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Consumer Health Products Canada

What Keeps Us up at night?

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Our Vision

"We see a future where self-care is an integral

part of Canadian health care and the use of

consumer health products is optimized

through improved consumer knowledge,

supported by health care providers, payers

and regulators, and strongly influenced by

Consumer Health Products Canada.

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Our Mission

"To foster an environment for the growthof the evidence-based consumer health

products market.

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Our Broader Purpose

"To advance Canadian self-care by building an

environment that improves the opportunitiesfor people to manage their own health

through the responsible use of safe and

effective consumer health products."

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Top issues

Federal Health Policy Environment

Food and Drug Legislation

Regulatory consistency Changing market competition

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Federal Policy Environment

100,000 new public servants

Good people move (40%); others stay

No institutional memory Complexity (transparency = stakeholder

overload)

Gomery effect + Krever

Political influence institutionalized

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Impacts from Complexity

Central government increase in size (mostly fromoutside government 7:1)

Increased complexity (Multiple accountabilities =

slower process)

Increased political influence on policy

Increased visibility of political overlay

PMO centric Accountability Act shifts power to individuals

(civil libertarians vote and donate)

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Impacts from Complexity

Civil service is risk averse (if the public service

was a hockey team, it would be composed

entirely of goalies Anon DM)

Proliferation of special interest groups

PMO Staffer can be more powerful than a

Minister

Minority government focus on short term

issues

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Examples

NHP Astroturf campaign killed C-51

Departmental efforts thwarted by political intervention(NHP enforcement)

I

ntroduction of Risk in legislation

14.No person shall manufacture, process, label, package,sell, import for sale, or advertise a therapeutic productin a manner that is false, misleading or deceptive or is

likely to create an erroneous impression regarding itsbenefits, risks, conditions of use, quality, quality,composition, design, construction, performance, originor authorization status.

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Food and Drug Legislation

Section 14 Advertising

Confidential Business Information

Powers of the Minister and inspectors where the Minister (inspector) is of the opinion

that VS

where the Minister (inspector) upon reasonalbe

grounds believes that

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Regulatory consistency

NHP, Food, Device, OTC all are Consumer

health product regulatory encumbrances

All are different Products of similar risk should be regulated

the same

Vitamin A (Drinks, Pills, creams) NRT (patch, pill, gum)

Facial tissues with an antimicrobial

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Regulatory consistency

Having multiple delivery vehicles can increase

red tape from inconsistent regulations by

having to clear several diverse regulatory

systems

Standards of evidence should not change by

changing the delivery vehicle

SOE need to be robust enough to prevent

fraud and danger but related to risk

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Regulatory consistency

NHP regulation (unique; self care oriented)

Part C regulation (Rx oriented but capture

OTC) Medical devices (Class 1; self care oriented)

Food regulation (health claim system)

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Regulatory consistency

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Changing Market Competition

M&A impact on political voice (fewer voices)

Health Care debate (Costs continue tooutpace resources)

Changes to health profession legislationexpands everyones scope

Pharmacist prescribing impacts (Consumer

products and now Rx) Pharmacy is #1 competitor and by law #1

distributor

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Conclusion

Complexity

Conflicts

Drain on organizational resources

We are getting outflanked

Politics trump science

Civil libertarians vote