Government Response to the Report of the Standing Committee on Health

News Release

March 1999

The Standing Committee on Health made fifty three (53) recommendations covering sixteen (16) broad areas. The government is pleased to accept and agree with all the recommendations. A summary of the recommendations and the government response is outlined in this fact sheet.

Definitions

Recommendations 1 and 2 of the Standing Committee's report deal with the need for an appropriate definition for natural health products (recommendation 1) and recommends that the new Expert Advisory Committee examine the status of bulk herbs (recommendation 2).

Response:

The government agrees with both these recommendations. It will be critical that a clear definition of "natural health products" be established so that the scope of products to be considered by the new Office of Natural Health Products is established. This will be a priority for both the Transition Team and the Expert Advisory Committee.

In relation to bulk herbs, this remains an outstanding issue which the government will address, in close consultation with stakeholders.

Expertise and Regulatory Structure

The Standing Committee's recommendations numbers 3 to 11 and 18 focus on creating a new regulatory authority and structure to regulate natural health products. Included in these recommendations is:

• the establishment of a new regulatory authority that reports directly to the Assistant Deputy Minister of the Health Protection Branch, Health Canada (recommendation 3);
• the need to move quickly within the next six months and to staff the new organization with personnel and working groups who have expertise and experience in natural health products and who are acceptable to both the government and the NHP stakeholders (recommendations 4, 5 and 6);
• the recommendation that all inspection personnel be specifically trained (recommendation 7) and that inspection of premises take place on a regular basis by knowledgeable individuals (recommendation 18);
• the recommendation that any need to amend the existing Food and Drugs Act should not delay the needed regulatory and administrative changes (recommendation 8); and
• the recommendations relating to the establishment of an Expert Advisory Committee, whose membership would be acceptable to both Health Canada and stakeholders. This Committee would also review options for research and laboratory capacities and report these findings to Health Canada. (recommendations 9, 10 and 11).

Response:

The government is creating an Office of Natural Health Products, headed by an Executive Director, reporting to the Assistant Deputy Minister of the Health Protection Branch. Further, this Office will be staffed with appropriate personnel selected by the government, with consultation taking place with stakeholders on the qualifications for the personnel.The Office will work in partnership with a variety of stakeholders and establish Advisory Groups as necessary as well as link with existing initiatives within and outside of Health Canada.

The Office of Natural Health Products will be responsible for developing educational and training materials for upgrading the skills of Health Canada inspection personnel and ensuring that inspection staff have the appropriate tools to function appropriately in relation to natural health products.

An Expert Advisory Committee will be established to help Health Canada and the Transition Team with the general and specific tasks necessary to implement all the recommendations contained in the report of the Standing Committee on Health. This will include designing a new regulatory framework for natural health products.

Safety, Quality, and Good Manufacturing Practices

The Standing Committee's recommendations in this area included the requirement to establish appropriate Good Manufacturing Practices guidelines (recommendation 12), to include specific quality control and testing for these products (recommendation 13) and that manufacturers, importers and distributors of natural health products should be obliged to hold valid establishment licences (recommendation 17).

Response:

The new Office of Natural Health Products will guide the development of appropriate manufacturing standards for manufacturers and importers of natural health products. It will determine, in consultation with stakeholders, the necessary requirements for licencing. The Office will also undertake or coordinate all the regulatory functions within the life-cycle of natural health products from pre-market assessment for product licensing through licensing of establishments, post-approval monitoring and the compliance and enforcement tools appropriate with ensuring health protection. These would include the development of appropriate training standards for inspectors of manufacturing and distribution establishments.

Efficacy

The Standing Committee recommended that manufacturers of natural health products be allowed to make health claims, including structure and function claims relating to the human body, and treatment claims, and that Health Canada should assess these claims in a way that looks at types of evidence, such as professional consensus and traditional references, and not only at clinical trials (recommendations 19, 20, 21 and 22).

Response:

Criteria to determine the applicability of claims made for natural health products would be developed by the Office of Natural Health Products, as well as guidelines determining the appropriate levels of evidence to support any claims made. This would be done with advice from stakeholders and the involvement of the Expert Advisory Committee.

Product Licensing

The Standing Committee on Health recommended a pre-market approval process for natural health products which would ensure that products are safe and that claims are supported by reasonable evidence. This process would be based on a risk management approach that recognizes that natural health products fall along a continuum of relative safety and therefore require different levels of control. This assessment would apply to pre-market licensing and post- market monitoring (recommendations 24 to 29). Recommendation 30 suggests that certain lower safety products be made available to consumers with appropriate warnings, while other lower safety product might require practitioner intervention. Recommendation 31 indicates that the new regulatory framework should be phased in to allow for adjustment time.

Response:

The Office of Natural Health Products will be responsible for establishing the parameters by which licensing of a product for market use would be applied, as well as determining the mechanics of market surveillance regarding adverse event reaction reporting and the use of existing or development of new monographs for these products. Efforts in the area of development of standards have been started by many countries and organizations worldwide. The Office would constitute an important link for Canada to these international processes and the sector would benefit from the elaboration of these standards.

Labeling

The Standing Committee on Health's recommendations on labeling include having sufficient, relevant information on products labels, and that labelling should be standardized to provide clear and consistent information for consumers (recommendations 32, 33, 34).

Response:

The Office of Natural Health Products, in consultation with the External Advisory Committee, will be responsible for establishing standards and determining what information to include on product labels. In doing so, the Office will rely on the excellent work done by the former Advisory Panel on Natural Health Products to guide its deliberations in this area

Section 3 and Schedule A to the Food and Drugs Act

Section 3 and Schedule A to the Food and Drugs Act was originally designed to ensure that individuals would seek medical attention for serious diseases, to restrict advertising when self-diagnosis and self-treatment is not considered advisable and to limit the possibility of fraudulent claims being made with respect to foods and drugs. The Standing Committee on Health recommended that Health Canada, in conjunction with stakeholders, review the diseases listed in Schedule A to ensure that only appropriate diseases are included (recommendations 35 and 36).

Response:

The Office of Natural Health Products, in consultation with stakeholders, will be responsible for determining the appropriateness of Section 3 and Schedule A relative to natural health products. A public policy development initiative, including stakeholders, is already being carried out in Health Canada by the Legislative Renewal Project in Health Protection Branch Transition. This initiative is renewing the legislative framework for health protection, including the whole issue of definition of food and drugs.

Importation of human-use drugs for personal use

The Standing Committee on Health recommends that, once the new regulatory framework is in place, Health Canada review the personal importation policy (recommendation 37).

Response:

Health Canada's current policy permits individuals to import a three-month supply of a drug product for their own personal use even though the product may not have been approved for sale in Canada. These products are not subject to the same review with respect to safety, quality and efficacy as are approved natural health products. The Office of Natural Health Products will be responsible for reviewing the policy on importation for personal use to determine whether it is appropriate and to outline permissible changes.

Cost recovery

The Standing Committee on Health recommended that Health Canada analyze the impact of overall cost recovery for natural health products; and that Health Canada does so in consultation with the industry to determine appropriate fee structures and amounts (recommendations 38, 39 and 40).

Response:

The Office of Natural Health Products will be responsible for undertaking further consultation with the different sectors of the natural health products industry to determine appropriate fee structures and amounts.

Appeal process

Health Canada maintains an appeal process to allow manufacturers, distributors, importers, retailers, practitioners and consumers to question government actions regarding products on the Canadian market. The Standing Committee on Health recommends that Health Canada work with stakeholders to establish an appropriate and effective appeals process (recommendation 41).

Response:

The Office of Natural Health Products, in consultation with stakeholders, will be responsible for establishing an appropriate, accessible and effective appeals process.

Informed choice

The Standing Committee on Health recommended that Health Canada, in regular consultation with its stakeholders, be more transparent and open with the public regarding its decision-making processes (recommendations 42, 43 and 44) and that Health Canada should immediately begin to encourage research on natural health products, the results of which should be widely disseminated to stakeholders and consumers (recommendations 45 and 46).

Response:

Health Canada works, on a consultative basis, with stakeholders, Expert Advisory Committees and Advisory Panels who advise Health Canada regarding various issues, including natural health products. The Office of Natural Health Products will be responsible for supporting research in areas of epidemiology and social science research and in the dissemination of information to Canadian consumers to enable them to make informed self-care decisions regarding the use of natural health products.

Natural health products practitioners

The Standing Committee on Health recommended that Health Canada inform its provincial and territorial counterparts of the regulatory changes (recommendation 47).

Response:

The practice of medicine is the jurisdiction of each province/territory and while Health Canada does not have a mandated role in the licensing of health care practitioners, it will determine mechanisms which would initiate this dialogue with its provincial and territorial counterparts.

Enforcement

The Standing Committee on Health recommended that the new regulatory framework be enforced in a regular and consistent manner, and that sufficient resources be provided for enforcement activities (recommendations 48 and 49).

Response:

The Office of Natural Health Products will ensure that inspection activities relating to manufacturing and distribution sites for natural health products, be undertaken by personnel specifically trained to inspect the natural health products sector to ensure compliance with appropriate good manufacturing practice standards.

Aboriginal healers

The Aboriginal community expressed concern that a new regulatory framework for natural health products may affect access to traditional herbs used by Aboriginal healers in healing ceremonies. The Standing Committee on Health recommended that specific products compounded for a particular individual should not be subject to the regulatory framework (recommendation 50)

Response:

The Office of Natural Health Products will be responsible for initiating a dialogue with the Aboriginal community in this regard.

Plant conservation

The increasing demand for natural health products places herbs and plants used in these products in a position to be depleted. The Standing Committee recommended that Health Canada work with Foreign Affairs and International Trade to ensure that existing international agreements are not violated and that additional strategies be developed, if required. (recommendation 52)

Response:

The Office of Natural Health Products, along with the Department of Foreign Affairs and International Trade, will address this issue with respect to international agreements and develop additional strategies to ensure the survival of these species.

Transition

The Standing Committee on Health recommended that the new regulatory environment for natural health products be established as soon as possible (recommendations 52 and 53).

Response:

A Transition Team composed of several outside stakeholders knowledgeable in natural health products and Health Canada staff will be established to ensure the timely implementation of all the recommendations of the Standing Committee on Health.