Bill C-51

As part of its Food and Consumer Safety Action Plan, the Conservative Government of Canada has tabled Bill C-51, which proposes a number of amendments to the Food and Drugs Act. This bill has caused considerable concern and is currently top of mind for a vast number of Canadians.

Rumours about Bill C-51 abound. Some think this bill will strip Canadians of both their rights and their access to natural health products. Others worry that Bill C-51 will violate the Canadian Charter of Rights and Freedoms by permitting search and seizure measures the likes of which have never before been allowed in Canada. There is even concern that Bill C-51 will allow Big Pharma to take over the natural health industry.

Alive wanted to cut through all the rumours to give our readers some real insight into the truth behind Bill C-51. So alive was delighted when Tony Clement, the Federal Minister of Health, contacted us to respond to our readers’ questions.

Q: Good morning Minister. Could you please explain to our readers what exactly your intention is with Bill C-51?

A: Sure. I’ll give you a bit of context. Last year at this time, of course, the whole country was reeling, as indeed other parts of the world were, with a whole series of recalls that were going on. The recalls were mainly on consumer products like children’s toys, chew toys, and there were some food products such as American lettuce that had been recalled as well.

It became clear that we were seeing a spike in these warnings and recalls that were all across the whole range of products–whether food or manufactured products such as children’s toys or kids’ jewellery. When I delved into this a little bit as Minister of Health, I realized that our umbrella oversight and regulation really had not been meaningfully changed in close to 50 years. I also realized we were quite behind the times in our abilities to react–and even proactively ensure–the health and safety of Canadians. I’m speaking generally now, not just about the natural health products industry per se.

In addition we had the Vioxx scare, which indicated that there was a need for a greater overview for prescription drugs. And generally when I looked into what our trading partners were doing, such as the United States and Europe for instance, they had many more modern techniques to ensure better safety and better information for consumers as well. So that was the context in which I created Bill C-51 and its companion piece of legislation, Bill C-52.

Q: Given that premise, why do you think there’s been so much public and media confusion regarding the purpose of this bill?

A: You know, I think that there’s certainly been a lot of scaremongering within the natural health products industry that has led people to draw false assumptions and false conclusions. This bill was not targeted against the natural health products industry, contrary to some accusations. And in fact, Bill C-51 and Bill C-52 will make it easier for approvals to take place for natural health products, rather than more difficult.

Q: It’s easy to say, “Well, some people have been scaremongering.” But that wouldn’t have been relevant had they been able to fully understand the bill. How do you think your government could have improved communications?

A: I think that it’s always important to report accurately, and we were doing that, and I guess I did not foresee that someone might be inaccurately communicating about the bill. So, in the meantime, we have created an amendment which is much more explicit about some of the protections and some of the requirements for Health Canada. For instance, it is clear that Health Canada has to act reasonably. The purpose of the bill has been made much more explicit in the amendment to the amendment that I tabled in June. So I think that now you can read the bill and understand how it interrelates with the Charter of Rights and Freedoms or with the Criminal Code of Canada.

Whereas before, perhaps one had to be a lawyer in order to draw the lines and draw the connections. So that’s a lesson that we learned and now we’ve made the appropriate adjustments, and I think it’s a better bill as a result of those amendments.

The other thing that I’ve concluded isthat the natural health product industry wants to be inside the tent. They don’t want to just be reacting to Health Canada, reacting to decisions made by Health Canada. And so what I’ve done inmy amendments to the bill is made it clear that we will have an advisory body made up of interested parties from the natural health products industry, practitioners, and even perhaps users of natural health products. They’ll be around the table–an advisory body that will assist Health Canada in understanding the industry and understanding the implications of any future decisions that it makes. That is a very positive step, one that’s unprecedented for the natural health products industry.

And for the natural health industry to be on the inside, to be part of an advisory body of Health Canada, I think that’s a great marriage. It’s an unprecedented degree of access for a branch of health care. I really believe it.

Q: One of the most common phone calls that I get from readers is, “Will Bill C-51 remove Canadian consumers’ access to natural health products?” How would you answer that?

A: Absolutely, no. The answer is, in fact, quite the opposite. As I said, if you look at the bill, it’ll take a risk-based approach to approving natural health products. And that approval process has been around since 2004, as you know.

We’re going to take a risk-based approach. So what we’re saying is for the vast majority of natural health products, the risk is very low. You’re talking about ingredients associated with food products, or herbs, or other natural products that have, in some cases, been used for hundreds or even thousands of years with no ill effects having been identified. So those products are going to be fast-tracked. That wasn’t the case under the previous regulations. So I’m actually making it easier for natural health products to be on the store shelves. And I think that’s going to be a great improvement for the choice that Canadians need and desire.

Q: Does Bill C-51 relax the safety regulations currently in place for pharmaceuticals?

A: No, actually it does quite the opposite. For the first time, I’m requiring mandatory reporting of adverse reactions to prescription drugs. And I’ll be requiring all hospitals to report all cases of reactions, whereas before, this was not necessarily the case. So what we’re trying to do is to not only have stringent approvals for drugs as they move onto the market, but we’re saying, “We’re going to continue to oversee you. We’re not just going to wash our hands the moment you get approval and say it’s somebody else’s job now to worry about any unintended impacts of drugs.”

We’re still going to be there reviewing, watching, getting the information in, and if the drug has an adverse reaction that was not picked up in the original approvals process, then we’ll have the ability to recall that product, whereas before I did not have that ability.

Q: Another concern that comes up often is your connection to the pharmaceutical industry and to Prudential Chem in particular. I understand that you’ve already divested yourself of these interests. Is that right?

A: Yes. I divested myself willingly without a requirement to do so over two years ago. And I can go on. Prudential Chem actually has a connection to natural health products as much as it does to pharmaceutical products. But that’s really immaterial, quite frankly. It’s also close to defamatory to suggest that I’m in the pockets of Big Pharma.

You only have to look at my record as a provincial Minister of Health. I was the first minister in Ontario to get the ball rolling for traditional Chinese medicine and naturopathy to be considered as approved and regulated professions. So my record is very clear on this. I’m a big believer in consumer choice. I’m a big believer that people should have the right to choose natural health products. That’s my record.

Q: Many people in the natural health industry are not only upset by the bill itself but also the way they saw it apparently rushed through readings. And as a result, several “Stop Bill C-51” websites have sprung up and many concerns have arisen. I’ve personally heard from many people who go to these websites and get very afraid. For a lot of people that’s where they’re getting most of their information. One concern that I hear raised continually is that it was lobbying by the pharmaceutical companies that brought about the revision of the Food and Drug Act. Is this true?

A: Absolutely not. I mentioned to you the origination of this bill was the fact that we had a major spike, a four-time spike, in recalls in this country and in our realization that our legislation was antiquated. I didn’t have the power of recall. Currently, I only have the power of recall for food. I have no power of recall for prescription drugs. No power of recall for deadly consumer products. That’s got to change. We’ve got to move into the 21st century here.

Q: Another consistent concern expressed by many readers is that they may become subject to the powers of inspectors through Bill C-51. How are they protected?

A: This is one of the things that we did with the amendments to the amendment that I tabled in June. As I said, all Canadians are protected by the Charter of Rights and Freedoms. They’re protected by the state of our reasonable search and seizure provisions that are found in our criminal law. These have not changed.

But what I did was I imported them much more explicitly into the bill. And so under this bill, Health Canada will not have the authority to enter a home without a warrant. To believe otherwise is completely false.

Health Canada will not have the authority to engage in unreasonable search and seizure. So that rumour is false, too. These rights are protected and they have to be. Health Canada officials have to exercise their powers reasonably and responsibly. That’s in the legislation.

Q: If Canadians take pharmaceutical drugs to treat disease–a cost to the health care system–they get tax relief. Yet if proactive Canadians take natural health remedies to prevent disease and save the health care system money, they’re denied relief. What’s your position on this?

A: Well, a lot of these are provincial decisions; it’s the provincial governments that have the ability to look at natural health products in this way. And I believe the Province of British Columbia, for instance, has been a real groundbreaker in this, in some areas. So I can’t step on their toes. They get to make those decisions.

But what I can tell you, as a Federal Minister of Health, is that I do believe in greater consumer choice. People are turning to more natural remedies and this is something that, as long as health and safety is respected, should be encouraged.

I’ll give you one example where I would like to see it encouraged. As health minister, I have instituted Canada’s first national cancer strategy. And, you know, I think there’s a real opportunity to ensure that we get input from the natural health products industry on our anti-cancer strategy, and to make sure that prevention and surveillance also includes the natural health products industry. So I’m on that page and I would like to see more of these things occur.

Q: According to Health Canada, 71 percent of Canadians regularly take natural health products. So why don’t you fully embrace this industry?

A: Well, I guess this is a little frustrating because I do embrace this industry. I do think it’s a legitimate branch of medicine and health care. I do believe we should encourage more consumer choice and more consumer options. And I believe that my bill, Bill C-51, actually does help get more natural health products on the store shelves. So that’s my intention, and I want to work with the industry. I want to see it blossom.

There may be cases of bad apples. They are in the small, small minority. And the reason why, incidentally, Health Canada started to regulate this area of health care initially in 2004 was because of demands from the natural health products industry itself. They wanted to get rid of the bad apples. So I believe what we can do is restore our partnership and that’s exactly what I’m doing.

Q: When pharmaceutical companies spend millions of dollars on research for their products, they do so knowing they’ll recoup the money and millions more once the drug is patented. But natural health products can’t be patented. So isn’t it unreasonable to suggest the same type of research for health products?

A: Well, I actually, respectfully, contend that’s incorrect. When I talked about a risk-based approach to approvals for natural health products, that’s what I meant. The risk-based approach is what we will incorporate into the approvals process.

If the natural health product has been around for hundreds or thousands of years, without deleterious effects, that will be taken into consideration. So you don’t have to do a whole new body of research if the thing’s been used for 5,000 years in China, for instance.

The one thing I would say, though, is if there’s a brand new compound that’s chemically complex, never been seen before, then yes, we would like to know that this particular compound can be used safely. As well as, what are the limits to its safe use if used in conjunction with other products? That sort of information should be on the label. But for the vast majority of the natural health products that have been used for many, many years, then that information is incorporated into our approvals process.

I’m not the expert on natural health products. I’m the health minister who takes political accountability for these things. So my point of view is the legislation is there to protect the health and safety of Canadians. If the health and safety of Canadians is not affected, I shouldn’t be interested.

Q: Given that no one’s ever died from using natural health products, that we’re aware of, why is it necessary to restrict them at all?

A: Well, first of all, perhaps no one has died in this country, but just across the border there were three Americans who died last month by ingesting toad venom, which they considered to be a virility product. So these things do happen.

Here in this country, I issue warnings every week about products that may in some way increase the risk of stroke or heart condition or might cause liver damage. These things are on the markets or maybe sold over the Internet. And so there is a health and safety angle to this that I think most Canadians would expect Health Canada to be involved with. Having said that, the vast majority of natural health products, in my opinion, are safe to use, can be beneficial in their use, and I in no way want to restrict them.

Q: I know you have already touched on this a little, but I want to be really clear on your opinion here, so given the history of natural health products, doesn’t it make more sense to test for safety rather than to insist on efficacy?

A: Well again, I know there’s a raging debate about some of these issues–we can set up a meeting or a telephone conversation with some Health Canada officials who can specifically go through the efficacy versus safety issues. The fact of the matter is, I think in most cases under this proposed legislation, it’s all about labelling, labelling, labelling. Tell us what’s in the package. Tell us what’s in the bottle. Give the consumer the right to choose and allow him or her to make an informed choice–as long as health and safety isn’t compromised. Health and safety is my primary concern.

Q: How do you think placing natural health products into a category of their own addresses consumer concern around Bill C-51?

A: Natural health products have been in their own category since 2004. We make that more explicit in Bill C-51 and the amendments. And I think that’s a good thing. We don’t want the Codex to be applicable, and the natural health products industry doesn’t want Codex to be applicable. So those groups out there who are saying, “Treat us like a food,” are selling out the industry, as far as I’m concerned. In fact, what we’re saying with our legislation is keep it as a separate category.

We’ve had regulations in place since 2004. That will not change. And we think it’s what the industry expects, and what Canadians expect, generally.

Q: So during consultations around those regulations, the natural health industry made 53 recommendations to the Canadian government and they accepted them. Why have these not been adopted by your government in totality?

A: Let’s face it. Those were made a long time ago and we were only elected two and a half years ago.

Q: So you’re saying that it takes time?

A: No, I’m saying that we’re a new government and we’re looking at it through a new pair of eyes.

Q: So how are you going to do that? How are you going to ensure that Canadians don’t get the wrong message if you revisit everything?

A: Well, I guess through consultation. You made a comment earlier about how the bill was rushing through, but it’s quite the opposite. It has not been voted on second reading yet and if we’re successful and it is voted on second reading, it’ll go to committee for yet another round of consultations, another round of potential amendments.

So this process is going to be quite involved and certainly there’s lots of opportunity for improvements to the bill. Beware of the politician who says this bill is perfect. I don’t think my bill is perfect. I think it can be improved upon and that’s why we have a public process by which we get that feedback.

Q: Finally, Mr. Clement, I would like you to speak to how you see the consultation process going forward from here. Can you reassure our readers that the natural health products they’ve come to rely on will be available, and that there won’t be massive increases in price because of unreasonable demands from Health Canada for testing or research?

A: Right. Well, I guess you’ve got a health minister and a Conservative caucus who are, in many cases, very close to their constituents who consume natural health products. We’ve heard the concerns, and I’ve heard some of the concerns of my fellow Conservative caucus members, and so we’re going to make sure that this bill is fair and reasonable.

At the same time, I have an obligation to protect the health and safety of Canadians and that will not go away. So I guess my message to your readers is that this bill will actually increase the availability of products. It will ensure better safety of products. And it actually ushers in a brand new partnership between the natural health products industry and the Canadian government. And that’s the part that I’m most excited about. When all of the sound and fury dies away, and you’ve got a new bill that’s more modern and more effective, then that will have very positive impacts in the years ahead, so I’m very optimistic.

I think that we’ve actually turned a corner and we’re finding that we agree on more things than we disagree on. And this will actually be very exciting for the natural health products industry in the future.