health canada’s regulatory oversight medical devices...

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

4

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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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


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…


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


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.


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


• 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.)


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.).


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


• 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


• 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