The decision by the Canadian government to set up a Natural Health Products Directorate to further regulate the country's natural health product (NHP) market has been called "a waste of time and money" in a new study released by The Fraser Institute, an independent public policy organisation.
In 1997, the institute calculated that 73 per cent of Canadians had used at least one complementary medicine at some point in their lives and that 50 per cent had used one in that year. In total, it was estimated that Canadians spent C$3.8 billion (€2.7bn) that year on complementary medicine.
"The risks posed to Canadians by natural health products are minimal," said the study's author, health economist Cynthia Ramsay. "Simply because more people are using complementary medicines such as echinacea and other herbal remedies does not warrant the creation of a whole new regulatory body to oversee their use."
Citing data from other countries, the study claims that there is substantial evidence to show that tighter regulations are not needed. In the UK, for example, adverse reactions to herbal preparations amounted to only 0.38 per cent of all adverse reactions reported last year, while in Australia, natural health products accounted for 1.16 per cent of the total adverse reactions to drugs in 2000.
More onerous regulations are costly and they can also mean that approval times for products take longer. "Just as there are potential concerns with rushing the approval process, there are also costs to delaying it, such as lives that could have been saved, or improved, if the product had been publicly available. There has been no attempt by the NHPD to weigh these costs in its decision to regulate NHPs," said Ramsay.
In most countries including Canada, a natural health product is considered a drug when the manufacturer claims that it improves health. An NHP is considered a food when no such health claims are made. Most countries state that they wish to ensure public access to these products and, therefore, they require lower standards of efficacy for NHPs than drugs though they demand the same levels of evidence with respect to quality and particularly safety for both types of substance. All countries require manufacturers of drugs and NHPs to meet good manufacturing practices, the Institute said.
In light of the international evidence, the study makes several key recommendations.
Firstly, it suggests that the Canadian government should concentrate on enforcing the current regulations on NHPs, the vast majority of which it says can be monitored through self regulation.
Secondly, more information should be made available to consumers so that they understand that most NHPs pose a minimal safety risk. Manufacturers of these products should be permitted to make health claims about their products, the study claims, adding that the restrictions on advertising for both NHPs and drugs should be lifted so that more information is readily available.
It also suggests that the market should be allowed to provide information on the interaction between drugs and herbs, since it is unreasonable to expect all foods or drugs to be labelled with every possible contraindication. "Already, there are many recognisable and reliable sources on the contraindications of NHPs. It is hard to see how increased labelling requirements will improve the situation," said Ramsay.
Finally, the study recommends that the Canadian government should carry out a more meaningful measurement of the costs and benefits of regulating NHPs. "The analysis of the costs and benefits of the proposed regulatory reforms provided by Health Canada in its regulatory impact analysis statements (RIAS) is of limited value. There must be concrete data to support the claim that the situation will be improved by the regulations and that their costs are worthwhile," Ramsay concluded.