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.