EU pharma sector reform must start in Ireland

Written by Robert Pocock Monday, 26 January 2009 11:29

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Letters to the Editior

The package announced by EU Commissioner Guenter Verheugen to reform the pharma sector (IMN 05/01/2009) for the benefit of European citizens, including protecting them better from counterfeit medicines, is very interesting, but as far as Ireland is concerned purely aspirational. Why is this?

Because in Ireland today, an unauthorised and untrialled counterfeit medicine – fluorosilicic acid – is distributed to millions of people by most public water plants. They do not employ licensed pharmacists nor do they provide patient information on individual dosage, needs assessment, or side effects of this medicine, all of which are statutorily required in the EU.

While this medicine was claimed in the 1960s by then Health Minister Sean McEntee to prevent dental caries in children, today so over-exposed to fluoride are the population of Ireland that, according to University College Cork’s (UCC) North South Survey of Children’s Oral Health, 2003, one-in-three Irish teenagers now has dental fluorosis or abnormal tooth enamel (1).

Not alone has Health Minister Mary Harney failed to withdraw the product responsible for this adverse reaction (in contrast to her immediate ban on magic mushrooms), but the Commissioner responsible today for enforcement of medicines legislation in the EU is none other than Verheugen. For this Commissioner to have any chance of support for future pharma reform, I believe he must first enforce here in Ireland the existing EU medicines legislation, which prohibits the advertising, presentation, or supply of all unauthorised medicinal, pro­ducts, such as fluorosilicic acid.

(1) There is a picture of dental fluorosis or abnormal tooth enamel on page 126 of: www.dohc.ie/publications/pdf/fluoridation_forum.pdf. Thirty-seven per cent of 15-year-olds in fluoridated Ireland have this abnormal enamel – UCC Survey.