Health Committee on June 12th, 2014

[The Chair, Conservative, Ben Lobb]

Thank you very much.

Next up, from the Canadian Health Food Association, is Helen Long.

Please go ahead.

[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.

[The Chair, Conservative, Ben Lobb]

Thank you.

That concludes our presentations, and now on to the questions.

First up is Ms. Davies.

Go ahead.

[Libby Davies, NDP, Vancouver East, BC]

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?

[Jeff Morrison]

Thank you, Ms. Davies, for the question.

I would add that polls show that pharmacists are the most trusted profession in Canada and are the most accessible health care providers. You are correct in that.

With respect to the question regarding NHPs, Ms. Long detailed quite extensively the process that NHPs go through, essentially to be approved, and as you've both mentioned, the risk tends to be somewhat lower.

[Libby Davies, NDP, Vancouver East, BC]

Somewhat lower, or a lot lower?

[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.

[Libby Davies, NDP, Vancouver East, BC]

Okay.

Before you turn it over, I want to follow up with you and ask you another question about prescribing health institutions.

You're basically saying it's more of a precautionary principle. That's what I hear you saying.

Could you give us an example of where you think a natural health product has posed a risk or does pose a risk? Let's be concrete about this. Is there stuff out there that pharmacists are aware of for which there should be a greater warning, other than what's provided in the labelling and product information?

[Jeff Morrison]

I'll ask my colleague Dr. Power to address that.

[Dr. Barry Power, Pharmacy Consultant, Canadian Pharmacists Association]

There are a number of natural health products that have been shown to interact either with mainstream medications or to pose a risk for certain things such as bleeding. There has been an increased use of natural health products, and as more people use them, we need to collect data that will show all of the risks.

We need to keep in mind that low risk does not mean no risk, and natural does not mean safe. By including natural health products in the bill, it ensures that health care professionals and consumers in Canada have access to better information, that they can make better decisions for their health, and make sure that everybody has a good understanding of the actual risks associated with the products. The current databases that we have are fairly thin on the risk side.

[Libby Davies, NDP, Vancouver East, BC]

I'm going to go back to Ms. Long, but before I do, I want to sneak in one other question for Mr. Morrison.

You raised the question of the definition of a prescribed health care institution, and you're right. In the bill that's all it says, so what does that mean?

I'm going to throw it back to you, because we're at the eleventh hour now with regard to making amendments and so on. What would you cover? What are your suggestions? I'll leave it to you.

[Jeff Morrison]

Thank you.

When we posed that question to Health Canada officials, I think it was made very clear that hospitals would be considered, but beyond that we're into some grey territory. As I said in my comments, there was an open question. For example, would a prescribed institution include community health centres? Would it include pharmacies? Would it include family health teams?

[Libby Davies, NDP, Vancouver East, BC]

Should it? Would it be helpful if it did?

Certainly community health centres should be included, but what about pharmacies? Is that something you're suggesting we include?

[Jeff Morrison]

The challenge with broadening the scope of the definition is whether these institutions will have the human resources and the capability to in fact do the work necessary to report these.

In theory it would be advantageous for all of these various institutions to report on such a basis, but in reality do they have the capacity to do so? That's the challenge for all of these various institutions.

[Libby Davies, NDP, Vancouver East, BC]

Quickly then, Ms. Long, would you like to respond to anything the pharmacists have said about the issue of risk?

[Helen Long]

Yes. Thank you.

Mr. Morrison commented on the act and the risk with all medication. I'd like to go back to my first and my key point.

In 1998 this Standing Committee on Health made 53 recommendations, number one of which was that NHPs are not drugs and they should not be treated as such.

I think anything that's too risky requires a prescription. When we talk about this issue, we talk about consumer education. We work extensively and we collaborate with Health Canada and we speak in our public pieces about consulting with your health care practitioner. I think working on a collaborative message around that education and making consumers aware is where we would like to go.

Patients and consumers do need to take some responsibility, and we would certainly like to educate them, but as you indicated, Ms. Davies, the risk is so minimal that's not where we think we need to be.

The standing committee agreed that these products are not drugs, and I think that's where we should rest.

Thank you.

[The Chair, Conservative, Ben Lobb]

Thank you.

Ms. Adams.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

Thank you.

Would you be kind enough to perhaps highlight for us which aspects of the bill before us should not be amended? Which aspects do you feel are the most critical and should certainly move forward?

I ask you this question in the general context of this really not having been updated by the federal government for 50 years now. So we do need to move the ball forward. We hope to create one of the most transparent systems in the entire world, a system that is genuinely focused on consumer safety and on patient safety, for the betterment of all Canadians' health.

So would both of you be kind enough to provide me with some insight into which aspects of the bill you think are great the way they are and should not be subject to amendment?

[Jeff Morrison]

Thank you for the question, Ms. Adams.

I identified in my opening comments a number of the aspects of the bill of which we are extremely supportive. I'll just mention some of those.

First of all is the inclusion of increasing penalties on those manufacturers who essentially wilfully put unsafe products on the market. Obviously the recall powers for Health Canada have long been absent, as you mentioned. The requirement for companies to revise labels to clearly reflect health risks is important. We welcome the reporting of adverse reactions, although again perhaps with some greater clarity in terms of how that would actually be applied. There is also the notion or the power to compel companies to do further testing of products, especially when at-risk populations are identified.

We think all of these are extremely welcome aspects of the bill.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

Thank you.

[Helen Long]

And thank you.

CHFA does support the bill as it is written. We support the exclusion of natural health products, and we do feel this addresses a number of areas that have been open since 1953. With a regulated system on natural health products, the benefits of which we enjoy in Canada on, we are pleased to fully support the bill as it is written.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

Thanks very much.

Would you be kind enough to provide some insight into the type of stakeholders you have consulted with and the membership you have reached out to in developing your remarks for today?

[Helen Long]

We have a membership of over 1,000 businesses across Canada, everything from the very small mom-and-pop independent health food store to one of the largest vitamin manufacturers in the country, and we reached out to all of those members, our stakeholders. We have worked and discussed with some collaborative organizations, and of course we are always in ongoing discussion with the natural health products directorate. That's the group we have reached out to.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

Thank you.

[Jeff Morrison]

I would to add that we've consulted with our board, with our provincial pharmacists associations, and with individual members. When the bill was introduced back in December, we issued a public statement.

As many of the members around this table know, we've worked on various issues related to drug safety. For example, we've worked with Mr. Wilks on prescription drug take-back days. A number of issues involve the broader issue of drug safety, and we've worked with and consulted with our members about them.

As I said in my opening comments, this is priority number one for pharmacists.