Thank you, Madam Chair.
Thank you for inviting me to appear before the committee.
CADTH is a not-for-profit corporation funded primarily by Health Canada and all the provinces and territories, with the exception of Quebec.
We are a health technology assessment agency. This means that we provide independent evidence-based assessments of the clinical effectiveness and cost-effectiveness of pharmaceuticals, diagnostics, and medical, dental, and surgical devices and procedures. We do not make the final decisions on what technologies will be funded by health ministries; however, our work informs technology-related decision-making.
The Canadian Agency for Drugs and Technologies in Health, CADTH, provides a range of services to support the effective management of pharmaceuticals and other health technologies in Canada.
The common drug review program supports coverage decisions by 18 of the 19 publicly funded drug plans in Canada. We do therapeutic class reviews on pharmaceuticals and conduct optimal use projects that encourage the appropriate prescribing and utilization of drugs and other health technologies.
CADTH's Rapid Response Service addresses urgent jurisdictional needs for information that informs policy and practice decisions about drug and non-drug technologies.
The agency also does large health technology assessments when warranted. For example, last year, we did a major review of robot-assisted surgery.
Finally, our horizon scanning products alert decision-makers to new and emerging health technologies that are likely to have an impact on the delivery of health care in Canada. As part of this service, CADTH also provides environmental scans of different health care issues, practices, processes, and protocols inside and outside of Canada.
That brings me to why the committee asked me to appear today. In March 2011 CADTH published an environmental scan on drug supply disruptions. The scope of this report is a bit beyond our normal mandate, as CADTH is not involved in pharmaceutical procurement or the drug supply chain. However, as the drug shortage issue was becoming more prominent, Health Canada asked us to provide them with some background information on this issue. The report we produced is publicly available on our website, and a copy of the report has been distributed to committee members. This document was referenced in the House of Commons on March 12 during the emergency debate on drug shortages.
I will now provide a brief overview of our findings on drug supply disruptions as presented in that report.
First, I want to be clear that CADTH's environmental scans are not comprehensive, systematic reviews. Typically they are very time sensitive, so the information is based on limited literature searches and personal communications. They are meant to be informative, but are intended to be considered along with other types of information.
Many factors can influence the occurrence and severity of drug shortages.
Shortages of the raw materials required to make drugs contribute to drug shortages and are believed to be particularly problematic when an active ingredient is obtained from a single raw material supplier.
Manufacturing issues may create or contribute to drug shortages; for example, quite often multiple products are produced on the same equipment, which means that an increase in production of one product will result in a delay in production of another. There can also be temporary or permanent discontinuation of products as manufacturers shift production or reallocate resources. There can be numerous other problems associated with production.
Business decisions by manufacturers can also lead to drug shortages. For example, company mergers can be a way to create internal efficiencies in response to economic downturns, patent expirations, or a lack of new products in the pipeline; however, when companies merge, less profitable product lines are often reduced or discontinued, and sometimes manufacturing facilities are closed. Mergers of companies with similar product lines can lead to product consolidation, possibly resulting in changing a multi-source product into a single-source product, and single-source products are the most vulnerable to shortages.
Another major factor is the reluctance by manufacturers to provide advance warning of potential disruptions. This can magnify the impact of a shortage.
Purchasing and distribution issues can also play a role in drug shortages. For example, the use of just-in-time inventory control practices that involve keeping minimal supplies of drugs in stock at all levels of the supply chain can result in an overall reduction of readily available drug inventories.
Strict enforcement of good manufacturing practices and other related regulations by drug regulatory bodies can also play a role in drug shortages.
Madam Chair, these are just some of the many factors that contribute to drug supply disruptions identified in CADTH's environmental scan.
The causes of drug shortages in Canada are believed to be multifactorial. It is difficult to determine the extent of drug shortages in Canada because manufacturers are not required to report disruptions in drug supply and because there is no single accountable Canadian organization that provides system-wide drug distribution oversight.
The current drug supply issues underscore the need for greater transparency in the system as well as for strategies at every level of the drug supply chain that help minimize disruptions to patient care.
Let me now briefly present a potential option for CADTH, should we be invited by the provinces and territories to play a role in managing future drug shortages.
CADTH is both a producer and a broker of evidence-based assessments of health technology. We are a credible and independent source of information. We have the skills and processes available to produce drug substitution advice, and we can broker such advice created by others. Because of our skills in searching, accessing, analyzing, and publishing evidence-based clinical information, we have an ability to be a central source of information relevant to a drug shortage.
The role that CADTH might be able to play could best be summarized as a clearinghouse of shortage information and relevant substitution advice, and perhaps to provide a link to currently available databases and information sources. Information from CADTH could be used to supplement local efforts and to support clinical decision-making at the patient-clinician interface.
We are currently exploring this potential role with our board of directors, with senior federal, provincial, and territorial officials, and with other stakeholders.
Madam Chair, thank you for allowing me to present to you today. I welcome any questions that you may have.
Thank you, Madam Chair, and thank you for the invitation to appear today.
The Canadian Pharmacists Association is the national association that represents individual pharmacists. Our members work in community, hospital, industry, and academia.
We are pleased that the committee has agreed to hold hearings into drug shortages. We suggested to the committee a year ago that such hearings be held and, in fact, the committee had scheduled hearings in March 2011, but the fall of the government and the subsequent election resulted in the cancellation of those hearings.
Although there's been a great deal of attention paid to drug shortages over the past months owing to the Sandoz situation, the fact is that drug shortages have been a serious problem for health practitioners and Canadians for at least two years.
CPhA identified the scope of this problem in a survey of our members that we conducted, and we released the report in December 2010. This work was prompted by reports that we'd been receiving as early as March 2010 about shortages. We've provided copies of this report for your information.
In the survey, you will note that 94% of pharmacists reported not being able to fill at least one prescription in the past week, with the average number of drugs in short supply being 10. At least half an hour per shift was being spent on drug shortages, although we heard reports of many hours per shift being spent addressing some significant problems. Most importantly, 70% of pharmacists reported their patients' health was adversely affected, and over 90% reported that patients had been significantly inconvenienced.
It's important to point out that dealing with shortages consumes a lot of pharmacist and physician time that should be available for direct patient care. It's only the diligent work by front-line health care professionals that's been able to limit the impact of shortages on the population.
Although it is difficult to say whether drug shortages have increased or decreased in scope or duration since that time, the fact remains that drug shortages are a source of serious concern for the Canadian health care system. The events related to the Sandoz shutdown are just the latest manifestation of what has been a major concern for some time.
As an association we've worked with government, industry, other pharmacy groups, and other health practitioners to look at responses and solutions to this problem. In the fall of 2010 we held meetings with industry groups, wholesalers, and other stakeholders to better understand the causes of the problem. That prompted us, later that year, to release our guide to addressing drug shortages to our members as one tool available for pharmacists to deal with shortages when they occur.
There are many aspects of the problem, including causes that we could discuss today—and Dr. O'Rourke has mentioned a number of the causes—but given the time constraints, I'd like to take a few moments to outline a number of the solutions and recommendations that we feel are needed to address not just the Sandoz-related shortages, but the full range of shortages that are plaguing our health care system.
First, we were pleased to see the House of Commons unanimously adopt a motion on March 14 that called for the development of a national strategy to address the long-term issue of drug shortages. We applaud parliamentarians for recognizing this need and would encourage the minister to take the lead on the development of a national strategy.
Second, in response to the Sandoz shutdown, we have welcomed Health Canada's efforts at sourcing alternative supplies and expediting approvals of equivalent or alternative drugs. However, this proactive approach to sourcing supply in the event of a shortage should not be restricted to drugs impacted by Sandoz. This is a role that we believe Health Canada could and should be playing at all times to proactively address shortages. This is the role that the Food and Drug Administration plays in the United States, and we would argue Health Canada could be doing the same.
We would also like to see an increase in effective collaboration between Health Canada and the FDA on drug regulatory aspects related to drug shortages.
Third, governments and large purchasing bodies need to be aware of the risks associated with tendering systems that result in sole-sourcing. Although it is true that sole-sourcing, which is often associated with bulk purchasing, can lead to lower prices, the fact is that when problems are encountered by that sole-source producer, shortages can and will be the result.
Sandoz, which supplies approximately 50% of Canada's injectable pharmaceuticals, is a perfect example.
We understand that HealthPRO announced before this committee last week that they have introduced a new policy whereby they will seek secondary suppliers for hospital drugs when alternative suppliers exist. This is a very welcome development, and one we would encourage other group purchasing organizations and provinces to adopt. However, we wish to point out that in many existing contractual agreements, clauses exist to impose a penalty in the face of failure to supply, yet it is our understanding that these clauses are seldom implemented.
Fourth, in order to ensure that health practitioners and the general public have the most up-to-date information possible, the Canadian Pharmacists Association established in March 2011 a stakeholder working group on drug shortages to develop a voluntary drug shortages reporting system.
Today I'm joined by my colleague Jeff Morrison, who's been the chair of that working group.
An initial version of that reporting system went live in November 2011. Information populating the system is being fed by member companies of Rx&D and the Canadian Generic Pharmaceutical Association. It was announced just last week that this information is now being collated on one centralized website, at www.drugshortages.ca.
The working group is now working on a more robust system that would, we hope, contain therapeutic alternative information and that would allow health practitioners to report directly into the system to validate a shortage. While the industry associations have committed $200,000 towards the establishment of this system, we need to put in place a sustainable funding model to ensure continuity of this reporting system.
Fifth, this is not just a Canadian problem. It is a global problem, and therefore requires global attention. Last fall we were successful in getting the council of the International Pharmaceutical Federation to issue a statement calling for global action on drug shortages.
We strongly recommend that the Minister of Health request that the World Health Organization and the Organisation for Economic Co-operation and Development add this issue to their agendas and immediately look into the global causes and solutions to drug shortages from an international perspective.
Lastly, we need a forum to bring together all stakeholders, particularly manufacturers and regulators, to identify the root causes of drug shortages, provide more information to the discussion, and then, more importantly, identify what solutions can be implemented to alleviate shortages. Reporting on shortages and dealing with them when they occur is all fine and good, but our goal should be nothing less than to prevent any shortage before it can interfere in the care of even one Canadian patient.
In closing, I would like to emphasize that is not only an access to care issue but also a patient safety issue. The uncertainty and inconvenience created through having to manage a lack of supply can result in patients receiving less than optimal treatment and increases the risk of error. Shortages also take up a lot of time on the part of pharmacists and other health care providers, time that would be better spent in treating and caring for our patients.
Thank you, Madam Chair. We'll be happy to take questions
Thank you very much, Madam Chair, for the invitation to appear here.
I have a couple of roles. First of all, I work as an emergency physician in downtown Toronto, and secondly, I teach health policy at York University. Moreover, I've been studying pharmaceutical policy issues for about 30 years now.
With regard to the first role, just yesterday we were discussing drug shortages in the emergency department at the University Health Network. We've had to modify certain practices because of these shortages. I'm well aware of the impact that drug shortages can have on doctors' prescriptions and patient care, which is what we're all concerned about.
I think drug shortages have been on the horizon for a number of years now. We've certainly been aware of them in the emergency department for a few years. It should not come as any surprise that we're now in more of a crisis situation. All it took was a fire to create a crisis.
What we need is proactive planning to avoid any similar situation in the future. Merely approving other generic manufacturers that are able to produce drugs is not really proactive planning. We need to go beyond that, and in that context I have a number of suggestions.
I believe that Health Canada should convene an expert committee to identify off-patent drugs. Most of the products we're concerned about are generics, off-patent, that are supplied by only one or two companies. They are considered critical to medical care. Examples of these critical products might be chemotherapeutic agents, morphine, anesthetic agents, or drugs to treat epilepsy.
Once these critical drugs have been identified, Health Canada should proactively identify possible alternative sources of these products and determine whether the companies making them are prepared to supply Canada in the event of an emergency. Contingency contracts could then be negotiated with interested suppliers.
In the future, any company marketing one of these critical drugs in Canada should be required to give Health Canada a minimum of six months' notice before they stop supplying the product, and Health Canada should maintain a list of these drugs and post it publicly.
One of the conditions for granting a notice of compliance to sell one of these critical drugs in Canada should be a commitment by the company to guarantee the availability of the drug for a minimum of three years. We already go beyond what's required in the Food and Drugs Act when we approve drugs or give them a notice of compliance; we now invoke patent issues, so asking for a commitment to supply the drug doesn't really break any new ground.
Finally, if we do have another crisis similar to the one we have now, we need to avoid any possibility that companies can take advantage of the situation by charging a premium for their products. In that regard, I think the federal government should consider establishing a publicly owned generic drug company to manufacture some of these drugs to ensure that the drugs will not only be available, but will be available at a reasonable price.
Thank you very much for your attention, and I welcome the chance to answer any questions.
Thank you, Madam Chair.
Thank you to the witnesses for being here today. You've really helped illuminate not only the problem but also what we need to do. I really appreciate that. I want to jump right in and focus on what we can do.
There's something in the pharmacists' report from December 2010 that you distributed that you didn't exactly say today, but it's very clear in your report, and I'd like to quote from it. On page 11, under “causes”, you say:
What is missing in the drug supply chain is any organization or party that holds accountability for the supply chain from a system-wide perspective. Neither government nor any third party has an oversight function for the drug distribution system, and therefore drug supply is dictated in large measure by the market.
You go on from there to spell that out a little more.
I think this is a very telling comment, because everybody is saying from varying perspectives that there is no oversight, no mechanism to do this. We're completely reliant or dependent on, or held captive to—however you want to put it—what's going on in the marketplace.
I would also comment that in the brief that was just presented by the Canadian Agency for Drug and Technologies in Health, you also point out that the drug shortages are often difficult. You mention the mergers and the reluctance to share details of the shortages, again for business case reasons.
There are two questions that I would like to get at and have you answer. First of all, Mr. O'Rourke, you suggested that your organization might be able to fulfill that function as an independent overseer of information and in looking for substitutes. I'd like you to spell out how you could take that on and how quickly. I'd like others to comment on whether or not that is feasible.
Dr. Lexchin, in your brief you speak about establishing a publicly owned company. I was very interested to read in your brief that in the mid-1980s there actually was such a publicly owned company, called Connaught Laboratories. I don't recall that myself, but I wonder if you can speak a little bit more about this. I think your recommendations are great. This additional one about having a publicly owned company to ensure that some of the essential medications are there and that we won't have to face these kinds of shortages is a very brilliant suggestion.
I'd like you to speak a little more on how Connaught Laboratories worked, if you have that information. I don't know what happened to it, why it went under, or whether it was just done out of business by the government. Then I'd like the others to address the question of what kind of independent agency we need to provide this oversight.
If I can add to that, I think it's a great question but a difficult one to find a solution for, because you have to look at some sort of partnership between the federal government and provincial governments to do so. Provincial governments make some effort to protect themselves, if you like, from the impact of shortages, with some generic drugs that have exception status on the formularies. When they’re single-sourced, they may be allowed to be sold at higher prices. The provincial governments have a role.
I think the federal government also has an important role. Health Canada has been developing some of that. We've seen it as a result of the Sandoz shortage.
Historically we've had this issue of the supply chain falling through the cracks. It's not something that is strictly the federal government's responsibility or the provincial government's responsibility. People have been happy to allow the manufacturers or pharmacies to manage the supply chain.
We certainly need a lot of discussion to work out the structure of some oversight agency. I think gathering data and gathering information is the first step.
One thing we have to think about is that we spend a lot of time regulating and approving new drugs that come onto the market. Then the organization that Mr. O'Rourke is responsible for, the common drug review, decides what's going to get listed. As a result, we spend a lot of time looking at what comes onto the market.
One thing we've got to look at is what goes off the market. One problem we've seen with a lot of drugs that have gone into shortage—and Sandoz is a specific issue of manufacturing, and that is another issue—is that they're old drugs. They've been generic for some time. They're low-value often low-volume drugs, but they're still clinically important. I think we have to look at how to address some of these older drugs that have been around for some time and how to keep them on the market.
Thank you very much, Madam Chair, and thank you all very much for coming today and expanding on this topic so that we can understand the many factors bearing on the situation we find ourselves in at the moment.
I was going to ask Dr. Lexchin about Connaught, but I think some of us are going to do some research on it and see. In fact, I think I remember that Connaught, if not government owned, was overseen by a public agency of the government at some time, in the same way, as you said, Air Canada was. I think there was a public component to it at some time.
This is something many people meeting with me have talked about. It's the concept, the idea, of looking at it. You cannot force a private company to make a drug. There's absolutely no way any government can do that. However, is there a way the government will have to belly up to the bar and look at finding a way to make sure that the absolutely necessary drugs for patient health and well-being are going to be accepted?
I just wanted to ask a couple of things. I'd like to go to Dr. Poston.
You've mentioned the U.S. Food and Drug Administration a couple of times. You mentioned that if we're looking at a global shortage, it might be worth our while—and I agree with you, actually—to start building blocks of people who can come and find solutions, either proactively or otherwise. The federal government and the U.S. Food and Drug Administration working together is a good idea.
Can you tell me, or can you flesh out for me, what exactly the U.S. Food and Drug Administration does to ensure that a shortage doesn't come and hit them between the eyes? How do they try to be proactive and prevent this from going on? I know that they take a very proactive role and I know that President Obama has actually pushed them to do even more. Can you just tell me what they do?
Yes. I had a great conversation with the acting director of compliance in the FDA, and I asked that exact question: “What do you do?” The FDA claims that in 2011 they alleviated roughly 190 to 195 shortages, so clearly they're doing something right.
What they said is that when they're alerted to a shortage—and they indicated that there's a high level of trust between manufacturers and the FDA—they essentially go through a four-step process.
Step one is to speak with domestic producers that have the capability to increase capacity for whatever drug is in short supply and to essentially request that they increase production.
Step two is to look at the drugs that are essentially in the approvals queue. They'll bring any drug that could be deemed an equivalent or an alternative to the drug in short supply to the top of the line; they'll expedite that particular drug.
Third, they'll talk to domestic producers that do not have the capacity to ramp up production and ask them if they could put that capacity in place.
Fourth, they'll look at foreign suppliers and issue the proper importation permits for foreign supply, again, of whatever drug.
They've indicated that as a result of this very proactive approach that they take, they've been able to alleviate roughly 190 shortages in 2011.
Thank you very much, Madam Chair. Thank you to the witnesses for providing us with your expertise this morning.
I wanted to discuss the actual motion that we're here to discuss, and I know we talked about it briefly at the beginning of the meeting. It is to examine “the role of government and industry in determining drug supply in Canada, how the provinces and territories determine what drugs are required in their jurisdiction, how the industry responds to them, and the impact this has on stakeholders.”
I know we've certainly talked about the role of government and industry. I don't know that we've talked as much about how the provinces and territories determine what drugs are required and how the industry responds, etc.
We know that the provinces and territories are responsible for the management, organization, and delivery of health services for their residents and that they have the primary responsibility for health care delivery, including which drugs they buy and how they source them. That's what I want to talk about.
Mr. O'Rourke, you talked about strategies to minimize the impact on patients. Sorry, I'm paraphrasing there. What are your views on the sole-sourcing of contracts, and if provinces are going to sole-source the contract, what role do you think they have in ensuring that there is some sort of backup plan?
Thank you so much, Dr. O'Rourke.
We've come to the end of that round. I want to thank our guests for being here.
Generally speaking, I know everyone rushes to the back. I'm going to suspend for only one minute so that Health Canada can move into position.
If there are any conversations, please hold them outside the room so that we can continue our committee work. I would ask the committee members to stay in their places so that we can get started right away.
Thank you. We'll suspend for one minute, and then I want to welcome our guests.
From Health Canada we have Mr. Paul Glover, assistant deputy minister for health products and food; Ms. Barbara Sabourin, director general of therapeutic products directorate, health products and food; and Ms. Sharon Mullin, director of compliance, enforcement and coordination division.
Welcome. We look forward to your presentations.
I understand, Mr. Glover, that you will be giving the full 10-minute presentation. Thank you.
Would you like to begin?
Madam Chair, I am pleased to have this opportunity to update the committee on the progress that Health Canada has made in support of the ongoing national effort to manage the shortage of medically necessary drugs supplied by Sandoz Canada. I would like to begin with a brief explanation of Health Canada's role in the country's drug approval and supply system.
Health Canada's primary role is to ensure that drugs bought or sold in Canada, whether in shortage or not, are safe, effective, and of high quality.
Once Health Canada has authorized a drug, producers and purchasers are free to enter into commercial contracts for supply. Drug companies manufacture and supply needed medications; provinces and territories make the arrangements with suppliers to purchase them. Drug makers are the first to know when the production may be interrupted; provincial and territorial health authorities are the first to know the impact of a shortage on patients, and can plan accordingly if given enough time.
The term of supply contracts, the cost, the amount of production, the rate of usage, the number of suppliers required, distribution, and penalties for non-delivery are all worked out between the purchasers and the suppliers. Health Canada has no role or involvement in this regard.
When a shortage arises, Health Canada, consistent with its mandate and authority, works closely with purchasers and suppliers to ensure that any new supplies of needed drugs are safe, effective, and of high quality. Madam Chair, I'm pleased to report to the committee that we have made significant progress in this regard.
Health Canada is currently reviewing 35 drug submissions on an expedited basis. Of those 35, Health Canada has already approved 11. As of this morning, we have also approved 59 requests for emergency access to needed drugs through our special access program.
In order to ensure that the support we provide is of greatest use, Health Canada prioritizes drugs for review based on the needs identified by the provinces and territories. I want to assure the members of the committee that at no stage of our expedited review process has safety ever been compromised, nor will it be.
I must also caution members that an authorization does not mean immediate arrival of additional drugs in hospital pharmacies. Manufacturing capacity has to be ramped up, and safety and quality have to be confirmed at every step of the manufacturing process.
Hereto, Health Canada has provided prompt support. We have approved 10 sites additional to Sandoz's list of approved sites. These sites perform manufacturing and product testing for the Canadian market. Purchases and suppliers, including Sandoz Canada, are expediting the manufacturing and supply process.
Finally, purchasers must decide whether or not to buy, once a new supply has been authorized.
We have to be clear that it is unlikely that these new drugs will be in the Canadian supply system for some weeks yet. In the meantime, the focus of health professionals and of Sandoz will be on minimizing the impact of the shortage on patients. In this regard, it is important to note that the Public Health Agency of Canada has made available to the provinces and territories needed drugs from the limited stocks available in the national emergency stockpile system. To date, no requests have been received.
Madam Chair, in addition to expediting drug approvals, Health Canada is focused on encouraging better information-sharing between suppliers and purchasers. Through the various networks supported by the health portfolio, we are bringing purchasers and Sandoz together on a weekly basis to exchange the latest supply information and to foster national coordination in the shortage response.
As the committee will know, the Minister of Health has long made it a top priority to encourage companies to fill information gaps around actual and potential drug shortages. Doctors and pharmacists need enough advance notice of a shortage for treatment plans for patients to be smoothly adjusted if needed.
Health Canada's collaborative work with industry has begun to pay off. It has resulted in a commitment from Canada's research-based pharmaceutical companies and the Canadian Generic Pharmaceutical Association, of which Sandoz is a member, to communicate potential and actual drug shortage information to Canadians via two existing public websites.
Industry, together with the health professional associations, has also committed to the development of a national one-stop drug shortage monitoring and reporting system in 2012.
The impact of the Sandoz shortage has made it clear that getting this one-stop information site up and running is more important than ever. The minister was pleased to note that Rx&D and CGPA have recently come forward with a commitment to support funding for one national site.
The committee also heard a few minutes ago the desire of the Canadian Agency for Drugs and Technologies in Health to play a helpful role in drug shortages going forward.
Madam Chair, Health Canada supports making public reporting of potential or actual drug shortages a requirement. The minister was pleased to note that in the response to her letter seeking increased transparency around shortages, industry associations have clearly committed their members to public reporting of anticipated and actual shortages. In addition, reporting obligations can be made formally binding if purchasers of drugs on behalf of provincial and territorial clients embed this reporting obligation in their supply contracts, as well as a requirement that suppliers have contingency plans in place in the event that they are unable to fill orders.
Indeed, one of the main bulk purchasers, HealthPRO, told the committee this week that starting this fall it will be awarding multi-supplier contracts for hospital-specific items, and that when there is only one supplier, they will be actively pursuing other suppliers.
I would just like to reaffirm for the committee that Health Canada will continue to play its part on this important issue by approving alternate sources of supply during the Sandoz shortage, and we are working with our partners to find longer-term solutions that help cushion patients against possible future shortages.
That concludes my remarks, Madam chair.
I would like to thank the committee for inviting me to appear today to discuss a topic of paramount importance. I would now be happy to answer your questions.
Thank you, Madam Chair.
First and foremost, to confirm for the member, I was not present during the previous panel, so I cannot comment directly on all of the interventions that they were able to make.
However, in response to the member's question, we do feel that it would be quite a challenge for Health Canada to play that particular role, as we do not know what is going on between the purchasers, the large bulk-purchasing agents, and the various suppliers. We would need to become party to all of those contractual arrangements. We do, however, think it's very important, and we encourage all jurisdictions to diversify their supply as we move forward.
Health Canada does take a look at all submissions provided to us from the drug companies, and we will provide alternate authorizations. In fact, in many instances we authorize numerous companies to provide the drugs available to the market. How we end up with a sole supplier of a particular drug....
In the current situation with Sandoz, of the eight drugs that the provinces identified as their highest priority, Health Canada had previously authorized alternate suppliers for all of those drugs, so it becomes a practice of purchasing that leads us to the sole-source supplier arrangements. We think that the best place for that intervention is between the suppliers and the purchasers. We've already seen that they're beginning to react and respond, based on their sole-source purchasing habits, and making the necessary adjustments.
Thank you, Madam Chair.
At no time do we believe that Health Canada, through any of our policies or actions, contributed to a drug shortage. Through a matter of policy, there are always drugs in our queue waiting for approval. When we understand that a drug is medically necessary and is of priority to the health system, we can expedite the review process. That's something we do and have continued to do, whether drugs are in shortage or not. We give priority to new, innovative therapies, rather than approving a second or third me-too drug, if you will, and we continue to do that.
We have, through investments in the program, significantly improved our performance. We are meeting all of our performance targets, with the exception of generic drugs. In all instances, as we approve drugs, we do so with the full intent of making sure that they are brought to the market as quickly and efficiently as possible; that is, we provide authorizations that the drugs are safe and of high quality. It is really up to the market to determine, once the authorizations are provided, if they will choose to purchase from that source that we have authorized.
We are, in fact, aware of a number of instances in which, after we have authorized a product, the market has chosen not to purchase from that, or potentially the authorization holder has decided not to enter the Canadian market, despite having gone through our approval process and paying us substantial fees to achieve our approval.
It is difficult for me to say exactly why these drug shortages happen, since we do authorize numerous sources of supply.
Thank you, Madam Chair, for the member's question.
The did become quite concerned over a year ago about the global problem of the increasing number of shortages that were being experienced worldwide, not just in Canada but as a global problem.
She wrote to the various industry associations, including Rx&D in terms of the brand names, CGPA for the generics, the biotech industry, the Canadian Medical Association, the Pharmacists Association, the distributors, the wholesalers, and others. She asked them to work together, first to improve transparency, so that if there were drug shortages, there would be a way to notify the health systems so that they could respond, and second to take a look at what they could do in reducing the number of drug shortages that were occurring.
In response to her recommendation, a working group was formed. They began as a collective to address this issue. They wrote back to the minister with a plan that had three phases. The first phase, which is already up and operational, involves the existing websites, the ones that exist today, where industry is now posting drug shortage information and making that available to any and all Canadians in the health jurisdictions. There are two existing websites.
Our response was while that was a positive first step, it was not sufficient; there needed to be a one-stop site where all health system practitioners, professionals, provinces, and Canadians in general could go to get information on drug shortages. That's the second phase, which is being accelerated right now. The two main industry associations have put money on the table to build this second phase.
That will be a positive step. That new site should have increased functionality, and not just with regard to what drugs are in shortage. It will address the previous member's question with regard to how to deal with a shortage of a particular drug, what alternatives can be used to treat a patient, and other information that might help health system practitioners deal with shortages.
The other thing—
Thank you, Madam Chair.
Very briefly, the provinces are responsible for the delivery of health services. The federal role and the role that we play is in the approval of the drugs. Are they safe? Do they do what they say they do? Are they made with quality, so that every pill that a person takes is the same pill and has the same medication in it? That is our federal role.
The other thing that we do—not through my organization, but under the federal Patent Act, through the PMPRB, the Patented Medicine Prices Review Board—is monitor pricing. If there is a view that prices of some of the patent drugs are exorbitant, then they can come in and set a maximum. That is the federal role with respect to this area.
Provinces then deliver the health services. In addition, they create formularies for what drugs they will choose to pay for in their population for seniors, for people on social assistance, etc. They make decisions about what they do and don't want to list on their formularies. The only exception is if a drug is provided in a hospital setting, it is provided. If that same drug is provided outside a hospital, it would be a provincial decision as to whether it was part of their formulary or not. In a nutshell, those are the main roles and responsibilities.
The final piece is the colleges and the role that they play in training their health professionals to use these drugs. There is what we call “off-label use”. Health Canada will approve a drug based on what the company says is the indication that they're looking for, and we will put that information to prescribers on the label. However, the college then trains physicians who can say, “That's great; that's what the indication is for, but we would also like to use this drug for other indications.” That's called off-label use. It is completely legal and allowed, and it is within their jurisdiction as well.
Thank you very much for your presentation, Mr. Glover, Ms. Mullin, and Ms. Sabourin.
In countries that have dealt successfully with this drug shortage, such as New Zealand and the United States, they do a couple of important things: they identify the drugs that are going to be short, they anticipate, and they manage.
Now given that you, as a federal government, are responsible for regulation and approval, you have a huge role to play in identifying and managing and fast-forwarding areas where you think there's going to be a shortage and in other areas involving manufacturing the drugs, etc. There is a role.
We heard from many people who presented here that the Food and Drug Administration has been very successful in using their mandate to predict, identify, and manage shortages. First and foremost, patients need medication when they need medication. Many patients who don't get that medication could die or could be severely impaired for the rest of their lives.
When we start talking about whose jurisdiction is what, it becomes moot. It isn't really about who you pick up the phone and call; it is about whether the patient gets the drug and gets to be well. At the end of the day, I think the responsibility rests with the people who regulate the drugs and who are able to work with others—as I would like to say, a leader—to try to find a way around this problem. It's about human beings. It's about Canadians. It's about protecting them and caring for them.
We're trying to find a resolution here. It's not a case of fault or blame. Could we put that aside for a minute?
In November 2011 the Food and Drug Administration told Sandoz that they did not comply with manufacturing standards. Was your department aware of that in November 2011? Were you aware then of what that impact could be on real people? I hope you didn't know. If you had, I would have thought you would have felt it was a moral obligation to warn people that this was going to happen, so that doctors, anesthetists, pharmacists, hospitals, etc. could start stockpiling.
Were you aware of the November 2011 FDA ruling? If you were, did you tell people? Did you warn them? If you didn't, why not? That's my first question.
Second, I continue to hear the federal government saying that they are just regulators and approvers, but you're the fifth-largest deliverer of health care in this country, so you're not just regulators and approval parties. You actually deliver services to the armed forces, the Inuit, the first nations, etc., so you need to know how these people you deliver services to are going to be able to get their medications and be able to get help.
Can you give me an answer about your knowledge of Sandoz and about thinking a federal leadership role is required, first in delivering care to the people you need to and second in terms of coming together and working with the provinces to make sure Canadians get drugs?
Thank you for the question.
We've spent a lot of time today talking about the things we have done in response to this crisis, including the special access program and the expediting of reviews and approvals. They were in response to the crisis.
We would like to take action to help the entire system better manage, and in fact prevent, crises as we move forward, so we will continue to push very hard for that one-stop site and will require the drug companies to post the information to that site for the benefit of all. It would be for my agency so that we can do our part. It would be for the provinces and territories so that they can do their part in planning for these shortages and can mitigate them. It would be for bulk purchasers, who could look at their supply and what's happening and respond accordingly. Finally, it would be for local practitioners, so that they can be aware that if they have patients who need those medications, they may need to come up with alternative treatment plans and know what substitutes are available to them. That website will be critical, in the longer term, to being able to do those things.
While we're very pleased that the drug companies have come forward and have said that they're committed to that site, we frankly don't want the drug companies running that site. We think it's beneficial that the site be run by a neutral third party. We believe that a group like CADTH would be ideally positioned. We're in contact with the provinces and territories to explore feasibility and whether there's unanimous agreement that it would be the best place to house this kind of information clearinghouse.
That would also position CADTH to play a unique role in terms of the expertise it has in alternate therapies and in gathering best practices they're already aware of within the health system and distributing them to all the players.
We will continue to push for the requirement, as per the motion that was debated and passed in the House. We will push to make sure that we have this one-stop site up and available, not just for Health Canada—we have our role to play—but for all levels of the health care system, so that they can take the appropriate action to respond.
I know that this is a long answer. I apologize to the member.
Finally, we will continue to encourage and have dialogue with other jurisdictions about what's working in the attempt to adopt best practices. We firmly believe, as this committee has heard, in some of the practices in place in other jurisdictions, in particular those that have clauses in the supply arrangements that first and foremost diversify supply. Sole-source arrangements are dangerous. We've seen that in the past and we continue to believe that this is the case.
We understand that moving to diversify supply has an impact on price, so we'll continue to work with the provinces and territories to make sure that we have best practices for distribution, diversification of supply, pricing arrangements, and other things. We will offer any support and assistance we can to encourage them to do that.
Thank you very much, Madam Chair. Thank you, witnesses, for coming here this morning.
Madam Chair, on page 3 of Mr. Glover's presentation, it states that Health Canada approved 50 requests for emergency access to needed drugs through a special access program. I would ask if he can maybe share more information on how the special access program works and how this helps during a drug shortage.
I will ask my second question right now, and then if I have more time, maybe I will ask one short additional question.
During our meetings and in our study, we've heard a lot about the factors that contribute to drug shortages. Among them, single-sourcing is one of the main ones, I believe. Of course, there are recommendations related to the website and on whether it should be mandatory to identify drug shortages.
Even if you know about possible drug shortages, and you have that information, how do you apply it? What do you do in the situation? What recommendations would you have for bulk purchasers, provinces, and territories in situations that are beyond human control? There could be a natural disaster somewhere that disrupts production; these are beyond any mandatory reporting on possible drug shortages.
Can you address both questions, please?
First of all, Mr. Glover, thank you for being here today. I'm glad to hear that Health Canada is making it clear that you do support public reporting and that it be a requirement, as you noted in your brief today.
The huge issue that we're missing is the lack of any oversight. We hear a lot of information about different roles and who does what, whether it's provinces or the purchasers, but there has been a lack of oversight and leadership.
We had some suggestions today. It's unfortunate that you didn't hear the earlier presentations, but the one in particular that my colleague referred to was a suggestion that Health Canada should convene an expert committee to look at the off-patent drugs that are considered critical and are supplied by only one or two companies. Never mind if they are short or not; it would be just to have an inventory of the drugs that are very well used and are supplied by only one or two suppliers. Following that, possible alternative sources could be identified through Health Canada with this expert committee, so that other arrangements could be made if there were an emergency. That, to me, is very much based on public interest and public health interest, which is part of your mandate as well as that of PHAC.
I wonder if you could respond to that.
As well, we know that the Auditor General has said that Health Canada has been slow to approve alternate suppliers. This has also been part of the problem. I know that right now we're under an expedited process, but how long will that continue? I think the Auditor General did make that a very clear issue in terms of the approval process itself.
We're working very diligently to determine how quickly.... We've undertaken a number of new processes. Unfortunately, I cannot give the committee an exact date today. We will be happy to follow up.
We're developing a work plan. We've hired new staff. We have to see how the training goes and how quickly they can get up to speed. We're also collaborating with foreign jurisdictions. If another jurisdiction has already approved a drug that is now in the queue for us, we collaborate with them. We want to see how those efforts work out so we can move through and get caught up as quickly as possible.
There is one thing about generics, and it was a deliberate decision. From a public health point of view, our priority was new, innovative therapies that are very important in treating new illnesses. Now we're catching up with generics. We have every intention of getting caught up, because we understand how important they are to the health system. We would be happy to table a more detailed plan with timelines on when we can do that.
On the issue of whether we should be overseeing where there's a sole source, we are happy to do our part. We will need to work with the provinces, and the provinces will need to work with the bulk purchasers. We license numerous suppliers. They are not responsible for telling us if they're supplying; we authorize the drug, give it a DIN, and give the company a notice of compliance. It then goes into the market.
In some instances there is competition among bulk purchasers for the best possible price. They don't collaborate and share that information. There would need to be a willingness from the health system to share with the provinces and with us whom they've chosen to supply which drugs so we could determine if there are sole sources for those drugs as we move forward.
Certainly if there's a willingness among all the jurisdictions to move forward—and we have a regular call with the provinces about that—we will be happy to do our part in that process.