Thank you very much.
Madam Chair, members of the committee, on behalf of the 1,900 members of the Canadian Anesthesiologists' Society who are practising anesthesia in Canada, I would like to thank you for this opportunity to participate in these hearings about the role that governments and the pharmaceutical industry play in ensuring Canada's supply of the drugs we require to meet Canadian health care needs.
This subject is drawing significant attention now from governments, from the media, and from the general public. Much of that attention arose from letters sent by Sandoz, a generic drug manufacturer, to its customers in mid-February of this year announcing that the company's Canadian manufacturing facility in Boucherville, Quebec, would be closed to redress manufacturing issues identified by a recent site visit by the U.S. Food and Drug Administration.
Those letters triggered a very real crisis in Canada's drug supply. I'll have more to say about that in a moment, but first I want to make it very clear that for Canada's anesthesiologists our drug supply concerns did not begin and will not end with the current Sandoz difficulties.
In January 2011, more than a year before the Sandoz letters, we wrote to the federal Minister of Health to say our members were reporting shortages of Propofol, a preferred anesthesia induction agent, and were concerned about reports of reductions in supply of Pentothal, an older but still useful drug.
We asked, “Does Health Canada have a methodology to identify situations where supply constraints meet the definition of a drug shortage that requires prescribers to choose an alternate therapy?” To her credit, the minister has taken a number of initiatives to begin to address our concerns. But the simple answer to our question about the department's ability to identify and anticipate drug supply problems was “no” then and is still “no” today. The fact that we desperately need an effective system to predict, identify, and manage around supply disruptions is even clearer today than it was then.
Nothing proves that more convincingly than the sorry history of the Sandoz manufacturing interruption. That interruption meant that dozens of critical medications would no longer be manufactured, while others would be available on allocation, based upon previous usage, for anywhere from 12 to 18 months. As I think you know, in many cases Sandoz is the only Canadian supplier of essential medications.
There were immediate impacts on our members and the patients we serve. Hospital by hospital, anesthesiologists began to encounter shortages, and they found themselves operating in an information vacuum. How bad was the problem? What measures were being taken to resolve it, to locate alternative suppliers or medications? Who was managing this problem?
Of course, the anesthesiologists called us, asking what was going on and saying they felt out of the loop. As we looked at it more closely, we realized that we weren't being left out of the loop of communications, consultation, and joint planning to manage the crisis; there simply was no loop. The information, consultation, and joint planning that should have been flowing to and among industry, governments, and health service providers just wasn't happening. That's because we have no system in Canada today to make sure it does.
Your committee is focusing on the roles of industry and government in the drug supply. Let's start with industry. In this case, we are talking about Sandoz, a reputable and competitive generic drug manufacturer that succeeded in obtaining sole-source contracts for key medications. The chronology here is interesting.
Sandoz was informed by the FDA in November 2011 that they would have to upgrade their manufacturing facilities. We don't know if or when Health Canada and provincial ministries of health became aware of this FDA order, nor do we know if they understood the potential impact closing this manufacturing facility would have on Canada's drug supply. But we do know that Sandoz did not inform their customers, Canada's health care system, until mid-February. On February 15 and February 17 they sent out letters, first reporting on the FDA order and two days later announcing an immediate reduction in the available supply of essential medications.
Could it have made a difference if governments and people such as Canada's anesthesiologists had been informed earlier? That question answers itself. There could have been time for hospitals to stockpile drugs. There could have been time to arrange alternative supplies from other manufacturers or to source suitable products from outside of Canada.
As we understand it, Sandoz was under no legal obligation to provide the earliest possible warning about these supply disruptions to its customers or to the Government of Canada. From a purely commercial standpoint, keeping their sole-source position as long as possible by delaying the announcement might seem to make sense. But it makes no sense at all from a patient's perspective. I repeat, there was no legal obligation here apparently, but I leave it to you as to whether or not there might have been a moral obligation on the company to share this information as early as humanly possible.
As we go forward and hope to avoid any repetition of this debacle, I hope your committee will recommend in the strongest possible terms that Canada adopt legislation placing a clear onus on companies to immediately inform governments and the health services system of any events that may jeopardize drug supplies.
What about governments and their role in all of this? I think it's fair to say that governments at all levels have been too slow to recognize the fragility of Canada's drug supply system, and that fragility affects drugs across the spectrum of costs. Oncologists are encountering supply problems with higher-cost medications needed for chemotherapy. Anesthesiologists are encountering shortages of drugs that, relatively speaking, are inexpensive.
We think the root of the problem lies in the fact that governments have, understandably, not focused on drug costs, while taking it for granted—given the tens of millions of dollars we have to spend—that supply would just naturally be there. Clearly, that's wrong. It's not the way it works in the real world.
Frankly, we don't have the answers to this problem. We're anesthesiologists. Our focus is the inescapable reality that the quality of health care—and the health services experience for millions of Canadians every year—depends on the capacity for anesthesia to contain and limit pain and suffering. You have to help us make sure we have the tools to do that all important task.
Some measures seem obvious: no more single sourcing, for example, and better monitoring of the pharmaceutical universe across health services in Canada. As to other elements in our overall efforts to contain drug costs, we need a renewed sensitivity to their impact on drug availability.
We need a requirement for industry to tell about events that might disrupt the drug supply and an acceptance by government of a requirement to ask, to monitor and make sure.
I have two last points. The first is the reality we are living with today. The truth is that the Canadian health service system does not routinely know, with any accuracy, which medications are or are likely to become in short supply. As a result, far too often these shortages are addressed clinic by clinic, hospital by hospital, city by city, region by region, province by province, drug by drug, and manufacturer by manufacturer. That's what's happening now in Canada with respect to the Sandoz supply disruptions, and that's simply not good enough.
The last point I want to make is just how well men and women throughout your health services system are doing and dealing with this crisis, clinic by clinic, hospital by hospital, city by city, region by region, and province by province. We hear a lot of doom and gloom about Canada's health services, but I assure you, you'd be proud to watch hospital pharmacists and anesthesiologists as they manage around the shortages by substituting one drug for another, or supplementing one with another, or manufacturing our own injectables from powder.
One final note. Canada is not alone in facing these challenges. Earlier this week, the WFSA, World Congress of Anaesthesiologists, in Buenos Aires, unanimously passed a resolution that called upon governments and industries to work with us to alleviate the drug shortage that affects patients all over the world.
So we're not alone, but the fact that there are new international problems of drug supply does not make it any less urgent that we take urgent action here in Canada.
That's the message Canada's anesthesiologists want to leave with your committee today. Our job is to keep pain at bay. We are very good at it. Please, urge the government to make sure we have the drugs we need to achieve that goal.
Thank you very much.