Food, Drug Act 'Needs Overhaul':
'External Forces' Gut Safety System, document reveals
by Mark Kennedy
The Ottawa Citizen
February 4, 2001
FRONT PAGE
The federal law that governs Canada's drug and food regulatory system is outdated and has a "narrow focus" on safety that ignores other factors such as the "need" to bolster the economy and promote competitiveness, says a Health Canada document.
Critics say the document, obtained by a public-health interest group through the Access to Information Act, lends credence to their long-standing allegations that the Chrétien government has bowed to private industry pressure and is quietly gutting the country's drug and food safety system.
The two-page document was prepared for Health Minister Allan Rock as part of his plan to overhaul and replace the Food and Drugs Act. The undated, unsigned document by Health Department officials outlines how the act dates back to 1953 and regulates a wide variety of proposed products that private firms want approved for sale -- including food products, drugs, medical devices and cosmetics.
Because of the importance and sensitivity for Canadians of the issues the Act addresses, Health Canada is particularly subject to be involved in litigation and media coverage."
"Think, for example, of tainted blood, herbal products, raw milk cheese, mad cow disease, etc.," says the document.
However, it notes that because of "external forces," the "Food and Drugs Act as we currently know it is disappearing on us."
For example, as a result of the creation of the Canadian Food Inspection Agency (CFIA) in 1997, Health Canada is no longer responsible for enforcing food safety regulations, although it still sets standards.
Ultimately, the document predicts, all that will be left for the act to regulate is drugs and medical devices. "The act is outdated and needs to be reviewed," it says, adding it is
not "well adapted'' to deal with complex issues that arise from technological advances, such as genetically modified products and the transplantation of animal organs to humans.
Under the capitalized heading: "NARROW FOCUS ON SAFETY,'' the document states: "The act does not allow for the taking into account of considerations other than safety and efficacy in managing health risk (ethical issues; social, economic and cultural considerations; need to improve the economy and to promote competitiveness; etc.).''
Mike McBane, of the Canadian Health Coalition, which obtained the document, says it is clear evidence "in black and white'' of how the government has given up on making safety the only thing that counts when it comes to regulation. He says Health Canada is actively courting the international drug, biotechnology and agri-food industries to locate their facilities in this country by saying that they will get much quicker regulatory approval for their products than in past years.
"We have a paper tiger, a system of paper inspection all based on self-regulation and voluntary compliance by the industry," says Mr. McBane.
"Health Canada and the food inspection agency are, in fact, just a trade association for the industry. What they now engage in is the dissemination of industry propaganda on the benefits of technology like genetically modified foods.''
The allegations come at a time of increasing scrutiny over how well the government is prepared to protect Canadians from companies seeking to rush their products to market while demand is hot and from the unknown but frightening threat of food-borne illnesses, such as E-coli, and the potential emergence of mad cow disease in North America.
In recent days, the government has been accused of not taking enough precautionary action against mad cow disease, which, in its human form -- variant Creutzfeldt-Jakob Disease (vCJD) -- has struck 91 people in the U.K. and Europe.
On Friday, the government responded by banning beef imports from Brazil (it already imposed a ban on British beef in 1990) because of information it received about the apparent risks of the product.
That won't dispel criticism. Tomorrow, the emotional debate over how the government should regulate proposed genetically modified food seeds in future will be re-ignited when the Royal Society of Canada releases a report on the subject.
On Tuesday, Auditor General Denis Desautels will release a report that is expected to unveil some embarrassing regulatory shortcomings at both Health Canada and the food inspection agency.
Catherine Lappe, a senior aide to Mr. Rock, confirms the Health Department is preparing new legislation to replace the Food and Drugs Act. But she says no final decisions have been made on how the bill will be drafted, or even when it will be introduced in Parliament.
Furthermore, Health Canada and the food inspection agency firmly deny they are moving towards a pro-business stance, thereby jeopardizing the safety of Canadians. Mr. Rock's officials say the government is merely moving towards a "risk management'' system in which regulators consider a wide range of factors -- with health safety being paramount -- before they make a decision on whether, for example, to approve a drug, or impose safety precautions to combat potential threats such as mad cow disease.
Food, Drug Act 'Needs Overhaul':
'External Forces' Gut Safety System, document reveals
by Mark Kennedy
The Ottawa Citizen
February 4, 2001
FRONT PAGE
The federal law that governs Canada's drug and food regulatory system is outdated and has a "narrow focus" on safety that ignores other factors such as the "need" to bolster the economy and promote competitiveness, says a Health Canada document.
Critics say the document, obtained by a public-health interest group through the Access to Information Act, lends credence to their long-standing allegations that the Chrétien government has bowed to private industry pressure and is quietly gutting the country's drug and food safety system.
The two-page document was prepared for Health Minister Allan Rock as part of his plan to overhaul and replace the Food and Drugs Act. The undated, unsigned document by Health Department officials outlines how the act dates back to 1953 and regulates a wide variety of proposed products that private firms want approved for sale -- including food products, drugs, medical devices and cosmetics.
Because of the importance and sensitivity for Canadians of the issues the Act addresses, Health Canada is particularly subject to be involved in litigation and media coverage."
"Think, for example, of tainted blood, herbal products, raw milk cheese, mad cow disease, etc.," says the document.
However, it notes that because of "external forces," the "Food and Drugs Act as we currently know it is disappearing on us."
For example, as a result of the creation of the Canadian Food Inspection Agency (CFIA) in 1997, Health Canada is no longer responsible for enforcing food safety regulations, although it still sets standards.
Ultimately, the document predicts, all that will be left for the act to regulate is drugs and medical devices. "The act is outdated and needs to be reviewed," it says, adding it is not "well adapted'' to deal with complex issues that arise from technological advances, such as genetically modified products and the transplantation of animal organs to humans.
Under the capitalized heading: "NARROW FOCUS ON SAFETY,'' the document states: "The act does not allow for the taking into account of considerations other than safety and efficacy in managing health risk (ethical issues; social, economic and cultural considerations; need to improve the economy and to promote competitiveness; etc.).''
Mike McBane, of the Canadian Health Coalition, which obtained the document, says it is clear evidence "in black and white'' of how the government has given up on making safety the only thing that counts when it comes to regulation. He says Health Canada is actively courting the international drug, biotechnology and agri-food industries to locate their facilities in this country by saying that they will get much quicker regulatory approval for their products than in past years.
"We have a paper tiger, a system of paper inspection all based on self-regulation and voluntary compliance by the industry," says Mr. McBane.
"Health Canada and the food inspection agency are, in fact, just a trade association for the industry. What they now engage in is the dissemination of industry propaganda on the benefits of technology like genetically modified foods.''
The allegations come at a time of increasing scrutiny over how well the government is prepared to protect Canadians from companies seeking to rush their products to market while demand is hot and from the unknown but frightening threat of food-borne illnesses, such as E-coli, and the potential emergence of mad cow disease in North America.
In recent days, the government has been accused of not taking enough precautionary action against mad cow disease, which, in its human form -- variant Creutzfeldt-Jakob Disease (vCJD) -- has struck 91 people in the U.K. and Europe.
On Friday, the government responded by banning beef imports from Brazil (it already imposed a ban on British beef in 1990) because of information it received about the apparent risks of the product.
That won't dispel criticism. Tomorrow, the emotional debate over how the government should regulate proposed genetically modified food seeds in future will be re-ignited when the Royal Society of Canada releases a report on the subject.
On Tuesday, Auditor General Denis Desautels will release a report that is expected to unveil some embarrassing regulatory shortcomings at both Health Canada and the food inspection agency.
Catherine Lappe, a senior aide to Mr. Rock, confirms the Health Department is preparing new legislation to replace the Food and Drugs Act. But she says no final decisions have been made on how the bill will be drafted, or even when it will be introduced in Parliament.
Furthermore, Health Canada and the food inspection agency firmly deny they are moving towards a pro-business stance, thereby jeopardizing the safety of Canadians. Mr. Rock's officials say the government is merely moving towards a "risk management'' system in which regulators consider a wide range of factors -- with health safety being paramount -- before they make a decision on whether, for example, to approve a drug, or impose safety precautions to combat potential threats such as mad cow disease.