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(05/01/16) A summary of 'Cochrane Collaboration systematic review of water fluoridation 2015' has been posted in Reports.
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(16/04/14) A critique of 'One in a Million: The Facts' has been posted in Reports.
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(16/04/14) 'Fluoridation: Popularity' has been posted in the Archive.
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(18/04/10) New fluoridation scheme for Southampton

(18/04/10) The Reports and Archive sections have been updated with further documents and links

(11/07/09) A critique of Prof. Newton's report to South Central SHA has been posted in Reports.
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(28/09/08) A critique of the South Central Strategic Health Authority Consultation Paper on Water Fluoridation in Southampton, has been posted in Reports.
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(07/09/08) A response to the Chief Dental Officer's 'Dear Colleague' letter of guidance for new schemes, endorsed by scientists from the York review, has been posted in Reports.
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(23/06/08) Isle of Man has announced on 12th June that it will not be fluoridating its water supply
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SHA Public Board Paper HA09/019 dated 18 February 2009

25th March 2009

Dear Olga Senior,

I am writing about the paper that you authored for the South Central SHA meeting on fluoridation on 26th February, having studied it with interest. Having had long-term involvement with fluoridation issues I write principally to point out an error in paragraph 4.2, but also to raise an additional point or two.

Lord Jauncey in the McColl case in 1983 did not hold that fluoridated water fell outside the Medicines Act 1968. It was a complicated case involving a number of claims, various findings of fact and four questions of law. The petitioner succeeded on the basis that fluoridation was ultra vires the regional council, but failed on questions of nuisance and breach of the Water (Scotland) Act 1980. The fourth head, an averred breach of the Medicines Act 1968, was reported in pages 243 - 246 of Lord Jauncey's opinion in the Scottish Sessions Cases No. 23 of June 29, 1983.

Under this head the judge stated: "Section 130 [of the Medicines Act] defines "medicinal product" and I am satisfied that fluoride in whatever form it is ultimately purchased by the respondents falls within the definition." This follows a statement under an earlier head in which he said: "Thus the water instead of being the object of treatment becomes the means whereby fluoride is carried into the consumer's body to effect a result which could also be achieved by the consumption of fluoride pills .." Lord Jauncey clearly saw fluoridated water as medicinal.

Mrs. McColl failed to prove a breach of the Medicines Act under sections (7(2)(a), 7(5) and 7(6)(a)) which turned on whether the council were responsible for the composition of the fluoride compound. Also "it is the supplier of a medicinal product and not the purchaser thereof who requires to be licensed." It was on these issues of composition and supply involving the need for a products licence that she failed to show that her regional council had breached the Medicines Act.

Lord Jauncey did not therefore, as you wrote, "[consider] whether fluoridating the water supply came within the Medicines Act 1968 and held that it did not". What he considered was whether Mrs. McColl had "[established] that any supply by the [regional council] of fluoride in the drinking water would be a supply to which section 7(2)(a) applies", and held that she had not. He added that he did not need to determine whether a supply of water fluoridated at 1 ppm "would otherwise be a supply of a medicinal product .. within the meaning of section 7(2)(a)". He had already decided that fluoridated water fell within the definition of a medicinal product.

This is a significant misinterpretation to have put before the SHA. Also under 4.2, it is worth noting that the relevant part of European Directive 2001/83/EC has been superseded, although the wording you quote has not changed. I believe the MHRA is open to challenge in the light of this wording which appears to cover the fluoridation of water. Of course fluoridation is not a means of "curing" a disease: its claims are prophylactic, in the same way as the anti-malarial medication I have recently been taking. At the bottom of 4.2 you are right that chlorine treats water; but you have missed the point, recognised by Lord Jauncey, that fluoride treats people, and intends and claims to do so.

As a Parliamentarian I find the idea that MPs and Peers can be referred to on scientific questions of safety and efficacy (4.3), in preference to a systematic scientific review of the calibre of York which was set up by Government for this purpose, to be unworthy of a serious briefing paper.

In seeking your comments on these points, I would also ask whether you had a reason for omitting under 'Legal implications (if any)', on the front page, the full 'Cabinet Office Code of Practice on Consultation', not just on written consultation. This code contains a criterion (2.3) which reads "As far as possible, consultation should be completely open, with no options ruled out." In the present case this would imply that the SHA could have presented more wide-ranging options for how the recent increase in caries among 5-year-olds might be managed, so that a wider public could judge the strength of the PCT's claim that only fluoridation would now meet the case. I wonder if the SHA board was aware of this criterion, since it seems not to have appeared in your paper. (I have not been able to access your Appendix 2, so may have missed the explanation.)

My background to the fluoridation question is as an opponent (I chair an All-Party Group to this effect). But I was also on the advisory board to the York review, and remain in touch with the independent scientists from that exercise who share most of my concerns about the direction that scientific and other arguments have taken since that review was published.

Yours sincerely,

Olga Senior
Director of Communications and Corporate Affairs
South Central Strategic Health Authority
Rivergate House
Newbury Business Park
Berks. RG14 2PZ.

cc. Dr. Geoffrey Harris, Chair, South Central SHA
Jim Easton, Chief Executive, South Central SHA

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