Back in the late 1990s, occasional busloads of American seniors would cross the border into Canada to buy drugs at generally lower prices than at home. Others bought drugs from internet pharmacies which claimed to be based in Canada although many were not.
From an American perspective, concerns were raised at the time regarding possible safety issues associated with an unregulated cross-border supply chain. From a Canadian perspective concerns were raised about the creation of potential drug shortages that would arise by trying to serve a much larger American market and also in terms of the longer term impact on Canadian public policy regarding price controls and public drug insurance schemes.
The situation came to a head in 2000 after the U.S. Senate had passed a Bill supporting drug importation from Canada. But because of the concerns over the supply chain and the safety of cross border drug sales President Clinton’s Health and Human Services (HHS) Secretary Donna Shalala, refused to endorse the plan.
More recently Senator Sanders has introduced a bill which would instruct HHS to put forward regulations allowing certified wholesalers, pharmacies and individuals to import qualifying prescription drugs from licensed Canadian sellers. To be “certified,” the seller would have to assert that they comply with the requirements of the legislation. There is no way for the FDA to verify that a foreign seller is in compliance, hence Senator Sander’s bill relies on self–certification.
The conditions set out in the bill will do nothing to avoid re-creating the unregulated bandwagon, and its inherent safety risks, that occurred almost 20 years ago and are impractical for several reasons.
First and foremost, although Health Canada and the Food and Drug Administration have relatively similar drug approval processes, apply the same standards and sometimes accept each other's data, the processes in the two countries’ systems are not the same. There are cases on both sides of the border where drugs are approved for different indications or dosages. The differences reflect varying views on the risks of specific products to consumers.
Moreover, Canada would also have to change its policy on imports and exports of health products, which currently limit the ability of companies to import drugs for re-export. The policy requires a product to meet all Canadian requirements, including labeling in both English and French, at the moment that it is imported. Most importantly for the current debate, as Health Canada has noted in a warning to consumer regarding personal importation and mail order pharmacy: “large quantities of products, which have not been reviewed for safety and/or efficacy, and which are of unknown quality, can enter the country and be distributed” thereby presenting a significant security risk for U.S. patients. Four recent FDA Commissioners confirmed as much in a recent letter to Congress.
Secondly, prescription drug supplies, which are manufactured at sites throughout the world, are shipped to a country based on its population size, which in Canada is approximately 35 million. The US, on the other hand, has 55 million beneficiaries in the Medicare program alone, and a total population of 324 million. There is simply no way Canada can supply the US prescription drug market without disruption to its own.
Drug shortages already occur in Canada: the Canadian Drug Shortage Database lists 268 entries in 2016 and 145 in the first two months of 2017. If Canadian wholesalers and pharmacies attempted to supply even a fraction of the number of Americans that Sanders says are unable to pay for their medications, shortages will skyrocket and cause significant distress to Canadian patients. Regardless of Canadians’ concerns, the main point is that Canada’s drug supply is never going to be a long-term solution to this issue.
Finally, drug safety risks will only increase as these self-certified Canadian wholesalers and pharmacies scramble to obtain more drugs to feed the U.S. and Canadian markets. They would have to turn turn to less reputable sources, such as China and India where the quality of medications from these countries is known to be questionable.
Senator Sanders’ bill has the potential to not only destabilize the Canadian system but to generate serious safety concerns for U.S. patients – it’s a lose-lose.
Author bio: Dr. Nigel Rawson is a pharmaco-epidemiologist, pharmaceutical policy researcher, and President of Eastlake Research Group in Oakville, Ontario. Educated in the United Kingdom, he holds an MSc in statistics and a PhD in pharmaco-epidemiology. Dr. Rawson held academic research positions in the United Kingdom until the end of 1989 and subsequently held professorships at the University of Saskatchewan and Memorial University of Newfoundland in Canada.