Health Supreme Update: Risk Analysis - A Study Of Canadian Health Products Legislation

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> Health Supreme Update: Risk Analysis - A

> Study Of Canadian Health Products Legislation

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> Health Supreme Update: Risk Analysis - A Study Of

> Canadian Health Products Legislation

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> August 25, 2004

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August 25, 2004

 

Risk Analysis - A Study Of Canadian Health

Products Legislation

Health

 

Legislation

 

 

In the late nineties, Canada was announcing that

natural health products would be regulated in an

innovative way. The intention was to establish a

" third category " for health products, separate both

from foods and from medicines, to appropriately

regulate natural health products. As it turned out

however, the new regulations led to a more drug

related environment for health products with onerous

prior approval procedures for products. MP James

Lunney protested with the health minister - to no

avail. The Alliance of Natural Health Suppliers and

Freedom of Choice in Health Care have filed legal

action against the Canadian government charging that

the definition of a drug in Canada is too broad and

that natural health products should not be included

under the drug umbrella.

 

While lip service is paid to " protecting

consumers " , just like in Europe, where a recently

enacted food supplements directive is threatening to

remove large numbers of higher dose and advanced

formulation supplements from shelves, the actual

outcome in Canada seems to be a crackdown on natural

health products, rather than intelligent legislation

to reduce excess risk.

 

Ron Law, who has done work in New Zealand and has

analyzed US statistical data on comparative risks has

recently completed a research into the Canadian

figures which is available here.

 

The upshot of the research, which I recommend for

study to any regulator called upon to decide on

natural health product legislation, is no surprise to

regular readers of this site. Like in New Zealand and

the US, health products currently on the market in

Canada present such a low level of risk that they do

not even register on the radar of appreciable dangers

to people's wellbeing.

 

" Consuming natural healthcare products " says Ron

Law, " appears to satisfy both the de minimis level of

risk at a societal level (0.25 deaths per year on

average; 1/120 th the de minimis level) and an

individual risk of 0.015 per million, or 1/67 th of

the de minimis risk level, and yet they have been

reclassified via contentious regulation as a subset of

drugs which appear to be some 250,000 times riskier.

There appears to be no evidential basis for such

regulation and regulating them in the same mindset as

high risk substances may well produce risks of its

own, especially regarding freedom of choice, and loss

of benefits due to reduced product availability. "

 

Yet Health Canada went ahead with a tightening of

regulations for natural health products which, similar

to the EU food supplements directive, threatens to

severely restrict the availability of natural and

nutritional health products to consumers. Apparently,

Canadian health authorities forgot to define what

would be an acceptable risk, the threshold below which

no restrictive action is necessary.

 

According to Ron Law, " ... acceptable levels of

risk must be defined before legislation or regulation

is implemented, otherwise how can there be any

certainty as to whether the regulatory environment

provides too much protection, thereby stifling

commerce. This applies especially to Small and medium

enterprises (SME). "

 

Often, intervention to restrict health product

availability is based on what some legislators

mistakenly believe to be application of the

precautionary principle . But even this principle,

which was developed for regulating environmental risks

and serious toxicity issues, is not a free pass for

removing products from the market.

 

" In light of the precautionary principle, if there

is potential based on toxicity data or field data for

serious or irreversible damage, and the evidence that

the substance meets the criteria is not conclusive

then the substance should be proposed for risk

profiling or full risk assessment. The precautionary

principle is not a tool for regulators to use to

remove ingredients from the market ‘just in case’ or

when there is no evidence of harm. It is always a

holding measure until more homework is undertaken.

Perhaps a recent case where precaution was taken

despite there being no evidence of harm relates to a

recent public advisory on Comfrey use. "

 

Health Canada's public warning against use of the

herb comfrey which included the statement, “Health

Canada is advising Canadian consumers not to use the

herb comfrey or any health products that contain

comfrey because they might contain a compound called

echimidine, which may cause liver damage. As a

precaution, consumers are advised not to topically

apply comfrey-containing products to broken skin. This

advisory applies to both approved and unapproved

products...”

 

Comments Ron Law: " The use of the words ‘might

contain’ and ‘may cause’ provide no confidence of

certainty. Use of the precautionary principle to

extend the warning to topical use is not evidence

based… there is no evidence to even suggest that

topical use of comfrey causes liver damage. "

 

Comfrey has been used for centuries as a medicinal

herb and this Canadian example shows where the current

legislative trend is leading: Indiscriminate removal

of healthy options from the range of " allowed consumer

choices " - often without justification and indeed

while other, much more serious risks go unattended.

Pharmaceutical medicine, for instance, has been found

to be a major cause of death in the so-called

civilized world where this kind of medicine is

dominant.

 

Health Canada even went so far as to

systematically remove the statistical data on medical

injury from published references, defining trauma or

injury cases as excluding " cases hospitalized because

of poisonings by drugs or gases, adverse effects of

drugs or medicine, and late effects... ”

 

It is difficult to make rational decisions with

cooked statistics. Yet, it happens. As a consequence

of statistical fudging by Health Canada, a Canadian

government report on the “Economic Burden of Illness

in Canada” does not list medical injuries among the

major factors, although it certainly should.

 

For more details and for a cogent discussion of

risk analysis and its application to health product

legislation, see the original report of Ron Law.

 

Posted at August 25, 2004 12:07 AM | TrackBack

 

 

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