Section 3 of the Food and Drugs Act prohibits the advertisement, to the general public, of a food, drug, cosmetic or medical device as a preventative, treatment or cure for certain diseases, disorders and abnormal physical states. These diseases and conditions are specified in Schedule A of the Food and Drugs Act and are commonly referred to as “Schedule A diseases.”
On June 1, 2008, amendments to the Food and Drug Regulations and the Natural Health Products Regulations will exempt certain drugs and natural health products from the prohibition if they are advertised only as preventatives, but not as treatments or cures, for Schedule A diseases. In addition, amendments to the Food and Drugs Act will result in the removal of several diseases from the list and the addition of others.
The details of these amendments are discussed below.
Exemption to Advertise Over-the-Counter Drugs and Natural Health Products as Preventatives for Schedule A Diseases
When the amendments come into force, natural health products (NHPs) and certain drugs will be permitted to carry prevention claims in labelling and advertising for diseases that are listed in Schedule A. Over-the-counter drugs (OTCs) and vaccines are included in the scope of this exemption, which applies to drugs that are not classified as narcotics, controlled substances or Schedule F prescription drugs. Advertising and labelling of prescription drugs will be unaffected by the amendments and, therefore, will continue to be subject to the prohibition on advertising in respect of Schedule A diseases, as will medical devices, foods and cosmetics.
According to the Regulatory Impact Analysis Statement accompanying the amendments, the rationale behind lifting the prohibition on prevention claims for NHPs and OTCs is that prevention of a Schedule A disease will typically not require the intervention of a health practitioner, in contrast to the treatment or cure of a Schedule A disease. Furthermore, the amendments recognize that patients are becoming increasingly informed and involved in decisions regarding their own healthcare; they are, therefore, demanding access to self-help alternatives and alternative healthcare options.
Revisions to Schedule A of the Food and Drugs Act
In September 2005, a Scientific Advisory Panel was convened to recommend criteria for adding diseases to or removing them from the Schedule A list. The panel included experts from healthcare specialties such as homeopathy, naturopathy, medicine, pharmacy, nutrition, advertising and patient advocacy. The purpose of establishing criteria was to create a transparent mechanism to ensure a consistent policy regarding the diseases that are listed in Schedule A. These criteria are outlined in the Regulatory Impact Analysis Statement, and the amendments to the Schedule A list have been made in accordance with these criteria.
The amendments to the Schedule A list generally reflect a policy of continuing to list lifethreatening diseases and acute forms of specific diseases. Alopecia, dysentery, gout, hypotension, impetigo, pleurisy and sexual impotence will be removed from Schedule A when the amendments come into force. Bladder, prostate, gall bladder and kidney diseases will also be removed from the list because they are general diseases of the major organs rather than specific diseases, whereas disorders of menstrual flow and edematous states will be removed because they reflect only symptomatic illnesses.
Some Schedule A diseases will be replaced with more serious and specific forms of the diseases. Heart disease will be replaced by congestive heart failure; anxiety state will be replaced by acute anxiety state; hernia will be replaced by strangulated hernia; arthritis will be replaced by acute inflammatory, debilitating arthritis; and liver disease will be replaced by hepatitis. Prior to the amendments, hepatitis was excluded from the list of Schedule A diseases to allow for the advertisement of hepatitis vaccines. Hepatitis has been added back to the list of Schedule A diseases since advertising of preventatives for Schedule A diseases will be permitted when the amendments come into force.
Several diseases and conditions will be added to Schedule A because they meet one or more of the criteria. These diseases and conditions consist of acute alcoholism, acute infectious respiratory syndrome, acute psychotic conditions, addiction (except nicotine addiction), dementia and hematologic bleeding disorders.
Schedule A will continue to be updated to reflect changes in scientific opinion and research, or to deal with issues that may arise upon the implementation of the amendments.