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Is the United States Coming for Canadian Medicines?

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For 20 years, United States politicians have been interested in fighting their high drug prices by bulk importing prescription drugs from Canada.

Recently, the politically-appointed head of the US Health Department has said they are proposing new rules to make allowances for this practice. The State of Florida, with a population of 25 million, has also passed new legislature and published a 40-page plan, and the Florida Governor has met with the President and the Health Secretary to move forward. This creates a clear and present risk to the supply of medicines for Canadians.

Presented by John Adams, Board Chair, Best Medicines Coalition and Co-Founder, President & CEO, Canadian PKU and Allied Disorders, this webinar offers an opportunity to learn more about this potential threat and how to approach the new Canadian government and urge necessary action before access to prescription drugs is potentially compromised.

Published in: Health & Medicine
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Is the United States Coming for Canadian Medicines?

  1. 1. Is the USA coming for Canadians’ medicines?
  2. 2. Is the USA coming for Canadians’ medicines?
  3. 3. “If they start avidly tapping our medicine supply, what does that mean?” asked Amir Attaran, a University of Ottawa law professor and health-policy expert. “What does it mean when the parasite is ten times bigger than the host? It could lead to the greatest drug shortage we have ever seen.” Attaran is urging Ottawa to protect Canadians against such laws by bringing in its own legislation that would restrict medicine exports to other countries. June 20, 2019 Is the USA coming for Canadians’ medicines?
  4. 4. Is the USA coming for Canadians’ medicines?
  5. 5. ▪ About Best Medicines Coalition ▪ Ongoing drug shortages in Canada ▪ USA landscape: prices, policy, politics ▪ Why bulk importation should concern all Canadians ▪ Canadian stakeholder and government responses ▪ What’s next ▪ Q&A Agenda
  6. 6. Best Medicines Coalition: Who we are
  7. 7. 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: Mission
  8. 8. ▪ Drug programs which deliver high standards of safe, timely, equitable and consistent access to medications for all Canadians. ▪ Drug review and post-marketing surveillance systems to address patient safety; knowledge of risks and benefits throughout drug lifecycle. ▪ Effective models for meaningful and equitable patient participation in drug reviews and policy development. Best Medicines Coalition: Goals
  9. 9. ▪ Drug shortages have critical, negative impact on Canadian patient care: 1. One in four Canadians have personally experienced or know someone who experienced a drug shortage in the last 3 years (CPhA: Survey of Canadians - 2018). 2. Canada experiences shortages of up to 1,000 medications at any given time. 3. Pharmacists report not being able to fill 50% of weekly orders due to supply issues, some temporary, some ongoing – spend 20% of their time on workarounds. 4. Critical shortages in key areas: epilepsy, hypertension, cancers, Parkinson. ▪ BMC providing patient voice to stakeholders and government on issue. ▪ BMC part of Health Canada Multi Stakeholder Committee on Drug Shortages. BMC Priority Issue: Drug Shortages
  10. 10. In other countries drugs cost an average of 56% less than in USA https://www.drugwatch.com/featured/us-drug-prices-higher-vs-world/ USA: Prices, policies and politics
  11. 11. https://www.drugwatch.com/featured/us-drug-prices-higher-vs-world/ USA: Prices, policies and politics
  12. 12. https://www.cbc.ca/news/canada/london/insulin-prices- united-states-canada-caravan-1.5195399 Insulin prices: ▪ “Insulin prices in the United States nearly doubled to an average annual cost of $5,705 US in 2016 from $2,864 in 2012, according to a study in January.” USA: Prices, policies and politics
  13. 13. Solution: USA bulk importation of Canadians’ medicines?
  14. 14. What is the plan: ▪ White House vetting draft plan from Department of Health & Human Services (HHS) and the Food and Drug Administration (FDA) to allow bulk importation of medicines allocated for Canadian patients from Canada. ▪ Colorado, Florida, Maine and Vermont passed state laws which would empower the state, wholesalers or pharmacies to import in bulk; implementation details in the works. ▪ About 20 other states are considering proposed laws, with more expected. ▪ USA drug industry likely getting ready to go to court over federal plan once approved, likely in 2020. USA: Top down, bottom up support for importation
  15. 15. What is different in this environment:  The first USA Health Secretary in 20 years supports a plan.  The President is running for re-election on it. What remains the same?  Relationships with allies are secondary to the needs of USA voters/politics.  USA patients have looked for this for +20 years: access to cheaper medicine without reforming the complex and broken healthcare system in USA.  USA politicians have also called for this for +20 years: the idea that they don’t have to reform the USA healthcare system & anger health insurance companies, pharmacy benefit managers or manufacturers by changing their financial stake in the status quo.  Congress passed the enabling law 20 years ago. USA: Top down, bottom up support for importation
  16. 16. https://www.floridatoday.com/story/news/local/2019/07/31/ drugs-imported-canada-under-trump-administration-plan-may-big-win-desantis/1880854001/ USA: Top down, bottom up support for importation
  17. 17. https://www.orlandoweekly.com/Blogs/archives/2019/09/27/ florida-gov-ron-desantis-is-fundraising-to-protect-trump-from-impeachment  DeSantis was in Congress.  Trump supported DeSantis for Florida Governor.  Elected Nov. 2018. USA: Top down, bottom up support for importation
  18. 18. https://www.myfloridahouse.gov/Sections/Bills/billsdetail.aspx?BillId=65571&SessionId=87 USA: Top down, bottom up support for importation
  19. 19. https://leg.colorado.gov/bills/sb19-005 USA: Top down, bottom up support for importation
  20. 20. Bipartisan agreement: Next USA President is in favour. Partnership for Safe Medicines presentation USA: Top down, bottom up support for importation
  21. 21. AARP has 38 million members AARP works with state legislators to introduce & pass Canadian import laws, like this one in Maine in 2019. Partnership for Safe Medicines presentation USA: Top down, bottom up support for importation
  22. 22. https://www.sun-sentinel.com/news/politics/fl-ne-trump- florida-drug-approval-20190731-h5tsjzzn6rf2lcbueovfls7r6i-story.html?outputType=amp Health & Human Services Secretary Alex Azar: “They are a lovely neighbor to the north, but they’re a small one,” Azar, a former drug company executive, had said. “Canada simply doesn’t have enough drugs to sell them to us for less money, and drug companies won’t sell Canada or Europe more just to have them imported here.” USA: Health Secretary Azar – before May 2019
  23. 23. https://www.hhs.gov/sites/default/files/safe-importation-action-plan.pdf USA: Health Secretary Azar’s HHS/FDA after May 2019
  24. 24. https://www.politico.com/newsletters/politico-pulse/2019/10/22/how-warren- could-pay-for-medicare-for-all-781166?tab=most-read ‘Speed it up’ October 22, 2019
  25. 25. Partnership for Safe Medicines presentation Law passed six years ago: Drug Supply Chain Security Act (DSCSA): ▪ Protects from counterfeit & unsafe medicines: all supply chain participants must be authorized (licensed). ▪ Drugs are serialized in 2D barcode by manufacturer. ▪ Standardized transaction e-documents required at each change of ownership ▪ Forces guardrails on how the supply chain works. ▪ Provides bi-directional evidence. USA: Track and trace safeguards against counterfeit drugs
  26. 26. Partnership for Safe Medicines presentation ▪ Importation is unsafe and cannot meet DSCSA requirements. ▪ Drugs from foreign markets don’t use same identifiers and cannot meet the documentation requirements. ▪ Result: no reliable record of where a drug was and who handled it before it enters the USA. USA: Track and trace safeguards against counterfeit drugs
  27. 27. Why bulk importation should concern all Canadians
  28. 28. Market reality: ▪ Canada has 1/9th the population of USA and about 1/9th the drug supply at best. ▪ Manufacturers allot pharmaceutical supply based on population by country. ▪ Canadian allotment can’t accommodate our needs and USA demands. ▪ Most drugs for Canadians are made abroad; Canada lacks power to “ramp up” production Bulk Drug Importation: Impact
  29. 29. Consequences for Canadians: ▪ Mass importation is a threat to the Canadian drug supply and would rapidly diminish it. ▪ Critical exacerbation of existing shortages . Consequences for USA: ▪ Not sustainable; mass importation an extremely short-term solution. ▪ USA patients will quickly be left with ongoing pricing and access challenges. Bulk Drug Importation: Impact
  30. 30. What does this mean for me as a Canadian patient?
  31. 31. Response: Canadian organizations speak out
  32. 32. 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. Response: What the federal government says
  33. 33. Global Affairs Canada key messages (September 2019): ▪ Should any external or international actions adversely affect the supply or costs of prescription drugs for Canadians, Canada would have no choice but to respond to protect human health in Canada. ▪ We encourage the United States to pursue domestic solutions to high drug prices that are more in line with those employed by other industrialised countries, including Canada. These include reference pricing (i.e., the price determined by the regulator considering various factors such as changes in the Consumer Price Index) and negotiating bulk discounts, which would have more immediate impacts on American prices and yield more sustainable results. Canadian Response: What government says
  34. 34. Canadian Response: Continued concerns
  35. 35. White House committed to seeing this through:  Expect draft regulations in November/December, with final rules drafted in 2020 and published at date to be determined by the President.  Anticipated that drug pricing issue and support for bulk importation will continue to gain momentum.  While importation solutions have been discussed previously, the White House and two top regulators are now on board. Support is bi-partisan; emerging as part of Republican re-election platform. Next Steps/USA: What to expect moving forward
  36. 36.  Canada/USA stakeholder meetings in Washington, Health & Human Services (HHS) Sept. 25, 2019:  Partnership for Safe Medicines  Canadian Pharmacists Association  Best Medicines Coalition  Alliance for Safe Online Pharmacies  Track-and-Trace expert  HHS confirmed it has plan to see the regulation through; encouraged Canadians with concerns to file comments during the public comment period.  One day later, the White House reiterated commitment on Canadian drug importation. The Health 202: Trump is finalizing an executive order allowing imports of some prescription drugs Sep. 26, 2019 Next Steps/USA: What to expect moving forward
  37. 37. Next Steps/Canada: What to expect moving forward Various possible policy levers: Food and Drugs Act amendments tabled (but not passed) in 2005 Other potential levers:  Bolstering border and regulatory enforcement services and policies.  Pharmacy colleges restrictions.  Internet broker restrictions.
  38. 38. Next Steps/Canada: What to expect moving forward In Canada:  Threat of critical drug shortages caused by bulk importation by USA did not emerge as federal election issue, but concerns will escalate as USA federal & state policy makers move forward.  Health care organizations will convene (post-election) with continued calls for clarity and specifics on Canadian government action plans and policy options.
  39. 39. How you can get involved  Stay informed: keep up to date on the issue through patient-led initiatives (for example, follow the Best Medicines Coalition on Twitter).  Take a stand: develop and elaborate your position on the issue.  Raise your voice: find opportunities to engage with federal and provincial governments to let them know you are concerned and want action. Call to action: The Federal Government must quickly and definitively clarify how it will protect the Canadian drug supply and move forward to do so.
  40. 40. bestmedicinescoalition.org john.adams@canpku.org
  41. 41. Q&A

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