The Health Canada Policy Toolkit for Public Involvement in Decision
Making
Level 3 Case Study:
Direct to Consumer Advertising
Background
Therapeutic Products Programme (TPP), within the Health Protection
Branch (HPB), began a public consultation process in order to develop
a renewed regulatory program governing the advertising of prescription
drugs. The overall purpose of the consultation process is that
it address the concerns of stakeholders and acknowledge present
realities, while continuing to meet health and safety objectives.
There are many conflicting views on the Direct to Consumer Advertising
(DTCA) subject among stakeholders. Some would like to see no restrictions
on DTCA while some would like a complete ban of DTCA - few are
satisfied with the current situation.
Presently, DTCA of prescription drugs to the general public is
limited under the Food and Drugs Act and Regulations. The Act includes
an outright prohibition on the advertising of any drug to the general
public as a treatment, preventative or cure of any diseases, disorders
or abnormal physical states, listed in Schedule A to the Act (section
3). Schedule A includes such diseases as cancer, diabetes and heart
disease. The Act also prohibits the sale or advertising of any
drug in a manner that is likely to mislead or deceive the public
(section 9).
The Regulations limit advertising of prescription drugs to the
name, price and quantity of a drug. DTCA of non-prescription drugs
is allowed, and is regulated under the Food and Drugs Act and administered
by Advertising Standards Canada (ASC). As well, the Pharmaceutical
Advertising Advisory Board (PAAB) administers advertising of prescription
drugs to practitioners, which is allowed. The TPP retains authority
for enforcement and compliance in relation to drug advertising,
and provides advice and guidance relating to advertising as required
to the PAAB and ASC. At this time, no single source of comprehensive,
balanced drug information for consumers exists in Canada.
As prescription drugs are available only through the intervention
of at least two health professionals, the physician and pharmacist,
some parties may argue that the current health care system has
enough checks and balances to ensure consumer health and safety.
Thus, it is argued that the current provisions limit free commercial
speech. Some stakeholders have even called for a challenge of the
law under the Canadian Charter of Rights and Freedoms.
If such a challenge succeeded, the current regulation would be
struck down, allowing unlimited DTCA in Canada without any health
and safety review of materials being possible.
Why Seek Public Involvement?
Increasingly, consumers are being encouraged to engage in shared
decision making. Also, consumers are asking for a say in policy
decisions that affect them. They are becoming partners with health
care practitioners in making treatment choices and consumers are
seeking objective information about prescription drugs. In addition,
there is a trend toward self-care. Some good sources of drug information
have been developed but these are not readily accessible or even
known to all consumers.
The TPP Policy Development guide iterates that for significant
and/or complex policy questions, consultations are appropriate
during as many as three stages: on the issue analysis (definition
of problem or issue), on the alternative solutions generated, and
on the ranking and selecting of the solutions. Due to the scope
and complexity of the DTCA issue and the impact it has on all Canadians,
the TPP chose a process which included public involvement at each
of these phases in the policy development process.
Who Was Involved?
The TPP worked internally with the Continuous Assessment Division
of the Bureau of Drug Surveillance, the Bureau of Veterinarian
Drugs, the Health Systems Policy Divisions of PCB, and Legal Services,
Health Canada. In addition, there was communication/coordination
with the Health Protection Branch Transition team and the TPP's
Working Group on Advertising.
Direct to Consumer Advertising
Public consultations included key stakeholders from various sectors;
provinces, government, academia, health practitioners, pharmaceutical
industry, consumer advocacy groups, media, advertisers and non-governmental
associations.
Description of the Process
The DTCA public involvement initiative has four distinct phases:
1. Initial Policy Analysis
The first phase, which took place from June 1996 until July 1998,
included internal and external consultations to evaluate the issues
and aimed at forming consensus around the goals and objectives
regarding the dissemination of information on prescription drugs.
The TPP initiated the regulatory review process of DTCA with a
multi-stakeholder consultation workshop that was held in June 1996.
Attendees at that session included representatives from the provinces,
academe, health practitioners, pharmaceutical industry, consumer
advocacy groups and the media. The task for participants in this
workshop was to provide their advice and opinions on the objectives
for DTCA regulations.
The objectives reached through this public involvement initiative
were to develop a regulatory framework that addresses key principles
in relation to DTCA, including:
- ensuring consumer safety
- ensuring that consumers have information to assist them in
making informed choices
- respecting the roles of health care practitioners
- respecting health care cost concerns
- providing a "made in Canada" approach that is enforceable as
well as consistent with the Charter.
In response to the outcomes from the multi-stakeholder workshop,
the provinces requested an opportunity to study DTCA from their
perspective. Bilateral consultations with the provinces and territories
took place in 1997-98. They reiterated their preference for a continued
ban on DTCA for prescription drugs.
2. Generation of Solutions
In fall 1998, the next phase of the consultative process began
when the TPP brought together a small group of stakeholders to
look at the DTCA issue in order to generate a spectrum of available
policy options and to assist the TPP in the design of the next
multi-stakeholder consultation workshop to be held in April 1999.
3. Assessment of Alternatives
In phase three, a small number of options were assessed by estimating
the pros and cons associated with each alternative. This was done
through a broad external consultation. The consultation session
on DTCA, hosted by the TPP, took place April 14-16, 1999. The views,
concerns and comments of stakeholders with respect to the options
developed during the second stage for a revised regulatory framework
for DTCA of prescription drugs. An "As Said" report was produced
in June 1999, and posted on the TPP website in August. All guidance
documents and policy directives pertaining to drug advertising
are also posted on the TPP website: this promotes transparency
and enhances understanding of the federal government's role with
respect to drug advertising.
4. Final Decision and Implementation
Analysis of the consultation materials will be undertaken in the
hope of developing long-term policy propositions, and eventually
to initiate a policy implementation plan. A small set of options
will be put forward for further analysis. One preferred option
was determined unavailable during phase three due to the breadth
of opinion of participants. These options must be endorsed by TPP
management and then further consultation on the subject can take
place, coordinated with HPB Transition's Legislative Renewal. After
these broader discussions take place, a preferred option will be
selected and draft regulations, guidelines, codes of conduct, etc.
will be produced. All of this will then be the subject of another
round of consultations. Only then can a final decision be made
and departmental approval requested.
Resources
Expenditures on the consultative processes used by the TPP over
the past three years have totalled approximately $50,000. For information
on other expenditures, contact Ross Duncan.
Summary of the Outcomes
As of the middle of August, the DTCA initiative is concluding
phase three of the process. The April 1999 consultation session
on DTCA of prescription drugs investigated a number of options.
However, given the lack of data and breadth of opinion regarding
DTCA of prescription drugs, no preferred option was agreed upon.
The options which were reviewed during the workshop included:
- Current Model (see Background section above)
- DTCA by any party allowed for a subset of prescription drug
products, those with an acceptable post-market safety profile,
and under defined circumstances (adherence to codes of practices
that
relate to form and content)
- DTCA by any party allowed for all prescription drugs under
defined circumstances, such as adherence to codes of practices
for form and content
- Other models put together by participants
- Eliminate name, price and quantity exemption in the Regulation.
Allow no DTCA of prescription drugs. Achieve information through
a national drug information system.
- Phased approach - Move from the status quo to option two and
eventually option three. Test results as you proceed and tailor
the next phase of implementation to findings.
Analysis
This consultative process was effective in informing and educating
key stakeholders about the role of the TPP with regard to DTCA:
its responsibilities; its working relationships with others; the
current state of research on the health and safety effects of DTCA
(via a literature review); and potential options. This process
greatly enhanced a multi-sectoral dialogue on this health protection
issue. It stimulated thinking and collaboration on key issues and
approaches to advertising and information dissemination for prescription
pharmaceuticals. To date, the consultative process has helped TPP
determine what options were available, and has helped to TPP come
to a better understanding of the opinions of the stakeholders on
DTCA, in order to assist in the decision-making process.
Factors for Success
The consultation informed stakeholders of regulatory issues and
concerns. The process led to a better understanding among the stakeholders
of the perspectives and problems of each group that participated.
Most importantly, it enabled the stakeholders to understand all
of the issues faced by the regulator.
There is ongoing coordination of research into the health and
safety effects of DTCA within the TPP itself and with other parts
of Health Canada, as well as with the U.S. Food and Drug Administration.
Barriers to Success
The breadth of opinion was very great. There were areas where
divergent opinions were evident among the group. Some parties believed
that prescription drug advertising, if regulated effectively, can
be a good means of disseminating high-quality information to consumers,
patients and the general public. Other parties felt that the fundamental
nature and goals of advertising make it an inappropriate mechanism
for the dissemination of high-quality information to consumers,
patients and the general public.
The selection process for participants at the TPP workshops relied
to a certain degree on the interest of stakeholders in the issue
and the knowledge of TPP staff as to parties that would clearly
add to the quality of the debate. In order to fully capture the
opinions of the broadest possible range of affected parties, however,
a more thorough participant selection process might have proven
useful.
The lack of evidence that DTCA would result in benefits which
outweigh the cost implications, and the absence of data which show
that DTCA has a positive or at least a neutral impact on utilization/health
and safety, made it difficult for the groups to come to an informed,
collective decision on the DTCA issue.
Policy Implications
This type of consultative process may be transferable to guide
policy decisions on other health-related issues. The process can
lead to better understanding and communication of the concerns
and problems of stakeholders and government.
The long-term impact in this case, however, cannot be discerned
at this time due to the lack of data on the health impact caused
by DTCA of prescription drugs.
Public Involvement Techniques Used
- Workshops
- Web-based documentation and communication
- Coordination of research efforts between levels of government
(federal/provincial)
Contact information
Ross Duncan
Policy Analyst
Therapeutic Products Directorate, Policy Division
Healthy Environments and Consumer Safety Branch
(613) 941-6226
Ross_Duncan@hc-sc.gc.ca
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