Canada’s regulatory framework for natural health products (NHPs) has undergone a prolonged, painful, implementation. And it doesn’t seem to be getting any better. The Natural Health Products Regulations were designed to provide Canadians with minimal assurances of product quality, safety, and efficacy, while recognizing that little high quality, objective evidence usually exists to substantiate efficacy claims. The results has been mixed. The regulations offer reasonable assurance of manufacturing quality and product safety, but it’s also led to the licensure of homeopathic remedies, some with specific “Recommended Uses” for what are indistinguishable sugar pills. At a minimum, however, the regulations should assure Canadian consumers that what is on the label is actually in the bottle. That’s a win. Plus, one of most important elements of the NHP regulations is the implementation of pre-marketing registration requirements. That is, only products reviewed and deemed to meet minimal standards of product quality, safety, and the (relaxed) standard for efficacy claims would be permitted to be sold as of 2010. Manufacturers were given six years to meet these requirements. Unfortunately, there’s a big backlog in the queue at Health Canada. About 12,000 products haven’t been reviewed yet. As I noted back in 2009:
Health Canada recent disclosed that they will not be enforcing the April 1, 2010 deadline, due to a backlog of applications. They indicate that about 60% of applications received have been processed: about 10,000 items have been approved for sale. (Approved products will have a NPN number or a DIN-HM number on the package). For products not already approved, as long as a manufacturer makes an application, they are permitted to continue to sell that product. Enforcement action against products that do not meet Health Canada’s regulatory standards may not occur until 2011. Based on Health Canada’s own estimates, about 7000 NHPs remain under review.
I’ve detailed at length the problems with Health Canada’s Natural Health Products Directorate, the unit that administers and enforces the Natural Health Products Regulations. In short, despite the regulations coming into effect in 2004, thousands of products remained unapproved in Canada, but are still openly sold.
At the end of 2009, pharmacy regulators took a bold move in favour of patient safety: they instructed pharmacies to stop selling unapproved natural health products. Here’s an excerpt of the statement from the National Association of Pharmacy Regulatory Authorities:
Pharmacists are obliged to hold the health and safety of the public or patient as their first and foremost consideration. As such, they must follow very specific standards of practice to fulfill this role. When presented with a product that does not bear a number issued by Health Canada, it leaves the pharmacist and their patient with no confirmation that the product was properly assessed for its safety, efficacy and quality nor granted approval for sale.
Even though an argument can be made that an NHP or homeopathic product without a product license is not necessarily unsafe, the reverse is also true. There is no guarantee that the required criteria for product safety were met. Pharmacists should not be placed in situations where they may be in a position to sell products that have not received approval for sale in Canada.
Pretty clear, right? Unapproved products were on pharmacy shelves. Health Canada’s approval is an important marker of product safety and quality. Therefore pharmacies should only sell (the now over 25,000) approved products. As additional products are approved, they can be sold in pharmacies. How did Health Canada react? Not like you might expect from a health regulator (emphasis added):
The National Association of Pharmacy Regulatory Authorities has recently raised concerns of this practice and through its January 2010 Position Statement, advises its members not to sell any unlicensed products. This creates a potential for disruption in the market place as well as legal and credibility issues for the department.
I can understand the legal and credibility issues: after all, if Health Canada had processed all the applications, there wouldn’t be this issue. And pharmacies are restricting the sale of unapproved products, when Health Canada didn’t act. But why the concern about the market place? And why no comment about the implications of ongoing sales of unapproved products? After all, Health Canada continues to be criticized for allowing these products to be sold. Tom Blackwell, writing in last week’s National Post made this point:
Federal law says even natural products — considered generally safer — must be approved under the natural health regulatory system before they can publish or air any kind of ad, and even then must stick closely to the claims allowed in the licence. Many companies that are waiting for word on their applications have chosen to ignore that rule, however, while others have not even attempted to get approval, observers say.
So what does Health Canada do? Well, they have decided to create a special exemption for unapproved products pending review, with the hope that pharmacies will start selling them again.
They’re going to do what?
In May, Health Canada announced that, with 12,000 products pending review, new regulations are needed to allow these unapproved products to continue to be sold, until they can be fully reviewed. To do this, they propose to give a time-limited exemption to most products that are currently sitting in the queue:
The intent of this regulatory proposal is to provide the proper legal framework for the natural health products market to remain in status quo until the Department could complete its work on all the unprocessed applications.
As part of the analysis, Health Canada did a cost-benefit analysis. They state that the “retail value” of the unapproved products is $221 million to $935 million, and that 25.9% of these sales will be in pharmacies. Consequently they assign a loss in sales to pharmacies of between $0 and $245 million because pharmacies have been instructed to stop selling these products. In Health Canada’s “worst case” scenario, all of the unapproved products (34% of total) would be pulled from sale, “with an estimated amount of up to $943 million being taken out of the economy.”
Health Canada then goes on to estimate losses in employment related to the removal of these products from the market. They estimate that 500 full-time and 350 part-time positions will be affected if pharmacies pull these products from pharmacy shelves. (Note, that this should have already occurred, based on the directive to pharmacies). They go on to state that the losses in the industry could be much higher if other retail markets stop selling unapproved products.
The analysis goes on to describe the benefits of the exemption. Pharmacies can continue to sell unapproved products. Consumers are can continue to purchase unapproved products. The latter is actually cited as a positive impact:
Consumers should benefit from the status quo of continuing to have access to eligible natural health products that are on the market for which product licence application has been filed but not yet fully processed by the Department
Health Canada provides the following assurance, though:
Consumers would be assured explicitly that key on-market safeguards would be in place for those products affected by the regulatory proposal, and that these products would be labelled and could be verified independently.
But these statements are contradictory. Either the regulations as they’re currently written protect the health and safety of Canadians — if they do, then rubber stamping the rest increases risk to Canadian consumers — or, the regulations as they’re currently applied provide no incremental protection over the rubber-stamp approval. Which raises the question, what value is actually being added through the approval process? Health Canada makes the following statement about this proposal (emphasis added):
An exemption number means that a product has undergone an initial assessment to ensure that information supporting the safety, quality and efficacy of the product has been provided, and the product has been exempted from the prohibition against sale without a product licence. It does not mean that it has been fully assessed for safety, efficacy and quality.
Health Canada’s cost-benefit analysis seems incomplete. There is no evidence presented that any of these unapproved products actually need to be sold, or that there are no currently-approved substitutes. The employment benefits to manufacturers who currently have approved products, and may benefit from possible higher sales, is not considered. There is no information presented to demonstrate that there is compelling therapeutic need to lower the quality, safety, and efficacy bar. Remarkably, there is no downside described at all in the analysis related to the fact that these products will not be “fully assessed.”
The Natural Health Products Directorate has been described as industry-friendly, and this regulatory proposal seems to reinforces that reputation. It’s been six years since the NHP Regulations came into effect, and it’s going to take about 2 1/2 more years to fully review unapproved products for safety, efficacy, and quality. Until then, Health Canada intends to maintain the status quo.
As a pharmacist who advises patients about natural health products, I’m not satisfied that Health Canada’s exemption provides me with adequate assurance to feel comfortable recommending unapproved products. I’ll put the patient first, and suggest consumers buy only fully-approved products. And I hope that pharmacy regulators feel the same way, and recommend against allowing these “unprocessed product exceptions” to be sold in pharmacies. The reality is that there are already 25,000 natural health products approved for sale in Canada – more than enough to fill every single shelf of the largest “big box” pharmacy retailer. There will be no empty pharmacy shelves as a consequence of selling only fully-approved products.
Health Canada seems to be putting business interests of the natural health products industry ahead of the health and safety of Canadians. Their assurance that the Natural Health Products Directorate “assures that all Canadians have ready access to natural health products that are safe, effective and of high quality” increasingly appears to ring hollow.