Last month, a group of Democratic lawmakers introduced a far-reaching bill designed to combat the rising cost of prescription drugs. One provision would allow Americans to import “qualifying” medicines that are manufactured at FDA-inspected facilities from licensed Canadian sellers and, after two years, from OECD countries that meet standards comparable to US standards. This is hardly the first time such legislation has been introduced, but the idea appears to be gaining some momentum now that President Trump has voiced support for importation. But would this be as simple as it sounds? We spoke with Timothy Squire, an attorney who co-chairs the international life sciences group at the Fasken Martineau law firm in Toronto. He suggests there could be some hiccups. This is an edited version of our conversation …
Pharmalot: This idea has been kicked around for a while and went nowhere. Maybe this time, something comes of it. Will it be as easy as the lawmakers believe?
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This approach will not work for many reasons. First, it shifts responsibility for review and approval of drugs and biologics to be sold in the US to Health Canada, an excellent regulatory agency but not the one governing the use of products in the US. The regulatory review processes are different, the standards are not the same, and the regulatory system in Canada is tied into provincial review of how useful new drugs are. Second, with shortages of medicines already a problem in Canada, this will only make things worse. US pharma companies could easily limit the amount of medicines that are shipped to Canadian wholesalers and pharmacies. Canadian patients will be the first to suffer, since they will not have access to medicines that they need. Further, US pharma companies would be able to put restrictions on the amounts that are shipped to Canada, making it even harder for patients to actually get access. The Canadian market for expensive medicines is so small compared to the US market that companies could cut back drastically in Canada to overcome the importation loophole. Similiar issues have been faced in cross-border sales in the EU, and companies have been able to limit shipment of medicines to countries with very low prices (e.g., Greece) vs. those with higher prices (e.g., Germany). While cost savings could be achieved, patients will lose out. Innovation is the key to the discovery of new medicines, and success in the US market helps drive investment in pharmaceutical and biotechnology R&D.
As long as the legislatures through lobbying are in the back pockets of pharma, not much will get imported. Patients who cares they will die sooner or later. Agony of bankruptcy due to high prices rather than disease kills many emotionally.