Issue 45 / 19 November 2012

WHY is cracking down on the deadly international trade in fake and substandard pharmaceuticals proving so difficult?

The WHO’s Framework Convention on Tobacco Control this month set in place a new treaty designed to combat the illicit international trade in tobacco products.

An excellent initiative, but it leaves us with in the bizarre position of having tougher international laws on cigarette counterfeiting than we do on the trade in falsified medicines.

An analysis in the BMJ last week argued a key reason why we have failed to combat this evil business is because we have focused too much on its infringement of intellectual property rights at the expense of addressing the far more devastating impact on public health.

The pharmaceutical industry is of course entitled to protect its investment in proprietary drugs by cracking down on those who attempt to counterfeit them, but a far more important consideration for regulators should be protection of the public from dangerous or ineffective medications pretending to be something they are not.

This is particularly a problem in poorer countries, where it has been estimated half of medicines for some life-threatening diseases may be fakes containing little or no active ingredient.

Earlier this year, I wrote about the proliferation of fake antimalarials, which promote growth of drug resistance because of their varying quantities of active ingredient.

The BMJ paper cites lethal effects of other falsified medications. More than 100 people died in Pakistan after a cardiovascular drug was contaminated with a toxic dose of an antimalarial, while in Kenya an international charity unintentionally supplied falsified antiretrovirals that criminals had managed to insert into its supply chain.

Cheap generic medicines are a target as well as expensive proprietary ones.

“Like most crimes, falsification is opportunistic, occurring where regulatory defences are lowest, not necessarily where profits are highest”, the BMJ authors wrote.

“Worryingly, medicines on WHO’s essential list may be especially attractive to falsify because there is a huge global demand and because most are unpatented, meaning criminals face no risk from angry patent holders suing or demanding prosecution.”

Producing fake versions of even the most basic drugs can turn a profit. In Bangladesh, India, Haiti and other countries, hundreds of people have died after taking falsified paracetamol syrup, most of them children.

Nor is the problem restricted to the developing world and its diseases.

In February, US regulators warned counterfeit versions of cancer medication bevacizumab containing no active ingredient could have entered that country’s supply chain.

So what to do about it? The BMJ authors argue it’s time for a treaty, one that focuses on protecting public health rather than the financial interests of manufacturers.

With 30% of countries estimated to have little or no regulation of pharmaceuticals, a concerted international effort offers the only reasonable prospect of success.

The proposed treaty would establish new public health crimes under international law and oblige countries to cooperate in reporting, investigating and prosecuting the criminals.

Replicating the global effort on tobacco control would be a good start.

Jane McCredie is a Sydney-based science and medicine writer.

Posted 19 November 2012

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