Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 11 - Evidence - April 10, 2014
OTTAWA, Thursday, April 10, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 10:29 a.m. to resume its study on prescription pharmaceuticals in Canada.
TOPIC: The nature of unintended consequences in the use of prescription pharmaceuticals.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
I'm Kelvin Ogilvie, a senator from Nova Scotia and chair of the committee. I will now ask my colleagues to introduce themselves.
Senator Seidman: Judith Seidman from Montreal, Quebec.
Senator Stewart Olsen: Carolyn Stewart Olsen from New Brunswick.
Senator Eaton: Nicky Eaton, welcome, Toronto.
Senator Seth: Asha Seth, Toronto.
Senator Enverga: Tobias Enverga from Ontario.
[Translation]
Senator Chaput: Maria Chaput from Manitoba.
[English]
Senator Cordy: Jane Cordy from Nova Scotia.
Senator Eggleton: Art Eggleton, Toronto, deputy chair of the committee.
The Chair: Thank you, colleagues. I want to welcome our guests this morning and remind everyone that we are dealing with the fourth phase of a four-part study on prescription pharmaceuticals in Canada. This phase has been dealing with the unanticipated consequences of such use.
Today we have departmental officials with us to help clarify the issues that have arisen. I will first introduce the groups that are actually going to speak and then I will welcome Dr. Tam, who is here to help with questions that may arise.
In that regard, I will start with Health Canada and introduce invite Dr. Supriya Sharma, Acting Associate Assistant Deputy Minister of the Health Products and Food Branch, and has with her Robin Chiponski, Director General, Health Products and Food Branch. I understand Dr. Sharma will be making the presentation. Please proceed.
Dr. Supriya Sharma, Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Health Canada: Thank you, Mr. Chair. I'm happy to be here today as the committee completes Part 4 of its study on prescription pharmaceuticals by examining the Nature of Unintended Consequences in the Use of Prescription Pharmaceuticals.
[Translation]
I would like to thank the committee for the important work it is currently doing on this issue and for the opportunity it has provided Health Canada to explain our role in regulating prescription pharmaceuticals in Canada.
[English]
Let me begin my introducing myself. As our chair said, I'm currently the Acting Associate Assistant Deputy Minister and Senior Medical Advisor of the Health Products and Food Branch, which oversees the regulation of health products in Canada.
I previously had the privilege of appearing before you during the third part of your study, which examined off-label use.
I am joined today by my colleague, Ms. Robin Chiponski, Director General, Health Products and Food Branch Inspectorate.
You will hear shortly from my colleague, Dr. Jane Aubin, Chief Scientific Officer and Vice-president, Research and Knowledge Translation of the Canadian Institutes of Health Research.
We are also accompanied by Dr. Robert Peterson, Executive Director of the Drug Safety and Effectiveness Network, as well as Dr. Theresa Tam, Branch Head of the Health Security Infrastructure Canada of the Public Health Agency of Canada.
Over the course of your study, a number of issues falling within the purview of the agency have been raised. Dr. Tam will be pleased to respond to any questions you may have from a public health perspective.
This is Health Canada's fourth appearance before the committee and I would like to take this opportunity to talk about initiatives we are implementing in order to strengthen patient safety through the regulatory process governing prescription pharmaceuticals in Canada.
As you know, Canada has one of the safest and most rigorous drug regulatory systems in the world. For prescription pharmaceuticals to be marketed in Canada, a manufacturer must meet the requirements of the Food and Drugs Act and its regulations by submitting scientific evidence demonstrating that a drug is safe, effective and of high quality for its intended use.
Once these pharmaceuticals reach the Canadian market, Health Canada monitors them for signs of potential new risks related to their use and takes the appropriate actions to reduce these risks. This post-market surveillance is essential to maintaining the balance between the health benefits and the risks posed by all health products.
Patient safety is Health Canada's main priority throughout the regulatory process from the review of clinical trial applications and the new drug submissions, to the monitoring of approved pharmaceuticals and the inspection of establishments for compliance with good manufacturing practices.
As I indicated previously, a prescription pharmaceutical that has been granted market authorization reflects the fact that the benefits of the drug outweigh the possible harms for its intended use. That said, prescription pharmaceuticals are never risk free and Health Canada is continuously working to mitigate possible unintended consequences of use. Many tools are currently being implemented to support this objective and overall patient safety.
First, I would like to highlight an important new legislative measure that will have a great impact on improving patient safety, including helping to contribute to the reduction of unintended consequences linked to the use of prescription pharmaceuticals.
On December 6, 2013, the Government of Canada introduced legislation amending the Food and Drugs Act, the proposed Protecting Canadians from Unsafe Drugs Act, or Vanessa's Law. This would improve Health Canada's ability to collect post-market safety information and take appropriate action when a serious risk to health is identified. Overall, these amendments would provide better protection of patient health and safety and greater consumer confidence in therapeutic products on the market.
Specifically, Vanessa's Law would require mandatory reporting of adverse drug reactions by prescribed health care institutions. While we know most drugs are prescribed and used outside a hospital, serious reactions generally lead to hospitalization. Hospitals and other health care institutions are therefore in a unique position to detect, identify and then report serious adverse reactions. Other new authorities under Vanessa's Law include the ability to compel new tests or studies on drugs, the ability to require a recall and tougher fines and penalties for non-compliance. The implementation of these measures would strengthen Canadian families' confidence in the medicine they and their children use.
I'll add at this point that I'm sure many of these are familiar to the committee as they were recommendations in Part 2 of the study.
Mr. Chair, in addition to introducing Vanessa's Law, the government is proceeding with several other key patient safety initiatives. For instance, in the 2013 Speech from the Throne, the government committed to ensuring that drug labels are written in plain language and that the potential side effects of medication are accurately indicated.
As a result, Health Canada is implementing the Plain Language Labelling Initiative to make improvements so that health product labels are clear, accurate and easier to understand. This will minimize opportunities for confusion with labels, packages or names.
Additionally, Health Canada provided $3.2 million over two years to support the Institute for Safe Medication Practices Canada's continued work to expand the reach and impact of the Canadian Mediation Incident Reporting and Prevention System, which helps improving understanding and information sharing about medication incidents and errors in order to prevent them.
Furthermore, the 2013 Speech from the Throne identified prescription drug abuse as a growing problem and indicated the government's intention to expand the National Anti-Drug Strategy to address this issue. Working with the non-governmental organization community and with provincial and territorial governments, Health Canada will move forward on key issues starting with enhancing prevention and treatment initiatives in the communities.
The department will help develop best practices for the treatment of pain, for prescribers and health care practitioners to assist them in bringing appropriate care to parents. We will also engage in public awareness activities about prescription drug abuse to help Canadians better understand its negative consequences.
In addition, Health Canada is currently working on guidance for companies waiting to develop tamper-resistant formulations as a measure to help deter abuse. This work involves discussions with international counterparts such as the United States.
The dissemination of relevant, timely and effective communications can also enhance patient safety by providing Canadians with the information they need to make informed decisions about their health. Increasing transparency strengthens the trust Canadians have in the decisions made by Health Canada.
As such, Health Canada has taken significant action to improve transparency and openness surrounding pharmaceutical drugs. Recent work to increase transparency and openness include the launch, in spring of 2013, of a clinical trials database on Health Canada's website. By providing this information in a centralized database, Canadians can have timely and accurate information about legitimate, authorized Canadian drug trials in patients.
Moreover, since 2012, Health Canada makes public more extensive information about health product regulatory decisions such as information on post-approval activities, including positive or negative decisions on subsequent submissions for new indications for prescription pharmaceuticals.
Also with the objective of increasing transparency and openness, Health Canada continues to work collaboratively through the multi-stakeholder committee on drug shortages with stakeholders from across the drug supply chain to advance concrete strategies to addressing drug shortages. These efforts have resulted in significant progress, including a protocol for the communication and notification of drug shortages, a toolkit identifying strategies to address shortages throughout the supply chain and improvements to the industry-led website www.drugshortages.ca.
As an additional measure, Health Canada has also asked all drug suppliers in Canada to publicly commit to drug shortage and discontinuance notification on drugshortages.ca. These commitments will be posted on a new Public Notification Register for Drug Shortages where the department will also post letters to drug suppliers who fail to comply with our expectations. If at any time it becomes clear the industry is not providing the transparency and accountability for drug shortages that Canadians expect and deserve, we will not hesitate to take further steps.
Health Canada was also one of the first regulatory agencies to post information on all domestic adverse drug reaction reports. The Canada Vigilance Adverse Reaction on-line database allows health professionals, industry and the general public to view and search for adverse drug reactions that have been reported to Canada.
Health Canada will continue building on previous achievements to make our information and decision-making processes more transparent to Canadians. That said, Health Canada is committed to being even more transparent and open when making regulatory decisions. That is why we have launched the regulatory transparency and openness framework and action plan just this week. The framework and action plan will show Canadians the concrete and incremental steps we are taking to improve their access to timely, useful and relevant health and safety information.
We are committed to ensuring that Canadians and their health care professionals have all the information they need to make informed choices about the medicines they use or are prescribed.
[Translation]
I thank you very much for this opportunity to appear and I am now available to take your questions.
[English]
The Chair: Thank you very much, Dr. Sharma. We will now turn to Canadian Institutes of Health Research, CIHR. We have Dr. Jane Aubin, Executive Vice-President, Chief Scientific Officer who will be presenting. We welcome back Dr. Robert Peterson, who is Executive Director of the Drug Safety and Effectiveness Network. Dr. Aubin.
Dr. Jane Aubin, Executive Vice-President, Chief Scientific Officer, Canadian Institutes of Health Research: Thank you very much, Senator Ogilvie. As Chief Scientific Officer and Vice President of Research and Knowledge Translation of the Canadian Institutes of Health Research, or CIHR, as I will abbreviate it, I would like to thank you for inviting me to speak about research activities related to unintended consequences of prescription pharmaceuticals in Canada. I am very pleased to be joined today by Dr. Bob Peterson, Executive Director of CIHR's Drug Safety and Effectiveness Network, or DSEN. Honourable senators, you probably recall that Dr. Peterson and Dr. Alain Beaudet, the president of CIHR, have already had the pleasure of appearing before you during earlier phases of your current study.
As you have already heard about the importance of DSEN in these earlier phases of your study, I will take only a few minutes to reiterate some of DSEN's key activities of interest for this last phase of your work.
DSEN, established by CIHR in collaboration with Health Canada and other stakeholders, responds to queries from public sector drug plan managers, policy makers, health technology assessors and regulators to increase evidence on the post-market safety and effectiveness of drugs in Canada. This complements Health Canada's requirements for rigorous premarket testing of new drugs and supports Health Canada's role in post-market monitoring by supporting focused research on how Canadians respond over time to approved drugs in the real world. DSEN also provides evidence used in determining economic value of marketed drugs, a factor essential to a sustainable Canadian health care system.
The research methodologies that exist within DSEN lend themselves well to addressing the outcomes from use of prescribed medicines, including those that are unintended. DSEN coordinates and funds the efforts of Canada's top research experts to provide authoritative responses to queries that consider both potential for benefit as well as potential for harm.
When extrapolating from clinical trials required for regulatory purposes to the "real world" of Canadian patients, there is uncertainty related to identifying those patients who may benefit from those who may be harmed by a particular drug product. In fact, this uncertainty over achieving or not a benefit from a prescribed drug is of great importance to both the prescriber and the patient. DSEN balances this uncertainty by examining both benefits and harms, wherever possible. The network uses rigorous scientific methodologies, which are extremely powerful tools for contributing to a risk assessment of the benefits and the harms of the drug or class of drugs.
To conclude on DSEN, I would like to point out that this network offers a credible source of research evidence generated at arm's length from industry and that neither CIHR nor DSEN have a regulatory responsibility. Rather, the new evidence generated via DSEN is conveyed to the appropriate decision makers in the Canadian health care system.
Honourable senators, I would also like to take a few minutes to address two important issues raised by previous witnesses.
The first issue relates to the need to support clinical trials that are essential to bring safe, innovative and effective drugs, vaccines and devices to the Canadian market. In his appearance before your committee in March 2012, Dr. Alain Beaudet discussed the importance of supporting clinical trials and highlighted the recommendations of the first clinical trials summit organized in 2011 by CIHR, Canada's research-based pharmaceutical companies and the Association of Canadian Academic Health Care Organizations.
I am pleased to inform you that a Canadian Clinical Trials Coordinating Centre is being established to implement the key recommendations of the summit action plan. This centre will support activities that will facilitate the establishment of clinical trials in Canada and foster international investments in clinical trials. These activities will also contribute to improving Canada's competitiveness in conducting clinical trials.
To conclude, I will address another important issue that has been raised by previous witnesses, which is the need for federal leadership in addressing antimicrobial resistance, or AMR. Let me highlight a few AMR initiatives that CIHR has been involved in over the last few years.
First, it is important to mention that research on alternatives to antibiotics and antibiotic resistance has been a research priority of CIHR's Institute of Infection and Immunity since the inception of that institute in 2000. In 2012-13 alone, CIHR invested more than $15 million in the area of AMR, including in the Novel Alternatives to Antibiotics Initiative that aims to support research projects focusing on novel approaches to antibiotic resistance.
As you know, in 2013, AMR was identified by the G8 countries as "a major health security challenge of the 21st century." Canada is playing an important role in tackling this global issue, and CIHR is leading internationally on this matter. Since 2008, CIHR has been partnering with the medical research council of the United Kingdom to create the Canada/U.K. partnership on antibiotic resistance. In 2011, two teams — each with one principal investigator from Canada and one from the U.K. — received support for research programs on AMR. The total investment for this program is $8 million over four years, equally shared between Canada and the U.K.
Through CIHR, Canada is also an initiating country and significant funder of the Joint Programming Initiative on Antimicrobial Resistance, a collaboration of Canada with 18-member states of the European Union. This initiative is testimony to Canada's excellence in this area, an excellence recognized by our being approached and our acceptance to co-lead the initiative with Germany and Sweden. Through this international initiative, a first call for research proposals was launched in January of this year. This collaboration represents a total investment of 14.1 million euros, or approximately $21.2 million Canadian, over three years.
Just last week, on April 3, Dr. Beaudet, along with his international counterparts, set the strategic research agenda of this global initiative on AMR at an international meeting held in Brussels. This agenda, which is available online, proposes a coordinated approach to support world class research on AMR that will be translated into new prevention and intervention strategies to achieve long-term reductions in resistance levels and better public health outcomes.
Thank you very much, honourable senators, for your attention. Dr. Peterson and I will be pleased to answer any of your questions.
The Chair: Thank you very much. I will now open the floor up to my colleagues.
Senator Eggleton: The questions I have are for Health Canada.
We have heard compelling and disturbing testimony during our review on unintended consequences about substandard drugs being supplied to pharmaceutical companies from pharmaceutical companies offshore, most notably from India. We found out, in the course of our study, that in the United States 80 per cent of medicines and medical ingredients are now imported. We haven't got a figure for Canada; maybe you can give us one that might tell us what it is. That certainly sounds significant for that country and I would suspect it is probably quite similar for this country, unless you tell me otherwise.
We also hear from the World Health Organization that it considers one in five drugs made in India to be fake. We have heard in our testimony the Indian government barely regulates exported generic medicines at all; enforcement of regulations is weak; and the government does a poor job policing many of its industries.
In the United States, we've heard of considerable activity by the FDA, the Food and Drug Administration. They have conducted hundreds of inspections — in fact, last year 111 inspections in India alone. What we have heard is that you have only conducted three inspections overseas. We have also heard that in the United States the company Ranbaxy pleaded guilty to fraud. They were fined $500 million and their medicines were removed from the market.
We also note, however, that 159 medicines from Ranbaxy are still listed on your website as being available in Canada, still with a DIN.
In addition to that, there have been removal of drugs from places like Dr. Reddy's Laboratories, Sun Pharmaceutical, and Wockhardt Ltd., all in India. Both have been removed with respect to the United States and also the U.K. in the case of Wockhardt.
A Canadian company has come into this picture now, Apotex. The Food and Drug Administration in the United States has put a ban on Apotex's medicines from its Bangalore site.
Why aren't we doing more to protect the health of Canadians? Why are we so far behind? Only three inspections. We still put the same drugs on the market that the Americans have taken off the market. Why is this?
Dr. Sharma: I will open up with a bit of information about the Canadian market and where we get our products from, and then I will turn it over for my colleague.
The inspectorate is the area of our organization that does the inspections, the compliance and enforcements around good manufacturing practices for pharmaceuticals.
In terms of Canada, we are approximately 3 per cent of the global market for pharmaceuticals. If you look at the products that are coming into Canada — and estimates vary — it is estimated that between 70 to 80 per cent of the products that come to Canada are actually manufactured somewhere else. Of those products, of the foreign sites, 50 per cent of the foreign sites are located in countries with which Canada has a mutual recognition agreement. We'll talk a little bit about what that is. It recognizes the equivalency of the good manufacturing practice standards in both those countries.
Of the other 50 per cent, half of those, or 25 per cent of the total, actually come from the United States. Overall, of the products that come from outside, approximately 25 per cent of them will come from countries such as China or India.
I will turn it over to Ms. Chiponski in terms of the other question.
Robin Chiponski, Director General, Health Products and Food Branch, Health Canada: Mr. Chair, this is a very complex question. There were many items that the honourable senator raised. If I can ask your indulgence, I will try to walk through the many aspects of this question.
My colleague Dr. Sharma has talked about good manufacturing practices. Those requirements are outlined in the Food and Drugs Act in its regulations. Those requirements state that regardless of whether a product is produced in Canada or overseas, it must meet the same standards. The question that follows is, how do you ensure that those standards are met?
Dr. Sharma spoke to you about the mutual recognition agreement. That is a legally binding instrument that we have entered into with other countries from which we have conducted an 89-point evaluation to determine whether or not our inspection regimes are similar and/or equivalent. The mutual recognition agreement framework has been in place for close to 10 years. There are 24 member countries that participate in that framework.
Through the process of that evaluation, we have determined that when those countries conduct an inspection, it is similar to the conclusions that we would reach had we conducted it ourselves. It is very difficult for any global regulator to be able to cover all the sites in Canada so all major regulators rely on this sharing of information and sharing of resources for conducting inspections.
You spoke about the FDA. Just to clarify, FDA is not a member of the mutual recognition agreement. They are a member of the pharmaceutical inspection cooperation scheme. We also have memorandums of understanding with the FDA that allow us to conduct similar types of relationships that we do under the mutual recognition agreement.
In the particular case of Ranbaxy that you spoke of, senator, even though we have a lot of alignment internationally in terms of how inspections are conducted and what those conclusions may be, sometimes Health Canada does find itself in a position where we have contradictory conclusions from trusted regulating partners around the world. In those situations we have to weigh the conclusions and the evidence considered by those contradictory opinions or conclusions.
In the case that you spoke of, in terms of the Ranbaxy sites, we noted that we had MRA partners as well as the WHO that concluded that the sites in question were in compliance. As you noted, the FDA concluded that they were not.
In that situation, we also considered what the activities were that the FDA undertook in light of their decision. We noted that in fact they did not recall the products that were already on the market and they did also note that citizens should not disrupt their treatment of the products that they were taking without consulting their physicians.
We took that as a signal that, although there were grave concerns that the FDA found, they did not feel that there was an immediate risk to the products on the market. However, we take our role very seriously in terms of mitigating those risks. So in the Canadian situation we did decide that the sites were in compliance but we worked with the company to quarantine the products coming from those sites and to require those products to be tested for compliance with the specifications before they were released on the market.
Senator Eggleton: The European Union tests every single batch of imported medicine — every single batch. How much do you inspect?
Ms. Chiponski: We take a risk-based approach to the products that we inspect. We look at what the testing regimes are within the context of an inspection. When an inspection is conducted, part of that process is to look at what their testing regime looks like and what kind of risk-based approach they are taking with all the products. It is difficult to test every product. There is a sampling-based approach taken in Canada. That activity happens either in a trusted MRA country or in Canada at the local importers' sites.
Senator Eggleton: You are disagreeing with the FDA about what it has removed from the market on the basis of their findings by hundreds of inspections, and you've only had three? You expect me to believe that?
Ms. Chiponski: Although we only conducted three inspections, as you've stated, I have also examined the information from our trusted regulatory partners who have also conducted inspections.
The Chair: I want to come in on this point, senator, if you don't mind.
The Ranbaxy case is, in my opinion, a case study in corporate fraud at the highest level. The FDA also approved its products up until the point where they received insider information that told them what to look for with regard to checking the products. In other words, the proof of product competency and viability, the pharmacological studies, were faked, and you had to know what to look for. Your comments are that you could rely on your partner organizations. You could have relied on the FDA at one point with regard to that. They approved them on the basis of the same information, but they were clearly shown to be a fraudulent organization.
We are somewhat skeptical with regard to the capability of all of these international bodies to verify the products unless they are actually tested and analyzed when they enter the country in which they are going to be used. In that regard, the senator referred to the company Wockhardt, whose insulin has been identified as being — I'll just say "inadequate." Yet, the last we heard, it was still available on the market in Canada. Perhaps it is not today, but the last we understood it was still available in Canada. It's an example of the issue that the senator is raising.
Senator Eggleton: Thank you, Mr. Chair, I appreciate that. Those are good supplementary comments.
Dr. Sharma: Perhaps I'll start. I think the concerns in terms of Ranbaxy as a company were shared internationally. We worked with our U.S. counterparts when information came to light, and as a regulator we were faced with the same issue that the FDA was. We have medications on the market, some of which are medically necessary, and we have information that calls into question the integrity of the data. It came down to the issue of what can we do to rely upon the data submitted to us?
We worked with them as well, and we had to do a case-by-case determination after the fact to ask, "What information did we receive?" This was not only for the products currently under review. We actually went back and looked systematically at all the reviews we had done, because we had the same questions: What studies were submitted and which ones were potentially called into question? Then we had to do the case-by-case assessment on what we should do with the products on the market.
Ultimately, the United States, as Ms. Chiponski has mentioned, was in the same situation. They were at the point where they said they were not in compliance, but they did not have enough evidence to take the next step and recall the products from the market because they were medically necessary.
Certainly we have a lot of concerns. One of the other things we've done in terms of international work is specific to India, for example. There was a concern voiced by the WHO a number of years ago around the government's ability to oversee the regulatory authority of the companies to the point where they were concerned that that would contribute to a global shortage of vaccines. They looked internationally to see what regulatory authority they could go to to help and advise the Indian regulatory authority to get up to a level that was acceptable.
Senator Eggleton: You're not answering my questions directly. You're skirting around them. You're not doing your job effectively and you're just skirting around and trying to give lame excuses as to why you don't better protect Canadians lives.
Dr. Sharma: In terms of the protection of Canadians and patient safety, that's our utmost concern.
Senator Eggleton: Sure.
Dr. Sharma: There is nothing else that drives the work we do other than patient safety. As Ms. Chiponski said, we need to take a risk-based approach to make sure we're applying the resources.
Senator Eggleton: You're not very credible.
Senator Seidman: I have many questions as a result of the witness testimony that we've heard over the course of Part IV of our study. If I could just start with one, and that has to do with the generic form of OxyContin. My understanding is that we have recently received letters from two U.S. senators pleading with Canada to follow the U.S. lead in banning the generic form of OxyContin because it is like heroin, in essence, and it's crushable and useable on the street. I would like to know why Health Canada hasn't taken any action on this.
Dr. Sharma: In terms of the original form of OxyContin, it was approved by Canada in 1996 with a very limited scope of use. When we received the application for the generic OxyContin, the original product was still on the market, or it was not withdrawn for any specific safety issues.
The way that the regulatory framework works for the generics is that their test is they have to come in and show they are equivalent to the brand name or the product currently on the market. In this case, the generic OxyContin manufacturers did meet that bar. We didn't feel that was enough, given the context with respect to the product. We actually introduced tough new measures on all manufacturers, in addition to the measures that are already on them through the Controlled Drugs and Substances Act around abuse, misuse and diversion, to report to us the information that they had around any suspicious behaviour.
Since the release of the generic OxyContin on the market, we continue to track those reactions or any reports. Currently on the market there are less than 1 per cent of the opioid prescribing —
Senator Seidman: I don't want to interrupt you, Dr. Sharma, I'm sorry, but you're not really answering the question. I understand exactly what you're saying, however recent information has made it very clear that Canada's right up there now in terms of drug abuse. The question is why we're not responding to our partners, the United States, in taking this generic form off the market. That's the question.
Dr. Sharma: We are working very closely with the United States in terms of their concerns. We have a slightly different regulatory framework than the U.S. and we have discussions with them about the decisions they made and the decisions they're making going forward on generic products.
In terms of the tamper-resistant nature, the tamper resistant — other form of OxyContin — is what called all of this into question even more so recently. It's moving really quickly.
When we have our discussions with the United States around their products and our products, we're really working in lockstep on our guidelines or the tamper resistant. But for generic OxyContin, as an example, it really was that the company came in with information to support that it was a generic version of a product that was currently on the Canadian market. As I said, we put other controls in place in terms of concerns regarding potential abuse and misuse.
The Chair: Dr. Sharma, on that point, the issue is not that it's equivalent to the original approved and patented form of OxyContin. That is, in fact, the other issue. It is legalized heroin. Testimony has indicated there is a new form that makes it much more difficult for that drug to be used as a narcotic in the normal sense of that term.
I'm taking liberties with the senator's question, but the question, I think, was why haven't we banned a legalized form of heroin when there is an alternate form that protects Canadian citizens to a much higher degree?
Dr. Sharma: Absolutely, that's a very good question. The issue is that we always have to balance the accessibility to products with the potential risks and benefits. For example, we may have a tamper-resistant formulation that is more difficult to crush and therefore less likely to be abused through intravenous or inhalation route. We've also had cases, for example, where we've had adverse reactions in terms of choking, intestinal obstruction, et cetera.
The challenge for us with any given product is to balance the risks and the benefits. We felt that for the generic OxyContin what was important is that we actually had controls in place to make sure that we have any reports or if there were any concerns. I have to say that it's now a year since that was on the market and we have not seen significant concerns in terms of additional abuse or misuse of that product.
Senator Seidman: In the name of time efficiency I will go on to my next question, which has to do with drug shortages. It's a big issue at this committee.
We've heard differing evidence and testimony about the value of the website drugshortages.ca. We had health professionals who expressed a number of concerns, including the very functionality of the website. It was dysfunctional, they said, it did not have up-to-date reporting and it had a lack of information regarding alternatives. We had representatives from industry saying that they're trying to improve it but they're not in a position to make any decisions on prescribing and best alternatives.
How many instances of prescription medication shortages have occurred in the last year? Are those more incidents than in previous years? Just to start. If I could just have a series of quick responses I would appreciate it.
Dr. Sharma: I don't actually have the total number as of current. We can provide that information. But I believe in the last year it was around 160, and that was the shortages and potential shortages. But we can get that number.
Senator Seidman: Has that increased since the previous year?
Dr. Sharma: The reporting has increased. The challenge with the website is to know whether or not that's a function of overall shortages being increased or of increased reporting to the website.
Senator Seidman: Does Health Canada report their activities to resolve shortages?
Dr. Sharma: In terms of the actual work that we do, no, we don't report the actual work that we've done on shortages.
Senator Seidman: So how do you respond to drug shortages, in fact? Do you do anything to reduce their impact? What exactly is the function there?
Dr. Sharma: I know the committee is well aware that drug shortages are a complicated and complex issue in terms of drug supply. Industry, of course, is in a position where they know what products they're bringing to market and concerns that they may have around the manufacturing process. The provinces and territories, being the purchasers, and through the group purchasing organizations, also have a lot of information at their disposal regarding how they are making those purchases.
From a Health Canada perspective, as I mentioned in my opening remarks, we are working with the provinces and territories through the multiple stakeholder steering committee on shortages. That includes members of industry, provinces and territories, group purchasing organizations and other governmental organizations, and a number of other stakeholders, to address the overall issue.
With respect to the role of Health Canada, we have certainly stepped in if there was an issue regarding safety and efficacy. For example, if there was a concern around good manufacturing practices, it would then be cause for us to do a recall. As we've said, we would look at the patient population and look at what would be medically necessary, and then to see if there is anything else we need to do. We've expedited reviews, for example, of alternative products to be brought to market in the case of drug shortages. We have a program, the Special Access Programme for emergency release. We've accessed that program to be able to mitigate drug shortages.
As well, we brought products in, through compliance and enforcement discretion, from other areas to be able to work with provinces and territories to get them where they are needed.
The Chair: Did I hear you correctly to say you have the authority to order a recall?
Dr. Sharma: With the passing of Bill C-17, we would have the authority. But in the case of a potential recall, even if there is a need on the manufacturing side for recall, we take a risk-based approach to see what level —
The Chair: But the point is that right now you have the authority to ask for a voluntary recall, but you do not have the authority to order recall right now; is that correct?
Dr. Sharma: That's correct. It's one of the authorities that are proposed in Bill C-17.
Senator Seidman: In times of shortage, would Health Canada fast-track approval of drugs that are already approved in other jurisdictions, like the U.S. and European Union, for example?
Dr. Sharma: Yes, we would, and we have. It was interesting; a couple of years ago, through the Sandoz shortage, we had that very issue come up. Companies have come to Health Canada to fast-track a submission. We did fast-track it. It was approved for use on the market and then it was never put on the market.
We'll do as much as we can to facilitate that, but it also depends on the rest of the system to use those resources and have uptake on those.
Senator Eaton: Good morning, and thank you.
The latest figures from the 2013 Report on the State of Public Health in Canada show that for every thousand Canadians, there are 670 prescriptions for oral anti-microbials every year, yet the U.S. Centers for Disease Control and Prevention estimates that up to 50 per cent of all antibiotics prescribed are unnecessary.
Do we have any kind of data in Canada that says that's not the case here, or is the same here? Would somebody like to answer that question? No? We don't have data?
Dr. Theresa Tam, Branch Head, Health Security Infrastructure Canada, Public Health Agency of Canada: In terms of anti-microbial use data, we do collect information on total antibiotic usage. There is no differentiation in that data as to what is an appropriate prescription and what is not.
Senator Eaton: Fine.
I read, Dr. Sharma, in your presentation that you have started a National Anti-Drug Strategy. Would you use some of this data as part of your strategy to reinforce what you're trying to do?
Dr. Sharma: Yes.
Senator Eaton: Could you elaborate a bit on when it will start and how it will play out?
Dr. Sharma: Absolutely. I'll have to turn to my colleagues, but I believe the National Anti-Drug Strategy started in 2010. The new part of it, which I referred to in my speech, is that looking at abuse of products had previously been focused only on illicit drugs. But this year, in 2013, it has been expanded to also include prescription drugs and abuse of prescription drugs. As the committee, I'm sure, has heard from other people, it is of grave concern for families and communities.
One of key pillars of that strategy is better surveillance and better information gathering. We can only do that through cooperation with various other provinces and territories and other non-governmental institutions. But certainly part of that, in terms of information gathering, is a key pillar of that strategy.
Senator Eaton: Have you started to reach out to hospitals, to pharmacies, to the Canadian Medical Association? Who are you reaching out to?
Dr. Sharma: I'm just referring to our group. We have already collected a broad range of data. We fund a group, the Canadian Alcohol and Drug Use Monitoring Survey, which helps track the use and abuse of opioid pain relievers. As well, we have the Canadian Student Tobacco, Alcohol and Drugs Survey, which collects some similar data but in a specific age group. Certainly under the Controlled Drugs and Substances Act, which is within the purview of my colleagues at the Healthy Environments and Consumer Safety Branch, they collect and monitor that data as well, specific to diversion and abuse as well. There is a lot of effort going on.
In terms of additional outreach, we absolutely work with the provinces and territories and, through them, with the regional hospital centres, and a very big push in terms of reaching out to First Nations communities as well.
Senator Eaton: I was going to ask you, because we heard absolute horror stories yesterday of the abuse and unintended consequences across Canada. Do you have specific strategies for First Nations?
Dr. Sharma: Absolutely. As recently as January of this year, the Minister of Health held a round table, including First Nations communities, with respect to prescription drug abuse. We had people from the health care environment, First Nations communities, law enforcement and other groups. Then there are other meetings happening with regional chiefs through the First Nations associations to continue the discussion, because, as you've mentioned, it's a real concern to us. The first step is to get more information and do more surveillance, and then put strategies in place to combat the prescription drug abuse that we're seeing.
Senator Eaton: Are you happy with the data collection you do as a whole on prescription drugs and neonarcotics? Do you think there are gaps that might help you further or do you think you have everything you need?
Dr. Robert Peterson, Executive Director, Drug Safety and Effectiveness Network, Canadian Institutes of Health Research: The direct answer to your question is no, we are not satisfied with that.
We have an organization now that is funded by CIHR and DSEN that has engaged almost all of the provinces in Canada, including several offshore databases, that allow for us to enter into pharmaceutical prescription utilization. We can get a fair amount of associated data from that, but that data is largely relegated to administrative health records that are satisfactory in terms of the number of prescriptions written. If we are working in an area where the data are recorded well, we may be able to get valuable diagnostic coding as well.
I will simply point out, relevant to the question asked earlier about anti-microbial use, that it's very difficult. We can usually only determine how many prescriptions are given for different antibiotics by accessing our administrative health records. At this point in time, we have access to more than 40 million patient records within Canada and offshore.
It's a substantive database, but it is limited by the types of information within the administrative health records. We don't get good, accurate diagnostic information. While I can tell you how many antibiotics were prescribed, I cannot tell you whether they were appropriately prescribed based on the diagnostic codes. Often there is a "diagnostic enhancement" of the coding for respiratory illness, so we would not find an antibiotic frequently coded for the common cold; we would often find it for bronchitis or for another respiratory illness that might justify an antibiotic prescription.
The answer to your question, once again, is no. We are really in need of a breakthrough, coordinated effort to allow us to link more information into the data that we have available. That would include laboratory testing and the outcomes of those tests that have taken place. Basically, we need to have the information that you would otherwise find in an electronic medical record in order to be able to answer many of these difficult questions today.
Senator Stewart Olsen: Thank you all for coming.
This is a fairly spirited discussion, but there are some serious questions that we all have and I think it's important we try to sort it out. It's a complicated issue and I commend you as you go forward toward transparency. I think that will result in many of the problems perhaps becoming easier and, as more transparency occurs, people will understand.
I have a question for you, Dr. Sharma. Is it your responsibility to remove a drug from market if it is found to be harmful or if the risks outweigh the benefits? I'm speaking about OxyContin. It seems to me that there are other pain-killers available. With the record of OxyContin, I wonder why we have not done that instead of going around in a circle with this particular drug.
Dr. Sharma: I understand the concerns. To talk a bit about the frameworks, on the Food and Drugs Act and regulations, we are really looking at the product for its intended use and intended population.
Senator Stewart Olsen: I got your inference that you studied the generic OxyContin and compared it to the brand drug and they were pretty much both equal.
What I would really like to know is who is responsible for saying, "This drug is too dangerous to be marketed in this country. Let's pull it off the streets"? I'm not saying it would do a lot for illegal use but perhaps it would do a lot for pharmaceutical misuse.
Dr. Sharma: In terms of the market authorization, the authority to act falls within the Food and Drugs Act and, because of the nature of the product, it also falls under the Controlled Drugs and Substances Act. Those are the regulations in the act that —
Senator Stewart Olsen: Who looks at that and says this drug is too dangerous?
Dr. Sharma: I appreciate the complexity. Our colleagues in the Healthy Environments and Consumer Safety Branch will look at abuse/misuse concerns and that would feed into the work of the Health Products and Food Branch around the ultimate market authorization. We work very closely together but it really depends on what the data is in terms of risks. Then you identify the risks — that is, can the risks be mitigated? Can you have a risk management plan? Can you have controls on the product?
Senator Stewart Olsen: Forgive me for interrupting but in the interests of time, so that everyone can get questions in, I heard your mitigating factors for OxyContin and I'm not convinced they are effective enough. There are too many people addicted to this product and it's being prescribed to too many people. I think it's a very dangerous drug. There are other drugs available that would do the same thing — perhaps just as addictive. That would be my comment on that.
If I could move on to DSEN, you mentioned you were doing a lot of risk assessments. Do you post the results of your risk assessments on a website so they are publicly available?
Dr. Peterson: There are two parts to your question, I believe. The risk assessment that would be done by the regulator, which Dr. Sharma indicated they will be making public, is something to which I would allow her to respond.
From the DSEN perspective, we have had a number of questions from our federal regulator with regard to the safety in the real world of products on the Canadian market.
Senator Stewart Olsen: Yes, that is what I am interested in.
Dr. Peterson: The answer to your question is yes, they are posted. The fact that we are studying the question is made public on our website. The methodology that we are using in order to do that evaluation is listed. We try to give indication of what our expected time frame would be. When the results are completed they are reported back to the decision maker. If it came from Health Canada, they see the results first. Then the publications actually appear in the medical literature, either in open source or medical journals.
Senator Stewart Olsen: That is good to know. Thank you, Dr. Peterson.
I noted that we fund two antibiotic-resistant major studies in the millions of dollars: one with the European Union; one with Great Britain. Is there some consideration about everyone working together on this thing and not funding two entities that may be actually doing the same work?
Dr. Aubin: The studies that you're referencing are being done in collaboration for the very reason that we want to avoid duplication of effort. We fund the Canadian principal investigators; in the U.K. they would fund their principal investigators who reside there. In the case of the new joint program with the European Union, it is exactly to avoid duplication that we're doing the collaboration, so results and best practices are shared, et cetera. Does that answer the question?
Senator Stewart Olsen: It does. Thank you so much.
Senator Seth: Thank you all for being here and for sharing your knowledge with us. In the past, we have talked about various prescription drugs and the unintended consequences; we have been discussing this for some time. Our last witnesses, who were from the RCMP and the Canadian Border Services Agency, told the committee here that they work closely with Health Canada to detect counterfeit products and to prosecute the offenders.
Can you evaluate the role of Health Canada in preventing the manufacturers from distributing counterfeit pharmaceuticals?
Ms. Chiponski: As you have already acknowledged, the responsibility of managing counterfeit is shared by at least three agencies in Canada. Your question is specific to what Health Canada is responsible for.
We work primarily with our Canada Border Services Agency partners at the border in terms of what products are coming into Canada. We set up policy guidelines and alert systems, and we have databases that allow us to communicate our concerns or our flags in the system. That information is also brought to us via our international partners. We communicate and update regularly about what the signals in the system may be and what to look for. If there is an actual product that comes to the border that is of concern, the Canadian Border Services Agency will refer that to Canada for an admissibility determination process. That could include one of Health Canada's labs conducting some scientific evaluation to determine whether the product is counterfeit.
It may prompt us to search other databases that we might have available to us or to connect with our information networks. We are also looking at, with our FDA partners, increased technologies that might be available on how to determine, in a faster, more efficient way, what might be a counterfeit product.
After all that analysis is done, we deliver a determination to Canada Border Services Agency about whether or not the product is found to be counterfeit or suspected of being counterfeit. At that time, the person or entity that tried to import that product is contacted, and Canada Border Services Agency works with them on the disposal of that product.
Senator Seth: Dr. Sharma, you have been telling us about Vanessa's Law, which requires mandatory reporting. What is this law? Do we collect the data from the various hospitals about prescription drugs? How does it work? I am not quite sure. Could you explain that, please?
Dr. Sharma: Currently, Health Canada has the authority to require the submission to Health Canada, by pharmaceutical companies, of the adverse drug reactions. The proposal, in Vanessa's Law, that is moving forward is to make that mandatory for proscribed health care institutions. It would be a hospital entity, and we are still sorting out which entities those would be. It would be a mandatory obligation on the hospitals to identify and to report the adverse drug reactions to Health Canada.
When we did our consultations, certainly, there was a lot of prescribing that went on outside of those health care settings. However, when we are looking at the definition of "serious adverse drug reactions," part of the definition is an adverse drug reaction that requires hospitalization or a prolongation of a hospital stay. We felt that the hospitals were in a unique position to have that information and then to provide it to Health Canada.
Senator Seth: I am still not sure. What happens is that a lot of health practitioners are prescribing in their offices, and sometimes those patients will not necessarily go to hospital. How about those adverse reactions?
Dr. Sharma: We encourage those to come in as well through the voluntary system. Whether it's members of the Canadian public, pharmacists or practitioners in the community, we have ways for those reports to come in, either by fax, email or phone. We encourage that as much as possible. It really comes down to the definition of "a serious adverse reaction" in terms of the ones that are of most concern. The next step that we're taking, as I mentioned, is to look at the hospitals and the hospital prescribing.
Senator Seth: So there will be a data system created in Health Canada? I am not sure how it will work.
Dr. Sharma: Yes, so there is an adverse drug reaction database that we have. That Canada Vigilance database is actually open to the public as well, so you can do the search. The new adverse reactions that will be coming in will be entered into that database as well.
One of the things that we have done over the past year and a half is to facilitate and enable electronic submissions of those adverse drug reactions as well to facilitate those coming in. They will come in and be part of that database as well, so we can analyze them for any trends or concerns. Again, that information will be made public as well.
The Chair: Dr. Peterson had an observation for you as well, Senator Seth.
Dr. Peterson: CIHR-DSEN is funding a pilot program now that is based in emergency departments, in order to develop a template and a standardized reporting form for emergency departments around adverse drug reactions. It is done for the purpose that I mentioned earlier. We don't have sufficient data in order for our colleagues at Health Canada to, oftentimes, make these difficult decisions. So frequency of events is important. However, quality of the report so that you can actually interpret either causality or the seriousness of the outcome is something that we are delving into now. This is a program that we've had in existence for more than a year. It is centred in British Columbia at this point in time. We anticipate that our next steps in the funding of this program will be to move it out to other provinces, with our ultimate goal to improve the quality of the data that we receive.
The Chair: Dr. Peterson, you know that we are thoroughly behind that kind of activity from what you have seen from our previous activities here.
Dr. Peterson: I do indeed, and it has been motivating.
Senator Enverga: Thank you for all of your presentations.
Just yesterday, The Globe and Mail, among others, published an article about a research study on Tamiflu vaccines. The study indicates several issues about the vaccine that I believe your agency has spent tens of millions of dollars to stockpile. There are many issues covered in that report by the Cochrane Collaboration. I haven't had time to read the entire report, which is over 500 pages, but some of the issues raised are quite alarming and include the issue that the effectiveness of the drug is overrated by the manufacturer; that there is research data withheld by the manufacturer and that there are adverse effects not reported. This leads to my questions:
One of the criticisms of the study is that the authors also advocate for access to complete trial data. During an approval process for a drug, are the manufacturers not obliged to report their full findings? What does Health Canada do when new information about adverse effects or other indications of some problem with an approved drug come to light, as in this example? What do your agencies need in order to be more effective in your responses to these kinds of situations in terms of legislation, financial or human resources? Is there something we can do?
The Chair: Dr. Sharma, do you wish to direct the response to this?
Dr. Sharma: I am wondering if Dr. Tam wanted to speak about the overall use and stockpiling of Tamiflu, and then we can speak to the regulatory side.
The Chair: Certainly.
Dr. Tam: Thank you to the senator for his question.
On the public health system side, Tamiflu is one of our most effective tools against influenza pandemics. We mainly stockpile for that particular purpose.
This particular study — and we welcome it because it is giving us more information to work on — fundamentally looks at randomized, controlled trials at the time of regulatory submission, if you like. They are very controlled environments, tested in a seasonal — that is, regular winter flu — season, on healthy people in general.
Public Health, in line with other researchers and studies, looks at what happened in the real world. We also have to take those studies into account. There were a number of those studies, conducted also during the pandemic of H1N1, that have shown that, in real life situations, these drugs were effective in reducing the risk of high-risk people going into the hospital and dying from the pandemic flu. Our indication is for pandemic influenza preparedness. We will take the information into account as we review the body of evidence along with others.
There is another study, just published in the Lancet, that says the opposite in terms of effectiveness when the antivirals were used in real-life situations.
There is another very large, multilateral study that we are looking toward getting the results of in a number of months, which also looks at very long time frames and large numbers of people in a real-life situation.
As we speak, the provinces and territories are meeting with us to review the next iteration of our pandemic preparedness plan and guidance document. As we review the antiviral chapter of that document, we will be looking at this evidence in line with that.
The balance of the body of evidence, from a Public Health perspective, at this time, is that it is the only intervention you will have during a pandemic. The balance of the evidence is still to continue to stockpile, but we will refine our recommendations as we go along.
Dr. Sharma: In terms of the regulatory role, we are constantly looking at medications that are marketed in Canada. If there is a signal or an indication that there is a new risk or a change in the risk profile of the product, then we will do an assessment.
That input information can come from anywhere. It may come from something as sophisticated as a Cochrane Collaboration study that looks at a number of different pieces of information. It can come from our adverse drug database. It can come from another international regulatory counterpart. That causes us to pause and to take a look at the body of evidence.
As Dr. Tam mentioned, sometimes we are in a situation where we have conflicting data, but we do our assessments and then look at the overall benefit-risk profile of the product to make sure that the benefits continue to outweigh the risks. If there is a new risk then we have to decide what to do with that. Sometimes it's communicating about those risks through risk communication either broadly out to the public or to health care professionals. Sometimes it is changing a label in terms of the warnings or the precautions or some other information on the label. We can go as far as stopping the market authorization of the product, so effectively taking it off the market.
As we've discussed before, our regulations are quite antiquated and parts of what we're looking at in the new Bill C-17 that's proposed is more authority to do that. Currently we don't have the authority, as we mentioned, to compel a recall. We're looking at authorities to compel new studies to be done.
For example, now where we're relying on the studies that are already there — and we do get studies that are not necessarily even completed — the companies are supposed to provide all information to us, but we don't have the authority to specifically require a study to be done. Nor do we currently have the authority to compel a manufacturer to change a label. All of that is done through our current regulatory measures. That's why we're seeking increased authorities through Vanessa's Law to be able to give us the powers to do that should the need arise.
Dr. Peterson: I believe that this is an example of how the regulations truly need to be amended. At the present time, for a product to come on to the market, the regulations specify there must be substantive evidence of an effect. That is not the same as evidence of a substantive effect. In this particular instance, the product was brought on to the market with substantive evidence of symptomatic relief of influenza.
What our public health colleagues are seeking and what we need in the case of a pandemic is a product that has a very substantive effect in preventing the serious outcomes of influenza in high risk populations. The Drug Safety and Effectiveness Network has worked with the public health agency in order to be certain that we are prepared in order to garner the evidence and collect the evidence in terms of a pandemic. In this particular instance, once again, the only way we're going to look at the effectiveness of the product during a pandemic is to await the pandemic and to look at how this has evolved.
We are prepared, however, to put some structure around that so that the next time this occurs we will be able to collect the evidence in a fashion that, hopefully, will be useful to the decision makers.
Senator Enverga: We have to wait for a pandemic in order to find out the effectiveness of this medicine; is that what you're saying?
Dr. Peterson: What I'm saying is that if you're asking the specific question, "How effective is it during a pandemic?" then yes, the answer is largely there, largely based upon the fact that a pandemic is typically the result of a mutation of the influenza virus and there is something that has not been seen before.
However, there are many ways in which you can address this in anticipation of that but it doesn't give you the real world evidence that I believe we've been discussing.
Senator Enverga: We have some procedures in place in case it happens; we are ready to look into it and find out what's happening; is that correct?
Dr. Peterson: We are prepared to take advantage of an unfortunate set of circumstances such as a pandemic to be certain that we learn as much as we possibly can.
Dr. Sharma: An example we've lived through is the SARS crisis. In that situation we had some information about products that could be used in that case. We had the science to show that there was what we call the biological plausibility that medications could be used to potentially decrease the length of the illness or decrease the symptoms. When we actually had the issue, Health Canada worked with the Public Health Agency and a number of other groups to collect data on how those antivirals and other products were used. When we did that we had some data that actually showed it did help in terms of duration and in terms of some of the symptoms, but when we looked at other adverse effects of the medications — and there were some effects on electrolytes and things like that — ultimately the benefits didn't outweigh the risks.
We have limited data when we actually make the decisions but whether it's a pandemic or another situation, there are always unknowns that happen. I think the important part is to have as much information as we have going into these situations and apply the best science and knowledge that we have; then, in the midst of an illness or a pandemic making sure we have the mechanisms to get that information and be able to adjust and react as we get information coming in.
Dr. Tam: Unfortunately, we did get the pandemic and during that pandemic data was collected. That is what I was referring to before. When we looked at the real-life situation during the pandemic, the publications are coming out to show that the antivirals had an impact for the high-risk groups that were affected in terms of the risk of death.
[Translation]
Senator Chaput: My question is for Health Canada. Doctor Sharma, in your presentation, you talked about launching a clinical trials database on your website in spring 2013. You said it is meant to provide Canadians with information about authorized Canadian drug trials in patients.
My questions are as follows. What led you at Health Canada to give priority to this information and launch a database? How much data do you have, and who provides you with that data?
[English]
Dr. Sharma: In terms of the clinical trials database, that's actually a public database. It's on our website and anyone has access to it. You can query the database with various questions. You can ask whether or not you want to see clinical trials related to a specific illness or a specific drug or a combination of those. That's a question that goes in.
It's a registry of the clinical trials that Health Canada authorizes. In the phases it would be phases 1, 2 and 3. It's a list of the actual clinical trial and the principal investigator and what they're actually studying. Since it has been launched almost exactly a year ago, over 300 clinical trials are in the database.
[Translation]
Senator Chaput: Does it give a complete picture? Does it give only positive results, or can users actually find less positive results as well?
[English]
Dr. Sharma: It's actually just the existence of the trial so it tells you that the trial is ongoing, it's approved in Canada and it's a legitimate trial. There currently isn't a way to disclose the results of the clinical trial. Certainly we are working with other regulatory authorities internationally. Europe is trying to move forward in terms of actually releasing the clinical trials data. They are currently involved in some legal cases in terms of those challenges. We are all watching very carefully around the actual results of the clinical trial as to how we can make those publicly available as well.
[Translation]
Senator Chaput: As a member of the public, what sort of information would I find if I went to that website to consult the database? Would it give me information about a drug or how successful that drug is? What sort of information would it give me?
[English]
Dr. Sharma: It tells you basically that the trial is ongoing. For example, if we have a parent who is concerned about a clinical trial that they've been approached for their child to take part in, this allows the person to go to the website and say, yes, it's a legitimate clinical trial and it has been authorized by Health Canada.
If someone is taking a medication, for example, and they want to be aware of what other trials are under way for that medication with the indications, for example, we've had a lot of patients in the oncology community and when a product is launched it's for a specific type of cancer, a specific indication, but at the same time there may be a lot of other studies going on for different indications. That provides them with that information as well.
[Translation]
Senator Chaput: A little later in your presentation, you talked about the concrete progress Health Canada has made in partnership with the industry. You talked about improving the website that is maintained by the industry. How have you contributed to that industry-led website?
[English]
Dr. Sharma: In terms of the actual existence of the website, the www.drugshortages.ca, it really was very strong direction from the Minister of Health at the time that actually directed industry to have that notification up and running. In terms of it being created in the first place, it really was at the direction of the health minister. Understandably, there are still improvements to be made in terms of the technical functioning of the website.
We have worked with industry in terms of what it looks like and what types of shortages and potential shortages would be notified. Beyond that, because I think we all have concerns about making sure that the shortages are actually notified and people are aware of them so that they can do appropriate planning, we have also introduced a commitment that industry would make to post those shortages to that website. If they don't and if they are not compliant, then we will actually post notifications saying that they have not been compliant with their commitment to post the shortages on drugshortages.ca.
[Translation]
Senator Chaput: Is there a link between the www.drugshortages.ca website and the Health Canada site? For instance, if I go to the Health Canada website, is there a link somewhere on your site that tells me that I can also consult the other site, or are the two completely separate?
[English]
Dr. Sharma: Right now they are separate. There are not only those two databases but there are other databases related to an individual product that are separate. Because of that, one of the initiatives that we are working towards, and it was actually announced as well as part of the openness and transparency initiative, we are pursuing what we call a health product register. It would be one site on the Health Canada website where you could search a product, and then there would be all the information related to it. For that health product, you would have the Canadian product monograph, links to be able to look at the adverse drug reactions, links to drugshortages.ca and links to any of the risk communication. We really are moving forward on a site to actually bring all that together. Currently that site is in IT usability testing.
[Translation]
Senator Chaput: To your knowledge, how many such websites are there, websites that operate independently, which, if they were connected, would be extremely beneficial to Canadians?
[English]
Dr. Sharma: From the Health Canada standpoint, if we look at the different databases, we have the clinical trials database that we talked about and the drug product database. We have a database on healthycanadians.gc.ca on recalls. We have a website where we post all the risk communications. I could keep going, but I am sure you understand.
The idea is, as you mentioned, to bring all of those together so that when you are searching for a product, you will be able to access those all in one place.
[Translation]
Senator Chaput: Do you not think that it should be Health Canada's responsibility to coordinate all those websites at some point?
[English]
Dr. Sharma: Absolutely, which is why we're moving forward. The health product register that I am speaking about is actually a Health Canada initiative. I think we are in a unique place to have access to that and to be able to bring those together in one place.
Senator Cordy: To follow up on the question on the shortages website, if a company doesn't comply and you actually post a letter, if they still don't comply and the letter is on-line, you said you would take further steps. What would those further steps be?
Dr. Sharma: To be honest, right now, it is all through moral suasion, should we say. Right now we actually don't have the authority. I think my reference in my speech was we moved forward with the voluntary reporting because it was actually the timeliest way to do that. It didn't require a regulatory change or introduction of a new regulation. Certainly we are relying on that voluntary mechanism. With the increased focus on it through the letters and the compliance, we are hoping that that encourages more reporting, but certainly further steps would be considered.
Senator Cordy: But you did say that if they don't comply after the letter on site, that you would not hesitate to take further steps. I was curious about that. There are no further steps, then; is what you are saying?
Dr. Sharma: I think what I was referring to is in terms of looking at a potential mandatory reporting, but that is not in place now.
Senator Cordy: That is not in place now, so, as it stands, there are no further steps?
Dr. Sharma: Not currently.
Senator Cordy: So we don't have further steps.
As you can imagine, this committee has heard very serious concerns from witnesses about unintended consequences of pharmaceuticals. We have also heard a large number of concerns that Health Canada doesn't seem to be doing enough to ensure that our pharmaceuticals are safe.
Senator Stewart Olsen was talking about OxyContin. Health Canada refused to prohibit the generic formulation of OxyContin. The 13 provincial and territorial health ministers asked the department to at least wait until a safety assessment had been completed on the generic OxyContin. What has been the result of this assessment of the safety of this generic OxyContin?
Dr. Sharma: In terms of the ongoing information that we are collecting through our colleagues at the Healthy Environment and Consumer Safety Branch, for the product that has been on the market, the generic product has taken a very small share of the overall prescribing of opioids, so less than 1 per cent. There has not been a significant change or there has not been a significant concern around misuse or diversion based on the surveillance that colleagues have done. We can certainly get more information for you on that, though.
Senator Cordy: So there is an assessment, or there is not an assessment?
Dr. Sharma: There is an ongoing assessment in terms of the concerns regarding abuse and misuse of the product that's on the market.
Senator Cordy: We heard yesterday some very scary stories about addictions from the Aboriginal community. Mr. Beardy, the regional chief for Ontario, referred to a report. This particular report that he referred to recommended that the generic form of OxyContin not be listed on the non-insured health benefits. Whether it is administered by the provinces or whomever, we are ultimately responsible at the federal level for the health of Aboriginals. Will you be looking at that recommendation so that OxyContin is not on that list?
Dr. Sharma: Yes. Actually, the transcripts or the original summary from the meeting have been forwarded to our First Nations and Inuit Health Branch at Health Canada. We have already referred that to them, and I would be happy to get more information from them regarding their reaction to the comments that were made.
Senator Cordy: To that recommendation. I would appreciate it if the committee could get that.
OxyContin comes under the field of opioids. As Senator Seidman said earlier, this is a public crisis in Canada, which has the second highest use of opioids in the world. Because Health Canada is continuing to allow opioid drugs to be distributed and prescribed in Canada, we must have some idea of how many Canadians are addicted to opioids that have been prescribed to them by their health care providers. Could you give us that information?
Dr. Sharma: Again, I would have to refer that to colleagues in the Healthy Environments and Consumer Safety Branch on the actual numbers. They are the groups that actually track that data. We can provide that to the committee, if that is a request.
Senator Cordy: Certainly the committee heard about the prescribing of what is basically heroin. We have all heard the term "hillbilly heroin" used a number of times. Heroin is legal to be prescribed in Canada under the opioids that have been allowed by Health Canada.
We also heard about education of prescribers for prescriptions, and we heard that most if not all of the information is coming from the pharmaceutical companies. Of course, if you are a pharmaceutical company and you are a salesperson for a pharmaceutical company, human nature being what it is, you are certainly going to talk about the good points, as any other sales person would do, and not necessarily talk about the side effects of taking it.
Is there a better way that we can do that so that those who prescribed pharmaceuticals can be aware of the side effects of those or the unintended consequences? If they were aware of the unintended consequences of opioids, I would hope that we would not be the second highest in the world in usage of opioids.
Dr. Sharma: I can speak specifically on the opioid side. I think that is a really good point.
In January of this year, we held a round table on prescription drug abuse and focused a lot on opioids as well. That was led by the minister. As I said, it brought together provinces and territories, health care organizations, law enforcement and First Nations communities. Part of that was a specific breakout session on prescriber education. We are certainly looking at how we can do that and how Health Canada, in our role, can facilitate having information specifically on prescription drug abuse and on opioids as well.
In the broader area of providing information, we get into where different responsibilities lie. Obviously the practice of medicine or the practice of pharmacy is something that is governed and regulated at the provincial and territorial level. From the Health Canada perspective, this relates a bit more to our openness and transparency.
Our goal is to provide the information that we have that's credible and timely with respect to the product, in again one place, so that people can make those informed choices. Whether it's an update with the full product monograph, or just this week we've announced that for the products already on the market we will be publishing drug safety summaries from the assessments that we do.
We're working with a number of our other colleagues. We just announced, for example, for one of our products a checklist that can be used at the point of care for prescribers.
Senator Cordy: That's all good, but despite all these discussions that you're having, 13 provincial and territorial health ministers asked Health Canada to at least delay — most asked that it banned — the production of the generic form of OxyContin, and that wasn't done by Health Canada. You may be having these discussions but the actions seem to be speaking more than your behind-the-scenes discussions.
Senator Nancy Ruth: This is a question really to any of you who want to answer it. I'm curious, with all the data collection, both nationally and internationally, whether at the clinical trial level or after the fact, is there any data collected on the use and outcomes of people of different genders, race or age? In what ways would it be useful to do so if it is not done, and how would these categories influence what you call "risk"?
Dr. Sharma: I can speak to the adverse reaction side of the equation. In terms of looking at the adverse drugs reactions, it is really the quality of the reports that we get that really make a difference. In those adverse reaction reports, gender is specified or able to be specified; age is able to be specified; and, of course, the other information around that.
I think recognizing it then, we can still do more in terms of certain vulnerable populations. We have embarked on different projects to be able to encourage and get more information. For example, we've worked with the Canadian Paediatric Society to put together the Canadian pediatric surveillance group. That is a group of over 2,400 pediatricians that care for in total over 7 million pediatric patients. We will work with them to get more information in and around the products they are using. There is a push on a regular basis to give tips of the month to encourage reporting and advise on how best to report, and if there are specific issues that have arisen for the product for the pediatric population, they will get notifications of that as well.
We're using that as a model to see if we need to target various different groups to not only get more information in so that we can make our assessments, but also to share information out.
Dr. Peterson: I can't contribute much more than that, only to say that for the metrics that you're asking for in terms of gender and age, et cetera, then all of that information is in the administrative health records that we have access to on a national basis. Receiving a question from the regulator or a high-level decision-maker in one of the provinces would permit us to address those questions specifically. However, these are done at relatively infrequent points in time. When a question comes, we access the data.
What we are truly looking for is to have real-time monitoring of the data as it accrues so to have access to data such that as the prescriptions occur we are able to look at them accrue and we can then, on an ongoing basis, look at how the drugs are being utilized. At this point in time, we can answer those questions but only when they are posed and then we go to each of the different provinces, in this case seven different provinces, seek information specifically from their data holders as to what we would need to do in order to access that data, and what information do we need to provide them in order to allow for them to agree to have that information be released.
Senator Nancy Ruth: Are you confident that the data is collected?
Dr. Peterson: The data along the metrics that you are asking for are collected, yes.
Senator Nancy Ruth: Dr. Sharma, you used the phrase "able to be collected." What does that mean?
Dr. Sharma: It means there is a field on the form that can be filled in. We recognize that having that there is not necessarily the only thing that makes sure someone fills it out, so that's why we are working. We are trying to stress the importance of good reporting, quality reporting. Again, it's not just the numbers of reports we get in but it's the amount of information, the level of detail that allows us to do that.
Certainly, from the company's perspective, we encourage them. They have to do mandatory reporting, but for us mandatory is not just fill the paper in, and we have our responsibility. It's to be able to give us quality information so that we can assess it.
That's why we work with different groups, practice groups to get information through other areas as well, even for not necessarily pharmaceuticals but medical devices. We've got sentinel systems. You actually have hospital sites that have increased training and more information and the IT capacity to provide information. It's not the just the stick, it's the carrot as well that I think is important.
Dr. Peterson: Just to clarify, we're actually referring to two different data sets here, Dr. Sharma is referring to the federal adverse drug reaction reporting data set, and I'm referring to the other 40 million records that we have that have data entered into them as a function of the practice of medicine. As a physician is billing their health care system for care, that data is collected in the administrative records. We get hospitalization reports and we are able to collect information in general, but that's not the same as the adverse drug reaction reporting system.
Senator Nancy Ruth: I put race in the question because if data is collected internationally, it's coming from all kinds of different racial groups. How is it put together and analyzed? Is it of interest?
Dr. Peterson: You are referring again I think to adverse drug reaction data.
Senator Nancy Ruth: Any kind of data collection.
Dr. Peterson: It varies across jurisdictions as to how accessible that information is. As I mentioned earlier, we have two offshore sets of data. We have the general practice research database from the United Kingdom, which is very comprehensive and collected, and is readily available for purchase. In fact, we have purchased access to that.
We also have reasonable access to market scanned data, which is United States managed care information that is available to us. However, the sad state of the current nation is that Canada does not have equivalent data to be made internationally available. As I said, when we wish to access our data we go province by province filing a request for that data with high specificity as to what we will do with it, and part of that application agreement is, it will not go beyond the researchers' hands that are addressing the specific question. When I mentioned that we need additional access to data, data that is sufficiently constructed so that we can share it amongst ourselves and share it internationally, that is a very specific requirement that we have at this time.
Dr. Sharma: With respect to information contained in clinical trials, you may very well have a race or ethnicity effect that you need to consider. For products that are coming on to the Canadian market, we know that we have clinical trials conducted in a variety of different countries under different specifications, so we have to look at that to see whether or not on the basis of overall data but also, for example, on ethnicity, that is still applicable to the Canadian market.
It's interesting because when we're looking at international trials, some of the things that are not necessarily related to ethnicity, coming from, for example, the United States, we have to factor in that in general Americans have a larger body mass index than Canadians. For some of the products we have to take that into consideration as well.
Internationally, the issue or race and ethnicity in clinical trials is looked at in a group that we participate in called the International Conference on Harmonisation. They develop standards and guidelines in terms of how to interpret that data. As we move forward, it's really interesting because we're finding more and more that genetics can play a very interesting role in terms of how products are working, how effective they are, but also risks as well. We are now getting more information about those specific generic links, and some of those are tied to race and ethnicity as well.
The Chair: I'm going to ask some questions, many of which, if not virtually all of them, I would like you to take under consideration and either get back to us in writing before your next meeting or be prepared to address them at the next meeting.
I have a second-round list, and I will do the same thing there. I will give you the questions asked, and then if it's possible for you to respond in writing before the next meeting that would be great. If not, have the responses for us at that time.
My first question is a practical one. While you were discussing the clinical trials website we attempted to access it and search for clinical trials in certain areas. For example, we entered in the medical condition category, "diabetes," "cancer," "AIDS," "hepatitis" and "depression." We had no responses in any category.
What we would like to know, when you look into this issue, is how friendly is the site in terms of searching for information by Canadians with regard to medical conditions and the nature of the response.
You have four principal categories: medical condition, protocol type, drug name and sponsor's name. The average citizen will not know any of the latter three. We were entering only under medical conditions, and I find it a little surprising that there is no trial going on in Canada in the categories I listed. If you can check into that issue for us, or if you have a sharp answer that says, "Well, you idiots, you should have been putting in the following," I would accept and welcome it.
Dr. Sharma: I do have a short answer. It is nothing like that. The answer is that we're actually having an issue with the website itself on the IT side. That's happened this week. We are looking into it but it's a technical issue, so no matter what you put in you will get no results for this week. We're trying to sort out what the actual technical difficulty is.
The Chair: I would suggest you do what others do in that case and put up a sign saying, "We are temporarily out of service." I can imagine a Canadian parent searching this and being frustrated as blazes. We were a little frustrated, maybe not as blazes, but we are raising the question. Thank you for the answer, and I would make that suggestion to you.
Dr. Sharma: Mr. Chair, I sent that email yesterday, just to confirm.
The Chair: All right. The questions I would like you to take away are the following: I would like to know — I'll speak for myself rather than it being a committee decision. Could you give us some indication of the legislative changes you would like to see and those that you feel you need in order to properly protect Canadians with regard to the medications that enter the Canadian system in terms of prescription pharmaceuticals? That includes issues to deal with such things as the questions you've heard here with regard to the generic version of OxyContin.
I would like you to provide any information that you have as Health Canada with regard to drug take-back programs in Canada. I'm just asking the question, so I'm not anticipating your answer at all. Any information you as Health Canada have with regard to deliberate take-back programs on prescription pharmaceuticals in Canada.
I would also like you to get, if possible, specific data with regard to border control of prescription pharmaceuticals. I'm speaking now with regard to the deliberate, random testing of prescription drugs that come in under an authorized label from foreign countries. I would like to know the number of those that are analyzed on an annual basis and any other information you could provide in that regard.
The final issue is a slightly different take on a number of questions you've had with regard to opioid use this morning. We've had testimony that suggests that in many cases there are non-opioid painkillers that would serve well under certain indications. We understand the issue of very deep and chronic pain, so I'm not into that.
We had clear testimony that indicated that there are non-opioid painkillers available and there are problems with them being available to Canadians in lieu of OxyContin, specifically, and these include that physicians often perhaps are not aware or are pressured by the patient into prescribing.
We realize Health Canada cannot control the practice of individual physicians. I also understand Health Canada cannot control the drug formularies in individual provinces, but it would seem to me there might well be a role for Health Canada in informing provinces with regard to serious medication issues, that there are alternatives in certain circumstances.
We heard that specifically in terms of a recommendation, not yesterday but in earlier testimony, with regard to the Aboriginal population, that they don't have available the alternative kinds of materials.
My final question is, with regard to you looking it up, do you have any opinions at Health Canada with regard to the narrowness of provincial formularies and their impact on drug shortages? We know, for example, that in a lot of common situations there are many drugs that have been approved by Health Canada for certain indications. I appreciate, again, that it's up to the physician to prescribe what he or she thinks is the best but, in a shortage of a particular medication, if there is very limited alternative authorized on the formulary is that having a negative impact on Canadians' health? And do you, as Health Canada, have any views?
I would like now to turn to Senator Eggleton and ask him to put his questions out to Health Canada that he had for the second round to get them to respond to either before or at the next meeting. We don't want to run out of time at our next meeting for these really important questions. If there is time left I'll come back and try and get you to respond to them today. I would like them on the record so you are aware of what we are anxious to hear about.
Senator Eggleton: The next round of questions and topic involves some back and forth, so I'll save it for next time.
I will add to your list of things. Based on the previous round of questioning that I had with respect to substandard products, I have a list of printouts here of your different drug products, some of them anyway, the ones from Ranbaxy. I would like to know the factory where these drugs are manufactured and, in each case, where you have a foreign, imported pharmaceutical, the name of the factory, the location of the factory, in addition to the pharmaceutical company.
I want them to add to the list. I have this list of the pharmaceutical companies and the drug; I want to know the location of the factory in each case for each drug.
The Chair: This is from Health Canada's list
Senator Eggleton: Yes, from Health Canada.
The Chair: While you're thinking about that, if you need to ask a question we'll follow up.
Senator Seidman: I will do the same thing as Senator Eggleton. I have some unresolved questions from this round that relate specifically to the subject matter that we discussed this round. The other questions I have are related to different thematic areas that we didn't touch this round, so it would be better to leave those, unless the chair says otherwise.
We didn't discuss, for example, the whole area of antibiotics used in animal feed and in animals and the impact on the whole antibiotic resistance that we face in the population. I'd like to leave that for the next visit you pay us, if I might. That's a fairly complicated issue and we would like to hear Health Canada's opinions on this subject matter next time around. You could put that out there as something you might want to prepare. We did hear about significant loopholes that allow for uncontrolled importation of antibiotics for use in animal feed, for example, and it is clear that the FDA has a significant program in effect now to reduce the use of antibiotics in food animals. That will be an area that I would like to explore next time round, if I might.
I would also ask you a couple more questions, when you come back, on drug shortages. I'd like to know exactly what kind of communication or information Health Canada provides for health care practitioners and patients, other than the website, which doesn't seem to be terribly effective; and if there is anything Health Canada can do within its legislative authority to reduce the impact of drug shortages; or if you need expanded legislative or regulatory authority to help you in addressing the impact of drug shortages. Also, does Health Canada respond to health care practitioners, when they submit an adverse event, by providing them information or any updates?
I'll leave it at that for now. Thank you.
The Chair: One of the reasons for getting some of the topics on is that you will have an opportunity to present at the next stage, and you can provide information in your opening remarks at that point and then follow up. These are important issues and we'd like to be able to move on them.
Senator Chaput: My question is with regard to what Dr. Peterson said. I'm coming back to the data, not the federal data but the other data. You said there are about 40,000 records that have data.
I would like to know more about those records and the ones that we should have access to, because it's really a priority. What do you need to have access to, and who should lead? Because you did say it was a specific requirement, and I believe that we should look into that matter. Thank you.
Dr. Peterson: Thank you, senator. I will supply that. It is 40 million, senator, but I will supply the information that you ask for.
The Chair: I think it's important to note, senator, that in our previous studies we went into this area in considerable detail, and we have made substantial recommendations with regard to the collection of data. So I want to allow an exploration of this in detail if Dr. Peterson can give you a specific answer, but it is an issue that we not only explored in detail but made substantial recommendations that would assist DSENs and others to have the data available.
Senator Chaput: Thank you, Mr. Chair. I was not on the committee then.
The Chair: I appreciate that very much.
Senator Chaput: If you could send me the information, I would appreciate that.
The Chair: We will provide the earlier reports as well.
Senator Seth: The Canadian Institutes of Health Research operates the Drug Safety and Effectiveness Network, which conducts research to support government decision making. What research has been conducted by DSEN in regard to the unintended consequences of prescription pharmaceuticals in Aboriginal communities and in the general population?
The Chair: I'm going to go to Senator Eggleton after I ask you two quick questions, and perhaps you can answer these quickly.
In the new 2014 budget, a total of $44.9 million over five years was announced. Does this represent new money or is this the reallocation of funds from within the existing budget of the National Anti-Drug Strategy? If you don't know, just check into that. But if you do know, is it yes or no? I gather you need to look into it. Thank you.
Finally, since it's apparent that you have been following our hearings, the question is: Does Health Canada perform the environmental assessments with regard to pharmaceutical drugs in the environment, which was referred to by Karen Dodds from Environment Canada?
Dr. Sharma: That's through the Healthy Environments and Consumer Safety Branch, and that's done under the CEPA act.
The Chair: Thank you. We were just completing our information trail on that.
Senator Eggleton: I want to clarify some percentages you gave in response to my questioning about imported medicines and medical ingredients. I said that in the United States, 80 per cent of medicines and medical ingredients are now imported, and that India supplies 40 per cent of generic drugs consumed in that country. I wanted to know the Canadian equivalent of those.
Dr. Sharma: We can get that.
The Chair: You did give us a breakdown of general numbers in that particular area, but if there are additional specifics that relate to Senator Eggleton's refined question on the generics, we would like all of those.
Senator Eggleton: What foreign countries, in percentage, do we get drugs from?
Dr. Sharma: Generics specifically?
Senator Eggleton: Both.
The Chair: I believe you told us in your earlier comments that 25 per cent are from India, China and the countries from which you do not have formal agreements; is that correct?
Dr. Sharma: Right. Yes, the 25 per cent of the imported drugs are from countries that we either don't have a mutual recognition agreement with or from the United States. So countries other than that would be 25 per cent of the imported drugs. We can get that to you.
The Chair: If you can clarify those numbers, it would be very helpful.
Senator, do you have a question that can be answered in four minutes or less? The gavel is coming down in four minutes.
Senator Eggleton: The agreements that you just talked about, do we have one of those with India?
The Chair: She mentioned India and China as being examples in this other 25 per cent. We don't have it with the U.S., but they represent a special category. She said in her earlier statements that 25 per cent of our drugs, approximately, come from the United States.
Dr. Sharma: We'd be happy to provide the countries that we have mutual recognition agreements with, if that would be helpful.
The Chair: As you can see, and as you know from our previous studies, this is a serious issue for Canadians, and the committee is taking it seriously. We have documents and testimony that perhaps give rise to the enthusiasm of our lines of questioning. We will ultimately write a report; therefore, it is in everybody's best interest that we get the best possible answers. We are going to write a report, and it will be a public document eventually.
We do very much appreciate the manner in which you have responded to us today in this challenging area. We know from previous testimony that you have a great deal of knowledge, collectively, in these areas. I think I'll leave my comments to that level at this point, because we are going to welcome you back on April 30.
With that, I declare the meeting adjourned.
(The committee adjourned.)