As referenced by John Adams in his 2024 CCSN Webinar on the US importing drugs from Canada, this is a slide deck from Health Canada which outlines the timetable and actions taken by the government on this particular issue.

1. 1
Canada's Response to Foreign Bulk Importation Programs
Special MSSC Meeting
February 1, 2024

2. 2
Purpose
Provide context and history of US importation
programs
Summarize Health Canada’s actions to
protect Canada’s drug supply
Outline the status of US importation programs
and Health Canada’s next steps

3. 3
Context
• Other countries importing drugs intended for the Canadian market in bulk could cause or exacerbate drug
shortages in Canada.
➢ Canada is a small market vulnerable to drug shortages.
➢ More than two-thirds of the drugs we consume (68%) are imported.
➢ 10-15% of drugs marketed in Canada are in short supply at any given time.
• November 30, 2020: A U.S. rule came into force allowing bulk importation of eligible prescription drugs from
Canada under a state-sponsored importation program approved by the US FDA
➢ Under “Section 804 Importation Programs” (SIPs), licensed US wholesalers or pharmacists can import, provided certain
conditions are met:
▪ Plans must not pose a risk to health and demonstrate “significant” cost savings
▪ Direct supply chain of one manufacturer, one authorized Canadian seller (DEL-holder) and one importer
▪ Drugs must be approved by both the US FDA and Health Canada
▪ Canadian sellers must be licensed by Health Canada for wholesaling (i.e., a drug establishment licence holder)
▪ Importation plans must be reauthorized after 2 years
▪ Amendments may add drugs or other participants (e.g., new Canadian seller) with US FDA approval
• January 5, 2024: Florida’s becomes the first state-sponsored importation program approved by the US FDA.

4. Health Canada Response to the U.S. Rule
March
2020
December
2019
November
2020
December
2020
August
2022
January 5,
2024
US introduces a
proposed rule
allowing bulk
importation of
Canadian
drugs.
Government of
Canada comments
on the US proposal
to publicly document
Canada’s opposition.
Canada makes an
interim order prohibiting
the sale of certain drugs
intended for the
Canadian market for
consumption outside
Canada if it would cause
or worsen a shortage.
The US rule comes into
effect.
Compliance promotion
activities to inform all
regulated parties of their
obligations under the
prohibition.
Florida and New
Mexico submit
proposals to the US
FDA.
August
2021
December
2022
The US FDA
approves
Florida’s state
importation
plan.
The Canadian
prohibition is made
permanent through
regulatory
amendments.
Florida files a lawsuit
against the US FDA
alleging that there
was an unreasonable
delay in approving
Florida’s proposal.
Colorado
submits a
proposal to the
US FDA.
4
Sept-Oct
2023
HC
conducts compliance
promotion
to remind industry of
its obligations under
the law for
exportation of drugs
intended for the
Canadians market

5. 5
The Food and Drug Regulations set out a measure to help safeguard the Canadian drug supply from foreign
importation programs.
• Under the regulations, DEL holders are prohibited distributing drugs meant for the Canadian market for use
outside of Canada if the distribution could cause or worsen a drug shortage in Canada.
• The DEL holder planning to distribute must determine that the distribution would not cause or contribute to
a shortage. A record must be kept of how the determination was made.
Regulations safeguarding Canada’s drug supply
This means that DEL holders must:
1. Complete a shortage risk assessment prior to the distribution of drugs meant for the Canadian market for use
or consumption abroad
 If distribution could cause or worsen a shortage: Distribution prohibited
 If distribution would not cause or worsen a shortage: Distribution permitted
2. Create and retain a detailed record of the information used to make the assessment. This record must be made
available to Health Canada upon request.
Key Features
Does not apply to drugs that are
manufactured in Canada for a foreign
market
Applies to all drugs subject to shortage reporting,
including any drug that could be imported under a
state-sponsored plan
Export for personal
use is not restricted
5

6. Canadian Response to Florida’s Importation Program
• The Minister has received assurances that the US government has no intention of creating access challenges for Canada
or triggering drug shortages.
• Minister Holland and Secretary Becerra have agreed that the two governments will work together to ensure Canada’s
drug supply is not negatively affected by importation programs.
• On January 8th, Senior Health Canada officials met with FDA Commissioner Robert Califf; a public statement was put out
by Health Canada the same day.
• On January 11th, the Minister of Health met with U.S. Ambassador David Cohen.
• On January 12th, the Minister of Health met with Health and Human Services Secretary Javier Becerra.
Canada expressed its disappointment to U.S. authorities and reiterated its position that bulk importation of drugs
from Canada is not an effective solution to the problem of high drug prices in the U.S.
Discussions between Canada and the U.S. on bulk importation have been productive
6
• A range of organizations have issued statements opposing bulk importation programs or indicated they will not
participate.
• Health Canada issued DEL bulletin 163 regarding regulatory obligations.
• The department also communicated directly with DEL holder and companies with drugs on Florida’s list.
Health Canada has worked closely with stakeholders to assess the sector’s response and promote compliance with
the regulations:

7. 7
Status of SIPs in US States
Implementation of state-sponsored importation programs
State Status
Florida Approved 2024-01-05
Colorado Pending
New Mexico Pending
New Hampshire Rejected due to incomplete submission
Maine, Texas, Vermont Legislation in place to allow a program, but no
formal proposal reported
12 states: Arizona, Hawaii, Illinois,
Michigan, Nebraska, New York, Ohio,
Pennsylvania, Tennessee, Virginia, West
Virginia, Wisconsin
Legislation introduced to allow a program but
not passed
Many US State governments have expressed interest in SIPs, but they are at different levels in
the development and approval process.

8. 8
Next steps
8
US engagement
➢ Continue to engage U.S. authorities through work with Canada’s
Heads of Mission and Trade Commissioners in the U.S. to reiterate
Canada’s position and gather intelligence on the advancement of
other state programs
Compliance Monitoring
➢ Actively monitor the Canadian drug supply
➢ Active compliance promotion with regulated parties to reinforce the regulatory
prohibition and their obligations
Stakeholder Engagement
➢ Continue to communicate Canada’s response to the U.S. rule and
state programs to address public concerns and provide assurance that
the Government of Canada will safeguard the supply of drugs for
Canada

9. 9
Questions?
References:
• Health Canada webpage on the prohibition on distributing certain drugs intended for the Canadian market for use
outside Canada
• Guide to distributing drugs intended for the Canadian market for consumption of use outside Canada → guidance
document to help DEL holders fulfill their regulatory requirements.
• DEL Bulletin on the regulatory requirements prior to distributing Canadian drugs outside Canada
• Compliance and enforcement policy for health products (POL-0001)→ policy on options that can be taken by Health
Canada for breaches in regulatory compliance
• Statement from Health Canada on FDA decision on Florida bulk drug importation plan
• Published readout from Minister of Health’s discussions with US officials on bulk importation of drugs