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Importation of medicines

The price of brand name prescription drugs is often lower in other countries than in the US. For this reason, some people in the US have started to buy prescription drugs from abroad, often over the internet. The US Food and Drug Administration (FDA), which has not approved the drugs that foreign vendors offer for sale to Americans, has warned that this is illegal and unsafe.

GSK has consistently opposed this practice because of the increased safety risks to patients. Our view of the risks was confirmed in 2004 by a report from the Department of Health and Human Services (HHS) Task Force on Drug Importation, chaired by the Surgeon General Richard H. Carmona. The task force looked at safety issues around illegal drug importation and the potential for cost savings to be made if the practice were made legal. The full report can be found online at www.hhs.gov/importtaskforce.

According to the report, drugs imported by consumers come into the US from a wide range of countries. These drugs are typically not approved by the FDA and may fail to conform in many aspects to the FDA-approved drugs available in the US. Specifically, the report found that “importation increases the opportunities for counterfeit and other substandard drugs to enter and be dispersed into the US drug distribution system… American consumers currently purchasing drugs from overseas are generally doing so at significant risk”.

The Task Force concluded that it would be “extraordinarily difficult” to ensure that drugs imported by individual consumers meet the necessary standards for safety certification. Noting that the FDA does not have sufficient resource now to ensure the safety of personally imported drugs, the report concludes: “There is no realistic level of resources that could ensure that personally imported drugs are adequately inspected to assure their safety since visual inspection, testing and oversight of all personally imported prescription drugs are not feasible or practical at this time.”

The Task Force report states that there are a number of new anti-counterfeiting technologies in development that, once they are universally adopted, may provide assurance on the safety and authenticity of prescription medicines. However it noted that, “widespread adoption of authentication technologies, while theoretically able to secure the US drug supply, is a daunting task that could raise the cost of imported drugs thereby reducing any expected savings from importation”.

The report concludes that the cost of carrying out safety checks on imported medicine, and profits going to middlemen, would in large part offset the potential savings from differences in prevailing prices. Based on an analysis of actual data on drug prices and volumes, the Task Force found that “total savings to drug buyers from legalised commercial importation would be one to two percent of total drug spending and much less than international price comparisons might suggest. The savings going directly to individuals would be less than one per cent of total spending. Most of the savings would likely go to third party payers, such as insurance companies and HMOs”.

The report findings have confirmed our view that patients should stick to trusted methods for saving money on approved medicines, such as savings cards, that are legal and safe. GSK is sensitive to patients’ concerns over costs and the lack of prescription drug coverage for the uninsured in the US. That is why we led the industry in establishing the first prescription savings card – the Orange card - and are a founding member of the Together Rx programme.

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