Every couple of years it seems that someone introduces a bill into the U.S. Congress that would one way or another legalize the reimportation of prescription drugs into the U.S. from other countries. In December of 2009, right around the time that the Patient Protection and Affordable Care Act was being debated intensely Senator Byron Dorgan (D-ND) introduced a bill to do just that.
You may recall that there was a dustup about how Senator Barack Obama had introduced a similar bill only a few years before that, but now as President, he made a deal with the drug industry that supposedly assured that drug reimportation wouldn’t be added to the Healthcare Reform bill in exchange for the industry supporting the Reform bill. Senator Dorgan’s bill did not pass but Healthcare Reform did (See Dr. Adam Fein’s coverage of the failure of Senator Dorgan’s bill, “Drug Importation: Dead Again”).
The reason I’m thinking about reimportation this week is that I came across an interesting document that was published last week by the Partnership for Safe Medicines (PSM) called “A Risky Proposition: How Opening The U.S. To Foreign Medicines Poses A Risk To Chronically Ill Americans”, a second edition. I’m not sure why it was released now—maybe someone is thinking about introducing another reimportation bill again (I guess it’s not Senator Dorgan anyway!)—but I have an opinion about the topic that is based on technology that some may think could make reimportation safe. More about that later, but first let me review the PSM document.
A RISKY PROPOSITION
The basic premise is that Americans who are currently under drug treatments for chronic medical conditions—a growing population including people with heart disease, hypertension, arthritis, diabetes, cancer, COPD, MS, HIV/AIDS, and a host of others—need to understand just how safe and secure our U.S. drug supply is today and just how unsafe all supply chains outside the U.S. are, and that the passing of a (re)importation bill by Congress would result in the loss of the integrity of our drug supply. In effect it would invite all the myriad of criminals who successfully attack drug supply chains outside the U.S. into our supply chain, thus destroying the luxury of safety that we enjoy here.
The paper points out that the U.S. pharmaceutical supply chain is the safest in the world. (Although they repeat the technically-true-but-misleading fact from the WHO that “…less than one percent of the medicine supply in the United States is thought to be counterfeit”. Nobody really knows what the exact figure is, but it would logically be significantly less than one percent. See my essay “Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack”.) The paper also points out that the percentage of counterfeit drugs in some countries is believed to be as high as 40%.
Of course, supporters of (re)importation will point out that the bills they introduce would specifically limit the countries that you could legally reimport from to a small number of very safe-sounding countries, like Canada, a few in Western Europe, Australia, New Zealand and Japan. The PSM paper doesn’t mention that directly but it does a pretty good job of explaining why reimporting from European countries is probably not such a good idea. The reason is that the European Union allows something called “parallel trade”, which tends to provide an unintended incentive to criminals to game the drug supply chain there.
“Parallel trade is one of the ways by which criminal enterprises exploit weak oversigh[t] systems in developing countries in order to introduce their fake products into the supply chain of far more developed countries. […] According to the European Commission, counterfeit medicine seizures rose 118% in 2008 in the European Union, and 8.9 million counterfeit pharmaceuticals were seized by EU custom officials.”
The paper spends a lot of space explaining how dangerous internet pharmacies are. It cites a recent study by the National Association of Boards of Pharmacy (NABP) that found that fully 96% of “purported online pharmacy sites […] were found to be operating outside state and federal laws and failed to meet the standards set by the NABP…”, and that 85% of those websites did not require a valid prescription.
The paper also cites a report by IMS Health that calculated that reimportation would save payers only 0.6 percent of total drug spending—hardly worth the increased risk it would bring.
May favorite citation is the one from FDA Commissioner Margaret Hamburg who told Congress that it would be “logistically challenging” for the FDA to guarantee the safety of imported medicines. I think that’s an understatement.
ANOTHER REASON TO BLOCK REIMPORTATION
The paper makes a good case for defeating any attempt to open up our borders to drugs that were intended for markets outside the U.S., but I come to the same conclusion even if those drugs were serialized and tracked with an ePedigree or Track & Trace system. Dorgan’s reimportation bill from 2009 included provisions that would have required reimported drugs to be shipped in containers that were marked with “…anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies.”
And here’s how it was supposed to work:
“During the inspections under subparagraph (A), verifying the chain of custody of a statistically significant sample of qualifying drugs from the establishment in which the drug was manufactured to the exporter, which shall be accomplished or supplemented by the use of anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies, except that a drug that lacks such technologies from the point of manufacture shall not for that reason be excluded from importation by an exporter.”
If I read that right, (re)imported drugs wouldn’t actually have to have anticounterfeiting or track-and-trace technologies on them because that can’t be the reason to exclude them. So what’s the point of even mentioning them in the law? It seems like they are only a suggestion, not a requirement.
Even if you could have excluded drugs that didn’t have anticounterfeiting or track-and-trace technologies on them, you would be putting way too much trust in their reliability in a reimportation scenario. I believe that these technologies have maximum value only when they are applied within a single legal jurisdiction like a single country or union (like the E.U.). In my view you need to have the coverage of a single law enforcement jurisdiction and justice system to ensure that investigations and enforcement actions can take place quickly and efficiently.
Reimportation always involves the movement of drugs within at least one country before the decision is made to export them to the U.S. During that time they are not under the jurisdiction of the U.S. FDA or U.S. Justice Department. If a crime is later determined to have taken place involving those drugs it will be much more difficult to investigate, catch and prosecute any criminals that were involved in the exporting country. In that case, the anticounterfeiting or track-and-trace technologies that were on the drugs or their shipping containers may not be of much help.
Technology isn’t going to make the reimportation of prescription drugs as safe as the U.S. supply chain is today, so if we allow reimportation, we will lower the safety of our drug supply. Is it really worth the projected 0.6% savings? Hopefully organizations like the Partnership for Safe Medicines will be able to convince our representatives that it isn’t.