3 million at risk from illegal medicine in dysfunctional Irish health system

6 December 2007

“Regulation of counterfeit medicines in Ireland is a contradiction when three million Irish consumers are exposed every day to an unlicensed medicine in their tap-water” said VOICE spokesman, Robert Pocock in Dublin today. Campaigners mounted a dawn protest at The Medicines Board World Summit of Heads of Medicines Agencies hosted by the Irish Medicines Board (IMB). The unlicenced product which has never been subjected to the requisite clinical trials is fluorosilicic acid, an industrial waste containing contaminants such as lead, arsenic and chromium, and which is known to bio-accumulate in bone. All of these are recognised carcinogens or neurotoxins.

The object of this summit is to crack down on imported counterfeit medicines, which the IMB puts at around 1,500 products, described by Pat O’Mahony, the IMB’s CEO, as unauthorised products. The IMB has stated that identifying these illegal products in the Irish distribution chain is a challenge.

VOICE’s Pocock commented “Why doesn’t the IMB also address itself to the much simpler challenge of doing a spot check on fluoride, an unlicenced product, and subjecting it to proper toxicological testing? VOICE already supplied a sample of this unlicenced product to the IMB last April to facilitate their work on ensuring compliance with the EU Medicines Directive. But no action seems to have been taken, and according to the Irish Expert Body on Fluorides and Health, today about 600 hundred suppliers nationwide are still dispensing this unauthorised medicine into 3 million consumer’s drinking water.”

In another example of the ‘dysfunctional’ health service, the people in Donegal who tested above safe intakes of fluoride earlier this year, reveal serious individual fluoride overload, with seven in ten adults found to have fluoride levels above the safe intake set by the UK Food Standards Agency. The Donegal 'patients' have expressed lack of faith in the health service because it has failed to constructively engage in measuring total fluoride intake by individuals, something promised to the Dáil by Mary Harney over two years ago.

Yet another example of this dysfunctional policy is the ongoing risk to bottle-fed babies, for whom the American Dental Association and the British Fluoridation Society advise that low-fluoride or no fluoride water be used to make up infant formula. Once again the Expert Body is out of step, still recommending tap water containing 0.7 ppm fluoride for use in formula, even though this is almost two hundred times the amount found in breast-milk.

If unlicensed medicines really do constitute a serious problem forinternational regulators, how then can the Irish regulator continue to disregard the unlicensed product in the water we drink every day?