ARCHIVED - Recommendations of the Schedule A External Working Group

The documents below do not necessarily reflect the views and opinions of Health Canada but rather of those Working Group members who prepared and supported them. Health Canada will consider the reports of the External Working Group and the results of any public consultations internally to determine what next steps are necessary.

Health Canada is pleased to make available below, the report of the Schedule A External Working Group. This report is being made available to Canadians in order to encourage discussion and debate regarding their views on the future of Section 3 and Schedule A of the Food and Drugs Act. Health Canada will consider the External Working Group's findings and the results of any public consultations internally to determine what next steps are necessary.

• Background Information
• Majority Report - Section 3 & Schedule A of the Food and Drugs Act
• Minority Report - External Working Group Report on Section 3 and Schedule A
• Frequently Asked Questions - Schedule A External Working Group
• Process and Recommendations

Process and Recommendations

Background

The Schedule A External Working Group was established by Health Canada in February 2003, based upon recommendations made during the Health Protection Branch regulatory review of the Food and Drugs Act and on recommendations of the House of Commons Standing Committee on Health. In order to reflect and capture the diversity of opinions and views surrounding Section 3 and Schedule A, the Working Group was comprised of representatives from government and regulatory groups, professional associations, consumer groups, advertising, media, foods, health products and medical devices.

Mandate & Process

The Schedule A External Working Group was mandated with:

• Reviewing Section 3 and Schedule A of the Food and Drugs Act;
• Providing recommendations on modification to or elimination of these provisions in the medium and long term; and
• Submitting a report of the Working Groups' findings to Health Canada.

Over a nine month period the Working Group analyzed, debated and deliberated the issues surrounding Section 3 and Schedule A. The members of the Working Group brought diverse experiences, perspectives and values to the table, and towards fulfilling their mandate. This diversity furthered the analysis and rendered the report more reflective of the various views in Canadian society.

Analysis

In developing its recommendations, the Working Group found the following issues to be relevant to its mandate:

• Advances in health care have lead to treatments for many of the diseases listed in Schedule A. Furthermore, modern therapies have allowed chronic conditions such as arthritis and diabetes to be successfully managed. In addition, with research advances, new products may soon be available for diseases that are not currently treatable.
• In addition to the paradigm shift toward self-care, holism and patients' increasing involvement in treatment choices, medical diagnosis plays an important role in the treatment and monitoring of serious diseases.
• Over the years, legislative amendments such as Schedule F and Sections 6, 9 and 20 of the Food and Drugs Act and voluntary industry codes (Advertising Standards Canada) have been developed to combat fraud in labelling, advertising and sale of treatments. The current regulation of health claims allows only evidence-based health claims on products advertised and sold to consumers. Products such as foods and low-risk medical devices must adhere to the government-approved claims set out in regulation. All self-care products and higher risk devices must undergo a pre-market evaluation to obtain a license to sell.
• The enforcement of existing or amended regulations would require a significant and ongoing investment of resources.

Recommendations

Consistent with the Standing Committee on Health recommendations, the Working Group unanimously agreed that Section 3 and Schedule A needed to be amended to meet the needs of Canadian society. However, there were differences in opinion as to what would be the best manner to make such changes. From the outset, the Working Group recognized that the issues before it were complex and would encourage much debate.

In particular, the key recommendations of the Working Group are:

1. A short-term option involving administrative amendments to Health Canada's Guidance Document on Section 3 and Schedule A;
2. A medium-term option involving regulatory changes such as replacing the current Schedule A with a shorter list of diseases and establishing a set of criteria for the review of Schedule A diseases; and
3. A long-term option involving legislative changes including removing Schedule A and amending Section 3 of the Food and Drugs Act to establish controls on advertising to any member of the general public for products covered by the Act, to diagnose, prevent, treat or cure a disease or condition.

In addition, two members of the Working Group felt that their views and opinions would best be expressed in a Minority Report. This report is available below.

Background Information
Minority Report of the Schedule A External Working Group