The current 60% failure rate for product license applications has mainly involved applications for single-ingredient products. This means that 60% of single ingredient NHPs have failed to pass Health Canada?s stringent safety and efficacy standards.

What Natural Health Products Will be Left Once Health Canada is Finished Judging 60% of Single-Ingredient NHPs Illegal and 80-90% of Multi-Ingredient NHPs Illegal ?

Because Health Canada has been so slow to process license applications, NHP manufacturers and retailers have not yet had to decide what they will do when the overwhelming majority of their products are deemed illegal.

The Immediate Threat

The immediate threat facing the Natural Health Product industry is the implementation of the drug-style Natural Health Product Regulations. The NHPPA is concerned that the industry is:

• being subjected to drug-style regulations that are too onerous for the risk profile presented by Natural Health Products;
• open to arbitrary attacks by the regulatory body;
• unprepared for upcoming challenges such as cost recovery for the Natural Health Product Directorate, and increasingly onerous standards for site and product licenses.
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The NHPPA is seeking to bring about a long-term solution to the current regulatory threat. The NHPPA is concerned that if the industry pursues a solution that is only short-term, that the industry could exhaust itself seeking a short-term solution and then find itself under regulatory threat in a couple of years time. For example, if the industry fights to force Health Canada to impose the current NHP Regulations more reasonably, there is nothing to prevent Health Canada from resorting to its current approach to the Regulations once the political pressure has subsided.

Prepared by Shawn Buckley, president of the NHPPA

Purpose of the Paper

Yesterday the Minister of Health introduced Bill C-51 into the House of Commons. The Bill passed first reading.

Is the Product License Failure Rate Over 60% ?

It is difficult to verify the actual numbers as the NHPD publications concerning the status of submissions are not clear. For example, from the last publication covering the period from November 2006 to November 2007 we learn that there were 11,302 product license applications processed. Of these 4,334 received licenses and 6,368 failed. This is 56% failure rate.