UK - House of Lords
Questions
Asked by Earl Baldwin of Bewdley
To ask Her Majesty's Government whether the statement by the Medicines and Healthcare Products Regulatory Agency in its lay summary for licensed product 00036/0103 that this "contains sodium fluoride, which helps prevent tooth decay" indicates that toothpastes with added fluoride require medicinal product licences.[HL13300]
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): It is the Medicines and Healthcare Products Regulatory Agency's (MHRA) view that the presence of fluoride in toothpaste does not, in itself, make the product a medicinal product. Oral hygiene products are permitted by the cosmetics directive to contain fluoride to a maximum strength of 0.15 per cent. Accordingly, the MHRA considers that a toothpaste containing more than 0.15 per cent of fluoride falls within the definition of a medicine, but those with lower concentrations do not.
Asked by Earl Baldwin of Bewdley
To ask Her Majesty's Government, further to the Written Answer by Earl Howe on 7 February (WA 18-19), whether they have made progress in deciding whether to reduce the fluoride concentration in United Kingdom water fluoridation schemes; and why they need to await consultations in the United States.[HL13301]
Earl Howe: There is currently no clear evidence to show that, in temperate climate zones, increasing the fluoride content of drinking water to 1 milligram part per litre imposes any risk to general health. It has been suggested that if people are using more fluoride supplements such as mouthwashes, tablets and drops the concentration in water can be reduced. However we are waiting to see if any new evidence is identified in the course of the consultation that the United States Department of Health and Human Services is undertaking on reducing its target concentration to 0.7 milligram per litre.
Asked by Earl Baldwin of Bewdley
To ask Her Majesty's Government, further to the Written Answer by Earl Howe on 1 November (WA 233-4), what is their authority for the view that fluoride when added to mains water to protect children's teeth does not constitute a medical treatment as opposed to a medicinal product.[HL13302]
Earl Howe: The Medicines and Healthcare Products Regulatory Agency considers that neither fluoride added to drinking water nor the resulting fluoridated water is a medicinal product which requires marketing authorisations as medicines.
The case law of the European Court of Justice indicates that it is for the national authorities of each member state, subject to review by the national courts, to determine whether either limb of the definition of the term "medicinal product" is satisfied. In particular, in the European Court of Justice, in the Commissioner of the European Communities v the Federal Republic of Germany [Case C290/90], the Court reviewed precedent and said:
"It is for the national authorities to determine, subject to review by the courts, for each product, whether or not it constitutes a medicinal product, having regard to all its characteristics, in particular its composition, its pharmacological properties as they may be ascertained in the current state of scientific knowledge, the way in which it is used, the extent to which it is sold, its familiarity to consumers and the risks which its use may entail".
Asked by Earl Baldwin of Bewdley
To ask Her Majesty's Government whether the statement by the Medicines and Healthcare Products Regulatory Agency in its lay summary for licensed product 00036/0103 that this "contains sodium fluoride, which helps prevent tooth decay" indicates that toothpastes with added fluoride require medicinal product licences.[HL13300]
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): It is the Medicines and Healthcare Products Regulatory Agency's (MHRA) view that the presence of fluoride in toothpaste does not, in itself, make the product a medicinal product. Oral hygiene products are permitted by the cosmetics directive to contain fluoride to a maximum strength of 0.15 per cent. Accordingly, the MHRA considers that a toothpaste containing more than 0.15 per cent of fluoride falls within the definition of a medicine, but those with lower concentrations do not.
Asked by Earl Baldwin of Bewdley
To ask Her Majesty's Government, further to the Written Answer by Earl Howe on 7 February (WA 18-19), whether they have made progress in deciding whether to reduce the fluoride concentration in United Kingdom water fluoridation schemes; and why they need to await consultations in the United States.[HL13301]
Earl Howe: There is currently no clear evidence to show that, in temperate climate zones, increasing the fluoride content of drinking water to 1 milligram part per litre imposes any risk to general health. It has been suggested that if people are using more fluoride supplements such as mouthwashes, tablets and drops the concentration in water can be reduced. However we are waiting to see if any new evidence is identified in the course of the consultation that the United States Department of Health and Human Services is undertaking on reducing its target concentration to 0.7 milligram per litre.
Asked by Earl Baldwin of Bewdley
To ask Her Majesty's Government, further to the Written Answer by Earl Howe on 1 November (WA 233-4), what is their authority for the view that fluoride when added to mains water to protect children's teeth does not constitute a medical treatment as opposed to a medicinal product.[HL13302]
Earl Howe: The Medicines and Healthcare Products Regulatory Agency considers that neither fluoride added to drinking water nor the resulting fluoridated water is a medicinal product which requires marketing authorisations as medicines.
The case law of the European Court of Justice indicates that it is for the national authorities of each member state, subject to review by the national courts, to determine whether either limb of the definition of the term "medicinal product" is satisfied. In particular, in the European Court of Justice, in the Commissioner of the European Communities v the Federal Republic of Germany [Case C290/90], the Court reviewed precedent and said:
"It is for the national authorities to determine, subject to review by the courts, for each product, whether or not it constitutes a medicinal product, having regard to all its characteristics, in particular its composition, its pharmacological properties as they may be ascertained in the current state of scientific knowledge, the way in which it is used, the extent to which it is sold, its familiarity to consumers and the risks which its use may entail".
posted by Bill at
3:10 PM
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