Proposed new legislation designed to overhaul the 50-year-old Food and Drugs Act is causing widespread concern in Canada's natural health industry.
Currently being debated in the House, Bill C-51 aims to protect consumers from unsafe food and health products and improve access to information about product safety.
Changes to the Act include a general prohibition against the manufacture, importation, advertisement or sale of products that endanger health or safety and new powers for the government to recall unsafe products.
Fines for violations will increase dramatically. A first offence for a summary conviction jumps from $500 to $250,000, and an indictable offence from $5,000 to $5 million.
While most agree that changes to the Food and Drugs Act are long overdue, the natural health industry fears that Bill C-51 pushes Natural Health Products (NHPs) further into the same category of laws that govern prescription drugs.
Under the bill, both drugs and NHPs are classed as "therapeutic products." NHPs include herbal remedies, vitamins, minerals, homeopathic medicines, sports nutrition products, and organic foods.
According to Health Canada, "therapeutic product" covers all products which are used for therapeutic purposes, such as medical devices, drugs, cells, tissues, organs, vaccines and veterinary drugs, as well as NHPs.
Donna Herringer, director of sales and marketing with Naturally Nova Scotia, says that grouping NHPs together with drugs under therapeutic products came as a surprise to her.
As a past president of the Canadian Health Food Association (CHFA), Herringer says CHFA and other groups lobbied for years to have NHPs classed as its own distinctive category, separate from drugs.
"The Natural Health Products industry fought very hard for 25 years to distinct NHPs from drugs because they are inherently safe. You don't hear of people dying from vitamins or minerals, yet every day there are deaths that occur from prescription as well as over the counter drugs."
But Health Canada spokesperson Paul Duchesne says the use of the term "therapeutic product" does not indicate a move toward a more drug-like regulation for NHPs.
"This definition allows for greater regulatory flexibility and does not change the current definition of a drug or natural health product, as defined in the current Natural Health Product Regulations. The definition of a natural health product remains within the Natural Health Products Regulations."
Duchesne adds that "there are benefits, such as facilitating international trade," that come from NHPs being considered under legislation as a subset of drugs.
Another worrisome aspect of the bill is that it will broaden current laws that allow for the seizure of NHPs without a warrant or a judge's approval, something Herringer calls "a grave concern."
"That's a very uncomfortable part of it. It's a very strong enforcement act that really empowers the inspectorate, the people who enforce the regulations."
The power to seize and detain a product already exists under the current Food and Drugs Act, something Brad Stephan, operations manager with the Alberta-based Truehope Nutritional Support Ltd., is well aware of.
In July 2003, 17 police and Health Canada officials stormed Truehope's office in Raymond, near Calgary, downloaded information from computers and confiscated stacks of documents.
Truehope was marketing Empowerplus, a combination of 36 vitamins, minerals and anti-oxidants designed to treat bi-polar and other mood disorders. Under the law, making health claims classifies a supplement as a drug. Health Canada seized personal shipments of Empowerplus and ordered Truehope to stop selling the supplement in Canada.
"The part that did the damage was when [Health Canada] stopped the product at the border," says Stephan. "We had suicides. We lost contact with 300 clients."
When Truehope continued to sell the supplement, Health Canada took them to court. However, in 2006 Truehope was found not guilty. The judge ruled that the company was "overwhelmingly compelled to disobey…in order to protect the health, safety and well-being of the users of the supplement."
Although Empowerplus had been undergoing a double-blind study at the University of Calgary, the study didn't meet the requirements of Health Canada and was shut down.
"Health Canada said the double-blind study couldn't go ahead as it was, it had to be done drug-style," says Stephan.
And this, say critics, is another problem with Bill C-51 because if Health Canada reviewers look at NHPs the same ways as drugs, they're going to want to see very high standards such as double-blind studies.
While most pharmaceutical drugs contain only one active ingredient, NHPs usually have multiple ingredients, each of which would need to be studied, costing hundreds of millions of dollars.
"The only people who can afford double-blind studies are the pharmaceutical companies because they can make billions and billions of dollars," says Herringer.
This is one of the reasons why, says Stephan, natural products with a long history of use should be assumed safe unless otherwise proven or demonstrated to cause harm.
Natural health products continue to grow in popularity. An Ipsos-Reid survey found that over 75 per cent of Canadians purchased NHPs in 2005. According to CHFA, the NHP industry is currently worth $2.5 billion in Canada.
Bill C-52 takes a "life cycle" approach, meaning that products which initially seem fine but have problems surface later on can be withdrawn from the market, something that historically was left up to the manufacturer.
This is one of the bill's strong points, says Shawn O'Reilly, executive director of the Canadian Naturopathic Association, because it will provide more "regulatory oversight" over drugs.
However, the definition of "practitioner" under the bill will exclude naturopathic doctors from access to natural substances that may, at Health Canada's discretion, be designated as prescription therapeutic products, says O'Reilly.
"Naturopathic doctors currently do not have prescribing rights and yet they are the experts in natural substances, so we have a concern there. Also some of the definitions seem to be contradictory to definitions that exist in provincial legislation which again would impact a naturopathic doctor's practice."
O'Reilly questions whether those who decide if a natural substance will be considered a therapeutic product or a prescription product "have the training, education and expertise to be making that decision."
Herringer says she feels that while crafting Bill C-51, the government focused only on getting something done quickly about unsafe products coming into the country while possibly limiting freedom of choice for Canadians in the process.
"They're acting fast but they're not acting thorough because on the one hand they will be protecting Canadian citizens but on the other hand they may deny them the freedoms of natural health products."
Meanwhile, a protest against Bill C-51 will take place outside the Calgary Federal Court on May 9. At the same time inside the courthouse, Truehope will be seeking a permanent injunction against Health Canada to prevent it from ever again seizing Empowerplus from Truehope's clients.
Re: New Changes to Old Act Worries Health Industry
Quote:
Concerns raised about proposed bill
Daniel Chiang, of Inspired Life Health Centre on Danforth Ave., worries changes to the Food and Drugs Act will prevent him from freely advising patients. (May 21, 2008)
Changes to the act
Proposed amendments to the Food and Drugs Act:
New offences relating to food, therapeutic products and cosmetics.
Licences for importing food and for interprovincial trade in food.
Changes to therapeutic product licensing.
Expanded powers for inspectors.
New enforcement measures, including mandatory recalls of therapeutic products and cosmetics.
______________________
Substantial increases in penalties. Disclosure of confidential business information in certain circumstances.
C-51 may restrict access to natural health products by lumping them in with pharmaceuticals, they say
May 21, 2008 04:30 AM
Every week, Daniel Chiang, a nutritionist and clinic owner at the Inspired Life Health Centre on Danforth Ave., treats more than a dozen patients, offering them "alternative medicine options" to help heal ailments ranging from the flu to digestive problems.
Sometimes, he suggests home remedies; other times it may be a nutritional supplement. He has always been able to recommend or suggest as he chooses. But now he worries this could change with Bill C-51, legislation – making its way through Parliament – that will modernize the Food and Drugs Act for the first time in over 50 years.
"There is a lot of uncertainty around the bill and how it will impact access to natural health products. No one seems to be quite sure," Chiang said. The confusion has generated controversy. Earlier this month, hundreds of people turned up at rallies across the country to protest the bill.
The Food and Drugs Act regulates the production, transport and sale of food, drugs, contraceptive devices and cosmetics, with a focus on ensuring products are safe, ingredients are disclosed and there are no false or exaggerated health claims on the product label.
Among proposed changes in Bill C-51 are greater penalties for rule-breakers, power for the health minister to recall unsafe drug products, and improved safety of all products.
But critics – who have been carefully monitoring the progress of the bill, which is awaiting second reading – fear changes to the act will restrict access to natural health products, delay their approval and give the health ministry unprecedented powers of enforcement.
Critics fear the ministry would be able to suspend or cancel clinical trials, disclose and demand confidential information, and impose costly fines for minor infractions – with no mention of an appeal process after such decisions. Maximum fines for an indictable offence under the act could increase from $5,000 to as much as $5 million.
"Basically, this is unbelievable granting of police state powers to essentially untrained field staff, inspectors at Health Canada, who are making life-and-death decisions based on misguided policy," said Peter Helgason, vice-president of political affairs for the Natural Health Products Protection Association. "What I don't understand is, what problem are they trying to fix with this?"
Tony Clement, the federal health minister who tabled the legislation this year, said increased government oversight is needed to protect the public.
"Canadians are concerned with the food that they eat and the pills that they take, so we're not going to back down. Everybody is going to be regulated. We're not going to exempt an entire industry from regulation."
Clement said the legislation affects other industries as well.
"For the first time, this country will have a mandatory system of reporting for adverse drug reactions in hospitals. Never has this been done before," he said. "For the first time, we are going to have a tracking system for food, from the farm to the fork. So if there is bad food out there, we can find out which farm it came from."
Critics of the bill believe that natural health products should not face the same stringent approval process as pharmaceutical industry offerings, said Penelope Marrett, the president and CEO of the Canadian Health Food Association.
"We need to have a separate category for natural health products, which we know are low risk with demonstrated benefits," she said.
However, Clement said the natural food industry will continue to be regulated by the Natural Health Products Regulations of 2004, with "higher fines and more inspectors."
Re: New Changes to Old Act Worries Health Industry
This new bill essentially gives the Health Minister of Canada (Tony Clement) the potential power to take out the natural health industry, or at least gain considerable control over it. He has been pushing this bill very hard, which makes you wonder if perhaps he has a hidden agenda.
Well, actually, it's a pretty obvious and blatant agenda: Tony Clement owns 25% stock of the Toronto-based pharmaceutical company Prudential Chem Inc. If this bill passes, Clement stands to make a lot of money when people start turning to their local pharmacy to replace the many health products that will be undoubtedly banned.
When is Canada going to learn that we can't trust the Conservative Party anymore. If we're lucky, a few more of these ridiculous bills will be proposed (but not passed) before the next federal election is called so everybody can get a better idea of how the Conservatives really want to run the country. It's been a rough few years, let's kick them out before they do anymore damage.
Last edited by Powder_Reality; 11-06-2008 at 19:58.
14-05-2008, 20:52
Similar Threads
Linear Mode
