“Don’t Touch My Bags If You Please, Mr. Customs Man”
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it is supposed to contain? What’s the reputation of the seller, and how easy would that be to determine in a country where you don’t speak or read the language? Let’s assume for the sake of argument that the vial really contains the drug it’s supposed to contain. Is the packaging truly sterile, so you won’t get an infection? Is the potency equivalent to the drug available in the U.S.? It’s unlikely that a copycat drug you are buying in India or China will have gone through clinical trials that are as rigorously monitored as in the U.S., and maybe there were no trials done at all. So how confident will you be that the drug will work? How will the dosage be calculated? Finally, what assurances do you have that the drug isn’t counterfeit? Caveat emptor—there will be no guarantees that the material you are buying will be biologically equivalent to the drug you couldn’t afford back home.
Intellectual Property—This is an issue that I imagine most patients are unaware of and, even if informed, would probably ignore. As pointed out by Ellen Ruppel Shell in her well-researched book Cheap: The High Cost of Discount Culture, there is often a significant price to be paid by buying a cheaper product that is not readily apparent to the consumer. Drugs made in countries that have not honored intellectual property laws (or where IP enforcement is difficult) can be significantly cheaper for many reasons, including the fact that the companies that make them don’t pay royalties or license fees on discoveries made and patented in other nations. Some patients will attempt to justify their purchases by claiming that U.S. drug makers are making excess profits and they are simply “sticking it to the man” by buying overseas. Others will argue that they’re just being smart consumers and buying drugs at a good price. Failure to honor intellectual property laws is not an issue generally faced by those traveling to foreign countries for surgery.
Legality—Having your drugs administered in a foreign country shouldn’t be too problematic, but can you legally bring those prescription drugs back into the U.S? The FDA regulates this importation issue. The Food, Drug and Cosmetic Act prohibits importation of unapproved new drugs, according to the FDA website. “Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness.” Furthermore, the FDA has developed guidelines for “Coverage of personal importations.” The guidelines state that the “FDA should consider not taking enforcement actions,” in certain cases “when the intended use of the drug is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.” However, Indian or Chinese made copies of U.S. biologics would not be allowed since the drugs are commercially available here, albeit at much high prices. While the FDA has discretion over whether or not they will allow your drugs into the U.S. “foreign-made chemical versions of drugs available in the U.S. are not intended to be covered by the policy.”
In summary, buying biologics in other countries and bringing them back to the U,S. wedged in between your T-shirts and dirty socks is not so much “importation” as it is “smuggling.” Will Americans be willing to take this risk? Is it happening already? I have no current numbers to share, but would not be surprised to find that this type of travel, even with the risks involved, is already happening at some level. Whether a trickle becomes a flood may depend on the outcome of the current healthcare reform efforts.