Mr. Speaker, I rise to address the House on the subject of this private member's bill, Bill C-420. The bill requests that the Food and Drugs Act be amended to classify dietary supplements, herbs and other natural health products as foods.
Furthermore, the bill seeks to revoke section 3 of the Food and Drugs Act, which prohibits the advertising to the general public of any food, drug, cosmetic or device for the treatment, prevention or cure of any of the diseases listed in schedule A of the act.
The bill attempts to use a very simple approach in dealing with a very complex issue and does not consider all the ramifications which would result. This bill would not ensure the safety, quality and efficacy of natural health products to the same degree as the current regulations.
The current natural health product regulations came into force on January 1, 2004. These regulations were developed after extensive consultations with Canadians, consultations which demonstrate that Canadians want a regulatory framework that ensures an appropriate level of safety and provides accurate information upon which to make informed choices about products. The natural health products regulations meet these demands.
Furthermore, these regulations support consumer confidence in the natural health sector and provide an appropriate and safe regulatory framework for natural health products.
Furthermore, revoking section 3 in schedule A without completing a comprehensive review and analysis of its impact would not be consistent with this government's commitment to ensuring the health and safety of Canadians in a manner that respects their views and opinions.
If this bill is passed, the regulation of natural health products in this country will be worse than at present. At the moment, there are more than 50,000 natural health products on the Canadian market covered by regulations which make them easily accessible and safe, effective and of optimum quality while at the same time providing for freedom of choice and cultural diversity.
Bill C-420 would result in natural health products, which are now regulated as subsets of drugs, being regulated as foods. However, natural health products are taken for therapeutic reasons and not for purposes of caloric intake or hunger. For this reason, natural health products are more appropriately regulated as a subset of drugs, but with their own set of regulations appropriate for products of this class.
The reclassification of natural health products as foods would not ensure the appropriate regulation of these products. Treating natural health products as foods, as proposed by Bill C-420, would not address the true differences between therapeutic products and food products and would not ensure the safety of Canadians in the same manner as the natural health product regulations.
As members are aware, foods, with very exceptions, are not subject to pre-market review and food labels do not provide treatment, dosage or warning information. The natural health products regulations require products to receive pre-market review and market authorization for sale in Canada. They also require site licences and adherence to good manufacturing practices for the manufacturing, packaging, labelling and importation for sale of natural health products.
Equally important, the natural health product regulations contain provisions regarding clinical trials and adverse reaction reporting. Bill C-420 does not address these safety requirements.
The regulations as they stand guarantee that such products are manufactured in keeping with strict safety and quality standards. They also allow natural health products to make numerous health claims, provided these are substantiated.
Pre-sale assessment and good manufacturing processes are measures aimed at ensuring that pertinent information is included on the labelling as well as stipulating exactly what must be on the label. In short, the regulations ensured that natural health products are both safe and effective.
This bill will, for all intents and purposes, eliminate the natural health products regulations, as well as product licences already issued under those regulations, not to mention the ten thousand or so drug identification numbers attributed to products now to be classified as natural health products.
As written, Bill C-420 does not meet the needs of Canadians and would require the development of a new framework for natural health products as foods. This would come at considerable cost for government and industry alike. Indeed, as members have seen, this bill does not ensure the same degree of safety and access to product information as the current natural health products regulations.
The passage of this bill would also not fulfill the manner in which Canadians and the Standing Committee on Health have requested these products be regulated. The natural health products regulations were developed based upon the 1998 recommendations of the Standing Committee on Health that a new and appropriate regulatory framework be developed for natural health products.
Canadians have asked that natural health products be regulated in an appropriate manner that ensures the safety of these products. In developing this framework, extensive consultations were undertaken in order to ensure the regulations take into account the full range of input provided by consumers, industry, practitioners and stakeholder groups.
Just as the natural health products regulations were developed only after extensive review and consultation with stakeholders, any changes to section 3 in schedule A should only be undertaken after considering the views of Canadians.
Section 3 in schedule A was introduced into the act as a mechanism to prevent fraud in advertising and labelling, to prohibit the advertisement and sale of treatments for conditions where self-treatment was not considered safe, and to encourage Canadians to seek medical attention for serious conditions.
In this area science and medicine are evolving. While there is still no known cure for many of the diseases listed in schedule A, such as arthritis and diabetes, modern therapies allow these chronic conditions to be successfully managed.
For example. a product could reduce the discomfort resulting from a specific health problem or slow down the progression of a disease. It is possible as well that new products might successfully treat diseases against which today's medicines have not been effective, without in any way diminishing the importance of the role played by the diagnosis , treatment and medical management of serious illness.
In its 1998 report “Natural Health Products: A new vision”, the Standing Committee on Health concluded that the present provisions of section 3 and Schedule A might unduly restrict health promotion advertising from which the consumer might benefit, and prevent self-medication where this might be justified.
However, the committee also found that many Canadians felt that section 3 in schedule A of the Food and Drugs Act still served a useful purpose, but needed to be modernized to reflect current concerns. Canadians continue to express these views.
Health Canada has undertaken significant efforts to review this issue in order to find solutions to ensure the health and safety of Canadians. In 2003 Health Canada initiated a review of section 3 in schedule A through an external working group consisting of representatives from academia, industry, media groups, government and consumer groups.
Consistent with the Standing Committee on Health recommendations, the working groups unanimously agreed that section 3 in schedule A needed to be amended to meet the needs of Canadian society. However, there were differences in opinion as to what would be the best manner to make such changes.
From the outset, the working group recognized that the issues before it were many faceted and would encourage much debate. Health Canada continues to move forward on this issue. The department is currently considering all proposals made by the external working group. For the reasons mentioned and many others, the Government of Canada cannot support Bill C-420 as proposed.