Evidence of meeting #34 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site.) The winning word was clause.
A recording is available from Parliament.
Conservative
The Chair Conservative Ben Lobb
Good morning, ladies and gentlemen. We're continuing our study of Bill C-17.
We have a full schedule here today, so we'll get right at it. We have a number of witnesses here for the first hour, and then we'll have some for the second hour. As we always do in these meetings, we'll try to start with our guests who are here by video conference.
Can you guys hear us okay?
Conservative
The Chair Conservative Ben Lobb
You can go first. You have 10 minutes or less to make your presentation.
We have Jim and Jody.
Go ahead, please.
President, Canadian Generic Pharmaceutical Association
Thank you, Mr. Lobb.
Welcome everyone. Thank you for the opportunity for Canada's generic pharmaceutical industry to contribute to your study of Bill C-17, Vanessa's law. Thank you for accommodating our need to appear via video conference this morning.
I am Jim Keon, the president of the Canadian Generic Pharmaceutical Association. I'm joined today by Jody Cox, our vice-president for federal and international relations.
I'll say just a couple of words about the CGPA, the Canadian Generic Pharmaceutical Association. We represent companies that specialize in the research, development, and production of high-quality generic medicines, fine chemicals, and new chemical entities. We are Canada's primary pharmaceutical manufacturers and exporters and are among the top research-and-development spenders across all industrial sectors. The generic pharmaceutical industry employs more than 12,000 Canadians in highly skilled scientific and manufacturing positions and operates large life sciences companies in Ontario, Quebec, and all of Canada.
The generic pharmaceutical companies have an essential role in Canada's health care system. Generic pharmaceutical products provide safe and proven alternatives to more expensive brand-name prescription drugs. In 2013 alone, the use of generic prescription medicines saved governments, employers, and consumers approximately $13 billion. Today, four or five prescriptions for generic medicine can be filled for the cost of one brand-name prescription. We are proud of the fact that two out of every three prescriptions in Canada are now filled with generic medicines.
Generic drugs are approved for sale by Health Canada and are identical or bioequivalent to the brand-name version. Each product must also meet the rigorous and internationally accepted standards established by the Food and Drugs Act and its regulations. Generic medicines are required to have the same quality, purity, efficacy, and safety profile as branded drugs.
By the time a generic version is licensed for sale in Canada, the drug has generally been on the market for between 12 and 15 years in Canada and other jurisdictions, and the safety profile of the drug is generally well established. Even so, Canada's generic drug companies take our responsibilities with respect to patient safety very seriously. For us, patient safety is paramount.
I'd like to make a few comments on the bill.
On behalf of the association and our member companies we would like to congratulate member of Parliament Terence Young for championing Bill C-17 and the minister for bringing it forward.
In general, the CGPA supports Bill C-17. We note that it is enabling legislation and that many of the finer details will be provided for in regulation, which we will of course follow very carefully. I will briefly address a few certain aspects of the bill.
First, I will address the new powers for the minister. Bill C-17 provides several new powers to the Minister of Health. They give the minister expanded powers to obtain safety information, modify labelling, recall drugs or take other corrective actions, and obtain a court injunction on 48 hours' notice or no notice at all in the event of a perceived health risk.
During their testimony to the committee, the minister and Health Canada officials pointed to a specific instance where it was felt that undue delays were created in negotiations with a manufacturer. In most instances, however, manufacturers voluntarily comply with the requests from our Canadian drug regulator, Health Canada. The CGPA is of the view that a thoughtful, risk-based dialogue between the manufacturer and the regulator generally brings out the best outcome for patient safety. As such, it is our view that a voluntary approach is appropriate and should be maintained. That said, we do support the minister having the ultimate power as a last resort.
Next is adverse drug reactions, ADRs. There is no question that information is a key component of assessing the risks associated with a medicine. While drug companies have had a mandatory reporting requirement for many years, the health care professionals who are the primary point of contact for patients have had no such obligation. As such, the CGPA supports a mandatory requirement for prescribed health care institutions to report adverse drug reactions. This new requirement will help to narrow an important information gap and will improve both the quality and quantity of ADR information available.
We have a comment about post-market surveillance. As previous witnesses have testified, Health Canada has been moving towards a life-cycle approach to drug regulation for several years.
While the current regulatory scheme focuses on drug review prior to and leading to market authorization, the amendments allow the minister to order a manufacturer to “compile information, conduct tests or studies or monitor experience in respect of the therapeutic product”.
While CGPA welcomes this approach, we look forward to consulting with Health Canada on the specific details of the regulation and guidance that will be associated with these changes. In particular we recommend that the regulations and guidance specifically clarify any shared duties or actions between generic and brand manufacturers of the same drug. I'm going to stop here, Mr. Chair.
In conclusion I would like to reiterate our support for the bill, and Jody and I will be pleased to answer any questions you may have this morning.
Thank you.
Conservative
The Chair Conservative Ben Lobb
Thank you very much.
Next up from Rx&D are Walter Robinson and Keith McIntosh.
Go ahead, guys.
Walter Robinson Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Mr. Chair and honourable members, thank you for inviting Rx&D to appear before Bill C-17 today.
My name is Walter Robinson. I'm vice-president of government affairs at Rx&D, and I'm joined by my colleague, Keith McIntosh, our senior director of scientific and regulatory affairs.
By way of background, Rx&D is the national trade association that represents 55 research-based pharmaceutical companies and members who discover, develop, and deliver innovative medicines and vaccines to Canadians. To be perfectly clear we support Bill C-17.
Legislative and regulatory modernization of the Food and Drugs Act that enhances and promotes patient safety is good public policy. We have been consistently supportive of these efforts and those of previous governments.
By way of background as well, we invest over $1 billion each year into Canada, with approximately 75% of this amount directed to over 3,000 clinical trials across the country. As you have heard before, clinical trials are required to bring safe, innovative, and effective medicines, vaccines, and devices to the Canadian marketplace. These trials are conducted in highly controlled, monitored, and regulated settings. The successful completion of trials provides the confidence to bring new drugs and procedures into clinical practice. Clinical trials also provide hope to patients and their families who have failed on or do not respond to conventional therapies.
We are proud of our long-standing partnerships with the Canadian Institutes of Health Research (and its predecessor, the Medical Research Council of Canada) and various provincial and para-public agencies.
But our most important contribution is working together to better the lives of all Canadians. It is here where the proper diagnosis, appropriate prescribing, and optimal utilization of medicines enable health system sustainability by reducing the need for physician visits, unnecessary hospitalizations, or avoiding costly and invasive surgical procedures.
Our industry is also on the front lines of health care provision with our federal and provincial partners in the delivery of vaccination campaigns. And we play a key role in supporting provincial health system strategies, such as primary care reform, age in place efforts, and community delivery of health care through pharmaceutical and other services.
As we have highlighted to this committee before, our members' activities are guided by a clear code of ethical practices. Acceptance of and adherence to this code in letter and in spirit are mandatory conditions of membership in Rx&D.
Rx&D and its members support Bill C-17, as I have stated, and other related efforts to improve patient safety across all stages of the development, approval, and use of all therapeutic products. And we agree with you that Health Canada must have a modern, efficient, and effective compliance and safety regime, a regime that is world-leading in its scope and receives the confidence of Canadians.
We also note that prior to any specific powers now proposed in Bill C-17, which essentially codifies the way we have been working with government, Rx&D members work closely with Health Canada to recall products, update or change labels, and implement any other important safety-related actions, either of their own accord or these warranted by Health Canada.
The foundation of any decision or regulatory intervention must be evidence-based and arrived at through rigorous scientific inquiry and standards.
Critical to this line of inquiry is a fulsome exchange of information among manufacturers, Health Canada, health care professionals and, increasingly, Canadian patients.
We pledge to work with the government, parliamentarians, and all stakeholders to make Bill C-17 and its adoption, if passed into law, as clear, efficient, and effective as possible. We would also suggest that the committee consider a number of aspects to further enhance and strengthen patient safety within Bill C-17. These include improving the exchange of information around reporting adverse events, which we support; encouraging and promoting the consistent dispensing of approved Canadian labels in pharmacy settings for innovative and generic medicines; additional oversight regarding counterfeit medications; and at a more practical level, more collaboration with international regulators such as the U.S. FDA, the European Medicines Agency, and their peers. As you heard in testimony before this committee, in several aspects they are further ahead than Health Canada on present safety regimes.
Every product has benefits and, yes, risks that are determined on the best available information and scientific practices. These benefits and risks are studied throughout a product's life cycle, and as the committee is aware, the vast majority of developmental therapeutic products fail for a wide variety of reasons, including unacceptable safety profiles, lack of efficacy, or situations where established risks clearly outweigh the benefits of a given therapy. Only one of 10,000 molecules in study ever makes it to market and to patients.
Vigorous and continuous attention to safety is a fundamental part of the development process from the early stages of drug development through to the entire life cycle of product even after discontinuance or product withdrawal. As other experts have testified before you, this process can span 30 to 50 or more years.
Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Rx&D members seek to meet or exceed all legal and regulatory requirements regarding safety, product quality, and the information that is provided to patients, their families and healthcare providers.
In conclusion and in reviewing your work today, we are encouraged by your commonality of passion and the solidarity of your commitment to patient safety. We share this number one priority. We look forward to your questions on specific aspects of Bill C-17 during today's session, and we'll be active participants during the gazetting and comment process if it's passed into law. At the beginning of our remarks, we noted that we support Bill C-17 and we sincerely urge Parliament to pass it into law.
Thank you.
Thank you for your attention.
Conservative
The Chair Conservative Ben Lobb
Thank you very much. Next up from MEDEC is Nancy Abbey. Go ahead, please.
Nancy Abbey Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies
Good morning.
On behalf of MEDEC, I want to thank the health committee for providing me with the opportunity to be here today.
My name is Nancy Abbey, and I am the executive director of the MEDEC Reuse of Single-Use Devices Task Force.
MEDEC is the national association representing the medical technology industry in Canada. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and help enable the sustainability of our publicly funded health care system.
The industry in Canada employs over 35,000 Canadians in approximately 1,500 facilities, and we have sales of over $7 billion per year.
We are committed to supporting the growth of a strong and vibrant medical technology industry that contributes to Canada's innovation economy.
Our member companies are fully supportive of Bill C-17, an act to amend the Food and Drugs Act, in order to improve patient safety by introducing important measures that will strengthen safety oversight and improve reporting of serious adverse events.
We have an opportunity to work together to further strengthen this legislation. Unfortunately, in the time we have today, I will not be able to review with you the full list of our recommendations, but they are contained in appendix 1 of our submission. I do, though, want to focus on two of our recommendations that would address a long-standing medical device issue that warrants particular attention by the committee, which is the reason I asked to appear before you today.
This issue is the reuse and reprocessing of single-use medical devices and the fact that there is no federal regulatory oversight regarding this practice, a fact that raises serious concerns regarding patient safety. It's important that I briefly outline this issue for you.
In an effort to save money, hospitals in Canada are reusing medical devices that are licensed by Health Canada for single use only. This practice is widespread. In 2008 the Canadian Agency for Drugs and Technologies in Health, better known as CADTH, reported that 28% of hospitals in Canada and 42% of hospitals with over 250 beds were reprocessing single-use devices either in-house or through a third party reprocessor.
Single-use devices are not designed, validated, or licensed to be disassembled, cleaned, reassembled, and reused, and doing so can jeopardize their performance, safety, and effectiveness.
In 2014 the vast majority of hospitals that are using reprocessed single-use devices are doing so by outsourcing this activity and signing contracts with third party reprocessing companies. The fact is there are no third party reprocessing companies for single-use devices based in Canada. This has resulted in a situation of hospitals across the country shipping used devices, licensed for single use only, to U.S.-based companies for reprocessing without any federal regulatory oversight of the reprocessors and the devices that are then being shipped back for use in our Canadian hospitals.
This is a long-standing issue.
In March 2004, over 10 years ago, the Auditor General of Canada recommended that Health Canada take action, such as regulating the reprocessing of single-use devices, to manage the health and safety risks related to the reuse of single-use medical devices.
The Health Canada Scientific Advisory Panel on Reprocessing of Medical Devices and the Canadian Orthopaedic Association have repeatedly called for Health Canada to regulate this activity.
Health Canada has concluded that the Food and Drugs Act, from which the medical device regulations derive their authority, is not intended to apply to the use of a device after its sale; therefore, Health Canada does not have the authority to regulate the reprocessing of single-use devices by hospitals or third party reprocessing companies.
Health Canada has been unable to take action given the current Food and Drugs Act and medical device regulations. With Bill C-17, there is an opportunity to change this situation.
Why are amendments important? Canada's medical device regulations require original equipment manufacturers to present substantive evidence of a device's safety, effectiveness, and quality prior to being given authorization to sell and market a device for its intended use in Canada. There are also specific requirements for documenting and reporting adverse events, with clear guidance on how to issue a recall should the situation warrant such action.
Third-party reprocessing companies are not required to comply with Canada's medical device regulations, a fact that raises important concerns regarding Health Canada's role in ensuring patient safety. For instance, Health Canada does not require third party reprocessing companies to submit any safety, effectiveness, or quality data for the devices they are selling and/or shipping back for use to our Canadian hospitals. Third party reprocessing companies are also not required to maintain any records of reported problems related to a device, nor are they required to report adverse events to Health Canada. They are also not required to provide a proposed strategy to the health minister as to how a device recall would be conducted and a proposed plan to prevent a recurrence of the problem.
Amendments to Bill C-17 provide an opportunity for Health Canada to be granted the authority to regulate reprocessed single-use devices and address these important patient safety concerns. It is our recommendation that Health Canada regulate third party reprocessing companies as manufacturers in the context of Canada's medical device regulations, as has been the case in other countries, including the United States.
We're recommending that amendments be made to section 30 of the act, as this is the section addressing regulation-making authority for therapeutic products, including medical devices.
With regard to the bill, our first recommendation is to modify the regulation-making power in proposed paragraph 30(1.2)(a) to include reprocessing as a listed activity in respect of which authorizations may be issued.
Our second recommendation is to add a subsection—adding to proposed subsection 30(1.2)—providing for the authority to make regulations requiring that reprocessors of devices licensed for single use obtain therapeutic product authorizations in respect of those reprocessed devices.
It's important to point out to committee members that neither of these recommendations would actually require Health Canada to regulate, but would grant them the option to regulate both the reprocessing companies and reprocessed devices without dictating when or in what matter. The decision before you today is a relatively easy one. Time would allow the right regulations to be developed. Without these amendments, however, that discussion about how to regulate couldn't take place.
I want to be clear on the benefits of your making these amendments to Bill C-17 to strengthen patient safety. There would be clear, appropriate requirements for evidence to demonstrate that reprocessed devices will perform as intended and are safe for patients when used by a trained health care professional. There would be the ability to ensure that patients, doctors, industry, and other stakeholders have access to clear information about the medical devices they use. Very importantly, it would allow for rapid identification of adverse events and ensure coherent and timely action in the event a recall is required.
In summary, MEDEC wants to reiterate its full support for Bill C-17. It is important to MEDEC members that patients and health care providers have confidence in the safety of our health care system. We all benefit when public trust is at its highest. Bill C-17 helps to build that public trust and grow Canadians' confidence in our health care system. We believe these amendments can address a long-standing issue and enhance this important piece of legislation to further improve patient safety.
Over the years, I have talked with many government officials about this issue. There is always an interest in seeing a sample of a single-use device that is currently being reprocessed, so today I've brought with me a harmonic scalpel. This is a device that is used during surgery to cut and seal tissue. On the back you can see what a fully assembled harmonic scalpel from the original equipment manufacturer looks like. On the reverse are the individual components that would actually happen as part of a resterilization. The reverse shows you the individual components when it's disassembled and what would have to happen in order for it to be then reprocessed and come back.
I'll pass it around for you to see it, if you would like.
Thank you for your time. I would be pleased to answer any questions.
Conservative
The Chair Conservative Ben Lobb
Thank you very much.
We'll begin our round of questions with Ms. Davies.
NDP
Libby Davies NDP Vancouver East, BC
Thank you very much to the witnesses who came today. There's been a lot of interest in this bill, so we're glad to hear you today. Unfortunately, there are a lot of other witnesses who also wanted to be heard, but we're rushing through at this point, so this is the last day of witnesses. As you probably know, we'll be going directly through to clause by clause on the bill when we've finished hearing the witnesses today.
I have just a couple of questions I'd like to put to all of you. In terms of overall drug safety, one of the issues we heard in a previous study of this committee when we were looking at the misuse or abuse of prescription drugs was the whole issue of marketing and the practice of providing samples to physicians, advertising in journals, and so on.
This is directed to Mr. Robinson, but others can respond to it too. What is your view of the legislation we've seen in the U.S., generally referred to as the “sunshine legislation”, that puts very strict parameters on the kinds of practices that can take place in terms of marketing, particularly with samples. In fact, as I understand it, the legislation in the U.S. requires full disclosure; there's a registry of what is provided to physicians. This is done in order to ensure there's a degree of transparency so that it's very clear what's being passed through. I think it's an attempt to ensure there isn't misinformation directed to prescribers.
I just wonder if you could comment on how the industry views that kind of legislation. We don't have it here in Canada, but because we are talking about drug safety, is this something we should be contemplating in this country?
Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Through you, Mr. Chair, I thank Ms. Davies for the question. I would point out that our code of ethical practices in chapter 16 shows how we work in concert with the Food and Drugs Act regulations that are already in place for the distribution of clinical evaluation packages, or as they're more commonly known, samples. I can also tell you that there is a diversity of opinion amongst our membership based on certain international practices of where companies are moving in one direction or another with respect to the appropriate promotion of the benefits of medicines.
If I could speak to that, we can only promote a medicine with respect to the approved Health Canada indication and product monograph. What has also happened in concert with a variety of clinicians is that there's much more security placed in doctors' offices or family clinics in terms of locking up, tracking samples, tracking the use. There has been a movement away, as well, from having stock of those clinical evaluation packages or samples to an actual invoicing or card system so that there is an audit trail of those.
They still have a very legitimate role, especially for people who only have access to limited public insurance plans, with clinicians making that choice to try a therapy, the appropriate diagnosis, the appropriate prescribing of a sample. So they have a role to play in clinical practice. We are working with clinicians, and we follow the Food and Drugs Act and our own code of ethical practices to ensure they are distributed and promoted in a law-abiding and ethical manner with physicians and other prescribers.
NDP
Libby Davies NDP Vancouver East, BC
So you think your own code of practice is sufficient, that it covers all situations? There might be misinformation being provided or inappropriate prescribing, because I can certainly tell you what we heard when we were studying this issue. The misuse of information or erroneous information that's provided to prescribers is a pretty major issue.
Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Through you again, Mr. Chair, we followed the testimony closely. There are four things that cover our conduct in Canada.
First is the Food and Drugs Act, the law of the land. As we've noted, we support the improvements proposed before this committee in Bill C-17. Second is our code of ethical practices. When it comes to the distribution of information and promotion, we are also guided by the parameters of the Pharmaceutical Advertising Advisory Board, or PAAB, and Advertising Standards Canada.
There is a great degree of rigour in the context of what our members can do. Again, by law and by our code, we can promote only the approved indication and label.
NDP
Libby Davies NDP Vancouver East, BC
Do I have a little more time?
I have another question. I think at our last meeting we had a number of witnesses who spelled out the need for independent research in terms of evaluating the safety and effectiveness of drugs. What's your opinion on that, in terms of whether or not there should be third-party evaluation to make sure there's proper oversight?
Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
As you've heard, and as we noted in our testimony, about 75% of our activity in this country is in clinical trials. That mirrors about 75% to 80% of global activity of the pharmaceutical industry funding clinical trials. It's in our interest to do so, to bring new medicines to patients.
I'd like to point out, though, that there is a lot of independent research, and Health Canada must approve every clinical trial that happens in this country. There is also posting of those trials in the context of ClinicalTrials.gov, and the new initiative that Minister Aglukkaq started and that Minister Ambrose has picked up.
There's a lot of transparency and disclosure of those results. They are conducted—if we have more time, I can walk through the steps—with a high degree of regulator rigour and independence in evaluating the results of the trials. Again, as I pointed out, most clinical trials fail for the reasons of unacceptable safety profiles.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
Thank you.
I'm picking up on that point. Clinical trials are something that we've been addressing extensively during these hearings.
Can you tell me—succinctly, please, if you would be so kind, because I'd like to split my time with Mr. Young—what you feel are the key elements to ensuring that there is transparency for patients and consumers across Canada.
Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
There are a variety of things.
I would also—very succinctly, Ms. Adams—point you to the work of your colleagues in the Senate. The Standing Senate Committee on Social Affairs, Science and Technology is lead by your esteemed colleague Dr. Kelvin Ogilvie, whom I know many of you hold in high regard. Its first report lays out the framework for improving the transparency, uptake, knowledge,and informed consent around clinical trials, and how Canada can have a very ethical and rigorous approach to that. The key elements are rigorous safety, a key line of scientific inquiry, and ensuring that we share those results globally, including adverse events that happen in those clinical trials. These things happen on a global stage, and Canada is one player in that regard.
That's as succinct as I can be, and I would direct the members of this committee to Senator Ogilvie's work in his committee—the phase one report. I've brought copies with me. It clearly spells out how we can improve and strengthen and enhance the safety of Canada's clinical trials regime.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
Thank you, Mr. Robinson.
I'd like to also thank Mr. Young for the amendments that he has brought forward to this legislation. We are certainly supportive of those amendments.
Without further ado, I will pass the remainder of my time to Mr. Young.
Conservative
Terence Young Conservative Oakville, ON
Thank you.
Mr. Robinson, you said that decisions to market prescribed prescription drugs are based on the best available evidence. Yet, the common practice amongst your members is to start clinical trials on new drugs by asking researchers to sign a contract. If they're ordered to stop the trial of the drug because the drug isn't working very well or it turns out that it's harming patients, they have to stop it and never talk about it again. There are very serious sanctions, which we've heard about publicly, if they ever do that.
The evidence that's covered up when those trials are stopped is often life-saving information, for example, if it's harming patients. In fact, the normal business practice amongst your members is to cover up the best available evidence on drugs. Can you please explain that to the committee?
Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Through you, Mr. Chair, to the honourable member, to start, I commend your work on patient safety.
As I pointed out earlier in our remarks, all clinical trials that are conducted in Canada by industry must be registered with Health Canada, and we need to report the adverse events and the outcomes of those clinical trials. The best available evidence is not only decided with respect to the conduct of the clinical trial, but is also moved through the rigorous Health Canada scientific and regulatory drug approval process to get a notice of compliance. They pronounce on the safety and the clinical efficacy of a product.
Further data and further requirement is usually found in Canada through our health technology assessment regimes, including pCODR, for cancer drugs; the common drug review, through CADTH; and even INESSS, in Quebec. There is not a one-point review of clinical safety information; it is an ongoing process through the drug reimbursement process.
That is the best answer that I can give you.
Conservative
Terence Young Conservative Oakville, ON
You talked about your members' products reducing unnecessary hospitalizations, which, in some cases, is no doubt true. Yet, researchers tell us that one out of the nine hospitalizations in Canada—that's admissions to hospital for internal medicine, which aren't planned—are related to an adverse reaction to a prescription drug. Clearly, thousands of patients are taking prescription drugs when the benefits do not outweigh the risks. They're not getting proper safety warnings; they're taking them as prescribed and still ending up in hospital.
Your products lead to unnecessary hospitalizations. It's the exact opposite of what your members claim their products will do. Why does that happen so often?
Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Through you, Mr. Chair, to the honourable member.
It is true that adverse events happen with medication. One of the things we pointed out, and which we believe could be improved in the bill, is that when adverse events occur, we would like to see not only a notification to Health Canada—and I'm glad that the sanctions for institutions and prescribers are higher now to report those adverse events—but also would suggest that they simultaneously be reported to the global manufacturer. Then we can update the global adverse event databases that our own members keep to ensure that the labels or contraindications, which you've talked about very knowledgeably at this committee, can also be changed.
That's why we also pointed out that we'd like to see the product label and monograph that Health Canada approves to ensure that when a patient goes to their local pharmacy and gets their prescription and perhaps an information sheet, it mirrors in plain language the Health Canada approved product label and monograph. We need that to happen more consistently.
The other thing we're doing, and we're quite proud of, is that with British Columbia's and other governments, we're participating in a personalized medicine initiative to reduce those adverse events, especially in seniors' populations. We know they may be on multiple medications, and by using biomarkers or pharmacogenomic markers, we ensure that a senior—my mother or somebody else's mother who is on five or six medicines and is prescribed the new ones—has a better profile so that we can reduce those adverse events.
Conservative
Terence Young Conservative Oakville, ON
Thank you.
From an analysis in the Canadian Medical Association Journal written by five leading experts on prescription drug safety, I have a list of drugs that have been withdrawn from the Canadian market for safety reasons. That means they were killing or injuring patients, and this is just since 2004: Vioxx was approved in 1999 and taken off the market in 2005; Bextra approved in 2002 and taken off the market in 2005; Mellarill approved in 1959 and taken off the market in 2005; Climacteron, 2005; Tequin, 2006; Zelnorm, 2007; Permax, 2007; Prexige, 2007; Raptiva, 2009; Meridia, 2010; Darvon, 2010; Thelin, 2010; Calcitonin, a nasal spray, 2013; and MEP, a Meprobamate-containing medicine, 2013.
This is just since 2004. Since 1997, I think the total I've always used and the best total I can find is that 27 drugs have been taken off the market for killing and injuring patients.