Regulating Natural Health

The Canadian natural health industry is diligently working with Health Canada to meet product-licensing requirements before a government-set deadline of January 1, 2010. For many industry manufacturers and suppliers, it’s become a frustrating process.

This month, Brian Wagner of NHP Consulting sheds light on the subject through his own experiences in dealing with Health Canada’s licensing regulations. Next month, Michelle Boudreau, Director General of Health Canada’s Natural Health Products Directorate, will give us her perspective.

Health Canada began regulating natural health products (NHPs) four years ago. The original purpose of the regulations was to preserve access to safe NHPs while promoting informed choice among consumers. Unfortunately, there are still more questions than answers as Health Canada struggles to implement its new regulatory system.

After four years of struggling, manufacturers and suppliers of NHPs are growing concerned with the bureaucratic process, and consumers are becoming anxious about the future availability of their favourite wellness products. Right now, Canadians need the facts.

Industry Discontented

The Natural Health Products Directorate (NHPD) is the arm of Health Canada that performs the day-to-day licensing of natural supplements and manufacturing facilities. The NHPD is in place to specifically manage NHPs and does not review pharmaceutical drugs. The role of the NHPD is to interpret and administer NHP regulations; it does not have the authority to change or amend legislation such as Bill C-51.

Four years into the process, where are we today? Most Canadians are largely unaware of the NHPD. Canadians are, however, noticing that certain advocacy groups are starting to rally for “health freedom” and other natural health issues. Indeed, there seems to be a new stirring on the issue of NHP regulation, and there is much happening in the background that Canadians need to know.

Canada’s natural health industry is generally dissatisfied with how the NHPD is conducting its day-to-day licensing. The original spirit of the entire system was to ensure access to safe products–with minimal involvement from government unless safety was an issue. The reality is that most companies are struggling to meet the stringent licensing requirements for products that Health Canada acknowledges do not pose any safety concerns. The issue, in fact, is all about efficacy–the health claims or benefits of a product.

Licensing Expectations

The licensing system is complex. Basically, when a company wants to sell an NHP in Canada (even if it is imported), the company is required to obtain a licence for that product. In theory, the licence needs to be obtained before the product is put on the shelves. In practice, companies are given a grace period until January 1, 2010 to obtain licences, and simply having an application in queue is sufficient until then.

Obtaining a licence is far from simple. A company must provide evidence that its product does what is claimed. The NHPD assumes that all NHPs are inherently dangerous unless evidence (from human experience) is provided showing otherwise. In other words, when the NHPD receives an application for a product licence, its primary assumption is that the product doesn’t work and could be harmful. It is up to the applicant to prove otherwise.

Demonstrating Efficacy

How difficult is it to demonstrate safety and efficacy? That depends. Products that have been used for centuries or that have been researched in clinical trials are fine. Examples include melatonin, ginseng, echinacea, chondroitin, and fish oil. But if there isn’t sufficient evidence (according to NHPD standards), the application is rejected–and the product must either be withdrawn from the market or be resubmitted for another licensing attempt.

Frankly, the required evidence simply does not exist for most products. The single greatest challenge facing the NHPD right now is how to deal with the efficacy issue. It would be wrong to suggest that industry isn’t trying to comply or isn’t doing enough research; instead, most products simply do not have the kind of research that the NHPD is asking for.

The products do have evidence attached, but asking specifically for clinical trial evidence is putting NHPs on par with pharmaceuticals. This was not the original intent of the regulations, and it is getting the NHPD into trouble.

To date the NHPD has rejected a staggering 50 percent of all submissions for containing insufficient evidence. This means that a product has a 50/50 chance of receiving market authorization right now. According to the NHPD, only a few dozen applications have been rejected for possible safety concerns; the rest have been rejected because applicants could not meet NHPD evidence requirements.

To make matters worse, the NHPD has been struggling with an escalating backlog. There are nearly 10,000 applications currently with the NHPD. Receiving actual feedback from the NHPD could literally take years.

Industry Deadline: 2010

Looming on the horizon is a January 1, 2010 deadline for licences. If a product does not have a licence by then, it is dead in the water. Even if the application is in queue, if it does not have a licence by 2010, it cannot be sold in Canada. To date the NHPD has indicated that it will not extend the deadline, despite the backlog. For industry, such apparently simplistic optimism from the NHPD causes trepidation and doubt in this new regulatory environment.

For suppliers and manufacturers, the concern is great and it affects everyone–small and large companies alike. Consumers and retailers need to know that the natural health industry is working hard to communicate with Health Canada in order to effect change and preserve access to natural health products. In early 2008 the NHP Industry Roundtable formed as a nongovernmental, grassroots gathering of concerned suppliers–representing about 80 percent of the natural health retail business in Canada.

Natural health products have a remarkable safety profile. The Standing Committee on Health concluded this, and the government recognizes it. Still, half the products are not being licensed. Some argue that new laws are needed; others argue that regulation itself is the problem.

The truth is that the NHPD is also in the dark. It, too, is learning. There is no international precedent for what it is trying to do, but that does not excuse its tardiness in progressing.

The NHPD’s mandate is to preserve access to safe natural health products. It simply cannot continue to be the exacting regulator of perceived benefit. Let Canadians decide–it’s their health and it should be their choice to determine if a product has benefit. Canadians need informed choice, not limited choice.

Industry Roundtable

The NHP Industry Roundtable is a gathering of concerned suppliers of natural health products in Canada. The group began meeting regularly in early 2008, bringing together many of Canada’s NHP suppliers because of growing trepidation over the performance of the NHPD.

The major points of consensus for this group are:

• The standards of evidence levels are for the most part unreachable.
• The vast majority of NHPs are safe and should be presumed safe by the NHPD.
• NHPD quality testing is overly complex.
• The NHPD needs to perform with greater transparency in its process.

The NHP Industry Roundtable is committed to increasing consumer and retailer awareness of these challenging regulatory issues and effecting change on various levels.

The Roundtable believes that regulation in and of itself is required in this industry but that considerable change to the process is needed. The Roundtable’s most immediate goal is to push the January 1, 2010 deadline back several years, to allow greater time for licensing compliance.

Product Licensing by the Number

Natural health products in Canada must have a licence by January 1, 2010. The NHPD is currently accepting new licensing requests while slowly working through a vast backlog. The numbers tell the story–at its current rate of processing, the NHPD can’t meet its own deadline. Take a look:

Product backlog to date: 9,513
Total received to date: 30,877
Total licensed to date: 8,977
Total rejected to date: 9,590
Percent rejected to date: 51.7%

• 2006 average submissions received per working day: 26
• October 2008 average submissions received per working day: 33
• October 2008 average rejections per working day: 15
• October 2008 average approvals per working day: 18

October 2008 overall backlog change per working day: zero change. In other words, as of October 2008, the NHPD is simply breaking even with incoming submissions, licences, and rejections–the backlog remains the same.