Health Canada Under Massive Attack by Natural Products Maker…

There is an important Court proceeding coming up this Tuesday, March 22nd, 2011 in a Federal Appeals Court in Calgary, Canada.

Opinion by Consumer Advocate Tim Bolen

Health Canada has already circulated two Memorandums that indicate that it knows they are going to lose this battle – and that loss will radically change the way they have to operate.  I’ll show you those memos, near the bottom of this article.

Reprinted from the Lethbridge Herald…

Truehope returning to court

There is no question that Health Canada, the North-of-the-border equivalent of the US FDA, is totally, and completely run by the very drug companies it was designed to regulate.  Just the same, in fact, as the US FDA is.

Health Canada, like its US FDA counterpart, has a well-lubricated revolving door of drug company executives turned Health Canada leaders, turned back to drug company executives. Continuously.

So, it is no surprise that Health Canada, itself, would take on the thought processes, and the moral lack, of the drug companies themselves.

There is no better example in Canada of how the drug lord run Health Canada operates than to point out how Health Canada attacks competitors to drugs – espoused, for instance, in the infamous raids, and seizures, involving Truehope Nutritional Support ltd, of Alberta, Canada, the manufacturer of EmpowerPlus.

Truehope, as you may remember, was, perhaps, the first natural products company to thrash Health Canada in a courtroom for their actions.  More, they improved their corporate bottom line during the process.

How’d that happen?  I wrote a whole article, with court filing details, back on November 3rd, 2009.  It was called “Truehope “Raids” Health Canada…”  The introduction paragraphs summarize the situation:

“Tuesday, November 3rd, 2009 –

Yesterday, a Canadian company Truehope, the makers of EMPowerplus, the first supplement product in North America to be protected against attack by a government agency by the Court System, started their second round of assault against Health Canada. 

Let’s wish them well…

In their first round they slapped Health Canada around a Canadian Courtroom, getting the Court to Order Health Canada to leave them alone.  The Court ruled, simply, that EMPowerplus, a supplement product that reverses Bi-Polar issues, did not require approval from Health Canada, and that it was “a necessity” to the people that used it.  Health Canada employees had stopped entry of the product into Canada (it is manufactured in the US) causing several people to die, and many others to suffer, without it.  No Health Canada employees, however, were ever criminally indicted for those deaths.”

Yup – they are attacking Health Canada one more time – and if they win this assault they will have completely removed Health Canada’s teeth, so to speak.  Health Canada might as well, after this, lock the doors and send the employees home.

Health Canada battled desperately through the court system, and in middle 2010 the local Judge decided that, for various reasons, Truehope did not have “Standing” to sue Health Canada – and Dismissed the case.

On October 29th, 2010, however, Truehope filed an Appeal, which you can read, in its entirety, by clicking Memorandum of Fact and Law October 29 2010 (as filed).

The Appeal will be heard, with Oral Arguments limited to four hours each side, on Tuesday, March 22nd, 2011, in the Federal Court of Appeals, in Calgary.

In short, the Appeal, if granted, would remove the drug lord’s most effective Canadian tactic – the use Health Canada as a tool to remove an industry competitor’s products from store shelves on a whim.  Health Canada would be required to get Court permission, in the form of a Warrant, to take any action – just like in any other type of case.  The Courts, of course, require evidence of harm, etc…, a situation very hard to find when discussing supplements.

In the words of the Appeal:

But, there are some important points to take hard look at here…

In the TRUEHOPE – PROVINCIAL DECISION Truehope’s basic Defense strategy was simple.  They were saying:  (1)  This product is necessary to save, and preserve lives and the mental health of thousands of Canadians – “The Necessity Defense.”  And (2)  There is no possible way, or process, to get a supplement product approved in Canada.  We tried everything.  We were totally blocked at every turn by Health Canada – “the Due Process Defense.”

Both of these Defenses were successful.

Step back, with me, and look at this situation as a whole.  For the first time, and I mean as a solid legal precedent, something called “The Necessity Defense,” was SUCCESSFULLY used in regards to a natural product in a legal system based upon English Common Law – and that is VERY important.  The second Defense used in the original case was “The Due Process Defense.”  Both of these legal defenses have relevance to what’s going on with the USA FDA’s attack on supplements and devices that compete with drugs, drugs, and more drugs.

English Common Law is the basis for the legal systems in Britain, Canada, and the US.  So, cases decided in one of those countries have merit in the others.  In the US we have virtually the same problem.

Here, we are going to take a look at the importance of these two legal concepts separately, and as a whole.

The Necessity Defense…

Usually, West’s Encyclopedia of American Law says, that a “Necessity Defense” is activated:

“Almost all common-law and statutory definitions of the necessity defense include the following elements: (1) the defendant acted to avoid a significant risk of harm; (2) no adequate lawful means could have been used to escape the harm; and (3) the harm avoided was greater than that caused by breaking the law. Some jurisdictions require in addition that the harm must have been imminent and that the action taken must have been reasonably expected to avoid the imminent danger. All these elements mirror the principles on which the defense of necessity was founded: first, that the highest social value is not always achieved by blind adherence to the law; second, that it is unjust to punish those who technically violate the letter of the law when they are acting to promote or achieve a higher social value than would be served by strict adherence to the law; and third, that it is in society’s best interest to promote the greatest good and to encourage people to seek to achieve the greatest good, even if doing so necessitates a technical breach of the law.”
Pay very close attention to the highlighted text just above.  There is a basis here, I think, to challenge the way vitamins, supplements, and devices that compete with drugs are regulated into obscurity.  Merchants, product manufacturers, and developers are simply NOT allowed to tell the truth about their products, for, according to FDA dictum, “that would make a claim,” and such a claim would require the over-a-billion-dollar process reserved for drugs.

But, what if those US rules were challenged on the simple basis that those rules violate the founding legal principles, as laid out below:

“first, that the highest social value is not always achieved by blind adherence to the law; second, that it is unjust to punish those who technically violate the letter of the law when they are acting to promote or achieve a higher social value than would be served by strict adherence to the law; and third, that it is in society’s best interest to promote the greatest good and to encourage people to seek to achieve the greatest good, even if doing so necessitates a technical breach of the law.”

Especially number three.

The Due Process Defense…

Truehope, in their strategy, pointed out, in depth, how far they went to get their product approved for use by Health Canada, and showed that no matter what they did, the answer was always the same “shut down, or move to the US.”  Then Health Canada would show up, once again, with drawn guns.

The Judge, in the original case decision, put it this way:

[51] The Defendants argued that getting a D.I.N. (Drug Identification Number) was not an alternative. The Defendants presented credible and reliable evidence that it would have been impossible to obtain a D.I.N. for a vitamin/mineral supplement because the drug testing regime to which D.I.N.s applied was not suited to the testing of a vitamin/mineral supplement which was a health food product. The Defendants presented expert evidence in this regard through Mr. Dales, on the classification of substances and on applications for approvals under the Food and Drugs Act and Regulations. Also, Mr. Stefan understood from his dealings with representatives of Health Canada that the Defendants would not be able to get a Notice of Compliance (a pre-requisite to obtaining a D.I.N.) and that the Defendants should not bother applying for a D.I.N. In addition, Dr. Kaplan’s experiences in dealing with Health Canada was that the Defendants would not get a D.I.N.

[52] Another alternative was negotiations with Health Canada. The Defendants made numerous efforts to met with Health Canada to work out a resolution to this developing problem. According to Mr. Stefan, the Therapeutic Products Directorate of Health Canada was not prepared to work towards a resolution with the Defendants. The only alternative suggested by representatives of Health Canada was to stop selling the supplement or leave the country and take the business to the United States. Despite numerous and various attempts to negotiate a solution with Health Canada, the Defendants were not successful in negotiating a resolution such as a Ministerial Exemption or an agreement with Health Canada. However, when Mr. LaJeunesse of the Canada Mental Health Association intervened with Health Canada on behalf of specific individuals to continue to obtain access to the supplement, his interventions were successful in every case.

[53] Health Canada’s response to the public outcry was to establish a 1-800 crisis line that received over one thousand telephone calls. The callers were advised to go to a psychiatrist. By this action, Health Canada recognized that there could be serious consequences and harm for individuals no longer able to access the supplement or the Truehope program. Because of the harm associated with conventional psychiatric treatment with medications that had negative side effects and the fact that participants would refuse to undergo such treatments, the Defendants did not consider referring the 3000 participants in the Truehope to psychiatrists to be a reasonable legal alternative.

Health Canada knows it is going to lose…

Click here to see the Memorandums (1) and (2)..

It will take a month or two for the Appeals Court to issue its written decision.

 

Stay tuned.

Tim Bolen – Consumer Advocate