Published: 25 November 2014
Consultations
Consultation on Proposed Amendment to Regulations under the Medicines Act 1981
November 2014
The Ministry of Health is seeking submissions, by 9 January 2015, on a proposed amendment to the regulations (Medicines Regulations 1984) made under the Medicines Act 1981.
The proposed amendment would have the effect of providing legal clarity that the fluoride substances used to treat drinking water are not medicines.
Background and rationale for the proposed amendment
In New Zealand, the addition of fluoride compounds to community drinking water supplies for the purpose of preventing and reducing tooth decay is a common practice. It is supported by the Ministry of Health as well as by public health authorities, medical science bodies and international organisations such as the New Zealand Medical Association, the New Zealand Dental Association, the World Health Organization and the World Dental Federation.
The fluoride is added to water in the form of Hydrofluorosilicic acid (HFA) and Sodium Silico Fluoride (SSF) by local authorities. The Drinking Water Standards for New Zealand (set under the Health Act 1956) specify that the maximum allowable concentration for fluoride in domestic water supplies is 1.5 milligrams per litre of water.
There is no universal acceptance of the positive health effects of the addition of fluoride to drinking water supplies. In the recent case New Health New Zealand v Attorney-General[1] the plaintiff has sought to prevent or constrain the fluoridation of drinking water, including on the grounds that the fluoride compounds used are medicines under the Medicines Act 1981 (the Act).
In the recent judgement the High Court dismissed the plaintiff’s claim that HFA and SSF properly come within the definition of "medicine" and recommended use of regulation-making powers under the Act to exempt HFA and SSF from being medicines for the purposes of the Act. This would serve to provide greater clarity about the issue by removing any possible ambiguity and would also regularise the status quo as regards the use of HFA and SSF in water fluoridation.
The regulation-making powers in section 105(1)(i) of the Act enable the making of a regulation to specify that substances or kinds or classes of substances are not medicines for the purposes of the Act. A regulation of this type would mean that HFA and SSF and such substances or kinds or classes of substances used for water fluoridation are not medicines and are therefore not subject to any of the requirements of the Act.
The Minister of Health has accepted a Crown Law recommendation to progress such an amendment.
Change proposal
It is proposed that a new regulation be made under section 105(1)(i) that:
Fluoride-containing substances, including the substances hydrofluorosilicic acid (HFA) and sodium silico fluoride (SSF) are not medicines for the purposes of the Act when they are manufactured and supplied or distributed for the purpose of fluoridating community water supplies.
Impacts of the proposed amendment
The proposed amendment would have no regulatory impact on:
- manufacturers and suppliers of medicines containing fluorides
- manufacturers and suppliers of fluorides used to treat community drinking water supplies.
The benefit of the proposed amendment is that it would preserve the status quo and provide legal clarity about the regulatory status of fluoride compounds used to treat community water supplies.
Next steps
The Ministry will consider feedback from submitters early in the New Year. A final decision on the proposed amendment is likely to be taken in late January or early February 2015 following consideration by the Minister and Cabinet. If approved, the new regulation is likely to come into force in February or March 2015.
How to make a submission
Please send your submission to:
Regulations under the Medicines Act 1981 Consultation
Medsafe
Clinical Leadership Protection & Regulation
Ministry of Health
PO Box 5013
Wellington 6145
or
email (putting fluoride in the subject line): askmedsafe@health.govt.nz
The closing date for submissions is 9 January 2015.
Submission form (Word document 15 KB, 2pages)
References
- New Health New Zealand v Attorney-General [2014] NZHC2487
