Federal/Provincial/Territorial Regulation of Consumer Health Products
(For Information only)
Summary:
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The Federal and Provincial/Territorial governments all have a role in regulating over-thecounter medicines and natural health products (consumer health products).
The F/P/T overlap in regulating conditions/place of sale creates delays in consumer access
to new products, which is compounded by delays imposed by international obligations, and
adds layers of complexity and costs for industry,
Separating the product approval and conditions of sale decision-making processes, makes
both more difficult for regulators and more onerous for industry.
Consumer Health Products Canada (CHP Canada) is seeking federal leadership to integrate
and streamline the decision making process for approving and determining the
conditions/place of sale for consumer health products at the federal level.
Background
The Federal and Provincial & Territorial governments all play a role in the process for regulating
consumer health products.
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The process begins with the Federal government’s (Health Canada) decision to approve a product for
sale in Canada, and a determination as to whether the product can only be sold with or without a
prescription.
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When Health Canada approves the “switch” of a product from a prescription drug to nonprescription status, the Prescription Drug List (established under the Food and Drug’s Act) is
amended to enable the ingredient at a certain dose, route of administration or for a specific
use, to be made available without a prescription.
Because Canada's system is ingredient based, rather than product based, the "switch"
applies to all competing products with the same formulation.
The act of switching an ingredient is considered a technical regulation as per the World Trade
Organization's (WTO) Technical Barriers to Trade Agreement. As such, Health Canada must
notify the WTO and its member countries and delay the finalization of the switch for at least 6
months in order to give enough time for competitors to adapt to the change.
The “switch” process then continues with the Provincial/Territorial governments, under the authority
derived from their respective Pharmacy Acts, who re-assess the need for a prescription requirement
and consider further conditions of sale, through drug scheduling.
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For example, some consumer health products can only be sold through direct pharmacist
intervention and are located behind the pharmacy counter; other products require a
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pharmacist to be present and must be sold in a pharmacy, while other consumer health
products can be sold in any retail outlet.
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The National Association of Pharmacy Regulatory Authorities (NAPRA) was established in 1995 in
part to achieve national harmonization of the conditions of sale for consumer health products by
establishing National Drug Schedules.
However, not all provinces fully recognize the National Drug Schedules and retain separate
processes for regulating the conditions of sale for consumer health products, which has created
delays for market access and inconsistencies how products are permitted to be sold across the
country.
Current Status
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The cumulative effect of (1) Health Canada’s review process for switching an ingredient (2) the
resulting WTO notification process and (3) the duplication of the federal decisions at the provincial
level has created lengthy and unpredictable switch process for industry. As a result, Canada trails its
major trading partners in attracting new consumer health products to the market.
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Canadians typically wait 7-9 years longer than consumers in the US or EU to gain access to
new consumer health products that have been switched from prescription status.
In 2014 (and confirmed in 2016) Health Canada launched a new initiative to develop a “Consumer
Health Product Framework”. The proposal describes their vision for an integrated governance
approach to consumer health products that could be used to bring together the federal Health
Portfolio, the provincial and territorial governments and relevant stakeholder associations to address
point of sale issues for these products.
NAPRA is questioning its ongoing role in the National Drug Schedules for a variety of reasons,
including: the lack of a legislative and regulatory framework to underpin its role; the lack of an
adequate consultative and policy capacity to maintain the National Drug Schedules in a changing
healthcare and industry landscape; and, concerns about the ability to enforce the drug schedules in
non-pharmacy settings.
The provincial drug scheduling process leads to uneven access to consumer health products, from
province to province, especially to new products that have had the prescription requirement removed
federally.
Provincial red tape can lead to delays in access to new products (up to two years in the case of
British Columbia) after the prescription requirement is removed federally. During this time, consumers
must continue to seek a prescription from their doctor for these products.
The NAPRA scheduling decisions sometimes conflict with the Health Canada decision, reversing the
decision to remove the prescription requirement for certain subsets of products/patients.
Considerations
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Federal integration of drug scheduling would:
o Allow for better decision making, by allowing product approvals to be made with full
knowledge of and control over the conditions under which the product will be sold.
o Reduce unnecessary duplication and red tape, and produce more consistent and predictable
outcomes for industry and consumers.
o Speed access to new consumer health products and reduce unnecessary doctor visits by
eliminating the need to revisit the federal decision at the provincial level
o Align with the Canadian Council of the Federation’s commitment to strengthen and
modernize the Agreement on Internal Trade to achieve the free flow of foods across the
country, strengthen Canada’s economic union and create a level playing field for trade within
Canada.
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Aligns with the recent F/P/T re-engagement on strategies to improve access to affordable
medicines and provides an ideal forum to discuss a way forward.
A two-stage switch process would:
o Streamline the regulatory process while still respecting international notification requirements,
is in line with the governments ongoing work to reduce regulatory red tape.
o Be feasible through policy, within the current regulatory framework.
Recommendations and Rationale
Federal, Provincial and Territorial governments have a role to play to resolve barriers to internal trade and
innovation that have been imbedded within the process for switching a product from prescription to nonprescription status. CHP Canada is seeking:
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Federal leadership to integrate the drug scheduling process within the consumer health product
approval process at the federal level, under existing authorities in the Food and Drugs Act.
o This would centralize decision-making where there is adequate administrative and policy
capacity and lead to better outcomes for Canadian consumers, the healthcare system and
industry.
Provincial leadership and the identification of provincial champions to work toward putting the
integration of the drug approval and drug scheduling processes on the F/P/T pharmaceutical policy
agenda.
Federal action to establish a two-stage switch process at the federal level that would enable products
to be switched first, followed by ingredient switches.
o Health Canada could utilize the existing “qualifier” section of the Prescription Drug List to
initiate a product-based switch using the Drug Identification Number or other identifying
information for the product.
o Following a period of time that could be used to both provide market exclusivity to the product
sponsor and satisfy the WTO notification requirements, Health Canada could then switch the
ingredient.
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