Merrill Matthews

This guide answers some of the questions about the safety concerns associated with prescription drug importation and whether consumers ought to have the right to buy imported drugs even if they are aware of the significant risks.

The issue is safety. Twice the Secretaries of Health and Human Services have been unable to determine that U.S. consumers would be safe with large-scale prescription drug reimportation. Reasons for opposing prescription drug reimportation include: 1) U.S. Government agencies recognize the danger of illegal imports, 2) drug counterfeiting is rampant outside the U.S., 3) Canada isn't safe either, 4) it's all authorities can do to monitor the safety of drugs within the U.S., much less worrying about drugs from overseas, and 5) trial lawyers will sue pharmaceutical manufacturers for not ensuring the safety of their products, even when they have no control over them.

Americans are increasingly buying U.S.-made prescription drugs from Canada and other countries and bringing (i.e., reimporting) them back to the U.S. However, reimporting these drugs is breaking U.S. law. Should drug companies continue to sell to vendors who knowingly break the law and may put patients at risk? Reimportation is creating several ethical dilemmas for prescription drug manufacturers.

This Desktop Reference will help state legislators identify effective actions that may save the states money without reducing access to needed medicines.

Of all the recent criticisms leveled at the prescription drug industry, the one that has resonated most is that drug companies are gaming the patent system. However, the Hatch-Waxman Act that governs the role between generics and brand name drugs is very complicated, and it has ultimately weakened intellectual property protections. It is naive to assume that branded companies are sidestepping the rules while generics always play fair.

By making a product available at several price points, differential pricing allows many more consumers access to the product—especially lower-income consumers. Requiring producers and vendors to sell their products, such as prescription drugs, at a single global price. (i.e., price controls) would not make drugs available at low prices; it would drive the price higher and deprive low-income consumers and nations of access to those products.

Almost every sector of the economy advertises as a way of getting critical product information to customers. The utility of advertising is widely recognized—except in the case of pharmaceutical advertising, which is blamed for increasing health care costs, intruding on the doctor’s authority, and misleading consumers. But after examining these charges, it is clear that prescription drug advertising isn’t the problem—it’s the solution.

The pharmaceutical industry is under political attack for being “too profitable,” for drug prices that are “too high,” for paying their CEOs “too much,” and for “profiting from pain.” Yet, when compared to other industries, it becomes clear that the pharmaceutical industry makes a compelling, socially-beneficial product, and performs within reason for an industry that takes enormous financial risks.

The pharmaceutical industry cites studies that suggest it costs more than $800 million to move a new drug through the 10-to-12 year discovery, development and approval process. However, critics claim those estimates are artificially inflated and that the actual costs are much lower. For example, Ralph Nader’s Public Citizen released a study last year claiming that the cost of creating a new drug is only about $110 million (in 2000 dollars). And that includes the cost of failures.

Although people often can get free use of someone’s intellectual property, that doesn’t make it right—or legal. Does it really hurt anyone? Is intellectual property really all that important?