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“Can You Safely Implement Canadian Importation?


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Panel for congressional briefings hosted by The Partnership for Safe Medicines and partner organizations, September 24, 2019.

Published in: Health & Medicine
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“Can You Safely Implement Canadian Importation?

  1. 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. 2. Dirk Rodgers Dirk Rodgers is an independent Track-and-Trace consultant who founded of, and has 25 years of experience solving problems in warehouse and supply chain automation IT systems.
  3. 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. 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. 5. What the DSCSA is Designed to Prevent, Levemir Theft Drawing based on Katherine Eban article “Drug Theft Goes Big,” Fortune, 2011
  6. 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. 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. 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. 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. 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. 11. Canadians Respond: Plans for Bulk Importation of Drugs September 2019
  12. 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. 13. Best Medicines Coalition: Who we are
  14. 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. 15. What does this mean for me as a Canadian patient?
  16. 16. Canadian response: Leading organizations speak out
  17. 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. 18. Canadian Response: Various possible policy levers Example: Food and Drugs Act amendments tabled 2005
  19. 19. Media Response: Canadian & U.S. interest
  20. 20. Canadian Response: Moving forward
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  23. 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. 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. 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. 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. 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. 28. Quick trafficking routes to the U.S. Organized crime will take advantage of importation loopholes Industrial pill press – 18,000 pills/hour