Opinion: Bill C-51

[Guest guest]

reposted from HANS e-News May 15,2008

Opinion: Bill C-51

by Ben Tucker

 

By now, many people in the Natural Health Product (NHP) community are

pulling their hair out over Bill C-51, an act to amend the Food and Drugs Act.

They

worry about problematic definitions in the bill, increased powers of the

Inspectorate, increased fines and lack of respect for constitutionally

guaranteed rights. They worry how this Bill, if passed, will affect their

access to

the products and treatments they rely on for their health.

 

The government predictably brushes aside these concerns, assuring Canadians

that the intention of C-51 is not to target the NHP community, but rather, in

the words of Prime Minister Harper, to crack down on those who " wilfully

expose Canadians to dangers. " When questioned about implications of C-51 for

NHPs, Minister of Health Tony Clement stated, " I would say for a purveyor or

manufacturer of a natural health product, if what is on the label is accurate

and if what is claimed about the natural health product is accurate, there is

nothing to fear from the legislation. " (1)

 

It all sounds so reasonable. It also completely neglects the long, sordid

history of Health Canada actions towards NHPs.

 

Ten years ago, the House of Commons Standing Committee on Health recommended

that the Food and Drugs Act be amended to include NHPs as a separate,

distinct legal category. (2) Instead, Health Canada chose to keep NHPs as drugs

under the law, because " an amendment at the level of the Act would have been

necessary. " (3) Now, we have Bill C-51, which amends the Food and Drugs Act,

and

instead of a legal third category, we have " therapeutic products " - drugs,

devices, and cells. (4)

 

Consider the case of Truehope and their product EMPowerplus, used to treat

bipolar disorder. Health Canada's own investigators concluded that the product

should be classed as a category II health hazard (5) - meaning that the risk

of harm is remote. (6) Nonetheless, Health Canada issued a public advisory

about the product and blocked access at the border. (7) They then set up a

1-800 crisis line to deal with desperate Canadians in fear for their mental

health, advising them to return to their doctors and go back on their

psychiatric

medications. (8) All this without evidence of harm.

 

In contrast, consider the case of Vioxx. Approved by Health Canada in 1999

as a treatment for arthritis, it was removed from the market in 2004 due to an

increase in cardiac events associated with use. As stated by the Canadian

Medical Association Journal, " t has now become clear that both the FDA and

(by inference) Health Canada were aware of the increased risk of

cardiovascular adverse events long before the drug was withdrawn from the

market. " (9)

Or take another example, Prepulsid, a drug to treat heartburn. At the

inquest into the death of 15-year-old Vanessa Young (who died taking

Prepulsid), it

was revealed that Health Canada was aware that as many as 10 Canadians died

while taking the drug, and that as many as 70 had died in the United States.

Despite a strong warning going out in the US, Health Canada did not insist on

one for Canada. (10) It was also learned that Health Canada was haggling

with the wording of a warning letter to physicians with maker Janssen-Ortho

when

Vanessa died. (11)

To anyone who has been paying attention to Health Canada's actions over the

last decade, there is much to fear about Bill C-51.

On January 1, 2004, the Natural Health Product Regulations took effect. They

were being implemented by the Natural Health Products Directorate (NHPD),

who mission is to " ensure that Canadians have ready access to natural health

products that are safe, effective and of high quality while respecting freedom

of choice and philosophical and cultural diversity. " (12) That sounds great,

because Health Canada's own polling revealed that 71 percent of Canadians

have used NHPs, 68 percent believe they can be used to treat illness, and 43

percent believe NHPs are better than conventional medications. (13)

One more statistic is worth noting from this survey; one which did not make

it into the NHPD's handy summary. A full 72 percent of Canadians believe that

they have the right to use any NHP they want to use. (14)

So, how is the NHPD's mission to deliver ready access to NHPs, respecting

freedom of choice and philosophical and cultural diversity going so far? As of

March 2008, the NHPD had received 4,569 compendial applications (those

adhering to a pre-set product monograph) with 4,121 completed by the NHPD. They

had

also received 21,398 non-compendial applications, and completed 9,772. (15)

Of the 13,893 applications completed by the NHPD, 7,440 were refused product

licences, representing a failure rate of about 54 percent. (16) Are these

unsafe products from " those who would willfully expose Canadians to dangers " ?

This is highly unlikely; do you think that Health Canada would hesitate to

point out that over half of NHPs submitted for licensing were unsafe?

What's more is that the vast majority of license applications left to

complete are the more complex, non-compendial applications. Does anyone believe

that the success rate for this group will improve?

It has been over four years since the NHP Regulations came into effect, and

we have less than 6,500 legal products in the Canadian market. This is a far

cry from Health Canada's estimate of 40,000 to 50,000 products in 2003. (17)

To add insult to injury, Health Canada states that " the Regulations should in

fact increase access to these products. " (18) Hokey-dokey.

When the regulatory process is complete, it will be government and agents at

Health Canada that decide which products we have access to. And if Bill C-51

passes, Health Canada Inspectors will be given the power to seize products

without warrant, access your computer and order you to disclose any documents

they want, transport products at your expense, and impose fines of up to $5

million, for each offence under the Act and for every day you do not comply.

Of course, the Minister of Health assures us that the NHP community will be

heard when Bill C-51 passes Second Reading and goes to Committee. Like so

many times before, you will be consulted and we will all come to a reasonable

compromise.

In her essay The Anatomy of Compromise, Ayn Rand stated that " in any

collaboration between two men (or two groups) who hold different basic

principles,

it is the more evil or irrational one who wins…When opposite basic

principles are clearly and openly defined, it works to the advantage of the

rational

side; when they are not clearly defined, but are hidden or evaded, it works to

the advantage of the irrational side. " (19)

Apply those insights to our present situation; ask yourself who is evil or

irrational; ask yourself who is hiding their principles, and who has the

advantage; ask what you will gain when you seek a compromise with Health

Canada.

It is clear that almost three quarters of Canadians believe in the principle

of freedom of choice, and believe we have the right to take any NHP we want

to use. No to Bill C-51!

1_http://www2.parl.gc.ca/HousePublications/Publication..._

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2 _http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-aprop..._

(http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/53_recommend_nhp-cps_doc\

1_e.html)

3 _http://www.hc-sc.gc.ca/dhp-mps/prodnatur/faq/questio..._

(http://www.hc-sc.gc.ca/dhp-mps/prodnatur/faq/question_general_e.html#6)

4 _http://www2.parl.gc.ca/HousePublications/Publication..._

(http://www2.parl.gc.ca/HousePublications/Publication.aspx?DocId=3398126 & Languag\

e=e & Mode=1 & File=

30)

5 _http://www2.parl.gc.ca/HousePublications/Publication..._

(http://www2.parl.gc.ca/HousePublications/Publicatio

n.aspx?DocId=3398126 & Language=e & Mode=1 & File=30)

6 _http://www.stopc51.com/_docs/court_transcripts.pdf_

(http://www.stopc51.com/_docs/court_transcripts.pdf)

7 _http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis..._

(http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2003/2003_41bk_e.html)

8 _