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
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
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 life-threatening 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
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.
The content of this article is intended to provide a
general guide to the subject matter. Specialist advice should
be sought about your specific circumstances.
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