Bill C-420

lunney Aims to Restore Freedom of Choice in NHPs
BY DR. JAMES LUNNEY, MP

Dr. James Lunney, MP was a chiropractor for approximately 24 years (last nine on Vancouver Island) before entering federal politics. He is the federal Member of Parliament for riding of Nanaimo-Alberni, on central Vancouver Island, BC. He is a member of the Canadian Alliance.

Much confusion currently exists about the new natural health product (NHP) regulations scheduled to come into force in early 2004. They were crafted under the old Food and Drugs Act, without the legislative renewal that was promised. Canadians had been led to believe that NHP would be considered by law as a third category; not food, not drugs. The reality is that under the new regulations, all natural health products will now be considered a subclass of drugs. They will be managed as food if no health claim, drugs if there is a health claim.

On March 20, 2003, I introduced Private Members' Bill C-420, which cuts right to the heart of the matter to restore freedom of choice in personal health care. Bill C-420 would place NHPs under the authority of a food directorate, and would release the scientific information to allow Canadians to make informed decisions about their personal health care.

HISTORY OF THE CONTROVERSY
In Canada, natural health products have historically been regulated as either food or drugs. Health Canada determines how these products are classified, and has the power to take products off the market. Unfortunately, Health Canada has treated every natural health product, no matter how benign or beneficial, as a drug as soon as a health claim is made.

In 1997, then-Minister of Health, David Dingwall, proposed new rules for NHPs, in an attempt to bring them all under the authority of a drug directorate. He also proposed increased fees for manufacturers and retailers, and the requirement for products to carry a drug identification number (DIN). Immediately, natural health product consumers, advocates, retailers and manufacturers across the country voiced their opposition, insisting that the new 'drug-style' rules were completely inappropriate for products with a long history of safe use. Such regulation would increase costs to the consumer and drive the smaller manufacturers out of business. Faced with a huge public outcry, newly appointed Minister of Health, Allan Rock, placed a moratorium on the new regulations and commissioned the Standing Committee on Health to report on NHPs. Their report, entitled "Natural Health Products: A New Vision" was delivered in 1998, and contained 53 recommendations, including that NHPs be adequately defined, that they be allowed to make health claims, and that Sections 3(1), 3(2) and Schedule A of the Food and Drugs Act be reviewed to determine if they were still relevant.

The government accepted the committee's 53 recommendations, and responded by setting up the Office of Natural Health Products (ONHP), with a Transition Team of seventeen experts to clarify and expand on the committee's work.

THE CANADIAN REGULATORY REGIME
Unfortunately, the government failed to heed much of the committee's and the Transition Team's advice on the regulation of natural health products. Canadians were led to believe that there would be a separate category in law for NHPs, neither food nor drugs, that would allow some degree of supervision and good manufacturing practices without the onerous, costly regime that applies to patentable drugs. However, Health Canada decided to forego this recommendation and offer only a regulatory definition, placing all natural health products as a subclass of drugs. There is no third category, and the antiquated clauses remain in the Food and Drugs Act which make it illegal to advertise or label that an NHP can influence any of a long list of diseases and disorders (Schedule A) remain.

As part of the government's regulatory policy, Health Canada was required to provide a Regulatory Impact Analysis Statement (RIAS), in order to show that the costs of regulation will not outweigh the benefits. When the new regulations were proposed (published in Canada Gazette, Part I, December 22, 2001), the RIAS was suspiciously lean on numbers. The Natural Health Products Directorate (NHPD) merely stated that it had performed a cost-benefit analysis, and used the results to formulate the regulations. No numbers, no proof. They did make an interesting statement in regards to the industry; it was recognized that "those NHP manufacturers who also manufacture drugs (and, therefore, hold valid establishment licences) would not incur significant costs for any additional NHP specific requirements. Manufacturers of NHPs only would probably incur some substantial costs." The government also failed to take the advice of the ONHP Transition Team to eliminate Sections 3(1), 3(2) and Schedule A of the Food and Drugs Act. The Team was unequivocal when they stated that these sections "are no longer relevant. They do not serve any purpose that cannot be accomplished adequately by other sections of the legislation or regulations. More importantly, the schedule does not reflect contemporary scientific thought. The weight of modern scientific evidence confirms the mitigation and prevention of many diseases and disorders listed in Schedule A through the judicious use of NHPs. It is time that the legislation and regulations reflect the prevailing science." Yet the necessary call from the Health Committee and the Transition Team for legislative renewal to accompany NHP regulations has been ignored.

Instead Health Canada announced (June 9) a new consultation on possible changes for a whole range of health bills shackling the antiquated Food and Drugs Act to the Hazardous Products Act, the Quarantine Act, and the Radiation Emitting Devices Act. Any guess on when real changes to the Food and Drugs Act might occur? Your lifetime or mine? Even more troubling, as long as a government Bill is before the House, no Private Members' Bill can be introduced that deals with any of the subject matter. Meaning if Bill C-420 is defeated, similar legislation could not be reintroduced as long as the government sits on a complicated consultation.

Sections 3(1), 3(2) and Schedule A of the Food and Drugs Act have been used to keep low-risk, low-cost, high-benefit natural health products away from Canadians. As soon as a health claim is made it triggers a 3(1) violation, Health Canada declares this product a drug and requires a multi-million dollar drug approval. This is not only unreasonable, it is unscientific and continues to be used to remove effective natural therapies from the marketplace.

RCMP RAIDS OFFICE OF SUPPLEMENT MANUFACTURER
Let me illustrate. Recently a vitamin and mineral formula was developed in Alberta. Early results show phenomenal success in alleviating Bipolar Disease, a severe mental health condition that costs individuals, their families and society dearly. Providing the right nutritional support has already released many Canadians from their nightmare experiences. The province initiated a scientific response and the Alberta Science and Research Authority approved and funded a $544,000 study.

Preliminary results have already been published in at least four peer-reviewed psychiatric journals. Unbelievably, Health Canada interpreted news of such success as a 3(1) violation, stepped in and shut down the study. In July, accompanied by RCMP, Health Canada raided the company offices and is now obstructing all access to this product. Sadly, Health Canada has all too often shown its adversarial attitude towards low-risk, low-cost natural remedies. The government assured Canadians that NHPs would be given their own category in law with regulations reflecting their higher margin of safety, that regulation of NHPs would respect freedom of choice, and that NHPs would be treated with fairness. What has emerged in the new regulations is a betrayal of trust. The Vancouver based Fraser Institute entitled its review of the proposed regulations "A Cure Worse than the Illness". The 50-page report authored by Cynthia Ramsay is a valuable resource for those wanting a digest of the new regulations.

Bill C-420 AIMS TO RESTORE FREEDOM OF CHOICE
Private Members' Bill C-420 was introduced to put the brakes on a bureaucracy out of control, and to restore Canadians' freedom of choice in personal health care. It would change the law and put NHPs under an appropriate food-style directorate; there would still be good manufacturing practices and supervision. It would also amend the definition of 'drug' to exclude food. Appropriate advice about the confidence level of health claims can be assured and Canadians can have the opportunity to access safe, low-cost options for personal health care.

Bill C-420 would also repeal Sections 3(1), 3(2) and Schedule A of the Food and Drugs Act, as recommended by the ONHP Transition Team that was assembled to steer the new NHP Directorate into being. Their recommendation has been ignored. Unless these antiquated, unscientific clauses are removed, Health Canada will continue to use them to classify any effective NHP as a drug. Canadians are being betrayed. Bill C-420 cuts to the heart of the issue. It's time to take the club out of the hand of hostile Health Canada bureaucrats who know nothing about health and care even less.

I am asking all Canadians who are informed about the benefits of natural health products and who are outraged by yet another government betrayal to contact their Member of Parliament and voice their support for Bill C-420. Together with caucus colleagues we have already submitted petitions with over 120,000 signatures calling for the changes in C-420, but much more effort is needed. The battle is not over 'til it's over! It's about access for Canadians to the best health care, the best science and the best health outcomes. Canada should be leading the world in health care outcomes. Let's remove the unscientific barriers and give Canadians every opportunity to enjoy optimal health. We have a window of opportunity. Phone, fax, write. Engage others. Contact our office. Join the battle!

Resources:

For more information and press releases regarding Bill C-420, visit www.jameslunneymp.ca

To find your Member of Parliament by Postal Code visit here

Standing Committee on Health (1998). Natural Health Products: A New Vision. Joe Volpe, Chair Ottawa: Government of Canada. Available here

Office of Natural Health Products Transition Team (2000). A Fresh Start: Final Report of the ONHP Transition Team. Ottawa: Government of Canada. Available here

Cynthia Ramsay (2002). A Cure Worse than the Illness: Canada's Proposed Regulatory Framework for Natural Health Products in Light of International Evidence. Vancouver, BC: Fraser Institute. Available here

Natural Health Products Directorate (2001). Natural Health Product Regulations. Canada Gazette, Part I (December 22, 2001). 4912-4971. Available here

Natural Health Products Directorate (2003). Natural Health Product Regulations. Canada Gazette, Part II (June 18, 2003). 1532-1607. Available here