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How Trump’s Canadian Drug Importation Executive Order Changes Things

Originally published on PharmacyChecker.com.

Three executive orders were signed by President Donald Trump last week. One of them is all about drug importation: measures already underway and new actions to help Americans buy more affordable prescription drugs from other countries. It has the potential to help many millions of Americans who are sick and tired of high drug prices or can’t even afford the medications prescribed to them. 

The executive order states that the “Secretary of Health and Human Services shall, as appropriate and consistent with applicable law, take action to expand safe access to lower-cost imported prescription drugs by…” 

Stopping right there, before listing the stated actions, you should know that it’s not accidental that the executive order uses the word “expand” when referring to safe access to lower-cost, imported prescription drugs. 

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Understand Executive Authority on Allowing Safe Personal Drug Importation

Originally Published as A Blueprint to Understand Executive Authority on Allowing Safe Personal Drug Importation on PrescriptionJustice.org.

Yesterday, President Trump announced four executive orders with the stated intent of substantially lowering drug prices. Briefly, the administration’s bluster on drug prices over the past three years has been far louder than any actions taken to actually do something about it. Better late than never.

The orders call for and include: 1) Lower prices on EpiPens and insulin, 2) Allowing personal drug importation, 3) Ending profit-taking by pharmacy benefit manager middlemen, and 4) “most favored nation” drug price negotiation in Medicare, meaning Medicare would get the lowest price on drugs of any country.

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NH Hops on the Wholesale Drug Importation Bandwagon. The Wait Continues.

Last week, yet another state, New Hampshire hopped on the Canadian drug importation bandwagon. Joining Vermont, Florida, Colorado, Maine and New Mexico, New Hampshire passed a law that would permit registered wholesale pharmacies to import lower-cost drugs from registered Canadian wholesale pharmacies. I have supported the initiative from the beginning, when the National Academy for State Health Policy (NASHP) came out with model legislation on drug importation from Canada. But now, frankly, I am annoyed. New wholesale drug imports from Canada can be helpful, but the issue seems to be used for political purposes. State legislators and governors, by passing Canadian drug importation laws, can say they are doing something, but nothing is actually happening.

One of the best opposing arguments surrounding these laws is that Canada is too small a country to take on large wholesale prescription drug exports to the U.S. With more and more states getting onboard with importation, the problem of Canada’s size becomes more salient. Expanding importation to the European Union is the key and yet this new state legislation, as well as federal law, does not address that.

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Hispanics Are More Likely to Use Importation to Find Affordable Prescription Drugs

A recent study in the Journal of the American Medical Association (JAMA) concluded that about 2.3 million people in the U.S. import medicine each year to save money. According to that same study, Hispanics in the U.S. are almost four times more likely to have imported medicine than non-Hispanic white people. I believe the percentage of Hispanic people is so much higher due to four main factors.

The first two factors are quantitative findings:

First, in 2018, almost 18% of Hispanics did not have health insurance, compared to only 5.4% of White and 9.3% of Black people. The JAMA study found that people who were uninsured were over three times more likely to import medicine than the insured.

Two, the JAMA study found that 4.4% of immigrants imported medicines for personal use, 3.2 times more than the average consumer. According to Pew Research, about 21% of Hispanics living in the U.S. are not American citizens, and 44% of all immigrants report Hispanic or Latino backgrounds.

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How JAMA & Kaiser Family Foundation Studies Have Concluded Millions of U.S. Adults Import Medications

According to a study published in the Journal of the American Medical Association (JAMA), 1.5% of adults in the U.S. who take prescription drugs purchase them from outside the U.S. to save money each year. That’s about 2.3 million people. In 2016, my review of a similar set of data estimated about four million per year. The Kaiser Family Foundation’s 2016 poll data was used to support an estimate showing that 19 million people, 8% of the adult population, have imported lower cost prescription drugs for personal use. What’s going on? 

The JAMA study authors used 2015-2017 government data from the U.S. Centers for Disease Control and Prevention, National Center for Health Statistics, National Health Interview Survey (NHIS), which collected an assortment of health information from 61,238 individuals. As explained in the JAMA study:

“Survey respondents were asked whether they bought prescription drugs from a country other than the US to save money during the past 12 months. We defined respondents as purchasers of medications outside the US if they answered yes to the question.”

Past estimates, including my own, have also used NHIS data but may have extrapolated incorrectly. The percentages should be applied not to the general adult population but to those who take prescription drugs. The adult population is about 256 million. In this study, the sample population of 61,238 represented 152.2 million people who take prescription drugs. The JAMA study found that 1.5% purchased medications outside the U.S. to save money, which comes out to about 2.3 million. My past estimates looked at 1.6%, which was an earlier NHIS estimate of adults who import, of 256 million people, which came out to a little over 4 million people.

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Transatlantic Drug Regulatory Cooperation: Moving Beyond Canada

Canada is a good option for Americans seeking to access their medications at a lower cost through personal drug importation, but even I agree with the pharmaceutical industry when they say that wholesale drug importation on a large scale is not workable with Canada. Why?  Simply because Canada is too small a nation to supply the U.S. market. I have written that there is much more promise if importation is expanded to the European Union. We already rely on the EU to assess U.S. drug safety, and current events have only brought that into greater focus.

Due to the world’s efforts to quell Covid-19, Regulatory Focus reported on increased cooperation between the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These drug regulators have engaged in regular consultations since 2003 in order to share insights and best practices. In 2014, that same cooperation led to the creation of Mutual Recognition Agreements (MRA). Due to an MRA between the FDA and EMA, the U.S. can rely on EU inspections of drug manufacturing establishments in any EU country. That means we have a lot of faith in EU pharmaceutical safety standards.

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