Bill C-17 (Historical)

Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)

An Act to amend the Food and Drugs Act

This enactment amends the Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures to, among other things,
(a) strengthen safety oversight of therapeutic products throughout their life cycle;
(b) improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products; and
(c) promote greater confidence in the oversight of therapeutic products by increasing transparency.

Time Allocation for Vanessa's Law—Speaker's Ruling

[The Speaker, Andrew Scheer]

I am now prepared to rule on the point of order raised on May 30, 2014, by the House leader of the official opposition regarding the validity of a notice of time allocation with respect to Bill C-17, an act to amend the Food and Drugs Act.

I would like to thank the House leader of the official opposition for having raised the question, as well as the Leader of the Government in the House of Commons and the member for Oxford for their contributions.

The House leader of the official opposition argued that the consultation required pursuant to Standing Order 78(3) had never taken place and therefore the Chair should rescind the notice for time allocation for Bill C-17. Furthermore, it was his contention that there was no need for the government to resort to time allocation at all since the bill had been on the order paper for six months, yet had received virtually no debate to date.

The Leader of the Government in the House of Commons confirmed that although the contents of confidential House leaders’ meetings could not be revealed, agreements had been proposed to the House leader of the official opposition and his staff. Notice of time allocation was then given only once it was evident that no agreement could be reached.

Through this point of order, the Chair is being asked to stand in judgment of two things, the first being whether or not there were consultations such that the conditions of Standing Order 78(3) were satisfied. The second is whether the time that the House had debated Bill C-17 was sufficient enough to warrant the use of time allocation.

House of Commons Procedure and Practice, second edition, on pages 669 to 670, states that:

The Speaker has stated that the wording of the rule does not define the nature of the consultations which are to be held by the Minister and representatives of the other parties, and has further ruled that the Chair has no authority to determine whether or not consultation took place nor what constitutes consultation among the representatives of the parties.

As recently as March 6, 2014, the Deputy Speaker addressed this very issue when, on page 3598 of Debates, he reminded the House that:

The nature of the consultation, the quality of the consultation, and the quantity of the consultation is not something that the Chair will involve himself in. That has been the tradition of this House for many years. What the Chair would have to do, in effect, is conduct an extensive investigative inquiry into the nature of the consultation. That is not our role, nor do the rules require it.

Therefore, it remains a steadfast practice that it is not the role of the Speaker to determine whether consultations have taken place or not.

With respect to the amount of debate a bill must receive before notice of a time allocation motion can be given, the Chair is being asked to render a decision on a matter over which there are no explicit procedural rules or practices, and thus, over which it has no authority. Rather, it is the House that retains that authority and therefore must continue to make that determination as to when and if a bill has received adequate consideration.

Accordingly, notice of time allocation for Bill C-17 was valid when it was given. I thank all members for their attention.

[The Chair, Conservative, Ben Lobb]

Welcome back. We're back in session.

We'll start going through the clause by clause portion of Bill C-17. 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 C-442, 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)

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?

Ms. Adams.

[Jeff Morrison]

It tends to be lower.

We would argue that if that were the case, that the risk is significantly lower, then by including NHPs within the bill, there's probably not a lot they would need to worry about. However, the risk still does exist.

I think what Bill C-17 does is to acknowledge that there is risk with all medication, that there needs to be processes in place to address that risk and identify it. Therefore, by putting it in—and I'll pass it over to my colleague in a moment to finish off the response—you are essentially covering the range of possible risk associated with consumption of any of these products. It's probably better to put them in than not.

[Helen Long, President, Canadian Health Food Association]

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 C-17 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.

[Jeff Morrison, Director, Government Relations and Public Affairs, Canadian Pharmacists Association]

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 C-17, 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 C-17. 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.

[Walter Robinson]

I would start by noting that many aspects of Bill C-17 already codify the manner in which Rx&D member companies have been interacting with Health Canada and other regulatory bodies, not only here in Canada but similarly with Health Canada's peer agencies, for a long time.

Regarding the issue around the specific article you mentioned—and I think that had to do with Dr. Lexchin and a few other journalists—you were cut off before when listing some of those products. As I noted, I can't speak to individual product issues. It would be best to address the companies to speak to those. From reading about it and from the research, I can tell you that some of those recalls were voluntary. They were not mandatory recalls. The companies themselves pulled them from the market.

You had a very clear question around plain-language labelling. I'd like to ask my colleague Keith McIntosh to speak to the things we've done around that and the things we've urged Health Canada to do. Some of these things have the best weight of suasion with regulatory authority.

[Keith McIntosh]

First I would note that we support the authorities that are proposed in Bill C-17 to provide the minister with the authority to compel label change or to compel a recall if that thoughtful dialogue isn't conclusive.

I think that reasonable scientific debate is a valid exercise, and I know that our members have patient interest at heart when they have that debate, regarding what the label should contain or when to conduct a recall. I think if we only require a mandatory recall or a mandatory label update, the regulator is not necessarily the most rapid vehicle. The manufacturer is in the best position to initiate one of those changes quickly.

[Walter Robinson]

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.

[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.

[Walter Robinson]

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.

[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.

[Jim Keon]

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.

[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?

Federal Framework on Lyme Disease Act

[Elizabeth May, Green, Saanich—Gulf Islands, BC]

, seconded by the member for Vancouver East, moved that the bill be read the third time and passed.

She said: Mr. Speaker, I would like to express my heartfelt thanks to all those who supported my bill. We can accomplish a lot when we work together in a non-partisan way.

I would particularly like to thank the Minister of Health, who supported this bill. She shared her opinions and was extraordinarily understanding. I also want to thank her team.

I have to thank, in particular, the member for Honoré-Mercier, because, in the spirit of non-partisanship, she gave up her slot today, June 11, so that this bill, which has received such widespread support from all corners of the House, could proceed through report stage, third reading, and make its way to the Senate. I am very grateful that Senator Janis Johnson is prepared to take it forward so that we can get this help to the people who need it most.

All members in this place are now much more familiar than they were with the threat of Lyme disease. This bill will not solve all our problems, but it will take us a long way forward. So many members spoke passionately in this place about the importance of the bill. I want to particularly thank members on all sides of the House. The hon. member for South Shore—St. Margaret's gave a passionate speech about the difficulties of diagnosis and what he sees happening in Nova Scotia. My friend, the hon. member for Victoria, talked about our friend who lives in his riding but works with me, Chris Powell and her daughter Nicole Bottles, who testified in committee.

The hon. member for St. Paul's gave me time in committee so I could ask questions, which I otherwise could not have done. There have been so many acts of kindness. It is unusual for a private member's bill to have been seconded initially by the hon. member for Thunder Bay—Superior North with the Green Party, seconded at the next stage by the hon. member for Oakville, a Conservative, who has himself stood on an important issue in Bill C-17, which I hope we can also pass expeditiously, Vanessa's law. Today I am honoured that the health critic for the official opposition, the hon. member for Vancouver East, would be my seconder.

I also want to thank the Parliamentary Secretary to the Minister of Health for her help. I know I will forget people as I keep thanking everyone. The hon. member for Sault Ste. Marie offered early help and support. Everybody on all sides of the House, including the health critic for the Liberal Party, have been unstinting in their willingness to help the bill pass, to get through amendments and clause by clause in committee. This bill is now called a federal framework on Lyme disease. It has the support, as I have said, of Health Canada.

I will share with the House things that I did not know when I first put this bill forward at first reading almost two years ago exactly. The Public Health Agency of the Government of Canada testified before the health committee that this is one of the fastest-growing infectious diseases in Canada. The evidence from the federal Public Health Agency is that it thinks by the year 2020 Canada could be experiencing 10,000 new cases of Lyme disease every year.

Every step we take in 2014 to put in place national approaches that work federally, provincially, and territorially for better education and better prevention so that people can avoid getting Lyme disease in the first place by knowing what to look for, by avoiding ticks, moving to better diagnoses, working with the doctors across this country, is crucial. The support of the Canadian Medical Association for this bill, the College of Physicians and Surgeons, and the Canadian Lyme Disease Foundation has been absolutely essential. All of these expert bodies recognize that this is a very complicated disease, very difficult to diagnose, and that we should no longer stand for any one of our friends, neighbours, or relatives to have to go to the United States for expensive treatment.

We do not want to hear any more stories from our own constituents who had to sell their homes to be able to afford the treatment that we can provide here in Canada through a federal framework on Lyme disease. Ultimately, we need much better research. I have mentioned a couple of times how indebted I am to the hon. Minister of Health. Funds have been put in place by Health Canada without being tied to this bill, because, of course, a private member's bill cannot put forward funds.

I will close now with the most deep and heartfelt thanks to all in this place tonight and every day. God bless them.

Concurrence in Vote 1--Senate

[Dan Albas, Conservative, Okanagan—Coquihalla, BC]

Mr. Speaker, again, the NDP continues to believe that its magical thinking will pan out in a way that supports Canadians.

That particular member, regardless of whether it is a discretionary or a statutory item, will vote in opposition, because the NDP ultimately opposes this government's agenda of low-tax policies that will help us grow our economy, create more jobs, and create long-term prosperity.

I understand that the member has certain ideas about the Senate and about whether it should be funded, but this government stands clear. We want to see a strong parliamentary agenda. We want to see things like Bill C-17, Vanessa's law, which I mentioned, go forward, because they are in Canadians' greatest interests.