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transcript
Health Canada’s Regulatory Oversight
Medical Devices Advertising
2016 MEDEC Regulatory Conference
Transformation through Collaboration
May 10, 2016
10:30 – 11:00
Alain Musende, PhD
Manager, Regulatory Advertising Section
Marketed Health Products Directorate
• To provide an overview of Health Canada’s regulatory
oversight on health product advertising, with a focus on
medical devices.
• A key aspect of the discussion will involve the upcoming
development and inclusion of medical device advertising
guidance in the Consumer Advertising Guidelines (CAG) for
Marketed Health Products.
Purpose:
Medical Device Advertising Oversight
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Why Regulate Health Product Advertising
To protect the health and safety of Canadians
Mandated by law
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Dynamic interaction
HealthCanada
Guidance DocumentsApplicable Federal Statutes: -F&DA and R
-CDSA
AssociationCodes
APACodes Health Product
Advertising
A P A Industry
APA: Advertising Preclearance AgencyCDSA: Controlled Drugs and Substances ActF&DA and R: Food & Drugs Act and Regulations
Context
General Public
Context (Continued)
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Direct-To-Consumer-Advertising
Restricted
Prescription Drugs
Permitted
Over-The-Counter
Natural Health
ProductsVaccines Medical
Devices
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Health Canada’s (HC) Roles
National regulatory authority for health product advertising.
Sets the parameters under which health products are marketed in
Canada (e.g. Product Monograph).
Puts in place regulations and policies to effectively regulate
marketed health products.
Provides guidelines for the interpretation of the regulations.
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Roles of Advertising Preclearance Agencies (APAs)
APAs perform the following: Offer independent mechanisms to resolve complaints
Review and preclear health product advertisements to verify that they are
compliant, accurate, balanced and evidence-based
The Canadian advertising preclearance system for marketed health
products is: A self-regulatory system
A voluntary system
Required by some industry associations for their members
Strongly recommended by Health Canada
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Review and Preclearance of Health Product Advertising
Complete information in the Guidance Document entitled “Health Canada
and Advertising Preclearance Agencies’ Roles Related to Health Product
Advertising” (http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_apa-
pca-eng.php).
Advertising materials for all health products directed to healthcare
professionals:
Pharmaceutical Advertising Advisory Board (PAAB) (www.paab.ca).
Advertising materials for nonprescription drugs and natural health products
(NHPs) directed to consumers: Advertising Standards Canada (ASC) (www.adstandards.com)
Extreme Reach (www.extremereach.com)
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Roles of Industry and Other Stakeholders
Industry and other stakeholders, such as physicians, are responsible
for:
Meeting the federally legislated requirements for advertising of
health products.
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Section 2 – Food and Drugs Act:
“Advertisement” includes any representation
by any means whatever for the purpose of
promoting directly or indirectly the sale or
disposal of any food, drug, cosmetic or
device.
Current Regulatory Requirements for Advertising
Note: Health Canada uses the policy “The Distinction Between Advertising
and Other Activities” to distinguish promotional campaigns from information.
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Section 20(1) – Food and Drugs Act:
No person shall label, package, treat, process,
sell or advertise any device in a manner that is
false, misleading or deceptive or is likely to create
an erroneous impression regarding its design,
construction, performance, intended use, quantity,
character, value, composition, merit or safety.
Current Regulatory Requirements for Advertising (continued)
Objective: To encourage advertising that is accurate and truthful, which will
help Canadians make informed decisions about their health.
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Section 3(1) – Food and Drugs Act:
No person shall advertise any food, drug, cosmetic or
device to the general public as a treatment, preventative or
cure for any of the diseases, disorders or abnormal
physical states referred to in Schedule A
Current Regulatory Requirements for Advertising (continued)
Note: Diseases listed in Schedule A to the Food and Drugs Act, such as
cancer, diabetes and depression, all require medical intervention.
Objective: To discourage self-diagnosis, self-medication and self-treatment of
serious diseases.
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Section 27(a) – Medical Devices Regulations:
No person shall advertise a Class II, III or IV medical
device for the purpose of sale unless the
manufacturer of the device holds a licence in respect
of that device…
Current Regulatory Requirements for Advertising (continued)
Objective: To avoid:
Health risks that may be caused by products with unknown
benefit/risk profile and quality.
Promotion of unauthorized claims (off-label promotion).
• The CAG provide guidance to industry for the development
of advertising material for non-prescription drugs and
natural health products that is in compliance with Section
9(1) of the Food and Drugs Act.
• Developed in a collaborative effort between Health Canada
and Advertising Standards Canada (ASC), which has the
lead.
What is the Consumer Advertising Guidelines for Marketed Health Products (CAG):
Medical Device Advertising Guidelines
Lack of Medical Device Advertising GuidanceMedical Device Advertising Guidelines
Section 9(1) – Food and Drugs Act:
No person shall label, package, treat, process, sell or advertise any drug
in a manner that is false, misleading or deceptive or is likely to create an
erroneous impression regarding its character, value, quantity, composition,
merit or safety.
Section 20(1) – Food and Drugs Act:
No person shall label, package, treat, process, sell or advertise any
device in a manner that is false, misleading or deceptive or is likely to create
an erroneous impression regarding its design, construction, performance,
intended use, quantity, character, value, composition, merit or safety.
• Since the CAG is currently under revision, it was deemed
relevant to take this opportunity to include medical device
advertising content.
• The inclusion of medical device content in the CAG will be
beneficial to the medical device industry and advertisers as
it will provide them with a tool to ensure consumer
advertising material compliance and to implement best
practices within their respective organizations.
Revision of the CAG
Medical Device Advertising Guidelines
• The medical device content will be consistent with the
current Health Canada licensing framework for classifying
medical devices (Class I to IV).
• The medical device content will assist industry in
developing consumer-directed medical device advertising
that is not false or misleading, and is fair and balanced (i.e.
in compliance with Section 20(1) of the Food and Drugs
Act).
Scope of the GuidelinesMedical Device Advertising Guidelines
• The medical device content will relate to lack of fair balance,
exaggeration of merits, omission of safety information, promotion
of off-label use, etc.
• The medical device content will focus on medical devices
advertised for sale to and purchased* by the general public and
not those advertised to healthcare professionals or institutions.
* This will include guidelines for medical devices that could be purchased by the
general public but for which the recommended use is through a healthcare
professional (dermal fillers, intrauterine devices, dental adhesives, etc.)
Medical Device Advertising Guidelines
Scope of the Guidelines (Continued)
• The medical device content will not include the advertising
of medical procedures involving the use of medical devices
by healthcare professionals and where the general public
does not purchase the medical device per se (e.g. laser
eye surgery equipment, laser hair removal equipment,
liposuction device, etc.).
Medical Device Advertising Guidelines
Scope of the Guidelines (Continued)
Class I
• Since there are no authorized indication claims for Class I
medical devices, the focus would be on ensuring that ads
are not false, deceptive or misleading and do not include
claims related to the prevention, treatment, or cure of
Schedule A diseases.
Proposed ApproachMedical Device Advertising Guidelines
Class II
• Since Class II medical devices are to attest for compliance
in terms of safety and effectiveness, and intended use
(section 32(2) of the Medical Devices Regulations), the
focus will be on ensuring consistency between the
advertised claims and the Attestation for Compliance.
Proposed Approach Medical Device Advertising Guidelines
Class III & IV
• Since Class III and IV medical devices are to be authorized
for sale by Health Canada following the review and
approval of a submission of a label and safety and
effectiveness studies (or summary) as evidence for claims
(Section 32(3) and 32(4) of the Medical Devices
Regulations), the focus will be on ensuring consistency
between the advertised claims and those authorized by
Health Canada.
Proposed Approach Medical Device Advertising Guidelines
• Led by ASC
• Stakeholders will be provided with the opportunity to
provide feedback and recommendations through a formal
consultation period (planned for this summer).
• The finalized document will always remain readily and
freely accessible to anyone in both official languages.
• The document will always be in accordance with Health
Canada’s interpretations of the applicable health product
advertising legislative and regulatory provisions.
Revision of the CAG & Incorporation of MD GuidelinesMedical Device Advertising Guidelines
• Health Canada is aware of the regulatory burden that this may
create to sponsors.
• Health Canada believes that the risks associated with a
combination product can be managed appropriately under one
set of regulations.
• With the announcement of the Drug / Medical Device
Combination Products Policy, drug/medical device combination
product classification decisions will consider the principal
mechanism of action by which the claimed effect or purpose of
the product is achieved.
Drug / Medical Device Combination Products Policy
Drug / Medical Device Combination Products Policy
• A combination product will be subject to either the Medical
Devices Regulations or the Food and Drug Regulations according
to the principal mechanism of action by which the claimed effect
or purpose is achieved:
– Where the principal mechanism of action by which the claimed effect or purpose is achieved by pharmacological, immunological, or metabolic means, the combination product will be subject to the Food and Drug Regulations.
– Where the principal mechanism of action by which the claimed effect or purpose is not achieved by pharmacological, immunological, or metabolic means, but may be assisted in that effect or purpose by pharmacological, immunological, or metabolic means, the combination product will be subject to the Medical Devices Regulations.
• Insulin injector pens (without insulin) are considered medical
devices. Advertising of these products must comply with:
Section 27 of the MDR (Class II)
Section 3 and 20 of the F&DA.
• Injector pens sold with an integrated insulin cartridge (i.e. injector
pens pre-filled with insulin) are drug/medical device combination
products. They are classified and regulated as drugs under the
F&DR since it is the drug component that is providing the
therapeutic effect.
Advertising of Insulin Injector Pens
Advertising of Insulin Injector Pens
Notes:• Since insulin is a Schedule D drug, the advertising of pre-filled insulin
pen injectors is not subject to the name, price and quantity restrictions set out in Section C.01.044 of the F&DR.
• Direct-to-consumer advertising of insulin injector pens is not a contravention of Section 3 of the F&DA (although diabetes is a Schedule A disease)…. except if such an ad is associated with a diabetes messaging or in a diabetes context.
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Example The new « buzz » in Canada for quitting smoking!
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
We were able to get rid of the nicotine part…
…had to replace it with our noniconicline substance…
…but couldn’t find a new trendy delivery tool!
Brought to you by the maker of WateryPatch, PlaceboPatch, Where’sMyPatch & NonStickyPatch
It works!
No Nicotine involved….but with a Patch!!!
NoNicoPatch The newest way to interfere with your nicotine receptors in the brain
Drug / Medical Device Combination Products Policy
• As it is the case for nicotine patches, NoNicoPatch is regulated as a drug under the F&DR since the claimed effect or purpose is achieved primarily by pharmacological means.
• However, unlike other patches, the delivered substance (noniconicline) has been added to the Prescription Drug List and therefore, advertising to the general public is restricted to the mention of name, price and quantity.
• Therefore, since the NoNicoPatch Ad both mentions the name of the product and the therapeutic indication of the product, it is considered in contravention of section C.01.044 of the F&DR.
• It could also be considered misleading and in contravention of Section 9(1) of the F&DA as it sends the message that success will be achievedby anyone using NoNicoPatch.
NoNicoPatch Ad
• IUDs impregnated with a drug are considered drug/medical device combination products.
• Since, in this case, it is the drug component that is providing the therapeutic effect (e.g., conception control) – while the device component acts mainly as a drug delivery tool - these are regulated as prescription drugs under the Food and Drug Regulations.
• Therefore, direct-to-consumer advertising of drug impregnated devices is restricted to the mention of name, price and quantity (Section C.01.044 of the F&DR).
Advertising of Drug Impregnated Intra-Uterine Devices (IUDs)
Advertising of Drug Impregnated Intra-Uterine Devices (IUDs)
Drug Impregnated IUDs IUDs without a drug component
Classification Drug Medical Device
Applicable legislative provision
Section 3(3) Food and Drugs Act : “Except as authorized by regulation, no person shall advertise to the general public any contraceptive device or any drug
manufactured, sold or represented for use in the prevention of conception.”
Applicable regulatory provision
Section C.01.044 Food and Drug Regulations: “Where a person
advertises to the general public a Schedule F Drug, the person shall not
make any representation other than with respect to the brand name, proper name, common name, price and
quantity of the drug.”
Section 24(2) Medical Devices Regulations: “[…] contraceptive devices, other than intrauterine devices, may be advertised to the general public by any means other than by the distribution of samples of the devices door-to-door or
through the mail.”
Impact on Advertising Advertising to the general public is allowed as long as it does not exceed
name, price and quantity (reminder ads)
Advertising to the general public is completely prohibited
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Conclusion
Health Canada is committed to protecting the health and
safety of Canadians by maintaining regulatory standards for
the advertising of health products.
Health Canada continues to work with advertising
preclearance agencies and industry to accomplish this
goal.
Health Canada is taking concrete steps toward greater transparency.
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Contact:• Alain Musende, PhD
Manager, Regulatory Advertising SectionMarketed Health Products DirectorateHealth Products and Food BranchTel.: (613) 954-6780 Facsimile: (613) 948-7996E-mail: alain.musende@hc-sc.gc.ca
• Regulatory Advertising SectionTel.: (613) 960-2868Facsimile: (613) 948-7996E-mail: mhpd_dpsc-advertising_reg_publicite@hc-sc.gc.caWeb site – Health Canada’s Regulatory Requirements for Advertising:http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index-eng.php