Risk Analysis - A Study Of Canadian Health Products 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 by Sepp Hasslberger on Wednesday August 25 2004
updated on Tuesday December 21 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2004/08/25/risk_analysis_a_study_of_canadian_health_products_legislation.htm
