organization that is similar to our professional association of hospital pharmacists. The AHSP website is populated through voluntary reporting by industry and includes a comprehensive list of current and resolved shortages, information on available products and multiple resources for managing drug shortages. The two websites that Canadian industries are currently using to post shortages information on a regular basis are a step in the right direction to getting similar transparency here in Canada. It is expected that when industry and the health care professional associations deliver on their commitment for a national drug monitoring system in 2012, they will strive for functionality on par with this American site.

Our government would like to see a comprehensive national drug shortage monitoring system in place in the coming months that would provide early notification to those who need it as well as the best practices guidelines and information for managing shortages.

Our government understands the significance of this issue and the opportunities of learning from our international partners. In this case, we believe that Health Canada is taking steps very similar to our U.S. counterparts to improve communication and transparency in order to prevent and mitigate the impact of drug shortages.

[Guy Caron, NDP, Rimouski-Neigette—Témiscouata—Les Basques, QC]

Mr. Speaker, I am pleased that the parliamentary secretary spoke about the reporting system. She made a comparison with the United States. In our opinion, the main problem is that manufacturers were not required to report the impending shortage. As early as 2010, they knew that shortages of some drugs were approaching. In her speech, the parliamentary secretary boasted about the voluntary reporting system. To be honest, there is not much difference between a voluntary reporting system and no system at all. If, for one reason or another, the companies do not announce that there will be a shortage of certain drugs, there is no way we would get this information.

In the United States, a significant shortage led President Obama to issue an order for mandatory reporting of upcoming shortages. The United States Congress is thinking of requiring six months' advance notice of shortages, and any company failing to comply could be fined up to $1.8 million.

Can the parliamentary secretary tell us how a voluntary reporting system could have prevented this, when manufacturers already knew that a drug shortage was coming? A mandatory reporting system would have allowed our health care providers to better prepare.

[Kellie Leitch, Conservative, Simcoe—Grey, ON]

Mr. Speaker, as I mentioned before, drug shortages are a global problem. Shortages are often temporary, but they are often resolved by industry. The intent of this government, as has been put forward, working in collaboration and in partnership with industry and professional associations, is to move forward with a national strategy in order to bring all players to the table.

As I mentioned, the jurisdiction for the actual health care services sits in the hands of the provinces, and we would encourage our provincial partners to step up and make sure they are looking at alternatives so that patients are receiving the medications they require by their provincial jurisdictions.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Mr. Speaker, I was very pleased to listen to the hon. member's speech because she laid out very carefully, as my colleague said, the parallel systems of the FDA in the United States and the Canadian system and how the Health Protection Branch of Health Canada is responsible, like the FDA, for the health and safety of Canadians. We also know that the federal government is responsible for ensuring medicare works and has set out five principles for doing this.

The point I am trying to make is that the member talked about looking at best practices. We saw the best practices in the U.S. The president, at the highest level of the country, thought it was very important for responsible government to protect its citizens and ensure they do not have the kind of situation in which patients may die or be placed at severe risk because they do not have the ability to get the drugs they need. The government knew of the drug shortages. Why did the government not pay attention to the best practices of the United States and follow the Food and Drug Administration in its mandatory monitoring and anticipatory regulations?

[Kellie Leitch, Conservative, Simcoe—Grey, ON]

Mr. Speaker, as I mentioned already, it is the responsibility of the provinces for health care services in this country and we would encourage our provincial partners to step forward, make sure they have alternatives so that all Canadians know that when they enter a health care facility, whether it be in the province of Ontario, British Columbia or New Brunswick, they can receive the care they expect from their health care provider that is in the jurisdiction of the provinces.

Our government is showing leadership. The Minister of Health is moving forward and making sure industry is working in partnership with the provinces as well as with professional associations to make sure we have a national registry, we can make sure we can identify these things early and make sure that people like me, physicians, as well as patients know and can anticipate shortages in the future.

[Parm Gill, Conservative, Brampton—Springdale, ON]

Mr. Speaker, I am very pleased to have the opportunity to address the House on the issue of drug shortages in Canada and around the world.

We know drug shortages are a concern for all Canadians, and we know this is not the first time our health care system has suffered as a result of a shortage situation. What we are experiencing here in Canada is a symptom of a much larger global problem. Drug shortages are global in nature and are felt by patients worldwide. If we are to resolve them, there will need to be collaboration on an international scale.

What brings us together today is our mutual concern over the drug shortages caused by the production slowdown at the Sandoz manufacturing facility in Boucherville, Quebec. The manufacturing issues that are currently ongoing at Sandoz in Canada are a local example of a global issue. Interruptions to supply such as the one Canada is facing can arise as a result of a variety of factors.

I would like to take this opportunity to share with the House some of the global factors that can bring about drug shortages here in Canada.

Often a drug shortage is a result of shortages in a raw material required to make the drug. These raw materials are often scarce and, in addition, they can be quite difficult and complex to produce. Perhaps most importantly, the ingredients for many medications are sourced internationally.

For example, a complex drug to treat cancer may be manufactured in Canada, the United States or Switzerland, but its raw materials can come from places such as India, China and Latin America. Furthermore, within these countries there are a limited number of suppliers of raw materials. When taken together, that means fewer raw material suppliers operating from a small number of countries but supplying the world's needs. The ability to meet the demands of the international community on a continuing basis is highly vulnerable to risk, which might affect that supply. Because of this worldwide dependency on a few raw material manufacturers, the market is in a constant state of flux between being able to meet supply demands and there being a lack of supply of the ingredients for the global market. Shortages of raw materials can occur when there is just one raw material supplier for a high-demand drug or if there is competition between several manufacturers for a raw material that is in short supply. As a result, our respective domestic supply chains are very much intertwined with international supply chains.

We also know that manufacturers in the countries we rely on for the supply of raw materials for drugs can run into many different types of production issues, which can deeply impact the overall global supply. As a regulator, Health Canada is responsible for reviewing the safety, quality and efficacy of drugs and for authorizing their sale in Canada. Once a drug is authorized for sale in Canada, Health Canada will monitor the safety of the marketed drug by collecting, analyzing and assessing adverse drug reaction reports that are submitted by the pharmaceutical industry, health professionals and consumers. If safety concerns are identified with a product, this may in turn result in a company recalling the drug, which in turn will result in a drug shortage for that particular drug.

The trigger for the remediation activities currently being undertaken at the Sandoz facility was the warning letter that was issued by the U.S. FDA. The U.S. FDA's observations for the facility focused on a product manufactured in Canada but intended exclusively for the U.S. market. Sandoz' international parent company, Novartis, made a business decision to focus on addressing U.S. concerns. As we are now clearly seeing, this decision has had a significant impact on Canadians.

In response to this letter, Sandoz decided to cease production on a number of its production lines in order to upgrade operations at its facility. However, some of those production lines were used to make drugs that were scheduled to be sold and consumed in Canada.

It should be noted that the reaction of Sandoz to the FDA ruling is not unusual. It is, in fact, fairly typical of the pharmaceutical industry to appease its customers with larger markets in order to assure its continued access to those markets. It also shows how global business practices of pharmaceutical companies should take into account the needs of our local population.

The business practices of the various players within the pharmaceutical drug supply chain can contribute to drug shortages in a number of ways. For example, manufacturers and wholesale drug distributors will routinely their supply by minimizing end-of-quarter or end-of-year product inventories. Manufacturers and wholesalers sometimes also limit the shipment of product based on the previous year's demand. Both practices can result in shortages at pharmacy and hospital levels.

In an effort to keep costs down and profits up, many manufacturers, wholesalers and pharmacies maintain minimal supplies of drugs in production or in stock. Just in time strategies like this can contribute to drug shortages. Some health care organizations keep little or no inventory on hand and are dependent on daily delivery by suppliers. In this case, a temporary supply disruption of a medically necessary drug can become a crisis for physicians and for patients.

Finally, we know that global pharmaceutical companies and manufacturers play a key role in bringing drugs to the market, but we also know that their business models have changed in the wake of globalization. Pharmaceutical industry consolidation has become the norm around the globe. When companies merge, less profitable product lines are often reduced or discontinued. Sometimes manufacturing facilities are closed altogether. When companies merge with similar product lines, this will often result in product consolidation, possibly resulting in changing a multi-source product into a single-source product. These practices result in fewer sources for drugs, leaving markets vulnerable to shortfalls.

When companies consolidate around the world, this means that the supply of drugs for both Canada and other countries increasingly rests on fewer and fewer production sites. Twenty years ago, a problem in one production site for a drug could be resolved by increasing supply at a similar site. In today's climate this is not possible because there is often only one company that produces a certain type of drug globally.

These are some of the global causes of the drug strategy shortages that we experience in Canada, but let us bear in mind that drug shortages are occurring around the world. To the south, the United States is experiencing drug shortages in increasing numbers. In the United Kingdom drug shortages are also emerging, often as a result of drugs meant for British markets being shipped and sold to Europe.

Un to now, the Canadian experience was not as drastic as that which has been experienced in the United Kingdom and Europe. Managing the global factors affecting supply of Canadian pharmaceuticals is a significant matter.

Our government recognizes that drug shortages are a concern for all Canadians. The health of those who rely on drug therapy and pharmaceuticals is a primary concern for this government. However, we should know that drug shortages occur in the global context and are as a result of a number of factors at work in the global supply chain.

[Anne Minh-Thu Quach, NDP, Beauharnois—Salaberry, QC]

Mr. Speaker, I want to thank my colleague for taking part in this very important debate on drug shortages. The thing that bothers me is that all the Conservative MPs who rose in this House this evening spoke mostly about provincial responsibilities, even though the emergency debate was about finding out what the federal government is going to do to help come up with solutions to prevent future shortages.

The Minister of Health said she was going to try to speed up the process for approving other suppliers more quickly and efficiently. Still, there also need to be reporting mechanisms to ensure that, for instance, a mandatory registry is imposed on the drug suppliers and that we have a plan B for the long term to make sure this does not happen again.

[Parm Gill, Conservative, Brampton—Springdale, ON]

Mr. Speaker, I would like to remind the hon. member, as I mentioned in my speech and as was mentioned earlier by the Minister of Health, that it is the responsibility of the provinces and territories to provide health care.

At the same time, our government and Health Canada have shown a very clear leadership by working very closely with Sandoz, the manufacturing facility. As we all know, this problem arose not because of the situation within Canada, but it was initiated by the U.S. FDA. Health Canada and the Minister of Health are doing everything in their power to ensure this issue is addressed in a very timely fashion.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Mr. Speaker, I have heard the Government of Canada speak about the jurisdictions, again and again.

I will simplify my question. Even if the Government of Canada refuses to take any responsibility for the well-being and health care of Canadians, it does have a responsibility for the health care and well-being of first nations people, Inuit, the RCMP, the Canadian Forces and veterans.

Will the government set up a mandatory reporting system that will anticipate and ensure that there will be no drug shortages for those people for whom it is directly responsible?

[Parm Gill, Conservative, Brampton—Springdale, ON]

Mr. Speaker, I would assume the hon. member, being a physician herself, would know and would clearly understand that when I say that health care is the responsibility of the provinces and the territories, it is true.

At the same time, the Government of Canada has a responsibility to ensure Canadians are protected and have adequate drugs that they require. It is the provinces and territories that work with the manufacturers. They are the real customers.

When it is out of the Government of Canada's hands, or the information does not get to the government or Health Canada in a timely fashion, it is limited in its resources. I hope that answers the question.

[Joy Smith, Conservative, Kildonan—St. Paul, MB]

Mr. Speaker, our government recently committed to a long-term stable funding arrangement with the provinces and territories, right up to 2017.

The member is part of the health committee and has done a great job. How will the government ensure there is accountability, such as ensuring the provinces and territories do a better job of ensuring there are medically necessary drugs for all Canadians?

[Parm Gill, Conservative, Brampton—Springdale, ON]

Mr. Speaker, I thank the hon. member for doing a wonderful job of chairing our House committee.

This measure brings financial predictability for all provinces and territories, as they can count on long-term stable funding arrangements that will see transfers reach $40 billion by the end of the decade.

[Laurin Liu, NDP, 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.

[Kellie Leitch, Conservative, 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?

[Laurin Liu, NDP, 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.

[Libby Davies, NDP, 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.

[Laurin Liu, NDP, 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.