Minority Report
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External Working Group Report on Section 3 and Schedule A
- Union des consommateurs
- Women and Health Protection
December 8, 2003
Introduction
The External Working Group on Section 3 and Schedule A of the Food &
Drugs Act was formed in February 2003 in response to one of the recommendations
of the House of Commons Standing Committee on Health, asking that Health
Canada:
"... conduct a study with the participation of
representatives from consumer groups, the food, natural health products and pharmaceutical
industries, and health practitioners to determine whether subsections
3(1) and (2) of the Food and Drugs Act or all of the diseases listed in Schedule
A should be deleted."
Commercial Interests
The Working Group includes representatives from the over-the-counter
drug industry, the medical devices industry, the natural health products
industry, the food industry, advertising and media. Additionally, patient
groups and professional associations with financing from the prescription
drug industry, over-the-counter drug industry and natural health products
are represented on the Working Group.
It is legitimate for Health Canada to request advice on health policies
from the regulated industries. However, such advice must be understood
within the context of companies' fiduciary responsibility to their shareholders,
and the responsibility of industry associations to uphold the interests
of their member companies. Additionally, conflicts of interests may arise
when a patient or health professional group has financialcop ties to an
industry or company that produces health-related products, or when an
organization's representatives have individual financial ties, for example
as paid consultants or advisory board members.
Most of this committee's non-governmental members have financial ties
to the industries that stand to gain from expanded health product advertising.
If the aim of this committee is to address whether, from a public health
perspective, changes to Schedule A are needed, then an advisory group
should be composed of organizations and individuals with expertise in
public health, and attention should be paid to avoiding all apparent and
real conflicts of interests on such a committee.
This minority report is from two members of the Schedule A External Working
Group from consumer organizations without financial ties to the pharmaceutical,
health product, advertising or media industries: Union
des consommateurs and Women and Health Protection.
Background
Why prohibit advertising of preventatives, treatments or cures for serious
diseases?
The list of Schedule A diseases was introduced into law as a health protection
measure, in order to protect the public against undue commercial influence
at a time when they are most vulnerable due to ill health. People who
are seriously ill, caring for an ill family member, or who fear future
death and disability are vulnerable in a way that differs from someone
who is facing a consumer product choice, such as buying a new car or an
item of clothing.
Advertising is a poor mechanism to provide unbiased information related
to the treatment of serious diseases. By definition, advertising aims
to sell a product. It cannot provide the type of complete, accurate and
unbiased information on pros and cons of all available treatment options
that the public needs in order to participate in informed treatment or
prevention choices.
Whether or not the original intent of the restrictions on advertising
imposed by Schedule A was to prevent charlatans from selling 'snake oil'
remedies to the public at a time when fewer regulatory controls were in
place, when it comes to health claims in advertising, the aims underlying
Schedule A restrictions remain as pertinent today. During the time since
Schedule A was introduced, advertising techniques have become much more
sophisticated than in the past, and are extremely subtle and effective.
The vulnerability of those seeking to prevent death and disability from
serious disease was highlighted in a recent letter to the medical journal
The Lancet by World Health Organization staff about an advertising
campaign in France. The campaign, which featured a tagged toe of a corpse
in the print version, and a man dying of a heart attack in the television
commercial, has also been running in Canada during 2003.
The letter's author, Dr Jonathan Quick, Director of the Essential Drugs
and Medicines Policy Division, and his staff, stated that this advertising
campaign: "contained misleading statements and omissions likely to
cause medically unjustifiable drug use or to give rise to undue risks."
The ads use fear of death to sell a product. They provide unrealistic
expectations of the effectiveness of the recommended prevention strategy,
since cholesterol testing and use of a cholesterol-lowering drug have
never been shown to prevent deaths from heart attacks in those without
previous heart disease. They also convey the impression that this strategy
is the most effective way to prevent cardiac death, which may lead viewers
to substitute this strategy for more effective interventions, such as
quitting smoking, exercise and weight loss. The Globe & Mail featured a full-page version of this ad on November 22, 2003, and complaints
to Advertising Standards Canada have thus far gone unheeded.
Similarly, in September 2003, a margarine producer promoted its product,
Becel, as part of a 'healthy heart strategy', in a Canadian magazine,
Healthy Woman, although the idea that eating margarine prevents
heart disease has long been discredited.
Is the Canadian public currently protected against misleading advertising
claims?
These examples point to a widespread problem of inadequate enforcement
of the law prohibiting deception in advertisements for health products.
Lack of enforcement leads to misleading and potentially hazardous messages
about medical treatments reaching the Canadian public, without any mechanism
in place to ensure swift removal of offending advertising campaigns or
correction of misleading information. As described above, these violations
include advertising of preventatives and treatments for Schedule A diseases.
The most recent review of the adequacy of enforcement of over-the- counter
drug advertising regulations was carried out by Health Canada in 1993,
and published in a 1994 report. Two-thirds of sampled magazine ads failed
to comply with the law. 'Minor' violations included exaggerations of benefits
and inadequate risk information, in other words misleading and inaccurate
information about the products' characteristics and health effects; major
violations were not defined. The 1993 review of broadcast advertisements
only included scripts submitted for review, not full commercials that
were heard and seen by the public. However, approximately one-third of
these scripts failed to comply with regulatory requirements. These violations
occurred while Health Canada was still directly responsible for monitoring
the promotion of OTC products and when it was pre-screening scripts for
broadcast advertisements. Since then responsibility for OTC promotion
has been turned over to Advertising Standards Canada.
No systematic evaluation of the adequacy of enforcement procedures has
been carried out during the last 10 years. To assume that the public would
be well protected, should current restrictions on advertising be lifted,
appears to be based on a leap in faith rather than a careful assessment
of available evidence.
A precautionary approach to health protection policy
We agree that the guiding principle in considering changes to Section
3 and Schedule A of the Act should be protection and promotion of public
health. A further question concerns where the burden of proof should lie.
When a new health technology or drug is introduced onto the market, the
burden of proof is on the manufacturer to provide systematic evidence
to Health Canada to show that the product has the claimed effect, and
is sufficiently safe; in other words that the product's potential benefit
will outweigh potential harm. Similarly, the onus should be on those supporting
removal or limitation of the scope of an existing health protection measure
to show that such a move will lead to greater benefit than harm. When
it comes to product-specific advertising of preventatives, treatments
or cures for serious diseases, such evidence is sorely lacking.
The question is whether a precautionary approach should be applied to
policy development on health-related advertising, or an approach giving
greater priority to economic development over public health.
If promotion of a specific intervention is desired, as is the case for
example for condoms and prevention of spread of sexually transmitted diseases,
advertising campaigns may be used by public health authorities without
any changes to Schedule A. It is also possible to make exemptions to Schedule
A restrictions involving a specific type of product, such as condoms or
sunscreens. Such exemptions already exist, and are preferable, on a case
by case basis, to removal of serious diseases from Schedule A, given the
importance of avoiding promotion of less effective prevention and treatment
strategies, or broad promotion of interventions that are beneficial for
patients at high risk, but will create greater harm than benefit in other
population groups.
An example of the potential for problems is the use of aspirin by patients
with previous heart attack and stroke, in order to prevent recurrences.
This is a useful preventative measure. However, advertising of aspirin
could lead to use in primary prevention in patients at lower risk or who
mistakenly believe that they are at high risk. In such patient populations,
risks of daily preventative aspirin therapy could easily outweigh benefits,
leading to more hospitalizations and potentially more deaths from stomach
bleeding.
As this example points out, non-prescription status does not necessarily
imply that a product is risk free, especially when used inappropriately.
Additionally, advertisements may lead to serious harm if they promote
the substitution of less effective approaches to disease prevention or
treatment, rather than the most effective available alternative.
There is a fundamental difference between limits on advertising
of products for serious diseases and limits on the public's access
to those products. Neither are limits on advertising synonymous with limits
on the public's access to information on options for treatments
and prevention of serious diseases. Limits on advertising are a means,
rather, to ensure that the public obtains information about options for
treatment and prevention of serious diseases from independent and unbiased
information sources, including health care professionals, and not from
emotive messages whose aim is to sell a product.
The distinction between advertising and labelling
Section 3 of the Food & Drugs Act refers mainly to restrictions on
advertising of products used to prevent or treat listed diseases. However,
it also includes restrictions on labelling.
If a product has been approved as a preventative, treatment or cure for
a Schedule A diseases, and the pre-market approval process includes approval
of product information, that information should be available to the public
in a format similar to the 'Patient Product Monograph' that Health Canada
is currently developing for prescription drugs.
For all products labelled for a Schedule A disease, this information should
include at a minimum, in plain language:
- The approved indication
- Dosage and administration
- Contraindications
- Adverse effects [both those that occur most frequently, and the most
serious potential adverse effects, organized in a readable and coherent
manner]
- Interactions to avoid
- Symptoms to watch out for and what to do in case of specific symptoms
or unforeseen adverse effects
- The Health Canada 1-800 number for reporting adverse effects
- A statement, in bold, indicating the need for ongoing assistance from
a doctor or other health professional in the management or treatment
of 'xx [Schedule A disease or condition]'
Provisions to introduce such labelling changes should include limits
on font size [both minimum and maximum], a complete prohibition of accompanying
images as well as advertising text and testimonials. As this is labelling
information, media could also be limited for example to the product package
and either print or web-based compendia of non-prescription health products
(on a similar model to the CPS). Labelling of a product associated with Schedule A diseases should only
be allowed for products with pre-approved product information.
Relationship of Schedule A to direct-to-consumer advertising of prescription
drugs
A separate provision in the Food & Drugs Act prohibits advertising
of prescription-only drugs to the public, with the exception of advertisements
that make no representation other than name, price and quantity. Additionally,
Schedule A covers any product, and is thus not limited to products with
prescription-only status. However, it acts as a second barrier to advertising
of most prescription-only drugs to the public, given that most prescription
drugs are used for prevention, treatment or cure of serious diseases.
Thus, elimination of Schedule A may be seen as a necessary but
not a sufficient legal change for the introduction of direct-to-consumer
advertising of prescription-only drugs in Canada.
Many of the same concerns that have been raised about direct-to-consumer
advertisements of prescription drugs (DTCA) are relevant to advertising
of non-prescription medicines to the public for prevention and treatment
of serious diseases. These include for example:
- unnecessary medicalization of the population,
- the creation of unrealistic impressions of treatment success,
- ignoring key treatment information, particularly in relation to treatments
that do not rely on marketed products
- interference with the doctor/patient relationship
- and presentation of an unbalanced picture of potential risks.
Currently, legal restrictions on non-prescription health product advertising
are consistent with conditions for self-care, in that products are advertised
for symptomatic treatment and for generally mild conditions. If Schedule
A restrictions are eliminated, advertising of non-prescription products
will focus on health conditions that normally require diagnosis and treatment
by a health professional. There is a risk of creating an imbalance in
the types of messages reaching the public about different classes of health
products and treatment options indicated for the prevention and treatment
of serious diseases. This is likely to create additional pressure from
manufacturers of prescription-only drugs for legalization of DTCA. Additionally,
prevention and treatment strategies that do not involve product sales
(such as wearing protective clothing, quitting smoking, exercising, losing
weight or reducing stress) will not receive the attention of product-specific
strategies, even when they are the most effective options available.
Should the scope of a law be limited through redefinition of terms?
We have strong concerns about the short-term recommendation being put
forward by the Working Group, as an example of an attempt to radically
limit the scope of an existing law through administrative policy. Such
an approach bypasses the need for full public and parliamentary debate,
and is antithetical to a commitment to accountable, open and transparent
government.
The following changes to the definition of terms in the law are being
recommended:
Redefinition of prevention to mean 'absolute' or '100%' prevention.
All other forms of prevention would be called 'risk reduction', which
is not mentioned in the law, and therefore would lie outside the scope
of the law.
This recommendation is neither in keeping with the spirit of the current
law, common understanding of the term prevention, nor the way that Section
3 has been interpreted during the last 50 years of the Food & Drugs
Act's implementation. We question whether it would stand up to judicial
review.
No product currently available for prevention of any of the listed Schedule
A diseases has the capacity to prevent the disease absolutely. Thus,
under the recommendation being put forward by the Working Group, the
prohibition on advertising of products for prevention would be eliminated
through the redefinition of such activities as promotion of risk reduction.
- Redefinition of 'treatment' to include only disease-modifying treatment,
not symptomatic treatment. Although not as drastic as the redefinition
for prevention recommended above, this is a recommendation to limit
the scope of the law by redefining terms within it. Many treatments
have both a symptomatic and a disease-modifying function, and in practice,
this redefinition would create the need for a more complex approach
to enforcement. Additionally, it is inconsistent with common understanding
of the word 'treatment'. Under current law, advertisers may state that
a drug provides symptomatic relief, and may specify the condition or
disease if it is not covered by Schedule A (i.e. the majority of minor
illnesses that are self-treated and do not generally require medical
intervention to prevent serious complications.)
Recommendations
1. Enforcement
Under current law, there is a need for effective, adequately resourced,
enforcement procedures, with active monitoring, adequate standards, correction
of misinformation that reaches the public, and effective prevention of
repeat violations. Additional public resources are needed. Enforcement
should be regularly evaluated, to ensure not only that the information
in advertisements is consistent with approved product labelling, but that
the message as understood by the public is consistent with a product's
characteristics and potential health effects, both beneficial and harmful,
including the proportion of people helped or harmed and the magnitude
of effect.
2. Schedule A Diseases
Most of the listed Schedule A diseases are serious and require medical
care, such as cancer, heart disease or kidney and liver disease. However,
Schedule A also includes some historical anomalies. We
recommend that the list be rationalized by applying an international disease
classification system that is currently in use for diagnostic coding in
medical care, and disease surveillance at a population level, such as
ICD-10.
The following criteria should form the basis for current and future inclusion
of diseases in Schedule A:
- The condition or disease results in a serious risks to individual
or public health, and/or generally requires diagnosis, treatment or
management by a health professional
- The disease is likely to spread without appropriate treatment
- Emergency situations where self care is inappropriate
- The severity of the disease limits the person's ability to make health
decisions
- The disease state is new and still under investigation
- The disease or condition is one which renders individuals especially
vulnerable to harm from unnecessary exposure to drugs and other health
care products (for example risks of teratogenicity through pregnancy-related
exposures, and specific risks to infants and children)
Criteria for inclusion of diseases in Schedule A, currently and in the
future, should provide guidance to government. These should not be inflexible
rules, but rather should allow the flexibility, should a future need arise
on public health grounds, to limit advertising of health products to the
public.
The members of the Working Group were asked to go through the list of
diseases in Schedule A and recommend modifications based on a similar
set of criteria. This exercise clarified for us the potential differences
in interpretation of such sets of criteria when they are applied to specific
diseases or health conditions. We therefore strongly
recommend that the criteria above be used broadly for guidance, with a
key emphasis on health protection, and that the final decision for inclusion
or exclusion of Schedule A diseases be left with a committee of independent
experts in public health.
3. Ensure that provisions governing advertising and product labelling
are separated within the law.
The current definition of advertising within the Food & Drugs Act
is clear and broad enough to cover a range of activities including indirect
as well as direct product promotion. We suggest that the 1996 Health Canada
Guidance Document "The Distinction Between Advertising and Other
Activities" be reviewed. In our opinion, this guidance document restricts
the definition of advertising and has contributed to an inconsistent approach
to enforcement of the law. We support labelling
of products that is consistent with approved product information. Labelling standards for products that a person buys directly from a drugstore
or a health food store should be as high as for prescription-only products.
Additionally, if the standards for evidence used to approve a specific
product for a Schedule A disease are lower because of the product's classification
(for instance not classified as a drug), this should be made clear to
the consumer, in a prominent manner, on the label, including a description
in plain language of the type of evidence provided.
4. Provide adequate resources for independent, unbiased information
on all available options for disease prevention, treatment and cure, including
information on Schedule A diseases.
This should be publicly financed, and should be produced only by individuals
and organizations with no apparent or real conflicts of interests involving
producers of health products or the media.
5. Fully accountable, transparent regulatory procedures are needed.
All laboratory, animal and clinical studies of safety and effectiveness
of a product that have been submitted to Health Canada in order for a
company to obtain market approval for a product used to prevent, treat
or cure a Schedule A disease should be publicly available. Additionally,
meetings of expert advisory committees discussing such product approvals
should be conducted in public, and the rationales for regulatory decisions,
should be made public.
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