In the international public health arena, regulation against 'falsified' pharmaceuticals again seems to be a casualty

While much of the world—both developed and developing nations—are setting up various types of tracking or serialization programs, action at the World Health Organisation (WHO; Geneva, Switzerland) has been hamstrung by a continuing debate between those who believe illegally manufactured drugs are a public health threat, and those who believe it is an intellectual property (IP) dispute, with tighter control merely being the rich nations imposing their will on the poor ones.

The latest chapter in this dispute is the run-up to a WHO meeting on the subject being held this week in Argentina. NGOs who wanted to participate were excluded by representatives of India (as reported by Reuters). Members of some of those NGOs, and others involved in the topic, have made the point that this ban violates WHO’s own policies, to no avail. A group of public health advocates had published an article in the British Medical Journal the week before, making the point that it is not difficult to write a treaty that distinguishes between “falsified” medicines (which are complete fakes that may contain no active ingredient, or even just a poison) and “counterfeit” medicines (which, in some legal interpretations, can mean a perfectly good drug that was not manufactured with a license by a patent holder).

As one source put it, “Legally, it is very easy to separate intellectual property wrongs from public health wrongs. Imagine yourself surprised to discover a corpse killed by fake medicine: would you cry out that someone was murdered, or shriek in horror that intellectual property had been violated? If you can spot the moral distinction in that question, then you know the difference.” But that perspective won’t be voiced at the meeting, at least by the banned participants.

In the developed world, with strong IP rights, the distinction between falsified and counterfeit is mostly moot—they’re both illegal—but in the developing world, the IP rights are disputed, especially when a life-saving medication is available but too expensive for broad distribution. Several years ago, WHO attempted to address the problem by creating the IMPACT program and writing model legislation that countries could adopt, but moving the subject to the international treaty level was stymied by the same IP dispute, helped in part by European NGOs that had the same stance as what appears to be the case in India now.

The situation is not hopeless; the WHO meeting might in fact come out with a recommendation that moves the subject forward. Roger Bate, one of the coauthors of the BMJ paper (and a resident scholar at the American Enterprise Institute), tells Pharmaceutical Commerce that as Indian, Chinese and other countries’ own pharma manufacturers grapple with the same falsified-medicines problem that established multinationals have, their governments’ policies might evolve. But meanwhile, untold thousands of patients will continue to suffer the consequences of fake medicines.