Welcome everyone. Thank you for the opportunity for Canada's generic pharmaceutical industry to contribute to your study of Bill , . 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 for championing Bill and the for bringing it forward.
In general, the CGPA supports Bill . 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 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.
Mr. Chair and honourable members, thank you for inviting Rx&D to appear before Bill 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 .
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 , 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 , 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 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 . 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.
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 , 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 , 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 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 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 . 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.
Mr. Robinson, Mr. Keon made a comment, and I'd like to hear your comments as well, after I explain what my question is. Referring to safety issues with drugs, he said that thoughtful, risk-based dialogue is the best way to approach these matters. Yet, through a journalist that did a film about Vanessa's story, back in 2001, I was able to get copies of e-mails that went back and forth between the vice-president of Janssen-Ortho—part of Johnson & Johnson—and senior Health Canada officials. Health Canada officials were asking them to either take the drug off the market or put a very clearly worded warning or do their utmost to make sure the drug wasn't prescribed to patients it shouldn't be.
I have those emails back and forth. Of course you can imagine it broke my heart reading them and seeing the Health Canada officials struggling to get Janssen-Ortho to recognize that this drug should be taken off the market. This was prior to Vanessa's death. These emails went back and forth right into March 2000, and Vanessa died on March 19, 2000.
I was shocked to find out that this is normal in the industry. This happened with the other 26 drugs that have been taken off the market since 1997. This is supposed to be thoughtful, risk-based dialogue. In fact it is the pharmaceutical companies, your members, trying to keep a blockbuster on the market longer because they're selling $100 million a month or something and pretending that the drug can be prescribed safely. The hands of Health Canada officials and the minister were tied prior to this bill. In fact, thoughtful, risk-based dialogue was really just a way to delay the withdrawal of the drugs so the companies could make more money.
Could you please comment on that?
Thanks very much, Mr. Chair.
Mr. Robinson, we talked briefly about the situation with proton pump inhibitors, common acid-suppressing drugs, that have been clearly linked to a hospital infection called Clostridium difficile. The risk has increased on the order of 40% to 275%.
Now, that information wasn't available when these products were approved, but over 20 years research has been accumulating. It was at least 10 years ago, when the first evidence came out in Montreal, which was considered the epicentre for this new infection, that I started raising questions with then Minister of Health Ujjal Dosanjh.
In terms of the risk of infection, we now know, through further studies, that people on those medications have not only an increased risk of infection of 40% to 275%; among those infected, they also have an increased risk of the worst complications, about 300%. They also have an increased risk of death, about 500%.
When I asked that question of the Honourable Ujjal Dosanjh in 2005, Health Canada contacted your member companies, four of which produce PPIs, although there may be more by now. The response I got back was that they weren't aware of any connection between their products and hospital infections.
Can you provide any evidence, since I know you're aware of this issue, that any of your member companies actually did any research to establish, voluntarily, whether there was a connection between acid suppression and hospital-based infections? That's 1,400 deaths a year currently; so over 10 years, at least 14,000 Canadians have perished, with hundreds of millions of dollars expended in hospital costs.
I want to thank the committee for having me and for including patients in the review and discussion on this legislation. I'm representing the Best Medicines Coalition, which is a national alliance of patient organizations. We're very interested in health policy and involving patients in the development of health policy, and our focus has been primarily around pharmaceutical issues in Canada. We try to make sure the patient voice is heard and listened to. I am a member of our board and I'm also a past chair of the organization. I'm also president of the Canadian Arthritis Patient Alliance, which is a national organization of arthritis patients from across the country.
We've been working with Health Canada for a number of years on developing this legislation. We think it's very important for patients, and BMC and CAPA are very supportive of this legislation.
I've been living with rheumatoid arthritis for almost 40 years, and part of living with this disease day to day is taking medications. Throughout the years there have been issues around some of our medications, and we've always had discussions with Health Canada about the limitations they have right now when there is an issue with a drug. The biggest example I can think of is Vioxx and all the issues around that. Vioxx was a drug that many patients benefited from. When there were issues with it, it was withdrawn. As somebody living with inflammatory arthritis, I can tell you we take far more dangerous drugs than Vioxx on a daily basis. Patients lost access to this drug. Had Health Canada had the powers that this bill will give them, patients who knew the risks and benefits and the possible uncertainties around Vioxx would still have access to the drug, and those who shouldn't be taking it would not have access to it.
As I said, we've been closely involved with Health Canada for a number of years on the consultation end of this legislation and everything it entails. I'd like to give credit to them for including all the stakeholders in this and listening to everybody's perspective, which, at times, surely got messy. Again, the Best Medicines Coalition and the patients I represent support this legislation under which Health Canada can have a regulatory framework that's modernized, and not operate under the constraints of legislation that was developed almost 40 or 50 years ago. We need to have better post-market surveillance in Canada. Health Canada has made great strides in the last number of years with MedEffect and with some of its initiatives, but they need to be able to get information when they need it and not be under the constraints they are currently working under.
We really believe this legislation is long overdue and very important for patient safety going forward. It's very important to involve patients, as has been done with this, to hear the broader perspective that we can bring to the table as people who actually have to put these drugs into our bodies to be able to live a healthy life.
We look forward to continuing to work with Health Canada going forward. Again, this is very important in the future for patients and post-market surveillance.
That's really all I have to say.
Thank you, Mr. Chair, and good morning to the committee. Thank you to the Standing Committee on Health for the invitation to appear this morning. My name is Jeff Morrison. I'm director of government relations and public affairs with the Canadian Pharmacists Association. With me—I'm very happy—is Barry Power, a pharmacy consultant with CPhA, an adjunct assistant professor at the school of pharmacy with the University of Waterloo, and a pharmacist himself.
As you know, CPhA is the national association representing the pharmacist profession in Canada.
Drug safety is a priority for the Canadian Pharmacists Association and for all pharmacists in Canada. Although it is not possible to completely eliminate all risks associated with the use of prescription drugs, pharmacists spend a lot of time counselling patients on the appropriate and safe use of the drugs they are taking. That is why the CPhA supported the general spirit and thrust of Bill , Vanessa's Law, when it was introduced by the minister in December 2013.
In particular, the CPhA supports the bill's intent to increase penalties for unsafe products and to provide Health Canada with new powers to recall unsafe products and to compel companies to do further testing on a product when issues are identified with certain at-risk populations, as well as the requirement for drug companies to revise labels to clearly reflect health risk information, including potential updates for health warnings for children.
However, there are some concerns and outstanding questions we have with regard to the bill. Although these questions and concerns may be addressed during the regulatory development process, we still wish to raise them with the committee this morning.
First, the bill provides a blanket exemption for natural health products. As NHPs are medicinal products and have the ability to cause harm, and given that Health Canada and several provinces state that between 60% to 70% of therapeutic products consumed by Canadians are in fact NHPs, the CPhA feels that NHPs should be included within the scope of the bill.
Second, the bill mandates the need for adverse drug reporting by stating the following, which I'm sure you know:
||A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.
However, this clause raises several questions that frankly the bill doesn't clarify.
For example, what is a prescribed health care institution? Is a pharmacy a health care institution? Will the downtown community health centre, of which I was the president, be considered a health care institution?
It would be helpful to specify the definition of a prescribed health care institution that is required to provide information.
Also, what is a serious adverse drug reaction? How is that to be defined? For example, is it necessary to report a well-known but serious reaction? All health care professionals know of many of the serious adverse reactions caused by chemotherapy, for example, during cancer treatment. Would they be expected to report these? Where do we draw the line between what is to be reported and what is considered well-established fact? Again, clarification within the bill would be useful.
Also, what will happen with this information? Will it be analyzed? Will all the information that is reported be made publicly available? If so, how so? As pharmacists we believe that Health Canada should be transparent in the provision and aggregation of the information it receives from this mandatory reporting, but at present, the legislation as written is unclear on whether this information will be properly analyzed and shared with health practitioners and with Canadians.
The same issue regarding transparency can also be applied to the bill's requirement that the minister may order the manufacturer to conduct additional assessments and tests of a questionable product or drug in regard to health and safety. The legislation states that the results of these tests will be provided to the minister. However, there is no allowance currently in the bill for providing that information more publicly, including to pharmacists, other practitioners, and Canadians. As you can probably guess, we feel it should.
Last, the bill also states that this reporting requirement “shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens”. However, this clause would appear to be at odds with the reality of the situation on the ground.
By its inclusion in the bill, the requirement for prescribed health care institutions to report adverse drug reactions will impose additional administrative burdens. Although technological solutions can and should help, the fact remains that additional human resources will be required to collect and provide this data. If the definition of prescribed health care institution is broad in scope—as I mentioned earlier, we don't have that—then the administrative requirements will likely increase. As a result, we're uncertain about how the bill can reconcile what would appear to be two contradictory goals of, on the one hand, increasing reporting, but on the other hand, without imposing administrative burdens.
In short, Mr. Chair, the Canadian Pharmacists Association is very supportive of Bill . Given pharmacists' preoccupation with safe and effective use of medications, the CPhA believes the legislation is a step in the right direction. However, as I've outlined, we feel that there are clauses within the bill that could benefit from greater clarity and certainty in terms of how they will be applied.
Thank you, Mr. Chair.
We are ready to answer the committee's questions.
Thank you. Joining me today is Carl Carter, our director of regulatory affairs and policy development.
It's with great pride that I appear before you today as president of the Canadian Health Food Association. CHFA is Canada's largest trade organization dedicated to the natural health and organic products industry.
As MPs, you should also have pride that Canada has a robust natural health product sector contributing $3 billion annually to the Canadian economy. CHFA represents over a thousand predominantly small and medium-sized businesses across Canada. Our members include manufacturers, retailers, importers, and distributors of natural health and organic products, and these can include foods, vitamins and supplements, herbal products, and more.
As members of the committees know from your own constituents, over 70% of Canadians use natural health products to improve the quality of their lives. The majority of Canadian families consume NHPs as part of a balanced healthy lifestyle and our sector has worked hard to ensure that Canadians continue to have access to these safe and effective products. CHFA members across the country applaud the Standing Committee on Health for their important work on Bill and its specific targeted focus on drug safety. CHFA fully supports the government's approach in this bill.
After an extensive and thorough review in 1998, this very House of Commons Standing Committee on Health concluded, as number one of its 53 recommendations, that NHPs are not drugs and should not be legislated as such. In line with this recommendation, NHPs have been regulated since 2004 under the natural health product regulations and these regulations are among the most rigorous and advanced in the world. Simply put, we support the exclusion of NHPs, as defined in the natural health product regulations, from Bill C-17. It's just common sense. Vitamins are different from pharmaceuticals and we commend the government for recognizing the relative low-risk profile of NHPs.
I am proud to highlight for committee members that NHPs are subject to extensive legislation and regulation in Canada, much more, for example, than in the U.S. According to Health Canada's most recent quarterly report, over 85,000 product licence applications have been submitted over the 10 years since the regulations were put into effect, and some 52,000 product licences issued. This is not a rubber stamp process. Before an NHP is authorized for sale, a company must complete a product licence application that is reviewed by the natural health products directorate. This is an entire section of approximately 100 staff dedicated to NHP safety. An application must demonstrate that the product is safe, effective, and high quality. Each application must provide information about the product, including medicinal and non-medicinal ingredients, evidence supporting any health claims, product labelling, and information about the manufacturing site. Many are unaware of, or perhaps take for granted, the lengthy pre-market assessment process required for NHPs. In addition, all NHPs licensed for sale in Canada must comply with Health Canada's good manufacturing practices and the natural health product regulations require a site licence issued by Health Canada to demonstrate compliance.
GMPs are a system designed to ensure NHPs are packaged, manufactured, stored, and monitored appropriately to ensure high-quality products are available to Canadians. All NHPs that have been assessed by Health Canada for safety, effectiveness, and quality have an NPN or natural product number on the label, which a consumer can easily find. It is worth noting again that Health Canada is a global pioneer in the regulation of natural health products and in pre-approval requirements of a product being sold in Canada. In contrast, the U.S. has a post-market system that clearly lags behind Canada in consumer safety of NHPs.
The licensed NHP database is a public, fully transparent government database of licensed products, approved label copy, claims, warnings, and the name of licence holders. Consumers, retailers, and medical professionals can and do consult the site regularly.
Serious adverse reactions to NHPs licensed for sale in Canada are rare. Health Canada monitors the safety profile of all products sold in Canada to ensure consumer safety. In addition, the marketed health products directorate provides a reporting and review framework for any adverse events to medicines or NHPs experienced by Canadians. NHP regulations under section 24 expressly require companies to report serious adverse reactions to the minister. As noted, Health Canada does not approve all NHP applications it receives and routinely requests additional safety information, formulation changes, or additional warnings.
Consumers and health care practitioners are encouraged to report any suspected adverse reactions to Health Canada through the online reporting system. Through this system, we know that adverse reactions to NHPs are rare, especially in comparison to pharmaceutical drugs. Information collected from adverse reaction reports is assessed to determine the most appropriate measures for risk management and intervention. When there are any changes to the conditions of use for a product, or if a product is withdrawn altogether, this information is conveyed to Canadians through communications, such as advisories online and other resource materials.
We commend the government for recognizing the relative low-risk profile of NHPs. In line with the Standing Committee on Health's 53 recommendations, in 1998, NHPs are not drugs, and they should not be treated as such.
Thank you very much for coming today.
There are some very specific issues that you've raised, and I think I'll begin with the natural health products. You've both raised it. Pharmacists say they should be in; the Canadian Health Food Association says they should be out.
We questioned the minister on this issue when she came before the committee. She said that at the end of the day they decided not to put them in because they were considered low risk. We've certainly had a lot of e-mails and correspondence from people both ways: people saying they should be in, and others saying they should be out.
I will go to Mr. Morrison. I think people really trust pharmacists; they're the go-to people. Pharmacists are more accessible to ask questions about safety. You have this prescription, or you want to buy something in the drug store, but you don't know what you should be using. You're the kind of go-to person to get that information.
You're saying that natural health products should be included. I guess it comes down to an issue of what we consider to be the risk relative to what is covered in the bill. I want you to think about that in terms of these major pharmaceuticals, the drugs that can have enormous side effects and adverse effects and can cause death.
In terms of natural health products, my understanding from all of the research I've done is that basically they're not going to kill you. In fact, I'm not aware of information that's says a natural health product, whether it's a vitamin or a herbal remedy, is going to kill you or severely injure you.
When you consider the risk, where do you place that in the spectrum relative to other things that are covered in this bill?
Welcome back. We're back in session.
We'll start going through the clause by clause portion of Bill . We have the departmental officials at the table, at the ready, if there are any questions. So feel free to ask questions or for clarification.
In addition to that, similar to what we did for Bill , the Lyme disease bill, we'll take our time and make sure everybody knows exactly what clause and what amendment we're talking about, so everybody feels good about what they're voting on.
There's lunch at the back and recognizing the fact that everybody wants to pay attention to the clauses and the amendments and to which way to vote, we can suspend at some point, when the committee feels like it, for five to 10 minutes, just to have a quick lunch so that everybody can stay focused on the clauses and the amendments, if that's okay with everybody.
We have two legislative clerks here to help us along the way if we have any technical questions. Karin is also still here as our analyst.
If everybody's ready to go, we'll get at it.
Similar to the case with the Lyme disease bill, the title and the preamble will wait until the end, and we'll get right at it.
(On clause 2)
The Chair: We have amendment CPC-1. On that, I'll say that if this amendment is adopted, so will be amendment CPC-2 since they are consequential. Would somebody like to talk about the amendment?
Certainly. Thank you, Mr. Chair.
On the first point, when we started discussing some of the text in the bill, this was raised by health care professionals. It's the first time you've had mandatory recall. It's very important that the threshold language be able to deal with the kind of event that we saw, a failure of a birth control pill to work.
So we went back and we pulled in our inspectors; we pulled in our legal team; and we really made sure that this new threshold, which we've never had before, would work for that. So we were satisfied that the language “serious and imminent” would do it. That was a very serious concern for us. We really made sure we looked at it.
On this other language, “injury to health”, that's a phrase that occurs in the existing act in different places and in other parts of what we're trying to amend through the bill. It's very important to understand how this language would operate throughout those, so any vagueness that this would introduce could prospectively be very troubling. It's something you'd have to be very careful about in introducing brand new language.
I will say that for NDP-1.1, we would include “in an adverse event or an injury to health”. Really what we're looking for there, especially if it's serious, if somebody is permanently debilitated or there's a life-threatening event to them, no matter how it happened, whether it was a package that went wrong, or the labelling, we would pick that up as a serious event.
And basically, the other thing I should mention is that in our label-change power later on, in that proposal it does contemplate changing package. So if there is a mistake around the package, if we do see that, then there's a decisive action that can be taken.
In contemplating the difficulty you sometimes see with devices, if you have an MRI in a hospital, for example, to recall it, you don't want to pull it out of the hospital. It would be a great expense, among other things. That's why, in proposed subsection 21.3(2), what's proposed there is a provision for the minister to ask for corrective action to be taken. If there is an issue that they have to correct out in the field—and this is quite usual for devices—it's contemplated within the wording of the order.
The effect would be that if the minister picked up and ordered a corrective action instead of a recall, the assumption is that the medical device would stay where it is and then the company would need to instigate that corrective action. They couldn't sell it or use it while that order is in place, but certainly, the corrective action would be subject to the order. Really, that picks up the point.
I would also point out that, to some extent, proposed paragraph 21.3(1)(b), in sending “to a place”, does contemplate quarantine, to the extent we're saying that instead of pulling it all back from the market and bringing it back to the person who put it into the supply chain, which is the usual recall model, we can actually have product directed to a certain place or stay where it is. The minister could use an order to effect that.
Chair, under Bill the minister will have all kinds of new powers to direct pharmaceutical companies to issue new documents, new warnings, new safety warnings to clarify things, and to go back and retest a drug, etc.
Currently the Department of Health makes product monographs all publicly available on the Health Canada website. A monograph is a factual statement. It's the statement that the pharmaceutical companies provide to Health Canada to get their first notice of compliance. They're required to update it on occasion. It describes the properties, claims, indications, and conditions of use for a drug and all the other information, including reference to studies. Anyone, any independent researcher anywhere in the world, can have access to that document, just by going on the Internet, to draw their own scientific conclusions.
In fact, under Vanessa's law, the minister has committed to publishing drug reviews. For the first time, drug reviews for drugs that are on the market will be available to any scientist in the world who wants to examine that documentation, as they can in other countries.
This proposed motion would require the minister to actually do an independent review when there's already been a review. Drug monographs are approved by Health Canada in the first place.
In that sense, this would be redundant.
Thank you, and sorry for the mix-up.
In NDP-5.1, we're suggesting that clause 6 be amended by adding after line 30, on page 6, the following:
||(c.l) respecting the registration of clinical trials and investigational tests involving human subjects and specifying the period within which the results of those clinical trials and investigational tests must be provided to the Minister.
Again, this comes out of the testimony that we heard from, I think it was Professor Herder. We believe that this amendment would add the range of clinical trials and observational studies to the mandate of Bill , and give the Governor in Council the power to make regulations about clinical trial registration.
All investigational studies, including not just phase 1 to 4, but also observational studies, should be registered and otherwise subject to transparency. In fact, we did hear from our witnesses that the importance of observational studies is becoming more evident. They are more likely to be used in the future, particularly in the context of rare diseases.
I think this adds a better range, in terms of the clinical trials and observational studies to be added to the mandate of the bill.
Mr. Chair, this amendment deals with disclosure. It's a subject that's come up quite a few times, both in terms of this bill and in our previous study looking at abuse of prescription drugs and the whole system of disclosure, how decisions get made, and how prescribing practices happen.
This amendment would add, after line 11 on page 7, the following:
||(f1) respecting the procedures for disclosing gifts or other advantages offered to or accepted from the holder of a therapeutic product authorization or the manufacturer of a drug or device, for limiting the value of such gifts or other advantages and for addressing any conflicts of interest involving the holders of a therapeutic product authorization or the manufacturers of a drug or device.
This amendment, if it were approved, would allow the Governor in Council to submit regulations requiring public disclosure of payments to physicians, medical institutions, colleges, and so on.
This amendment is based on the idea of what already exists in the United States, which is called “sunshine” legislation. In the U.S., manufacturers of drugs, medical devices, and biologicals, working with the U.S. government, actually have to report any payments and items of value over $10 given to physicians, physician associations, medical institutions, etc.
We're not suggesting that this would exactly follow the U.S. legislation, but we think the principle is really, really important. It should be covered in this bill.
So we're not suggesting the specifics of the U.S. legislation, but we do identify that this is an area where further regulations are needed. Possibly Mr. Lee or Mr. Edwards will say that there's a question of jurisdiction here, that it pertains to provincial jurisdiction, but we believe it could be spelled out that if it involves any company or corporation or business that works with the federal government, then it would under federal jurisdiction.
We offer it in that spirit.
Okay. Are there any comments? Is there any debate on amendment CPC-11?
Seeing none, I will call the question.
(Amendment agreed to [See Minutes of Proceedings])
The Chair: That's the only amendment for clause 14. Shall clause 14 carry as amended?
(Clause 14 as amended agreed to)
(Clause 15 agreed to)
The Chair: At this point, we're through the bulk of it. We're just going to go through the title, the preamble, the short title, etc. If you have any questions, put your hand up, but it should be pretty straightforward.
Shall the short title carry?
Some hon. members: Agreed.
The Chair: Shall the preamble carry?
Some hon. members: Agreed.
The Chair: Shall the bill as amended carry?
Some hon. members: Agreed.
The Chair: Shall the chair report the bill as amended to the House?
Some hon. members: Agreed.
The Chair: Shall the committee order a reprint of the bill as amended for use of the House at report stage?
Some hon. members: Agreed.
The Chair: That concludes Bill .
Mr. Young, did you have a point?