This document discusses why importing prescription drugs from Canada is not a viable solution to high drug costs in the US. It notes that previous state-level importation programs failed due to lack of savings and inability to adequately regulate foreign pharmacies. Proper testing of imported drugs is very expensive and would consume any savings. There are also safety concerns, as importation would undermine track-and-trace systems and Canada's drug supply is already limited. Law enforcement experts warn that importation could exacerbate the opioid crisis and organized crime may exploit regulatory loopholes. The document argues policymakers should focus on real solutions rather than unrealistic importation proposals.

1. Why can’t we just
bulk import cheap
medicine from
Canada?
Shabbir Imber Safdar
Executive Director
Phone: 415-630-3736
Email: shabbir@safemedicines.org
August Webinar series
The Partnership is a coalition
of 70 healthcare professional,
wholesaler, manufacturer, and
patient organizations
dedicated to fighting
counterfeit medicines.
Don Bell
33 year law enforcement veteran
Ontario Provincial Police
Canada Border Service Agency

2. 2
Importation proposals - HHS 2019 Announcement
2003 Medicare Modernization Act
Pathway #1: Consider proposals to
import medicines from wholesalers or
pharmacists (or states on behalf of those
two).
Pathway #2: Provide new NDC codes to
existing manufacturers of FDA-approved
medication for foreign markets.
ApproachGovernedby
Unknown. There are testing and
equivalency standards that are
referenced but have not been cited yet.
Pharmacists and Wholesalers (or states
on their behalf like FL, VT, CO, and ME)
Whocan
applyto
import?
Manufacturers
Only certain types of drugs allowed,
statistical sampled testing for purity,
proper labels, documentation for all
transactions, affirmations for cost and
safety, and ongoing oversight.
Restrictions?
Unknown

3. 3
So why won’t this work?

4. 4
Importation programs don’t save enough money to keep
going, even without the cost of testing.
lllinois’ Experience With ISaveRX, 2003–2006
● Expensive, failed to adequately inspect dispensing
pharmacies, closed due to a lack of patient
savings created. (IL, WI, VT, MO, KS)
Minnesota RXConnect 2004-2010
● Failed to adequately keep foreign pharmacies
compliant, closed due to a lack of patient savings.
Maine’s 2013 Importation law
● Within 90 days of it going into effect, counterfeits
were found in the medicine supply.

5. 5
Testing medication is expensive and consumes savings.

6. 6
Testing medication is expensive and consumes savings.
The law allowing
importation requires that:
“..each batch of the
prescription drug in the
shipment was statistically
sampled and tested for
authenticity and
degradation.”
To test just one sample of this
medicine from a 30 day supply, it
would cost between $2,500 and
$4,100. However for statistical
confidence and reliability, as
required by the law, you need
many more samples.
Confidence / Reliability Number of samples Cost range
90.0% 22 $55,000 - $90,200
99.9% 6,904 $17.26mm-$28.30mm
99.999% 1,151,287 $2.88bn-$4.72bn

7. 7
It breaks Track-and-Trace.
There is no track-and-trace system
in Canada.
Track-and-Trace is a ten year long
implementation in the U.S., and
we’re only halfway into it. It is
costing hundreds of millions of
dollars to implement across the
entire U.S. industry, and it doesn’t
include Canadian wholesalers or
pharmacies.
“There is simply no
way to alter the
DSCSA
[Track-and-Trace law]
to enable importation
without undermining
its purpose and value.”
Dirk Rodgers,
Track and
Trace expert
from
RXTrace.com

8. 8
Healthcare experts and regulators on both sides of the
border think it’s unsafe.
What experts oppose importation?
● Boards of Pharmacy in both US and Canada.
● Former Canadian health ministers and every previous
HHS Secretary and FDA commissioner since 2003.
● Canadian and American Pharmacists.
● Nearly three dozen United States state pharmacy
associations.

9. 9
It’s dangerous for law enforcement and will make the
opioid crisis worse.
July 2016
Drug importation is opposed by the National Sheriffs’ Association, the Major
County Sheriffs Association, the International Association of Chiefs of Police,
National Association of Drug Diversion Investigators, among others.
Fake pills in 48 states, 33 states have fatalities

10. We have a poor record of prosecuting Canadian
counterfeit criminals.
10
Terms of plea deal for Kris Thorkelson
● Six months house arrest and four and
a half years of probation;
● a $250,100 fine; and
● Turn over records and cooperation.
The plea agreement does not require him to:
● serve any jail time;
● surrender his pharmacy license;
● enter a guilty plea of selling counterfeit
drugs.
He is not prohibited from holding any kind of
pharmacy license or starting a new
pharmacy business to export to America.CanadaDrugs.com sold off most of the rest of their
inventory to Americans for many more months while
“shutting down”

11. 11
Late-stage cancer patient Betty Hunter
was treated with counterfeit Avastin in
2011. Ms. Hunter died three months
later.
Source: Medicin der
Dræber

12. 12
There are huge drug shortages in Canada already….
Canada’s drug supply would be drained in 201 days should just 20% of U.S.
prescriptions shift to dispensing out of Canada.
(Shepherd, Health Econ Outcome Res Open Access 2018, 4:1)

13. 13
...and Canada is not on board with importation.
Fearing shortages and price spikes, Canadian
patient groups, healthcare groups, regulators,
and the federal government are all opposed to
Americans importing their medication supply.
Over 1,700 medicines in Canada are in
shortage.
Canadian Prime Minister Justin Trudeau
"Health Canada has always as a matter of
course ensured that regardless of external
or international pressures there is a steady
and solid supply of medications that
Canadians need for Canadians.
We recognize the new situation brought on
by American announcements and Health
Canada will continue to ensure that our
priority is always ensuring that Canadians
have access to the medications they need
at affordable prices.” Aug 1, 2019

14. Not all packages from Canada come from inside Canada.
Many are transhipped without entering Canada.
14
National Post, Nov. 2014
Canadian Federal
Industry Minister
James Moore "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."
Statement of 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…”
Letter from Diane C. Gorman, Assistant Deputy Minister of
Health Canada to U.S. Surgeon General Richard H.
Carmona, 2004

15. 15
Operation Pangea XI - 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.
Total street value CAD 1.4 million
Annualized value CAD 63.9 million

16. 16
Organized crime will take advantage of importation loopholes
Industrial pill press – 18,000 pills/hour Quick trafficking routes to the U.S.

17. 17
How do discussions about importation hurt Americans?
Americans engage in unsafe behavior.
When the public hear politicians promote black market
importation, they go online and google “Canadian pharmacy”,
not understanding that this isn’t safe.
Every dollar spent on designing fantasy plans to create “safe
importation” is wasted. No such plan is safe.
It postpones real solutions.
Every legislative session wasted discussing the unicorn of
importation delays actual solutions that can be implemented
safely and quickly.

18. Sign our letter to Secretary Azar and Acting
Commissioner Sharpless
18

19. We must speak up now to focus our leaders on solutions to
the healthcare cost problem that can actually work.
19
Track importation efforts on
our website
Contact
shabbir@safemedicines.org
to have your organization
become a member of the
Partnership for Safe
Medicines

20. Questions
20
Shabbir Imber Safdar
Executive Director, Partnership for Safe Medicines
Phone: 415-630-3736
Email: shabbir@safemedicines.org
Don Bell
33 year law enforcement veteran
Ontario Provincial Police
Canada Border Service Agency