Presentation to Health Canada's Natural Health Products Directorate
by the Health Action Network Society on September 27, 2011
Because of members' concerns over losing natural health product (NHP) choices, Health Action Network Society (HANS) requested a meeting with the Director General of the Natural Health Products Directorate (NHPD). On September 27th, the Director General Scott Sawler and two Health Canada officials paid a visit to our office in Burnaby.
HANS Executive Director Lorna Hancock and Dr. Alan Martin presented the views that HANS members have made clear over the years, and gave the group a written report that we are sharing below. Mr. Sawler was appreciative of our position but made it clear that his Directorate can only work within the Food and Drugs Act and does not have the power to create a third regulatory category just for NHPs. Nonetheless, he appeared to understand our concerns and he also indicated a commitment to making the approval process smoother. It is our understanding that the Food and Drugs Act is currently under review and this would make it much easier to bring about the changes we seek. We will keep you informed.
As is well known, the use and sales of natural remedies have increased dramatically in the last two decades. And with this rise have been various attempts at government regulation. The issue first came into prominence in the mid-1990s when the federal government said it planned to control the sales of supplements and other natural remedies in the interest of public safety. The popular outcry was extraordinary. Thousands of people indicated their displeasure at this prospect.
HANS, in response to appeals from members, held several forums for public discussion of the issue. At first we underestimated the public's outrage, but after filling the ballroom of the Hyatt Regency Hotel in Vancouver with about 1,700 people, it became clear that regulation of NHPs had hit a raw nerve in the Canadian public. In essence, Canadians demanded control over what they saw as effective, safe, natural remedies, and the end of government interference in what they saw as their natural rights.
"Show us the bodies!"
Given the government's emphasis on safety, one of the public's rallying cries was: "Show us the bodies!" People argued that there were many other areas (tobacco, alcohol, pharmaceutical drugs, motor vehicle safety) where the government could get a much better health return on its investment than in regulating NHPs, where safety had never been an issue. There were no bodies. Indeed there has never been a registered death attributed to any NHP.
This led to public questioning of the government's motives, and soon fingers were pointed at the pharmaceutical industry. Many believed that, with the rapid increase in value of the NHP market, the pharmaceutical companies wanted better access to this multi-billion-dollar market. Imposing regulations that required expensive and time-consuming approval of NHPs was viewed by some as a strategy to move control into the hands of those with substantial enough resources to do this, eliminating the smaller players.
Recommendations overlooked
Health Canada responded to this public outcry by suspending regulations that were to have come into effect in January 1998, and by establishing the Advisory Panel on NHPs. This led to a full public review of NHP regulation by Health Canada's Standing Committee on Health, which was published in November 1998. Four months later the government responded by accepting all 53 of the Standing Committee's recommendations. At the same time the Health Minister created the Office of NHPs to pursue this agenda. Some four years later, in a private member's bill, James Lunney pointed out that over a million people had communicated displeasure to the government about proposed NHP regulation, and he introduced Bill C-420, which was essentially an effort to ensure and speed up the implementation of the Standing Committee's recommendations. This bill was not passed.
Post-regulation backlash
In January 2004, new NHP regulations came into effect and would require all NHPs to be licensed for sale in Canada. In addition, a site license was required by manufacturers, packagers, labelers and importers of NHPs. However, in stark contrast to public demands, Health Canada's earlier pronouncements and the Standing Committee's report, NHPs were included as a subset of drugs, instead of being put into a third category subject to its own criteria as many had suggested.
This is of particular interest because in 2004, while in opposition, Stephen Harper issued the following public statement under the heading "Moving Forward on Health Care Reform: Natural Health Products":
Canadians voluntarily spend $1.6 billion on natural health products to promote personal health. Yet Health Canada continues to remove effective natural health products from the marketplace and shut down research into them because they are regulated under a drug-style rather than food-style regulatory regime.
Natural health products would benefit from moving towards a more food-style regulatory regime as outlined in Dr. James Lunney's Private Members Bill C-420. This would make regulating natural health products more in line with the safety record and non-patentable nature of these products. Regulation will be required to ensure Good Manufacturing Practices, inspections, product testing and quality assessment of health claims that will afford Canadians both the assurances and the access they have been seeking.
Stephen Harper will pass Dr. James Lunney's Bill C-420 in order to regulate natural health products as "food-style" rather than "drug-style" products.
Stephen Harper will increase federal research into natural health products.
It is worth noting that Mr. Harper, in this public statement, agreed with many Canadians that NHPs were regulated under a drug-style rather than food-style regulatory regime. Clearly, the thrust of Mr. Harper's promise was to make sure that NHPs were to be treated more like foods than drugs, in large part because of their excellent safety record. He also promised to pass the Lunney bill. What has happened since?
Safety record overlooked
The simple reality is that the government has failed to make sure that NHPs are treated more like foods than drugs. In short, the government has failed to respond to the primary concerns of the Canadian public in not acknowledging the extraordinary safety record of NHPs. Instead, NHPs are now subject to unnecessarily rigorous requirements.
This has had the effect of driving NHPs off the market in part because safety may not be documented (despite a long history of traditional use) and also because of the high cost of demonstrating efficacy. Our members report that many remedies they seek are no longer available, and that U.S. producers of NHPs have been frustrated by Canadian regulations to the point that many have stopped shipping to Canada altogether. A further concern is the chilling effect of these regulations on new product development. Adding to the confusion, there seems to be a contradiction between official estimates of products lost and the public's perception of this. This is not helped by the inclusion of many seemingly regular commercial products, such as Colgate and Crest toothpastes, Red Bull and Rolaids, requiring a natural product number (NPN) and therefore being included in statistics showing the number of NHPs on the market.
Slowness in processing applications for NPNs, postponing of deadlines (currently it is until further notice) and continuing public and industry dissatisfaction confirm that the regulations are not working. Seven years ago, Prime Minister Harper pledged support for what our members are asking, namely a return to a more food-style regulatory regime. Not only has this not happened, the regulations have moved more towards the drug end of the spectrum.
Re-evaluation required
It is not too late to rethink the whole process and return to the public's number-one demand and the Standing Committee's position (and the Lunney bill) to change the status of NHPs from a subset of the drug category and establish a true third category with its own regulations. This would be much simpler than the present situation as it would recognize the inherent safety of NHPs and thus greatly simplify the requirement to demonstrate safety.
The requirement of efficacy could also be greatly simplified by having two tiers in this third category. NHPs bearing no claims would be exempt from any proof of efficacy, while those making claims would have to demonstrate their validity. While manufacturers may want to make health claims on labels, we believe that consumers would be more than willing to give up health claims in return for the freedom to choose these products. For this to happen, the current regulations should be suspended indefinitely and the whole process subjected to an independent review.