Saturday, November 1, 2008

Where Have All the NHP's Gone?

For those of you that are unfamiliar with Bill C-51, it is a new bill that has been under hot debate for the past year because it deals with Natural Health Products (NHP's) and pharmaceuticals. I researched both sides and I present to you, Pt. 1 of a two part look into Bill C-51, what it is about, what the arguments are on both sides and how it can effect us all in the long run....

The Bill that caused a thousand arguments has been tabled for the time being as Ontario residents gear up for an election, but that doesn’t mean that the big bad Bill has been put out to pasture. The issues with Bill C-51 are two-fold, in this article we will discuss the increased regulation of natural health products (NHP) and what this could mean for you. In part two, we’ll look at the pharmaceutical issues connected with Bill C-51 and how that ties our health care breakdown together, but let’s start with vitamins….

Bill C-51 seems to be a hot button topic in the GTA, and why not, a proposed Bill that limits our ability to both purchase and store natural health products? That seems crazy when you consider an NHP can be anything from a vitamin C tablet to ground up mushrooms from the rainforest. Before touting the advantages of natural health products over pharmaceuticals, let’s consider the first fundamental issue with Bill C-51, the language.
The language of the Bill seems to make these debates more heated because, as many government documents tend to be, it is vague and leaves a lot of important issues open to interpretation. For example, on page 14 of this 62 page monster, under section 15.1 (4) the Bill states
“…The Minister may, by order, designate a therapeutic product-either individually or by class-as a prescription therapeutic product..”
Here is what appears to be a simple sentence, giving the Minister the ability to label anything previously considered an NHP as a prescriptive NHP, and thus severely limiting the average person’s access to the product. The language is much too vague and gives this illustrious ‘Minister’ what appears to be complete power to designate prescriptions. There is no mention of required scientific research to support such a change in status, nor is there any committee or group that needs to be consulted. This makes many people nervous, especially when you consider the individuals who are being handed this power. Take a look at Tony Clement, our Health Minister and you might see what can cause these concerns. The individuals in power do not generally look like the healthiest people. Take Mr. Clement, pretty soft in the middle, carrying a little extra weight in that oh-so dangerous ‘spare tire’ area . For a man who is supposed to be concerned with the health of every Canadian, he looks remarkably unhealthy.
So, we have just agreed, through the vague language of Bill C-51, to allow an individual, perhaps someone who has never taken an NHP, to decide which NHPs should be available over the counter and which should be prescription only. One of the supplements you can look forward to asking your GP to prescribe is St. John’s Wort, a mild and natural mood enhancer that has been used for centuries as a solution to depression and anxiety. How many doctors do you think will be handing out prescriptions for St. John’s Wort when Zoloft and Prozac keep dropping off trunk loads of samples?

The imprecise language is prevalent throughout the Bill with vague references that allow for great things like free reign search and seizure perpetrated by an inspector who can be chosen, just like the Minister, from a pool of individuals with no previous experience with NHPs. This inspector can;
(pg 24. Section 23.1)
“Enter a place, including a conveyance and
(2) examine or test anything
(2b.) open a receptacle or package
( c ) examine a document
( d ) seize and detain for any time that may be necessary.”

The inspector has the ability to do all of these things without a warrant or member of law enforcement present. That seems like that have more ability to seize and detain than our anti-terrorism laws and regulations allow. Odd, last time I checked, Canada has never seen a loss of life from NHPs.

Let’s move away from the language, otherwise we will be here until after the American election, let’s just suffice it to say that the authority granted to inspectors and ministers under Bill C-51 makes me very nervous, and I have always been a law abiding citizen. Onward and upward, let’s look at some of the reasons why this bill may have been introduced in the first place and examine those motives.
John Biggs of the Edmonton Journal mentions a study conducted by Health Canada in 2004, shortly after the initial Food and Drug Act began to include NHP’s. In this study, Health Canada polled Canadians coast to coast to find out what concerned them most about the Food and Drug Act and what they would like to see amended/included. Overwhelmingly, the polls came back telling Health Canada that Canadians wanted easier access to NHPs and a basic regulation system to ensure that pharmaceuticals being brought into the country were sufficiently tested before finding their way to the marketplace. What Canadians ended up with, was the beginning of NHPR, natural health product regulations.
The NHPR were supposed to create a safety net for Health Canada, allowing them to eliminate dangerous products quickly and efficiently. What we ended up with was a jumble of information, exaggerated on both ends by alarmists who didn’t want change. The hard science group was alarmed that NHPs were being given the same consideration and respect that had been reserved exclusively for pharmaceuticals until recently. Those who supported NHPs were worried that increased regulations would make it harder to find NHPs and also increase the current price point. In an effort to appease both sides of the issue, Heath Canada created a new blanket term, ‘therapeutic products’ that can cover both NHPs and drugs.

Our quick history lesson takes us up to the inception of Bill C-51 that continues to keep both categories under the ‘therapeutic products’ umbrella. Strangely enough, this Bill has done the exact opposite of what Canadians asked for 4 years ago. Now, NHPs can be denied access to Canada, even products that have been sold in Canada for decades can be re-assessed and denied entrance. The cost of licensing and testing to sell an NHP in Canada has gone up exponentially and although the government consistently tells us the cost of NHPs will not increase due to Bill C-51, how can any consumer in their right mind assume that an increase in cost to sell in Canada will not be reflected in the retail price. On top of all that, by classifying drugs as ‘therapeutic products’ the Bill has made provisions for new and exciting drugs to flood the market place with very little research to back up it’s claims.

I think perhaps the most frustrating part of researching Bill C-51 is the complete lack of acknowledgement that the government seems to have initially given the Canadian people. After checking the Government of Ontario’s health website, www.healthycanadians.ca, I was angered by their assumptions. The FAQ page for Bill C-51 made statements like;
“ NHPs will NOT be regulated like pharmaceuticals.
Bill C-51 will NOT increase the cost of NHPs
Bill C-51 will NOT regulate the growing of personal herb gardens.
Bill C-51 will NOT target practitioners.
Bill C-51 will NOT require all individuals to obtain a prescription for NHPs”

They make these statements just as I have written them, with capital letters and a simplicity that implies we are too simple to understand the language of the Bill. If NHPs aren’t meant to be regulated like pharmaceuticals, then why are they placed in the same category and treated the same in the document? In fact, you created a brand new blanket term to include NHPs and drugs. Seems an odd move if you don’t want to treat them the same.
Bill C-51 WILL in fact raise the cost of NHPs. How can anyone with any concept of money disagree? Bill C-51 requires more documentation, more scientific trials and more intense licensing programs. When the companies suddenly have to spend more to get the same amount of product sold in Canada, where do you think the increase expenditure will be placed? On the retail cost of course! On top of all that, now all stores/locations that sell NHPs will also have to go through a more stringent licensing process, which costs them more money and thus, will increase their mark-up on such products.
Bill C-51 MIGHT regulate your herb garden. After researching this topic, this is one of the topics batted back and forth most frequently because it seems very unreasonable. Most politicians say that such paranoia is absurd, but answer me this; If you don’t want to regulate my herb garden, why allow for language that makes that a possibility? Don’t you want to protect your citizens? Once this Bill is in place, any desired changes are a major issue, involving appeals and amendments. Perhaps today the government doesn’t want to peek into your vegetable garden, but ten or twenty years down the road, if that Bill makes it legal, who’s to say what will be happening?
If you don’t want to regulate private gardens and self-sustainability, then clarify the language.
The same point can be made for the final two statements. Our government’s official stance is that they do NOT target practitioners and will NOT require prescriptions for general NHPs but again, if they don’t want the power, then change the language. As it currently sits, even if the government doesn’t exercise the authority now, it still exists and can be exercised at any time in the future, so just relieve our minds, and adjust the language, give us back our piece of mind and our privacy, not to mention our vitamins and herbs.

A few amendments have been proposed to Bill C-51, and unfortunately, the majority of the C-51 fighters do not bother to stay current with the positive changes, I suppose, similar to the pharmaceutical warriors, anything that doesn’t make their point, breaks their point. The new amendments would give NHP’s their own category apart from food and drugs, which honestly, would probably solve many of the problems with the Bill hopefully loosening the restrictions slightly on NHPs and tightening them for drugs. The amendments would also potentially acknowledge traditional and cultural uses of NHPs. Finally, the amendment would include wording to regulate the inspector’s abilities to search and seize, giving Canadians back their piece of mind. If these amendments pass after the election, many of the arguments should subside and Canadians can focus on the next hot button topic, because let’s be honest, there will always be one of those.

4 comments:

Ex-drone said...

Alayna:

I have to disagree respectfully with your analysis. I fear that it has been overly influenced by the propaganda being spread by StopC51. Behind that movement is a supplement company that had a run-in with Health Canada a few years ago and has been trying to get back at them ever since.

Bill C-51 will not limit access to NHPs. They have been regulated since 2004 when the NHP Regulations came into force. C-51 will not impact the Regulations. Whatever NHPs have been for sale over the last four years will continue to be on the store shelves after C-51 is passed.

The language with which you seem uncomfortable about giving power to a Minister is typical for enabling Acts like the Food and Drugs Act, which give regulatory power to the Governor-in-Council (i.e., the Cabinet) or to a Minister. In reality, the Governor-in-Council will defer to the applicable Minister, so there is nothing unusual here. The Health Minister is advised by an NHP Directorate, which is led by a naturopath, staffed by NHP professionals and advised by an Expert Advisory Committee of CAM practitioners. In addition, Health Canada is continuously travelling the country conducting consultations on NHP regulations and other issues.

I am puzzled when you say "If NHPs aren’t meant to be regulated like pharmaceuticals, then why are they placed in the same category and treated the same in the document?" That is the difference between legislation, in which terms and categories are broad, and regulations, in which they are more specified. For example, a provincial highway traffic act would talk about "vehicles" in the legislation but break out "cars, truck, buses, motorcycles, ..." in the regulations.

Under the current Food and Drugs Act, NHPs are already a sub-class of drugs. Their difference from drugs is specified in the NHP Regulations. The introduction of the term "therapeutic product" actually clarifies the situation, since NHPs are not typically considered to be drugs. Nevertheless, the difference between the types of therapeutic products will continue to be specified in the separate regulations.

If Health Canada wanted to do anything underhanded, such as to restrict NHPs to being prescription products, they have that power now. Given that they have not exercised that option over the last couple decades when they had the chance and authority to do so, I don't see why they would suddenly start doing it now. No NHPs require a prescription now, and based on the risk-based approach of the Bill, no NHPs will require a prescription after C-51 is passed.

With respect to the power of Health inspectors, in fact the power of all federal product inspectors, I think you should check what powers they currently have. Federal inspectors currently have many of the powers you fear giving them. See the current Food and Drugs Act:

"23. (1) Subject to subsection (1.1), an inspector may at any reasonable time enter any place where the inspector believes on reasonable grounds any article to which this Act or the regulations apply is manufactured, prepared, preserved, packaged or stored, and may

(a) examine any such article and take samples thereof, and examine anything that the inspector believes on reasonable grounds is used or capable of being used for that manufacture, preparation, preservation, packaging or storing;

(a.1) enter any conveyance that the inspector believes on reasonable grounds is used to carry any article to which section 6 or 6.1 applies and examine any such article found therein and take samples thereof;

(b) open and examine any receptacle or package that the inspector believes on reasonable grounds contains any article to which this Act or the regulations apply;

(c) examine and make copies of, or extracts from, any books, documents or other records found in any place referred to in this subsection that the inspector believes on reasonable grounds contain any information relevant to the enforcement of this Act with respect to any article to which this Act or the regulations apply; and

(d) seize and detain for such time as may be necessary any article by means of or in relation to which the inspector believes on reasonable grounds any provision of this Act or the regulations has been contravened.
"

For a detailed anaylsis on these powers, please check our article Bill C-51 and the Power of Inspectors for a side-by-side comparison of those powers before and after C-51.

I am puzzled why you say that "Bill C-51 WILL in fact raise the cost of NHPs." The Bill does not change how NHPs are regulated. The Bill merely enhances the enforcement measures for food, NHPs, drugs, cosmetics and medical devices in the Food and Drugs Act. Currently, the maximum fine is only $5,000 and there is no provision to mandate a product recall. These are outdated measures. Since the process by which NHPs are licensed or accessed by consumers is not changed by Bill C-51, I do not see why they would become more expensive.

When you say "answer me this; If you don’t want to regulate my herb garden, why allow for language that makes that a possibility?" The answer is easy. Legislation is always broadly stated because the details are always in the regulations. That is just how the law works. It is more efficient that way. If you believe that there is some loophole in the wording of C-51 to allow for the regulating of herb gardens, then I guarantee that I can make the same case under the current wording of the Food and Drugs Act. Since it has been relatively unchanged for the past couple decades without the government conducting SWAT assaults on private homes, I don't why they would start doing it anytime soon.

I invite you over to Ottawa Skeptics, where we have a number of articles debunking the fear mongering of StopC51.

Barry Green

bodybylayna said...

Thanks for your input!
I am always happy to discuss our differing opinions.
I did read all of the articles presented by the Ottawa Skeptics website and personally found that many arguments were dismissed without sufficient evidence, but that is just my opinion.

I would be interested to hear your opinion on the other half of Bill C-51, allowing untested pharmaceuticals to be placed in the marketplace and retroactive studies to be conducted with information from Canadians taking the drug.
Thoughts?

Anonymous said...

Dear Barry,

It is not propaganda. It is a valid opinion and concerns by citizens, and your use of the word propaganda is very, very bias and discredits your argument from the get-go.

I was lucky enough to go to a lecture series on the subject. Funny enough, the lawyers and doctors who are working on this said the exact opposite that you have said. So who opinion is propaganda? Who do you work for?

One of the keynotes was a man who worked for the government was fired for disagreeing with the current minority governing body on this piece of legislation. Fired for disagreeing, fired for whistle-blowing. Is that democracy?

Secondly, in the law the act states that any properties or monies seized goes to the Prime Minister- that's a little weird, no?

Most importantly, this is blatantly being pushed by big pharma. Vitamin C and turmeric have never killed anyone, yet pharmaceuticals kill people on a daily basis.

This week I am commiserating the death of one of my best friends- who killed himself from being put on prescription anti-depression pills that were frequently switched to 'get the combo right.' He was 21, and the pill he was on was latter banned as it proved to actually make people suicidal.

My traditional doctor got me hooked on Codine when I was 15. It took years of struggle to get me off the dependence, and I have finally begun healing myself (as a whole person, not just a list of symptoms) through Heilkunst Homeopathy.

So- if you are looking to protect the general public- go after the companies that hook people onto their substances. They are making billions of our government, and are NOT making anyone better.


If the Natural Health Industry is going to be cracked down upon- then do so to the allopathic stream. They shouldn't be allowed to hide behind their money and lawyers.

It is my decision as an adult in a democracy to decide what should go in my body. If I have chosen to pay extra to heal myself NATURALLY, not through a chemistry experiment that has only been around for a few decades, then I should have the right. Period.

What the government hasn't addressed is how this ties into codex-alimentarius- an international law that no Canadian has voted on, and that has many human rights groups up in arms.

bodybylayna said...

Thank you both for your opinions!
I think one of the biggest problem with both NHPs and pharmaceuticals is that the average Canadian is not very well informed and is just following instructions blindly whether they are from a medical doctor or a homeopathic doctor.
If we could all make the effort to educate ourselves, even if our opinions differ, at least we will all be arguing with the same sets of facts and questions.
I am a private and concerned citizen with no agenda. If my articles are biased, the bias is based on my life experience and research, what about yours?