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
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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
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!
…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: [email protected]
• Regulatory Advertising SectionTel.: (613) 960-2868Facsimile: (613) 948-7996E-mail: [email protected] site – Health Canada’s Regulatory Requirements for Advertising:http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index-eng.php