According to a story in Reuters, Canada is not happy about the prospect of wholesale drug importation programs now in planning stages in the states of Colorado, Florida, Maine and Vermont. It’s concerned about drug shortages and the prospect of higher drug prices in Canada if these programs move forward. Cue the pharmaceutical industry and its AstroTurf front groups’ “I told you so” moment.
It’s true that while small-scale importation from Canada is feasible, larger scale importation is not.
The future lies in pharmaceutical international trade beyond just Canada to include countries such as Japan and those in the European Union. Expanding importation programs to include the EU and Japan was recommended by Jane Horvath in a wonderfully written op-ed in Stat News earlier this week. Ms. Horvath is the leading healthcare policy expert working with the National Academy for State Health Policy and the states on drug importation programs.
The gist is that the U.S. will need access to a much larger market. Canada, with its population of only 37 million, is about 9 time smaller than the United States. In contrast, the EU population is over 500 million, 54% larger than the U.S., and Japan’s population is 127 million. Between Canada, the EU, and Japan, you have a market that is twice the size of the U.S.
As it happens, the focus of Ms. Horvath’s article was not the necessity of importing from more countries but on debunking the false claim that prescription drug importation programs will undermine and evade FDA safety regulations, noting that they will – and must – follow FDA regulations, including compliance with the Drug Supply Chain Security Act. [It’s worth noting that modifications to the DSCSA may be necessary so that FDA-registered companies can lawfully re-label an imported drug with the necessary identifiers in accordance with the law].
Seeing the writing on the wall about Canada’s pushback on importation and the longer-term realities, Horvath wrote: “States need to be able to import directly from Europe and Japan, not just from Canada.” Current U.S. law allows for importation of lower-cost medicines from Canada with proper certifications from the Secretary of Health and Human Services – but not from other countries. On personal importation, the law is actually more flexible: The FDA can use its enforcement discretion to allow individuals to import from any country. But for full, express legalization of lower-cost prescription drugs from the EU and Japan, the law will have to be amended.
What’s going to get really hot is the issue of how liberalizing drug importation in the U.S. could affect drug prices in other countries. They could very well go up! I’ll just put this out there: left wing, progressive groups, some that I really like, have been dead silent about drug importation for this very reason. They don’t want drug prices to go up in other countries. They just want them to come down here. Something’s got to give.
In the meantime, Americans continue to suffer because they can’t afford their medication – and buying from foreign pharmacies directly is sometimes their only option.Tagged with: Drug Supply Chain Security Act, Jane Horvath, Japan