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

4:55 p.m.

Liberal

Geoff Regan Halifax West, NS

Mr. Speaker, I thank my hon. colleague, and I agree with her comments. In fact, the minister and the Conservatives have been talking tonight about the fact that they did not know. My colleague made the argument eloquently, as did my leader, about the Canada Health Act and its role and the responsibilities of the government under it. Even if the minister and the Conservatives did not agree with us, in their role as inspectors of the safety of drug manufacturing, they ought to have known much sooner. They ought to have been able to give notice.

We know there has been a problem with drug shortages for two years now. There have been problems at the Sandoz Canada plant since at least July 2009. That the government had no idea makes us very seriously concerned about the competence of the government and what is going on over there.

Drug Shortages
Emergency Debate
Government Orders

4:55 p.m.

Liberal

Bob Rae Toronto Centre, ON

Mr. Speaker, I wonder if the hon. member would agree with me that this ideological attempt by the Conservative Party to simply throw all the responsibility onto the provinces and then to blame a particular company for a particular problem is in fact a complete evasion and abdication of responsibility on the part of the federal government?

Whatever the Prime Minister may like to think, the Government of Canada has a major responsibility and role in the health care system. It is a regulator. It is speaking to something which has been deemed by Canadians to be a key aspect of Canadian citizenship. It is also a large provider of health care to veterans and to aboriginal people. It can no longer abdicate this responsibility.

In that regard, I wonder if the member would not agree with me that this particular federal government has completely failed in its responsibility with respect to the safe supply of drugs?

Drug Shortages
Emergency Debate
Government Orders

5 p.m.

Liberal

Geoff Regan Halifax West, NS

Mr. Speaker, when a member's Party leader asks if the member agrees, the member gets a little worried about what he is going to say next, and hopes to agree.

I find myself in the happy position of saying, “Yes, I agree completely with his comments.”

Drug Shortages
Emergency Debate
Government Orders

5 p.m.

Oshawa
Ontario

Conservative

Colin Carrie Parliamentary Secretary to the Minister of Health

Mr. Speaker, I am sharing my time with the member for Kildonan—St. Paul.

I am pleased to be taking part in this important debate this evening. I believe that all members' constituents have expressed their concerns about the drug shortage by email, telephone and even fax.

Some have family or loved ones who worry about possible delays in needed surgery. They are unhappy about the scope of the shortage. Understandably, people want to know how this happened. They want to know what is being done to fix the problem.

This evening the government will address all aspects of this complex and frustrating situation. We have just heard the Minister of Health lay out the broad strokes of action she is taking to help address the shortage. I would like to express my deep appreciation for her, for the work she has done to make drug makers like Sandoz and drug purchasers live up to their responsibility to do better and to prepare better for shortages.

I know that she and her officials have worked 24/7 to help solve the drug shortage issue since suddenly learning about it a few weeks ago. Before we can understand the proper role of the federal government on drug shortages, I think it is important to understand the basics of drug approval and supply in Canada.

The federal government's main role is to ensure that drugs purchased or sold in Canada are safe, effective and of high quality. Once Health Canada has approved a drug, the manufacturers and buyers are free to enter into commercial contracts for its supply. The terms of these contracts—cost, quantity, rate of use, number of suppliers required, distribution and penalties for failure to supply—are all agreed to by the buyers and the suppliers.

Provincial and territorial health authorities have set up bulk buying groups to buy drugs for patients. This model has worked for provinces and territories because it has maximized their purchasing power and price leverage over suppliers. It has worked for suppliers because it means they do not have to negotiate separate deals with each government, health authority or hospital.

The federal government has no involvement in or knowledge about the nature of these arrangements. Indeed, one would wonder how the provinces and territories would react if the federal government tried to dictate to them any terms of these private, commercial arrangements.

The most important consideration in any shortage situation is the needs of the patients. Doctors and pharmacists need enough advance notice of a shortage so that treatment plans for patients can be smoothly adjusted if needed. When production and distribution of medically necessary drugs is interrupted, a drug maker is the first to know that a shortage is about to happen. This means it will not be able to fulfill the terms of its supply contracts. The drug maker is responsible for advising its health care customers in advance what drugs are affected and how long they may be in shortage.

Drug makers must also identify alternative supplies that can make up the shortfall to customers. This may be found within their own operations or from other suppliers that make similar drugs in Canada or in other countries. The drug maker must also come up with a plan to solve the problem that caused the shortage in the first place. When supplies are interrupted, hospitals, clinics and health professionals must implement strategies to ensure the most efficient use of existing supplies and to minimize the impact on patients. They keep patients advised of the supply situation in each facility and community and adjust treatment schedules and procedures if required. If a shortage is significant and long in duration, alternative supplies may be sought from drug makers within Canada or in other countries.

Once we understand the basic facts of how drug purchasing and supply works, then the proper role of the federal government in any shortage situation is clear and logical. When there is a shortage, Health Canada, consistent with its mandate and authority, works closely with purchasers and suppliers to ensure any new supplies of needed drugs are safe, effective and of high quality. Health Canada has a variety of tools available to help do this. It works closely with companies so they can quickly resolve manufacturing, quality and distribution issues. It works with manufacturers to ensure alternative suppliers, changes in manufacturing processes or locations can be reviewed and market authorized on a priority basis. It ensures all necessary licensing requirements are met. It works with international counterparts, such as the U.S. Food and Drug Administration, to identify additional sources of supply and to share needed safety and quality information. It provides priority access to alternatives on an emergency basis.

Health Canada will use the right tool for the situation at hand. The time required for each will depend on the specific request, but Canadians can be assured that Health Canada responds on a priority basis.

Health Canada is expediting authorization processes during the ongoing Sandoz shortage, but safety will never be compromised. The last thing anyone wants is for patients to be harmed by unsafe drugs authorized in a rush to fill supply gaps. A team of departmental experts has been assigned to deal with shortage requests. They are providing fast, real-time guidance to purchasers so they have a clear understanding of the safety information needed when a new source of supply is found. Through the various networks supported by the health portfolio, Health Canada is bringing together purchasers and companies to exchange the latest supply information and to foster pan-Canadian coordination of the shortage response. Through co-operative relationships with other trusted regulators, such as the U.S. Food and Drug Administration and the European Medicines Agency, Health Canada has ready access to the wealth of information that will help expedite approval of foreign sources.

One of my colleagues will be addressing the recent and growing global nature and impact of drug shortages a little later on. Despite the ample evidence of this phenomenon, we have not seen a parallel increase in the systematic sharing of shortage information or advance contingency planning on the part of drug purchasers or suppliers. Purchasers express surprise and frustration at shortages that have appeared to have come up out of the blue. Rather than seeking multiple sources of product as a cushion against supply interruptions, we have seen a greater reliance by them on fewer suppliers. Sandoz, for instance, has been allowed to become the sole or dominant supplier of many critical medications. Producers do not appear to have done any real work to identify alternative sources in advance, even though they are fully aware of the global supply constraints.

I cannot say why this state of affairs has been allowed to develop, but the bottom line is that in a shortage situation there is no substitute for information. The right information needs to get in the right hands at the right time. This means doctors, pharmacists and patients getting enough advance notice from manufacturers so that treatment plans can be smoothly adjusted if needed and if possible. That is why the Minister of Health has been encouraging companies to fill information gaps around actual and potential drug shortages and make it a top priority.

Health Canada's collaborative work with industry has paid off. It has resulted in a commitment by Canada's research-based pharmaceutical companies and the Canadian Generic Pharmaceutical Association, of which Sandoz Canada is a member, to collect information from member companies on current and impending drug shortages. They have committed to communicating this information to Canadians on two existing public websites on drug shortages.

Industry, together with health professional associations, have also committed to the development of a national one stop drug shortage monitoring and reporting system in 2012. The minister commends companies that have stepped up to provide more information.

However, she is disappointed, and with good cause, that Sandoz Canada has not met this commitment in the current situation.

The government is disappointed with the lack of clear and timely information that Sandoz has provided to Canadians about this serious shortage. The company knew months ago that it was coming, but it did nothing to find other supplies until very recently and it only advised customers and Health Canada about the extent of the impending shortage a few weeks ago. I am cautiously optimistic that Sandoz has heard our concerns about information sharing and making information available as soon as possible to provinces, territories and medical professionals.

While Health Canada officials were speaking with Sandoz about possible disruptions in light of the FDA warning letter, requests for specific details about which drugs would be affected were not responded to. Today the company has said that it is responding to the Minister of Health's concerns about transparency, committing to share information about potential future drug shortages 90 days in advance.

I want to encourage Sandoz by saying that if the company were to take this step, it would go a long way to rebuilding trust that patients need for the company to be successful in the long run.

Drug Shortages
Emergency Debate
Government Orders

5:10 p.m.

NDP

Isabelle Morin Notre-Dame-de-Grâce—Lachine, QC

Mr. Speaker, the parliamentary secretary spoke a great deal about the role of the federal government in all this, and he also bragged about what Health Canada is doing.

Health Canada currently has a voluntary reporting system. What we are asking for is that the system be mandatory in order to have drug producers tell us in advance if they are going to have a problem with certain drugs so that we can plan for it. It is not true to say that the federal government does not have a role to play in this.

I would like the member opposite to explain why he says that this is not the federal government's role. I do not know where he gets that idea, but imposing a mandatory system falls under our federal jurisdiction. I would like to hear what he has to say about that.

Drug Shortages
Emergency Debate
Government Orders

5:10 p.m.

Conservative

Colin Carrie Oshawa, ON

Mr. Speaker, the member's question is being asked by a lot of people. What she does not understand is it is the provinces and the territories that sign the contracts with the companies and the suppliers. Any of the details within those contracts are details between the provinces and the suppliers. As I said in my speech, even if we brought this forward, I doubt the provinces would want to give us that information. Frankly, the provinces, within their jurisdiction, could make these regulations.

I would encourage her to look at the jurisdictional issues and encourage her province, if it wants to take this step forward, to go ahead. I think it could do that.

Drug Shortages
Emergency Debate
Government Orders

5:10 p.m.

Liberal

Hedy Fry Vancouver Centre, BC

Mr. Speaker, I listened carefully to the hon. member make statements about what he saw as the federal role and what the federal jurisdiction was about. The member says that it is obviously the provinces that are at fault for sole sourcing. He said that Sandoz was at fault for not telling everybody on time.

The hon. member has pointed out why a voluntary system does not work, if the government does not get the warning on time. However, the hon. member also took responsibility as a federal government for the manufacturing, the quality control, the contamination, and all that occurs in the manufacturing plant.

I keep asking this question and I would really like to hear an answer. Given that the Food and Drug Administration in the United States pointed out the problem in 2009 and given that the Minister of Health passed the inspection of Sandoz just prior to the second letter from the FDA in 2011, why does the government continue to say that it did not know? If it did know, and it knew the provinces were sole sourcing, then why did it not warn the provinces back in November 2011?

Drug Shortages
Emergency Debate
Government Orders

5:10 p.m.

Conservative

Colin Carrie Oshawa, ON

Mr. Speaker, if members listened to the question, it was quite convoluted. It went every which way. I am not sure if it takes me up to Nunavut and back again.

I would like to answer the question the member brought forward and, if she was paying attention, the minister did answer that in her speech.

The drug that was found in Sandoz manufacturing was manufactured for the American market. It was not a drug that was being sold on the Canadian market. Health Canada went into the plants and determined that the drugs made for the Canadian market were fine and it did not find any problems with them.

The member is getting this mixed up between the American and Canadian markets. Some of the comments seem to be mixed up with the Canadian and American systems.

We are very proud of the Canadian health care system and we are committed to working with the provinces and territories because it is within their jurisdiction. We want to help them come up with a good solution for Canadians.

Drug Shortages
Emergency Debate
Government Orders

5:15 p.m.

Green

Elizabeth May Saanich—Gulf Islands, BC

Mr. Speaker, I hope members will bear with me. I want to ask a question that goes above and beyond the current moment of crisis.

We seem to have a persistent problem of accessing painkilling drugs globally and we recognize that. However, there has been an idea that has been floated for a number of years with the Senlis Council relating to Afghanistan. The hon. member may know where I am going with this question now.

There has been some very viable and impressive proposals to use poppies for medicine. In Afghanistan, there is an ongoing problem of development, poverty and conflict. A solution that makes sense to us in the Green Party is a system to develop painkillers from the poppy crops of Afghanistan. This industry would be legal and end the heroine trade, which is illegal and dangerous. It would provide painkilling opiates and the shura councils would be the local coordinators of this in Afghanistan.

I would add that this has been done in Turkey and it worked. It shut down the illegal opium trade by creating a safe, secure supply of painkilling drugs to the world, while also providing some sustainability to those farmers and that—

Drug Shortages
Emergency Debate
Government Orders

5:15 p.m.

Conservative

The Speaker Andrew Scheer

I have to stop the member there. The parliamentary secretary has about 30 seconds to respond.

Drug Shortages
Emergency Debate
Government Orders

5:15 p.m.

Conservative

Colin Carrie Oshawa, ON

Mr. Speaker, I did see the newsreels today with this proposition brought forward. Unfortunately, at this stage of the game I have not had a chance to really look at what the report had to say, so I cannot make an educated comment on her question. I will try to look into it further and see if we can have a conversation later.

Drug Shortages
Emergency Debate
Government Orders

5:15 p.m.

Conservative

Joy Smith Kildonan—St. Paul, MB

Mr. Speaker, I am pleased to speak to this important issue. Primarily, though, I know a lot of this is under provincial jurisdiction, but this is an emergency debate that has to be addressed.

It is important to understand the issue of drug shortages and the roles and responsibilities of all the groups involved in the aspect of drug shortages. This involves many people, industry health professionals, provincial and federal governments and third-party people.

Drugs are manufactured and supplied by industry. It is generally accepted throughout the world that industry is most appropriately placed to understanding the supply needs for its product, for managing its inventory to meet these needs and understanding the potential impacts of supply interruptions on its customers. It is up to customers, which include governments, to get the right deal with the right guarantees to meet their needs.

Health Canada has no authority to require manufacturers to bring products to the Canadian market or to require them to maintain adequate supplies to meet the needs of patients. These are very important decisions in the supply chain, but they rest with manufacturers. As a regulator, Health Canada's primary role is to ensure that drugs sold on the Canadian market meet high standards with respect to safety, efficacy and quality. This includes: reviewing product submissions for market authorization; inspecting and licensing facilities that manufacture, distribute, import, test, label or package health products; enforcing good manufacturing standards; and conducting post-market safety surveillance. Most of these activities are very technical and involve a wide variety of scientific and medical experts. I will explain each activity in simple ad clear terms without all the confusing technical jargon.

Before a drug is authorized for sale in Canada, it must undergo a pre-market assessment of safety, efficacy and quality by Health Canada. When a manufacturer decides it would like to market a drug in Canada, it files a submission with detailed information about a drug's safety, efficacy and quality. Health Canada does not solicit submissions for market authorizations. Aside from the basic administrative details, a drug submission has three important elements.

The first is the data and information about the safety and efficacy of the product. This includes detailed results of studies conducted on animals and humans to identify the potentially beneficial and harmful effects of the drugs. I am told that these studies are usually conducted over several years and can involve hundreds or even thousands of patients.

The second element of a submission is the quality information. This includes details of the product development, method of manufacturing and the controls and tests to be used to measure the drug's quality.

Finally, the third element is the product information. This is the information that will be given to patients and health professionals to explain when and how a drug should be used, as well as outline possible side effects that patients might experience.

I am told that a drug submission typically consists of between 100 and 800 binders of data that have to be carefully evaluated by the department's scientific experts. Evaluation of the submission is typically done in three stages, and that is screening, scientific review and then finally the label review. During this process, Health Canada may request additional information from the applicant to clarify information in its submission. For many instances, Health Canada will seek the advice of domestic and international experts, including trusted regulatory agencies in other parts of the world, such as the United States or Europe.

All drugs have side effects and risks associated with their use. The goal of this review is to determine that the product's benefits outweigh the risks. Only when they do, it has market authorization, including a drug identification number or notice of compliance issued to permit the sale of the drug in the Canadian market. Most submissions are reviewed in the order they are received. However, in exceptional circumstances, Health Canada has the discretion to expedite the review of a drug submission. This is a submission management tool that can be used to help maintain access to critical drugs in Canada.

I would also like to talk about the review process for generic drugs, since this is where most shortages seem to occur.

I have just outlined the main elements of a submission for market authorization. These elements are the same for generic and brand drugs. All products must have filed sufficient evidence of their safety, efficacy and quality before they can be sold in Canada. However, the type and amount of data required to demonstrate this are quite different for brand and generic drugs.

For generic drugs, a manufacturer must demonstrate that the drug product is comparable to a Canadian brand name counterpart. This means that the generic product must contain the same active medicinal ingredient, strength, dosage form and route of administration as a brand name product. This ensures that the generic drug will have the same clinical effects as a brand name drug.

In addition to the pre-market assessment done by Health Canada for each drug, all facilities that manufacture, package, label, distribute, import or test a drug must hold a valid Canadian establishment licence. The purpose of establishment licensing is to make sure that what was approved when the market authorization was granted is made consistently and to safety standards. For example, each and every pill must have the same consistency and contain no contaminants. This is achieved by making sure that everyone involved in the supply chain, including manufacturers, is following an internationally recognized standard for manufacturing practices known as good manufacturing practices, or more commonly as GMP.

The key elements of good manufacturing practices include, among many other things, qualified personnel, validated equipment to prove procedures, suitable storage and transportation, and proper record keeping. Drug establishments in Canada are inspected by Health Canada and an establishment licence is only issued if Health Canada is satisfied that the site meets the good manufacturing requirements.

For foreign sites, Health Canada uses its mutual recognition agreements or other similar instruments to assess and access the quality of products that are imported for sale in Canada. It is important to note that the companies doing business in Canada that supply foreign markets must meet that foreign jurisdiction's requirements.

Health Canada does not have responsibility there and has no authority to manage how industry addresses these requirements. Once an establishment is licensed, however, it is inspected by Health Canada on a cyclical basis. The inspection cycle is variable, depending on the activities conducted at each manufacturing facility and their track record. These inspection cycles are in keeping with those of our international regulatory partners.

During the course of an inspection an inspector may face situations where the facility does not comply with Canadian standards. All compliance and enforcement actions to be taken are assessed on a case-by-case basis according to the principles outlined in Health Canada compliance and enforcement policies. The primary objective of any compliance and enforcement strategy is to manage the risk to Canadians and to use the most appropriate level of intervention to ensure that the responsible party comes back into compliance.

Several factors are used by Health Canada to determine appropriate enforcement action, including risk to health and safety, compliance history of the regulated party and the degree of co-operation involved. In very exceptional circumstances and without compromising health and safety, Health Canada may also consider the potential impacts of enforcement action on product availability. In general, when a non-compliance issue is identified, it is brought to the attention of the company or individual involved, who is then responsible for proposing an action plan to resolve the non-compliance issue.

Health Canada assesses the acceptability of the action plan in order to grant compliance with Canadian requirements. It is the company's responsibility to take action in a timely manner to resolve all issues identified during the course of an inspection and ultimately to meet Canadian legislative and regulatory requirements. If a company is unable or unwilling to comply with Canadian requirements, enforcement actions are considered.

There are several measures that Health Canada can use when a regulated party does not comply with the regulations. Health Canada may cancel, refuse, suspend or amend an establishment licence, or issue a warning or publish a public communication to all Canadians.

In addition to post-market activities related to the establishment licences, manufacturers must monitor the safety of their product on an ongoing basis. Health Canada plays an instrumental role in monitoring the safety and effectiveness of health products once they are on the market.

To facilitate adverse drug reporting, Health Canada has developed a website, set up a toll-free number, as well as reporting centres across Canada. Health Canada also receives and considers safety information from around the world. This is important because some safety issues are very rare and can only be detected in larger populations.

Drug Shortages
Emergency Debate
Government Orders

5:25 p.m.

NDP

Libby Davies Vancouver East, BC

Mr. Speaker, this is actually a question I had hoped to ask the parliamentary secretary, but time ran out. I know that the hon. member across the way is also the chair of the health committee, so I am hoping that she might be able to provide some information.

One thing we know is that the Minister of Health has said that the government will speed up the approval process for new suppliers. The question, though, is where will those suppliers be and will they be more generic producers or those of higher-priced prescription medications? This is something that is obviously of concern to the provincial health authorities and hospitals because their supplier was a generic supplier. If the alternative suppliers the government says it is looking to expedite are basically non-generic brand names, this will obviously have severe cost implications.

I wonder if the member might be able to address that as a member on the government side and chair of the health committee. Does she know whether it will be generics or brand names?

Drug Shortages
Emergency Debate
Government Orders

5:25 p.m.

Conservative

Joy Smith Kildonan—St. Paul, MB

Mr. Speaker, as we know now, Health Canada is expediting our authorization processes during the ongoing Sandoz shortage to help hospitals and doctors assess alternative sources of supply in all areas. It is never at the expense of safety, however. Never. The last thing anyone wants to happen is for a patient to be harmed by unsafe drugs authorized in a rush to fill supply gaps. As we know, those supply manufacturers are selected at the provincial level by provincial governments.

Health Canada's rules and regulations for authorizing drugs and the plants they are manufactured in are designed to ensure that drugs sold in Canada are safe, effective and of high quality.

Drug Shortages
Emergency Debate
Government Orders

5:25 p.m.

Liberal

Hedy Fry Vancouver Centre, BC

Mr. Speaker, my question for the hon. member is about the fact that everyone has admitted there is no oversight body, whether in the government or not, and no third party oversight body to look at the whole issue of identifying, anticipating and doing something about impending drug shortages so they do not occur. We are speaking now about provinces bulk buying and buying from sole sources, et cetera. This may very well be for generic drugs only and certain things that are used in hospitals, but if we have a global shortage of drugs, what happens when we need to access a drug?

Pharmacists are saying their ability to access drugs is compromised. They are waiting for drugs and there are shortages. Accordingly, there needs to be some kind of body that anticipates a shortage, identifies which drug will be in short supply and finds a way well before we do the kind of emergency procedure that was done to try to find whatever drugs we are missing. It is not always going to be this easy.

I would like the member to tell us what the government proposes to do to protect patients who are currently at risk.