BC-DRUGIMPORTS-CON:KRT – op-ed, world (760 words)

Europe’s experience shows strong safeguards are needed

(EDITORS: The writer is addressing the question, “Do re-imported drugs pose health risks for Americans?”) (EDITORS: We suggest paring this article with DRUGIMPORTS-PRO.)

(ARCHIVE GRAPHIC)

By Graham Satchwell

(KRT)

The U.S. presidential election saw re-importation of prescription drugs become one of the major dividing lines between Republicans and Democrats.

President Bush says the jury is still out on whether re-importation is safe, while most Democrats say there is no reason that Americans shouldn’t import cheaper medicines from abroad if it lowers costs for patients.

Meanwhile, the Kaiser Family Foundation and the Harvard School of Public Health recently released results from a survey that found 80 percent of Medicare beneficiaries supported legalization of drug re-importation from Canada if it would lower costs.

Cost is clearly an important factor, but what about safety? It is politically popular to say that the debate about re-importation and patient safety is a conspiracy cooked up by Big Pharma to safeguard profits made on branded drugs.

But is this fair? What does the European experience of re-importation have to teach America? And, if this is a problem, what can we do about it?

Re-importation of goods, including medicines, within the European Union is perfectly legal and is known as parallel trade.

Of course, obtaining a product from one country where it is relatively cheap and selling it into a country where it is relatively expensive is the basis of all international trade and has been going on for thousands of years.

Parallel trade of medicines, in particular, is a growth industry in Europe. Market share has increased from 11 percent in 1999 to 17 percent in 2003. But why should consumers care unless the rise in re-importation affects them personally?

The frightening truth is that this rise does affect individuals’ safety in a fundamental way – even if they don’t realize it.

There are two main reasons for concern:

n First, my investigations into the links between counterfeit medicines and organized crime show that the greater the number of re-imported products entering a country becomes, the greater the chance that substandard medicines, counterfeit or otherwise, will enter the legitimate distribution chain. In other words, re-importation means you, your family or someone you know is more likely to be harmed by taking a medicine that is not what it purports to be.

n Counterfeit medicines also are a lucrative source of illicit income for international criminals. Interpol, the international policing body, along with other experts on counterfeiting are amassing evidence that criminals are increasingly moving into this trade rather than more traditional crimes like trafficking in narcotics and people.

This crime is currently worth the investment on any sensible risk-benefit analysis: the profits are high and the risks are low. The simple truth is that this crime is invisible. Regulators and law enforcement agencies are not looking for it, and the consumer remains largely unaware.

Yet, any growth or sustainable market in re-imported medicines into the United States will mean a corresponding growth in the movement of medicines around the world and a corresponding extension of the sick and lethal business of counterfeiting drugs.

With this in mind, it behooves politicians to heed the warnings and resist moves to increase re-importation into the United States until greater safeguards are in place to protect the public.

The FDA recently announced a faster timetable for the introduction of Radio Frequency Identification tagging of pharmaceutical products. This is just the sort of protective action that consumers of medicines need wherever they live.

These steps must be taken before Americans are encouraged to get bargain basement prices on re-imported medicines that will sometimes be other than what they seem, and are likely to do much more harm than good.

The first rule of medicine should remain, as it has for centuries, “first, do no harm.”

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