This document discusses concerns around safely implementing importation of drugs from Canada. It summarizes perspectives from experts in drug supply chain security and Canadian policy. They note that importation could undermine the Drug Supply Chain Security Act, as drugs from foreign markets don't use the same identifiers and documentation. It may also diminish Canada's drug supply and leave Americans without long-term solutions. The document outlines risks like counterfeiting and how Canadian authorities do not inspect all shipments. It questions whether importation could realistically work given these challenges to safety and oversight.

1. Can you safely implement
Canadian importation?
Shabbir Safdar, Executive Director, The Partnership for Safe Medicines
Dirk Rodgers, RxTrace
John Adams, Chair of the Canadian Best Medicines Coalition
Don Bell, former Canadian Border Services Agency

2. Dirk Rodgers
Dirk Rodgers is an independent
Track-and-Trace consultant who
founded of RxTrace.com, and has
25 years of experience solving
problems in warehouse and
supply chain automation IT
systems.

3. What the DSCSA is Designed
to Prevent—Epogen
“Uplabeling”
Diagram from “Dangerous Doses” by Katherine Eban, 2006
In November 2005, Timothy Fagan’s father (left),
and Maxine Blount’s brother (right) testified in
2154 RHOB about their family members’
suffering as a result of counterfeit Epogen and
Procrit.
Screenshots from C-SPAN

4. What the DSCSA is Designed to Prevent--Counterfeit Avastin
Betty Hunter was treated with counterfeit Avastin for lung cancer
in 2011. Ms. Hunter died three months later.
Source: Medicin der Dræber

5. What the DSCSA is Designed to Prevent, Levemir Theft
Drawing based on Katherine Eban article “Drug Theft Goes Big,” Fortune, 2011

6. How the DSCSA Works
● All supply chain participants must be authorized (licensed)
● Drugs are serialized in 2D barcode by manufacturer
● Standardized transaction documents required on each change
of ownership
○ Forces guardrails on how the supply chain works
○ Provides bi-directional evidence

7. The DSCSA Transaction Statement
“…the entity transferring ownership in a transaction—
● (A) is authorized as required under the Drug Supply Chain Security Act;
● (B) received the product from a person that is authorized as required under
the Drug Supply Chain Security Act;
● (C) received transaction information and a transaction statement from the
prior owner of the product, as required under section 582;
● (D) did not knowingly ship a suspect or illegitimate product;
● (E) had systems and processes in place to comply with verification
requirements under section 582;
● (F) did not knowingly provide false transaction information; and
● (G) did not knowingly alter the transaction history.”

8. Importation Is Unsafe and Cannot Meet the DSCSA
DSCSA tracing begins with original
manufacturer and documents the full
chain of ownership
Drugs from foreign markets don’t use
same identifiers and cannot meet the
documentation requirements.
Result: we have no reliable record of
where a drug was and who handled it
before it enters the U.S.

9. Undercutting the DSCSA would be expensive
The entire supply chain (manufacturers through pharmacies)
are spending more than $2 billion to implement the DSCSA
The DSCSA protects Americans from counterfeit and unsafe
medicines
Undermining these efforts would be costly and dangerous to all
American consumers

10. John Adams
John Adams is the current chair of
Canada’s Best Medicines
Coalition, a national alliance of
patient organizations with a
shared goal of equitable and
consistent access for all
Canadians to safe and effective
medicines. He is also President &
CEO of Canadian PKU and Allied
Disorders.

11. Canadians Respond:
Plans for Bulk Importation of Drugs
September 2019

12. Ensuring all Canadians have safe and timely
access to medications that have been shown,
based on best available evidence, to improve
outcomes for patients.
Best Medicines Coalition: Our Mission

13. Best Medicines Coalition: Who we are

14. Market reality:
▪ Canada has about one-tenth the population of the United States and about one-
tenth the drug supply
Consequences for Canadians:
▪ Mass importation will rapidly diminish Canadian drug supply
▪ Critical exacerbation of existing shortages C
Consequences for Americans:
▪ Not sustainable; mass importation an extremely short-term solution
▪ American patients will quickly be left with ongoing pricing and access challenges
Bulk importation from Canada: Will it work?

15. What does this mean for me as a Canadian patient?

16. Canadian response: Leading organizations speak out

17. Government of Canada technical briefing to stakeholders (August 20, 2019):
▪ The Government of Canada continues to monitor the situation and is engaging
U.S officials
▪ All options available to the Government to respond to this issue are being
considered
▪ Ensuring that Canadians have access to the medicines they need is a top priority
for the Government of Canada
▪ The Government is committed to improving the accessibility and affordability of
drugs in Canada
Canadian response: What our government is saying

18. Canadian Response: Various possible policy levers
Example: Food and Drugs Act amendments tabled 2005

19. Media Response: Canadian & U.S. interest

20. Canadian Response: Moving forward

21. The picture can't be displayed.

22. bestmedicinescoalition.org
john.adams@canpku.org

23. Don Bell
Don Bell is a 30-year veteran of
Canadian law enforcement who
served as chief superintendent
of the Ontario Provincial Police
and director of intelligence and
enforcement for the Canada
Border Services Agency.

24. “Trans-shipping”
“Canadian” drugs are not coming from Canada’s
approved drug supply.
Black market sellers acquire drugs from other countries
and evade inspection of them by trans-shipping them
through Canada.
Health Canada does not inspect or certify these
shipments.

25. Operation Pangea XI (October 2018)
● Joint effort between the Royal Canadian Mounted
Police (RCMP), Canada Border Services Agency (CBSA),
Health Canada and INTERPOL Ottawa.
● 3,586 packages inspected in eight-day blitz
● 87% of inspected seized or refused, as counterfeit
and/or unlicensed, such as illegal prescription drugs.
Counterfeit drugs are routinely shipped into and through Canada,
but are not inspected
Total street value CAD 1.4 million Annualized value CAD 63.9 million

26. Canadian Federal Industry Minister James Moore, National Post, Nov. 27, 2014
"Canadian authorities do not inspect every shipment of
products headed for the U.S. marketplace to ensure
that packages don’t contain adulterated, counterfeit or
illegal drugs. […] Canada’s health-inspection regime is
designed to ensure the safety of medications for
Canadians, not for other countries."
Leona Aglukkaq, Canada’s minister of health 2008-
2013
“The Government of Canada has never stated
that it would be responsible for the safety
and quality of prescription drugs exported
from Canada into the United States…”
Diane C. Gorman, Assistant Deputy Minister
of Health Canada, 2004
Not all packages from Canada come from inside Canada. Many are
transhipped without entering Canada

27. “Canadian” online pharmacies
Online pharmacies often brand
themselves as Canadian even
when the medicines they are
selling have not been produced
for the Canadian pharmaceutical
market.
Patients have trouble distinguishing real, licensed Canadian
pharmacies from drug sellers that pose as Canadian.

28. Quick trafficking routes to the U.S.
Organized crime will take advantage of importation loopholes
Industrial pill press – 18,000 pills/hour