Mr. Speaker, I rise before the House today to address a subject that is important to the health and well-being of Canadians. We know our health care system relies on a safe, secure and reliable supply chain for medicinal drugs and our country's doctors need to know that when they write prescriptions for patients or make requests for drugs to be available during surgery, that they will be there.
Health Canada is our country's regulator with regard to the safety, quality and effectiveness of the drugs available in Canada, but it is up to industry to produce drugs and it is up to the customers purchasing those drugs to ensure their suppliers will be able to fill their requests. That is the system we have created in conjunction with the provincial and territorial governments. Those are important facts that should not and cannot be lost in this debate. The circumstances that have led to the current situation have raised several red flags with regard to how some provinces have chosen to source their medicinal drugs. Unfortunately, the situation is more difficult than it might have been if Sandoz Canada had taken the steps we expect a drug manufacturer to take in these kinds of circumstances.
Last November, four months ago, Sandoz was notified by the U.S. FDA of concerns about production quality standards related to one product at its Boucherville plant and that product was not even produced for the Canadian market. Similar FDA findings were made about two Sandoz plants in the United States. It is important to note that at no time did the FDA find that the production issues were of such gravity to require Sandoz to cease production at any of these facilities. At no time before mid-February was notice given to anyone, neither Health Canada nor the country's customers, that this issue with just one product line at Boucherville would have such major supply consequences for all Canadians.
Following up on the FDA findings, my department inspected the plant and found it to be compliant with our rules for safe, quality production. My officials held discussions with the company about how it planned to address the FDA findings, but the size and scope of the company's production cutbacks was never revealed. That is, until February 15, when Sandoz simultaneously informed Health Canada and its customers that it was significantly cutting the output of medically necessary products from the plant. When the company was asked what alternate sources of supply it had secured to make up for the shortfall for its customers, it said that it was just starting to do that.
Sandoz made a decision to temporarily stop production of some products without first finding alternate sources for its customers who needed these drugs. Technically, its customers may be provincial or territorial governments and health authorities. It is the provincial and territorial governments that are responsible for the delivery of health care. They are the ones that deliver to Canadians in need of medical treatment. Ordinary people who are sick or in pain are the consumers and they are vulnerable. Sandoz has a responsibility to see that its customers are informed of anticipated shortages as soon as it becomes aware of the potential problems so Canadians are not left without an essential supply of its products.
Since December, there have been two public websites up and running that Sandoz could have used to post warnings of these anticipated shortages. It did not post that information until it was urged to do so by my officials at Health Canada. In a letter sent to Sandoz 10 days ago, I made it clear that I was disappointed with its lack of transparency and its failure to secure an alternate supply of drugs for which production was being interrupted. Hospitals and clinics, bulk drug purchasers, provincial and territorial governments and Health Canada have had to poke and prod Sandoz at every turn. Supply pledges made by this company have frequently not been met by distributors. Sandoz has promised to provide updated supply information to health professionals, but their worried calls to my department for help indicate that either the information or the supply, or both, are not getting through.
On Sunday, March 4, Health Canada became aware of a fire at the Boucherville plant through media reports. My department officials also received an email from Sandoz on March 4 confirming the facts. My officials urged Sandoz to go public with information about the fire, especially with their customers, again, the provinces and the territories.
When it became clear that information was not forthcoming, my officials advised the provinces and the territories of the fire, at noon on March 6. At the urging of my department, and only after we had advised the provinces, Sandoz finally issued a press release March 6. Only then did it publicly concede that the fire had forced a suspension of all production at the plant for at least a week. It took the company almost three weeks after the February 15 notification to deliver submissions for alternate supplies to my department in order that they be assessed for safety and effectiveness.
Sandoz is now scrambling to come up with a plan to solve the problem that interrupted production and created that shortage. Sandoz is also working to find alternative suppliers to make up for the shortfall from its production line.
I want to assure members of the House that our government is doing everything within its power to help minimize the impact of the shortage on hospitals and patients. We have been working around the clock to provide support to the provinces and the territories as they manage their drug supplies for their jurisdictions.
As I have mentioned, the current situation has highlighted the fact that there is over-dependence on the part of the provinces and the territories on a single supplier for essential drugs. The provinces and the territories cherish their independence when it comes to choosing suppliers. Provincial and territorial health authorities have set up bulk buying groups to purchase medically necessary drugs for patients. These groups sign supply contracts with drug makers. They determine who their supplier is, how many suppliers they need and establish penalties for non-delivery. In short, they are the ones that enter into contracts with industry. If they decide to enter into a contract with a sole provider, it would be beneficial to also have a backup plan.
There is ample evidence of more frequent drug shortages, but we have not seen a parallel increase in the sharing of shortage information or advanced planning on the part of drug purchasers or suppliers. Purchasers express surprise and frustration at shortages that have appeared to come out of the blue, but rather than seeking multiple sources as a cushion against supply interruptions, we have seen a great reliance by them on fewer suppliers. Producers do not appear to have done any real work to identify alternate sources in advance, even though they are fully aware of the global supply constraints.
While we respect their independence, we would advise against creating a supply chain that is reliant on just one supplier. Our advice has been, and continues to be, that provincial and territorial governments not become overreliant on one source of medicinal drugs.
What role does our government play? We are assisting the provinces and the territories by identifying approved Canadian suppliers for drugs if their current source should be unable to fill a request. When asked, we are fast-tracking approvals of products, including those produced abroad, without compromising our higher standards of safety. We are ensuring that all of the important players are in contact with one another and that they have the latest information about potential or current shortages.
We have also been working with companies and health stakeholders to increase the amount of information available to Canadians on potential and actual shortages. In fact, I initiated this last summer when I wrote to industry with a request to find an efficient way to inform those purchasing drugs of potential or upcoming shortages. In these situations there is no substitute for advance information to allow doctors and patients to adjust treatment.
To date, industry has started to respond and we have had some success on this front. Two websites are now being used to post such information. Industry and professional health care associations also need to do their part and continue to work on information sharing and ensuring they create stability in their supply chains to prevent drug shortages from occurring. When supplies are interrupted, hospitals, clinics and health professionals implement strategies to ensure the most efficient use of existing supplies and to minimize impact on patients. They keep patients advised of the supply situation in each facility and community and adjust treatment schedules and procedures, if needed.
Our approach on this has been to strongly encourage industry to be more open with information about shortages. If industry fails on this front, we will consider regulations that would require drug manufacturers and suppliers to provide information about potential shortages in a timely manner. Sandoz has committed to posting information for health professionals on current and potential drug shortages on its website, on the University of Saskatchewan Drug Information Services site and an equivalent French-language site. We expect Sandoz to keep providing information on what products may be in short supply. The timeliness and completeness of the information Sandoz provides will be closely monitored to determine if changes need to be made in the future to ensure Canadians have access to the information they need.
I have advised Sandoz that providing timely, accurate and comprehensive updates on the supply situation to its provincial and territorial customers is key and anything less is unacceptable. I was encouraged to hear about the letter that Sandoz sent out today in response to my letter to it, saying that it would respond to our call for transparency and sharing of details about drug shortages in the future a full 90 days in advance. I only wish there had been 90 days notice in this instance before the company had made changes to its level of production. I will choose to take Sandoz as its word, but will re-emphasize that millions of Canadians will be watching closely to see if it follows through. For information on any actual potential local impacts, we encourage Canadians to contact their local health care authorities or health care professionals. Health care professionals may wish to contact the company directly for more information.
As we work our way through the situation, the well-being of every patient and the health and safety of all Canadians will always be our priority if faced with an actual or potential drug shortage. Doctors, pharmacists and patients need enough advance notice from industry so treatment can be planned in accordance with the supply of medicines available.
My department is the driving force behind the posting of information on shortages by industry on the public website where Sandoz is now posting shortage information. This is an important first step in responding to my call for increased transparency on drug shortages, but I have also called on industry and health professional stakeholders to follow through on their pledge made in the fall of 2011 to create a national one-stop drug shortage monitoring and reporting system in 2012. The Sandoz situation has underlined the urgency of completing this work as soon as possible.
My department has a variety of tools available to help minimize the impact of any shortage. We will work to help maintain the supply of high-quality, safe and effective drugs by working closely with companies so they can quickly resolve any issues related to the manufacturing process, the quality of the products and any issue related to distribution. We are working with the manufacturers to ensure that any changes in the manufacturing process or location can be reviewed and authorized on a priority basis. That would also include any requests to supplement the supply from another manufacturer. We will be ensuring that all the necessary licensing requirements are met so there is always the assurance that drugs are safe and effective.
We are working with our international counterparts, such as the U.S. Food and Drug Administration, to identify additional sources of supply and to share information. We will also be making sure that the necessary information is available to the provinces and the territories for access to alternatives should there be an emergency. In other words, we will use all of the means at our disposal to help ease the impact of any shortage. Our response will be tailored to the situation as it arises.
Canadians can be assured that Health Canada is already fully engaged in our response to this situation, and we are equally ready to adapt our response as the situation evolves.
We also strongly encourage provincial and territorial health authorities to source drugs from multiple suppliers so that they are not vulnerable to production interruptions from a sole supplier.
It is also worth reminding members of the House that drug shortages are a worldwide preoccupation.
Members may recall the isotope shortage not so long ago. This is an example of how we had to collaborate with the provinces and the territories, as well as health care providers in order to find alternatives for imaging and tests that were much needed by cancer patients. There were a lot of positive lessons learned from that experience, and we are much better accustomed to finding alternatives.
Health professionals are equipped to recommend alternative drugs for patients when shortages do occur. Through our co-operative relationships with trusted regulators, such as the U.S. FDA and the European Medicines Agency with high safety standards like Canada, we have ready access to a wealth of information that will speed up our approval process for new sources.
We are expediting our authorization processes during the ongoing Sandoz shortage to help hospitals and doctors access alternative sources of safe supply. We will never compromise safety.
We have a team of experts assigned to deal with shortage requests. We are providing guidance to purchasers so that they have a clear understanding of the safety information we require when a new source of supply is found.
Overall, Health Canada's rules and regulations for authorizing drugs and manufacturing plants are designed to ensure that drugs sold in Canada are safe, effective and of high quality. Our safety standards are high because the health and safety of Canadians are what matter most.
Canadians deserve the maximum protection from drugs that are unsafe or do not work. We apply the same standards to all drugs, whether they are made in Canada or imported from another country.
Proof that a drug will improve the medical condition for which it is manufactured is required. We will authorize a drug only after we determine that the potential health benefits for patients outweigh the potential risk of using the drug.
We also require that drugs be packaged and distributed with information that will help doctors and patients make informed choices about their use. Drugs must be made by qualified, trained personnel and in a plant that is equipped to make and store the drugs according to the approved formula without contaminating it. A drug must also be tested for safety, effectiveness and quality before it leaves the plant, and it must be labelled correctly.
These are the standards to which we will adhere throughout any shortages, but working within the regulatory framework, we believe that we can help alleviate the shortages as they arise. We will help by sharing information between governments, health professionals and stakeholders. We will continue to work with manufacturers and stakeholders to share all relevant information on potential and actual shortages. Having a reliable source of information will give doctors and other health professionals the time and the opportunity to adapt according to the predicted supply disruptions.
When alternative supplies are identified, we will fast-track approval without compromising safety.
We will keep working with Sandoz to keep abreast of the production levels at the Boucherville plant so that we can interpret the impact any change might have on Canadians.
We will be making sure that all of the important players are in constant touch with one another and that they have the latest information about potential shortages.
There is nothing more important to this government than the health and well-being of Canadians. As we work our way through the current situation, we will also be looking to the future. We will be looking for ways to help the provinces and territories create a drug supply system that does not leave Canadians vulnerable because of changes on a single production line.
From now on drug suppliers and purchasers have to break with comfortable and profitable supply habits and assumptions. From now on we as a country cannot allow ourselves to remain in a position where the decisions of one drug maker can so seriously disrupt the entire health care system.
In fact, all of the players in our drug approval and supply system have to be sure that their thinking and planning is always with a goal that is in the best interests of the patients and their needs. Canadians deserve nothing less.
