Record of Proceedings: September 21, 2005 - Scientific Advisory Panel on Schedule A of the Food and Drugs Act (SAP-Sch A)

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Record of Proceedings

Scientific Advisory Panel on Schedule A (SAP- Sch A)

September 21, 2005

Committee members present: Peter Walker (chair), David Jenkins, Joel Lexchin, John Millar, Richard Pollay, Frank Viti, John Harrison & Shelley Stepanuik

Regrets: Paul Saunders, William Semchuk & Rudi Verspoor

HC staff: Theresa Burke, Eric Ormsby, Conrad Pereira, Joy Bregg

*Abbreviations for Health Canada Bureaux/Divisions and other terms used in this record:

HC = Health Canada
PB = Policy Bureau
TPD = Therapeutic Products Directorate
SAP - Sch A = Scientific Advisory Panel on Schedule A

In the morning, a PB representative presented background information on the issues surrounding Schedule A and Task I. An open discussion followed, moderated by the Chair, where the SAP-Sch A deliberated the issues before making their final recommendations to HC. The same process was repeated in the afternoon for Task II.

Opening remarks & adjustment of agenda (Mr. E. Ormsby)

The meeting was opened by the Manager, Office of Science, TPD, who outlined the process and intended outcome for this meeting.

Welcome, Chair's address (Dr. Peter Walker)

The Chair welcomed all participants and lead a roundtable Conflict of Interest Declaration.

Presentation: Overview of Task #1 (Ms. T. Burke)

There are two reasons why the SAP-Sch A is tasked to deliberate both on the amendment and repeal of Schedule A:

(1) Health Canada committed to the Schedule A External Working Group (EWG) the convening of an expert scientific panel to develop criteria and review Schedule A diseases, disorders or abnormal physical states in order to reflect current scientific understanding. Task I fulfills this commitment.

(2) Bill C420, proposes to repeal Section 3 of the Act and Schedule A. Health Canada must consider the potential consequences of repealing Section 3 and Schedule A. The panel will comment on whether HC has given adequate consideration to the consequences and if there are any outstanding issues remaining. This is the second task for the panel.

Open discussion - Task I

Questions for Task I

1) The purposes for which Schedule A and Section 3 of the Food and Drugs Act were promulgated in 1934 have been addressed for the most part by other legislation. However, the EWG Minority Report has suggested that Schedule A and Section 3 are still needed to serve the interests of public health, i.e., the advertising of drugs for serious diseases may encourage inappropriate self-diagnosis and/or self-treatment. Both EWG Majority and Minority Reports have indicated that Schedule A is outdated with respect to content.

a) What criteria should be used to modify Schedule A? For each criterion, state the rationale.

The panel discussed issues related to criteria for placing diseases on Schedule A. Discussion included, but was not limited to, points below:

• Criteria proposed by the EWG (both the majority and minority reports) were discussed in detail. The greater focus was on the list of criteria in the minority report since this includes the criteria in the majority report.
  
  
• How many criteria had to be met in order for a disease to be placed on the list. There was consensus that one criterion was sufficient for a disease to be placed on the list.
  
  
• It was observed that the effect of advertising on the public must be considered. For example, advertising can increase drug use or lead to more apropriate or less appropriate drug use, etc. One member expressed the opinion that promotion, even to health professionals, does not lead to better prescribing or better health outcomes for consumers.
  
  
• One member expressed the opinion that there are some serious diseases that nevertheless can be treated with products that do not have significant safety risks. Therefore, it might be appropriate to allow advertising for these products in the context of treating these serious diseases.
  
  
• One member expressed a concern that restricting claims for foods inhibits manufacturers from developing and marketing healthy products.
  
  
• One member suggested that the stage of the disease should also be considered. For example, for people in the early stages of diabetes advertising may be acceptable since management of the condition does not require expert knowledge. However, management of the later stages of diabetes does require expert knowledge and therefore advertising would not be appropriate.
  
  
• Section 3/Schedule A is not the only provision limiting advertising.

After detailed discussion of the criteria proposed by the EWG, the panel recommended the following criteria be used to modify Schedule A:

1. The condition or disease results in serious risks to individual or public health, and generally requires diagnosis, treatment and management by a health professional.
   
   
2. The disease is likely to be spread within the population without appropriate treatment.
   
   
3. There is an emergency situation where self care is inappropriate.
   
   
4. The severity of the disease limits the person's ability to make health decisions.
   
5. The disease state is recent (i.e., the disease state has only recently been recognized by medical science) and it is unclear whether or not self treatment is appropriate.
   
   
6. The disease or condition is one which renders individuals especially vulnerable to harm (i.e. dementia, pregnancy, malnourishment)

b) Based on these criteria, recommend modifications to Schedule A, i.e. removal or addition of any diseases, disorders or abnormal physical states. For each modification, state the criteria used.

The following modified list of diseases was recommended. The criteria numbers are in brackets:

Acute Infectious Respiratory Syndromes (2, 5)
Acute psychotic conditions (3, 4)
Addiction (1)
Alcoholism (acute) (1, 3)
Anxiety state (acute) (3)
Appendicitis (3)
Arteriosclerosis (1)
Arthritis (acute inflammatory/debilitating) (1)
Asthma (1, 3)
Cancer (1, 3)
Congestive heart failure (1, 3)
Convulsions (3)
Dementia (4)
Depression (1)
Diabetes (1)
Gangrene (3)
Glaucoma (1)
Haematologic Bleeding Disorders (1)
Hepatitis (1, 2, 3)
Hernia (strangulated) (3)
Hypertension (1)
Nausea and vomiting of pregnancy (6)
Obesity (1)
Rheumatic fever (3)
Septicaemia (3)
Sexually Transmitted Diseases (2)
Thrombotic & Embolic disorders (1, 3)
Thyroid disease (1)
Ulcer of the gastro-intestinal tract (1, 3)

Presentation: Overview of Task II (Ms. T. Burke)

(2) Bill C-420 is a private member's bill which has passed Second Reading in the House of Commons and is at the Standing Committee on Health. One of Bill C-420's proposals is to repeal Schedule A and subsections 3(1) and 3(2) of the Food and Drugs Act (hereafter referred to as Schedule A and section 3). Task II is a component of Health Canada 's analysis of the potential consequences in the event that Bill C-420 passes.

Open discussion - Questions for Task II

Questions for Task II

2) Health Canada has drafted the document "Issues Associated with the Repeal of Schedule A and section 3 of the Food and Drugs Act". This document outlines what legislation and other tools have come into place to address some of the issues for which Schedule A and section 3 were originally used.

a) Having reviewed the document, do you agree that Health Canada has addressed the issues it has identified?

There was general agreement that HC had addressed the issues identified in the document. It was emphasized by some that HC must be proactive in setting up amendments to the regulations in the event Schedule A is repealed and all agreed that HC must do a better job now of enforcing existing regulations.

One member stated that while he agreed that HC discussed the consequences of eliminating Schedule A/Section 3 he did not agree that the measures that it set forth in the document will be sufficient to compensate for the repeal of Schedule A/Section 3. His position was that HC has not shown that it is capable of enforcing its current regulations regarding advertising and therefore until it can do that he has no confidence in the measures that it put forward in this document and cannot support the elimination of Schedule A/Section 3.

b) Do you foresee any outstanding issues not identified by Health Canada?

One member suggested that current control of advertising is inadequate. For example many claims for over the counter (OTC) products are allowed without adequate supporting evidence. A concern was expressed that HC does not act on direct to consumer advertising (DTCA) complaints.

One member suggested that there is a need to educate consumers. The food industry will not respond and market healthier foods if they are not allowed to make health claims. Information on the health benefits of some functional foods is not generally available to consumers. There was discussion on the difference between education and advertising.

One member expressed the opinion that post-market surveillance is still weak. The amount of information currently available is still inadequate.

c) How should these additional issues be addressed ?

One member suggested that an independent Federal body be set up to review all promotion where health claims are to be made. Compliance with regulation should not be on a voluntary basis. Regulations should be enforced.

One member suggested that companies (e.g., food manufacturers) could be allowed to make health claims provided they also provided consumer education. There was one suggestion that advertising of food products might be treated differently than advertising of drugs. A concern was expressed in response that education may still be biassed toward the company.

One member expressed the concept that educational activities sponsored by companies marketing foods and drugs are likely to be biassed in favour of the products being sold and therefore professionals should pay for their own education and not depend on industry for education.

One member suggested that the Federal government could fund education chairs, the way it funds research chairs in academia.

With respect to post-market surveillance, more information should be made available and in a more timely manner.

Adjournment of meeting

The Chair closed the meeting by thanking all participants. If upon review of the proceedings it becomes clear that further discussion of some points is necessary, a teleconference or even another meeting of the panel may be arranged.