Buying Meds from a Canadian Pharmacy: Current Legal Status and Expected Changes
As this Kaiser Health Tracking Poll published in late 2016 shows, at least 8% of the US population or 19 million Americans either buy prescription medications from abroad themselves or know someone in their family does that. 52% of these people save more than $199 every month by buying meds online and for 38% the savings exceed $300 a month. The reason people go on the Internet in search of medications is the price – the same drugs cost 3 times higher on average in the US than in the UK, for example.
When calculated based on total retail Rx spending per capita per annum, medication prices in Canada appear to be only 30% lower than in the US. However, certain medications cost up to 83% cheaper there and Canada is so much closer to the US than European countries, so it’s reasonable that Americans choose to order meds from north of the border.
Universal publicly funded healthcare is available to all Canadians. All hospital stays and in-hospital medicinal therapy are free. Prescription drugs are either paid for out-of-pocket or covered by private insurance plans when the patient takes them at home. The Canadian government even covers the cost of treatment in the US for patients when the required therapy is not available domestically or when the waiting times are too long.
Personal Importation of Prescription Medicines from a Canadian Pharmacy into the US: Current Legal Status
The article on the official FDA website says that it is illegal to import drugs not approved by the FDA ‘in most circumstances’. Importation of FDA-approved Rx drugs is allowed as long as a valid prescription is present and the equivalent of a 3-month supply is not exceeded. For controlled substances, such as opioid painkillers or benzodiazepines, the allowed amounts are even lower – the maximum is 50 doses.
There are exceptions when US citizens are allowed to import even those medications that haven’t been approved by the FDA yet. These include:
- Importing drugs used to treat a serious condition when no FDA-approved treatment for such condition is available;
- The imported medication is not commercialized or promoted to US residents;
- The drug does not represent an unreasonable risk;
- The person importing the medication without FDA approval can certify in writing that it is intended for their own use and can provide either the contacts of the doctor who prescribed this medication or a valid proof of the fact that the imported drug is intended for the continuation of therapy started abroad.
Provided all of the above conditions are met, the maximum of 90-days’ worth of medication from a Canadian pharmacy will be allowed into the country.
In spite of the FDA regulations, 19 million people in the US still continue ordering medications from abroad, even when the criteria listed above do not apply. As this article by Neil Osterweil suggests, it is due to the fact that the FDA does not oppose importation of medications for personal use. The officials are after those who import meds to sell to other people.
Expected Changes to the Personal Importation Laws
There are at least two legislative initiatives currently being discussed with the aim to further liberalize international pharmaceutical trade between the United States and Canada:
‘Safe and Affordable Drugs from Canada Act of 2019’ Bill
Introduced by Senators Chuck Grassley and Amy Klobuchar in January 2019, this bill aims to legalize personal importation of medications from Canada into the US. It proposes that all such imports are deemed legal under the following conditions:
- The medication must come from an approved Canadian pharmacy – a list of such pharmacies is to be prepared and published on the website of the US FDA;
- The medication being imported must be similar to an FDA-approved medication – i.e. it should contain the same active ingredient, be available in the same strength and dosage form;
- The patient importing medication from abroad must have a valid prescription from a US-based healthcare specialist;
- The medication must be dispensed by a licensed Canadian pharmacist;
- The medication must be purchased for personal use in a quantity that does not exceed a 90-day supply.
There are also some limitations stated in the bill – for example, it does not allow importing photosensitive drugs, drugs that require refrigeration, infused or inhaled drugs, drugs containing controlled substances or biological products or manufactured by means of biotechnology processes.
‘The Affordable and Safe Prescription Drug Importation Act of 2019’ Bill
This bill has been introduced by Senator Bernie Sanders and Democratic Representatives Cummings, Khanna, Welch and Neguse. It offers to let both individuals and US-based businesses import medications from Canada. The Canadian retailers will only be allowed to supply licensed products by FDA-approved manufacturers.
Similarly to the Grassley and Klobuchar Act, this bill does not allow the customers in the US to order more than a 90-day supply of any medication. A person purchasing drugs from Canada must also have a valid prescription from a licensed US doctor. The bill prohibits importation of controlled substances, inhaled anesthetics or compounded medications.
Even if the passing of the above bills on the federal level takes a while, it does not mean that people will have to wait nationwide. The state of Vermont is now leading the change after Governor Philip Scott signed the importation bill into law on May 16, 2018. The bill still needs to receive the federal government’s approval and it will only cover a limited list of drugs that provide significant prescription cost savings to Vermont consumers but the progress is obvious. Besides, there are similar bills under consideration in at least 16 other states.
The changes in the legislation are anticipated by the people – 88% of the 2019 KFF poll participants supported an easier approval procedure for generic drugs and 80% voted for allowing US-based customers to import prescription drugs from Canada.
Drug Importation from Canada Will Not Solve the Problem, Scientists Say
There are scientists claiming that the legalization of drug importation from Canada is not going to resolve the drug price crisis. The 2017 article by Rawson and Binder lists the reasons for that:
- Drug manufacturers are unlikely to increase production in Canada or increase supply to this market in an attempt to make up for potentially higher demand from the US. The pharmaceutical companies don’t know, which drugs exactly will be in demand and what the potential size of the cross-border market will be, so the customers in both Canada and the US are likely to face shortage of medications.
- There are medications approved by both Health Canada and the US FDA but used to treat different conditions in the two countries – such as cancer drug olaparib, for example. As the result, patients will not be able to get Canadian prescriptions for some of the medications prescribed to them by their US doctors.
- The FDA will need to allocate additional resources to supplier/drug certification and it’s unclear if such resources are available.
This point of view is backed up by Dr. Mary D. Shepherd, whose projection model shows that Canada would run out of medications in 5-7 months if just 20% of Americans started filling prescriptions north of the border.
If the above forecasts are true, the United States government should better focus on bringing the drug prices on the domestic market down rather than try to solve the problem by liberalizing importation laws.
Although importing medications for personal use is still technically illegal in the United States, it’s clear that the legislation is going to change soon. Exorbitant drug prices are a major problem with up to 25% Americans struggling to afford their medicines. The government is aware of this problem and working to solve it and, in the meantime, US citizens buying drugs in foreign pharmacies will not face prosecution when ordering in reasonable amounts and avoiding controlled substances from abroad.
- Annual spending on prescription medications per capita, 35 countries compared - https://data.oecd.org/healthres/pharmaceutical-spending.htm
- Kaiser Health Tracking Poll Report, November 2016 - http://files.kff.org/attachment/Kaiser-Health-Tracking-Poll-November-2016-Topline
- Importing medications from Canada into the US, a 2019 poll - https://personalimportation.org/understand-the-issue/survey-importation-from-canada-is-safe-and-affordable/
- Medication price differences, the US vs the UK - https://www.scientificamerican.com/article/how-the-u-s-pays-3-times-more-for-drugs/?redirect=1
- Rx Spending per capita per year, multiple countries compared - http://theconversation.com/why-the-us-has-higher-drug-prices-than-other-countries-111256
- Medication price comparison, Canada vs the US - https://www.pharmacychecker.com/askpc/is-medicine-in-canada-cheaper/
- FDA on personal drug importation into the United States - https://www.fda.gov/about-fda/fda-basics/it-legal-me-personally-import-drugs
- US Customs and Border Protection policies on importing controlled substances - https://www.cbp.gov/travel/us-citizens/know-before-you-go/prohibited-and-restricted-items
- Current state of affairs with drug importations for personal use - https://www.webmd.com/healthy-aging/features/letter-and-spirit-of-drug-import-laws#1
- ‘Safe and Affordable Drugs from Canada Act of 2019’ Bill - https://www.grassley.senate.gov/sites/default/files/Safe%20and%20Affordable%20Drugs%20from%20Canada%20Act%20of%202019.pdf
- ‘The Affordable and Safe Prescription Drug Importation Act of 2019’ Bill - https://www.sanders.senate.gov/download/final_-affordable-and-safe-prescription-drug-importation-act-of-2019---bill-summary?id=3F55AA41-4A20-426D-8CEB-987A30F3A838&download=1&inline=file
- Vermont S.175 Drug Importation Bill status - https://legislature.vermont.gov/bill/status/2018/S.175
- Bills to lower pharmaceutical costs, map by state - https://nashp.org/rx-legislative-tracker-2019/
- Kaiser Family Foundation 2019 poll regarding policy changes aimed at lowering drug costs - https://www.kff.org/health-costs/press-release/poll-nearly-1-in-4-americans-taking-prescription-drugs-say-its-difficult-to-afford-medicines-including-larger-shares-with-low-incomes/
- NSB Rawson, L Binder, Importation of medications from Canada into the US - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478407/
- MD Shepherd, Drug supply projection model in case personal importation ban is lifted in the US - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5621936/