Bill C-51 – Jackboot Inspections, Big Pharma Intrigue, or Good Government

Great work by aDam for picking up on the ideological stance being adopted by some natural health product (NHP) advocates concerning Bill C-51.  The Health Minister’s 22 April 2008 speech on the Bill indicates the government’s desire to “gain the ability to continuously monitor the safety of products even after they are approved,” especially through licensing and inspection.  The speech was given to a food and consumer safety conference and so was focused more on the food regulatory aspects than on NHPs.  However, as aDam points out, much of the Bill’s criticism is coming from the NHP community, which is strange because, just a decade ago, they were trying to get Health Canada to regulate NHPs as a way of giving the products credibility.

In the mid 90s, it was the NHP community, and not “Big Pharma,” who pressured the government to compel Health Canada to develop and implement regulations for NHPs in Canada.  The report Natural Health Products: A New Vision provides an overview, at least from the perspective of 1998.  Bill C-51 is really just the logical extension of that implementation process.

To produce the report, the House of Commons Standing Committee on Health heard testimony from across the broad spectrum of NHP practitioners, industry and advocacy groups.  Based partly on this testimony, the Committee established that:

a primary objective of any new regulatory framework for NHPs must take into account the well-being of consumers.  On the whole, our desired outcome is a regulatory framework for NHPs that (1) protects the health of consumers (2) respects consumers’ access to products and (3) guarantees product safety and quality.

With two of the Committee’s Guiding Principles being:

Safety:  Safety of NHPs is of primary concern.
Quality:  The NHP industry must meet clearly defined and established standards of quality.

To meet these Guidelines, the Committee recommended, again based on NHP advocacy, that:

Health Canada, in collaboration with the NHP industry, establish appropriate [Good Manufacturing Practices (GMPs)] guidelines reflective of the different nature of NHPs;

GMP standards for NHPs include specific quality control and testing for herbal products;

Manufacturers, packagers, importers and distributors of NHPs, whether located in Canada or abroad, be obliged to hold valid establishment licenses;

Inspection activities be performed consistently and on a regular basis by inspectors knowledgeable about the products.

Bill C-51, in part, addresses these recommendations.  Given that Natural Health Products: A New Vision was written 10 years ago when a different political party was in power, the implementation of C-51 is an amazing example of regulatory follow-through.

NHPPA’s discussion paper identifies many of the salient changes to the Food and Drugs Act that will be put into force by Bill C-51 but provides a paranoid assessment of the impact of those changes (although not as paranoid as the educate-yourself website where Bill C-51 equals “Nazi Germany’s 1933 Enabling Act”).  The paper also illustrates the NHP advocates’ selective amnesia on their position:

The last time consumers and the industry rebelled against Health Canada enforcement actions against NHPs, the rallying cry was “don’t treat our foods as drugs”. … Would the rallying cry have been successful with the new term: “don’t treat our foods as therapeutic products”?  Or to be more accurate: “don’t treat o[u]r natural health products as therapeutic products”?

Really?  That’s funny.  Back in 1998, the Advisory Panel on Natural Health Products (APNHP) preferred this now despised term:

Touching on the contention that NHPs are not adequately described as either foods or drugs, the APNHP recommended that the term “drug product” in the Food and Drugs Act be renamed “therapeutic product”

Similarly, back then:

The vast majority of witnesses who discussed GMPs were of the view that manufacturing standards were necessary to ensure NHPs’ quality and safety.  The compliance to current GMP guidelines has resulted in extensive renovations and the purchasing of expensive equipment by Canadian establishments dealing with NHPs to ensure these high safety and quality standards.  In fact, the Committee was told that Canadian GMPs are among the highest in the world and that Canadian NHPs gain international recognition because of their high quality.

However now, when it has come time to implement the enforcement mechanism, we find that:

roughly 60% of natural health product license applications are failing.  The majority of these license applications are for single ingredient products which are easier to licence then multi-ingredient products.  The percentage of failed license applications is expected to increase as more multi-ingredient product license applications are considered.  My estimate is an overall failure rate of 70%.

In the mid 90s, the NHP industry needed Health Canada to formally recognize NHPs through legislation in order to ensure safety and quality:

They wanted to know how consumers could be certain about such factors as purity, potency, and cleanliness of the products they purchase.  They heard repeatedly that Canadians must be assured that “what’s on the label is in the bottle.”

Now, they seem to be saying that you should trust the industry to ensure safety and quality, and therefore why bother with regulations, inspections and those difficult-to-meet licensing requirements.  I guess the NHP industry just wants to be treated like their products – big on claims but not on formal evidence.

04. May 2008 by barry
Categories: Alt. Med, Topics | 2 comments

Comments (2)

  1. I’ve just found this site, could I just borrow the technical
    information from the web site or do I need special permission?. I am doing a school project.


  2. Sorry if this isn’t related.

    Does anybody know a good regulation compliance site?.

    Should be a full off technical specs since I’m doing research for work.

    Thans alot