"Problems with importing medicine from Canada" - webinar slides
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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.
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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](https://image.slidesharecdn.com/problemswithimportingmedicinefromcanada-webinarslides-190806235634/85/Problems-with-importing-medicine-from-Canada-webinar-slides-7-320.jpg)
![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](https://image.slidesharecdn.com/problemswithimportingmedicinefromcanada-webinarslides-190806235634/85/Problems-with-importing-medicine-from-Canada-webinar-slides-14-320.jpg)
"Problems with importing medicine from Canada" - webinar slides
- 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