Mr. Speaker, in response to (a), Health Canada has set a goal for itself to address the Natural Health Product, NHP, product licensing backlog by March 31, 2010. This date is not set out in law or regulation--it is an internal deadline adopted by Health Canada. The only date set out in the regulation is December 31, 2009 at which time all natural health products which were previously issued a drug identification number under the Food and Drug Regulations will be required to have a product licence, as per Section 108 of the Natural Health Products Regulations.
Health Canada is confident that, building on our progress to date, we can address the backlog by March 31, 2010.
In response to (b), the Natural Health Products Directorate, together with the Health Products and Food Branch Inspectorate, are currently developing a compliance strategy for 2010.
Significant progress has been made to address the backlog of applications: as of June 2009, 47% of the product licence application backlog has been completed or is in the process of being completed and of the remaining 6661 applications, 48% have been addressed--meaning that the applicant has received at least one deficiency notice from NHPD as part of the assessment of their application. Of the product licence applications not considered in the backlog, 59% have been completed or are in the process of being completed and of the remaining 4836 applications, 25% have been addressed--meaning that the applicant has received at least one deficiency notice from NHPD as part of the assessment of their application. Of all product licence applications received since 2004, NHPD has completed or is in the process of completing 70%.
In response to (c), Health Canada continues to review applications and issue regulatory decisions. Some of those decisions will be refusals. To date, however, there have been more licences than refusals.
The Natural Health Product Regulations, NHPR, require that an applicant submit information to support the safety, efficacy and quality of a product for assessment by the NHPD. An estimated 25-30% of applications received do not include enough information or relevant information to allow the directorate, on behalf of the minister, to conclude that the product is safe and effective.
An applicant that does not include sufficient information in an application, to allow a licence to be issued is provided with an opportunity to submit further information to support the licensing of the product; in 26% of submissions, the applicant chooses not to take this opportunity and does not respond to a request from the NHPD to do so.
In response to (d), Health Canada’s priority is to protect and promote the health of Canadians by ensuring access to natural health products that are safe, effective, and of high quality. Only NHPs that are supported by adequate levels of evidence and carry appropriate labels will be authorized for sale and issued a product licence.
The safety and efficacy evaluation of a natural health product, NHP, includes an assessment of its recommended conditions of use and the existing totality of evidence related to the NHP.The information that is considered acceptable by NHPD in reviewing applications includes a range of data including:
(i) safety and efficacy information that is developed by the NHPD and made available to product licence applicants such as ingredient and product monographs and labelling standards (nearly 150 of these are now available and has been used by applicants to allow for the licensing of thousands of products);
(ii) reference to safety and efficacy information published reference texts and pharmacopeia (e.g., texts for homeopathic medicines and traditional chinese medicines);
(iii) reference to safety and efficacy information from small-scale trials that is publicly available from a variety of sources;
(iv) reference to relevant decisions made by other regulatory agencies.
In response to (e), Bill C-51, An Act to Amend the Food and Drugs Act, died on the Order Paper with the dissolution of Parliament in September 2008. Consultations with stakeholders resulted in revisions and additions to the Bill, which were to be introduced during review by Committee.
One proposed addition was the introduction of a definition for NHPs at the level of the act, clarifying that NHPs are separate from drugs. It is important to note that the proposed amendments to the Food and Drugs Act would not have affected the way that NHPs are regulated in Canada. Under the Natural Health Products Regulations, NHPs are already regulated separately from drugs. The standards of evidence used to assess the risks and benefits of NHPs will continue to incorporate history of use, traditional uses and cultural practices.
In response to (f), Health Canada remains committed to ensuring safe, effective and high quality NHPs. In budget 2008, $33 million over two years was dedicated to implement a new approach to the regulation of NHPs and ensure the safety of Canadians. The government is committed to ensuring that the regulation of NHPs balances the protection of consumers’ health and safety with the freedom to choose alternative products.