Mr. Speaker, I would like to inform you that I will be splitting my time with the member for Lotbinière—Chutes-de-la-Chaudière.
When I rise in the House to address an issue I am pleased to do so, but not tonight. The very serious shortage of medically necessary drugs that has brought us to this emergency debate could have been mitigated if only Sandoz Canada had planned ahead and had been transparent with its customers. I must say that the more I learn about the company's behaviour, the angrier I get.
We can discuss every aspect of the drug shortage issue tonight. We understand that it is a complex global phenomenon with many causes.
We know of the serious work that our Minister of Health has done to bring purchasers and suppliers together to find a co-operative Canadian solution to this global challenge. These solutions are based on information sharing and solid contingency planning. They are direct, efficient solutions based on a clear and logical understanding of how the drug approval and supply system works in Canada. The minister's goal has been to help ensure that the right information gets into the right hands at the right time so that advance planning and notice can take place, alternative sources of supply can be found and treatment plans for patients can be adjusted if necessary.
I read the newspaper over the weekend. The warning system does not work well when the warning comes too late. Sandoz clearly did not warn the world about a looming shortage until it was too late to avoid it.
Last November, four months ago, Sandoz was notified by the U.S. FDA of concerns about production quality standards related to one product at its Boucherville plant. This product is not even produced for the Canadian market. Similar FDA findings were made at the Sandoz plants in the United States. It is important to note that at no time did the FDA find that the production issues were of such gravity to require Sandoz to cease production at any of these facilities.
As we all know, Sandoz is a virtual sole supplier of many medically necessary drugs for hospitals and clinics across the country. However, members now know that because of the painful events of the past few weeks, Sandoz was presumably aware of these facts in November. Nonetheless, before the middle of February, the company did not give full details of its plan to shut down its plant in Boucherville. This is especially concerning, considering it would have major supply consequences for all Canadians.
Following up on the FDA findings, Health Canada inspected the plant and found it to be compliant with our rules for safe, quality production. The department's officials held discussions with the company about how it planned to address the FDA findings, but never during those discussions were the full details or plans of the company's production cutback revealed, that is until February 15. That is when Sandoz simultaneously informed Health Canada and its customers that it was significantly cutting the output of medically necessary products from the plant.
When the company was asked what alternative sources of supply it had secured to make up shortfalls for customers, it said that it was starting to do that. So the company dropped a bombshell like this on the Canadian health care system and then said it was just starting to identify other suppliers. Sandoz did not even include an estimate of how long the shortages would last. It had to be asked.
The House has been aware of the work that the minister has done to encourage drug makers to be more transparent with customers and Canadians about drug shortages. Early last fall, she received a commitment from several professional and industry associations for a voluntary plan to provide more timely, accurate and comprehensive information about drug shortages to health care professionals and patients across Canada.
Sandoz Canada is a member of the Canadian Generic Pharmaceutical Association which contributed to the development of this plan. However, I have to say that the abject failure of Sandoz to date to provide clear, precise and timely information on the massive impact of its production cutbacks is completely contrary to the spirit and principles of the pledge made in the fall.
The information provided to Health Canada officials, the media and the public has been, at best, reactive, fragmented and incomplete. As a result of this information vacuum, health care providers across the country find themselves having to piece together the full scope and extent of the supply situation and scramble to maintain patient care. Hospitals and clinics, bulk drug purchases, provincial and territorial governments and Health Canada have had to poke and prod Sandoz at every turn. Supply pledges made by the company have frequently not been met by distributors. Sandoz has promised to provide updated supply information to health professionals, but their worried calls to Health Canada for help indicate that either the information or the supply, or both, are not getting through.
Then on Sunday, March 4, Health Canada became aware of a fire at the Boucherville plant through media reports. Health Canada also received an email from Sandoz on March 4 confirming there had been a fire. Health Canada urged Sandoz to go public with information about the fire, especially with its customers, the provinces and territories.
When it became clear that information was not forthcoming, at noon on March 6, Health Canada advised the provinces and territories of the fire. At the urging of Health Canada, and only after Health Canada had advised the provinces, Sandoz finally issued a press release on March 6. Only then did it publicly concede that the fire had forced the suspension of all production at the plant for at least a week.
It took the company almost three weeks after the February 15 notification to deliver to Health Canada submissions for alternative supplies to be assessed for safety and effectiveness.
Health Canada is expediting its authorization process during the shortage to help hospitals and doctors access alternative sources of supply.
Through the various networks supported by the health portfolio, we have been taking a leadership role by bringing together purchasers, provinces, territories, health care professionals and Sandoz to exchange the latest information on supply and to ensure that our collective efforts to address shortages are coordinated. Health Canada has a team of experts assigned to deal with shortage requests.
We are providing guidance to purchasers so they have a clear understanding of the safety information we require when a new source of supply is found. Through our co-operative relationship with other trusted regulators with high safety standards like Canada, such as the U.S. Food and Drug Administration and the European Medicines Agency, we have ready access to a wealth of information that will expedite our approval of foreign sources.
I want to assure Canadians that, notwithstanding these urgent circumstances, we will never compromise safety. The last thing anyone wants is for patients to be harmed by unsafe drugs authorized in a rush to fill supply gaps.
In Canada, the federal government has taken a leadership role in encouraging enhanced co-operation among all players in the drug approval and supply system. The Sandoz situation shows there is still a lot of work to do to improve information sharing and contingency planning by purchasers and suppliers. It is still our hope that this will happen. We believe that a voluntary purchaser-supplier solution is the most effective and efficient way to handle shortages. If necessary, the government will regulate mandatory advance notification in order to ensure Canadians get the information they need and deserve.