Hearings at Supreme Court November 2017
It is likely a decision will not be made for 6 to 18 months. While this decision is pending it is unlikely any new fluoridation schemes will be started or the Health (Fluoridation of Drinking Water) Amendment Bill will be enacted.
Rulings so far:
Stuff New Zealand – Supreme Court grant right for another appeal for New Zealand’s fluoride “test case”,
Media Release from the Court of Appeal.
Mainstream legal opinion by Law Firm Buddle Findlay.
In his Declaratory Judgement in October 2014, in the High Court in Wellington, Judge Collins ruled that HFA and SSF satisfied all the key elements of a medicine:in that they are used for a therapeutic purpose and they achieve their intended action on the human body by a pharmacological means..Judge Hansen had earlier come to the same conclusion when he ruled against New Health New Zealand in March 2014 in New Plymouth..
Despite fluoridation chemicals meeting the usual description of a medicine, Judge Collins ruled they were not medicines since they were added to the public drinking water at a concentration lower than 10mg/L.
The Judge has made a patently obvious error as he has referred to a section in the Act that regulates Prescription, Restricted and Pharmacy only medicines. Not meeting the classification for one of these types of medicines, does not mean a substance is not a medicine, it just means it is a general sale medicine.
Judge Collins then advised the Ministry of Health to apply for an exemption from the Medicines Act for all fluoridation chemicals. Despite 1300 submissions, the Government quickly approved the exemption in February 2015.
New Health New Zealand is appealing this decision and the decision made by Judge Hansen in the High Court in New Plymouth in 2013. This will be heard at the High Court on the 5th and 6th of July 2016.
On the 27th January 2015 Minister of Health, Dr Coleman, signed into law a Regulation which exempts all chemicals containing fluoride from being considered medicines if they are delivered via the public water supply. The absurdity of this should be plain for anyone to see. Sodium fluoride is already, and continues to be, a classified medicine. However, if a council adds it to the public drinking water supply it is not a medicine.
Medsafe received 1300 submissions on this proposal yet took only eleven working days to complete their proposal. Obviously they would not have had time to read all the submissions let alone consider them.
Official Information Act response showing the reason for the rushing through of the exemption of fluoridation chemicals to the Medicines Act.
“This would have the effect of rendering the appeal moot, an outcome that would save considerable legal costs for the Crown.”
In 2012 New Health New Zealand (NHNZ) brought a judicial review against the South Taranaki District Council on their decision to embark on fluoridation in the townships of Patea and Waverly. The Council had undertaken consultation and found the 85% and 75% of submissions received from Patea and Waverley respectively, were against introducing fluoridation.
The Judicial Review by NHNZ rested on charges that the Council did not have legal authority to add fluoride chemicals to the drinking water and that fluoridation was a breach of human rights. The Judge ruled against NHNZ but within his ruling he said that fluoridation was being used for a therapeutic purpose. NHNZ are appealing this ruling and is expected to be heard later this year.
NHNZ then sought a Declaratory Judgment against the Ministry of Health declaring fluoridation chemicals to be medicines. The Medicines Act states that any substance where a therapeutic purpose is claimed (regardless of whether the therapy actually works) is subject to the Medicines Act.
In October 2014 Judge Collins ruled that that HFA and SSF satisfied all the key elements of a medicine in that they are used for a therapeutic purpose and they achieve their intended action on the human body by a pharmacological means. He then incorrectly concluded that since they are added at a level less than 10 mg/L (10ppm) that they are not classified as medicines. However, the clause he refers to says “if the medicine is not an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram” (my emphasis) is in a Section of the Regulations that only refers to classification of Prescription, Restricted and Pharmacy-only medicines. He ignored the fact that medicines not classified under one of those three heads are still medicines – specifically general sale medicines. If his conclusion were valid, then all the thousands of prescription, restricted and pharmacy-only medicines would no longer be medicines if they were less than 10 mg/L. That would be an absurdity and is not the case. They are still medicines; they are just classified as general sale medicines rather than Prescription, Restricted or Pharmacy-only.
It is patently obvious that Judge Collins decision was wrong. Judge Collins himself must also have been aware that his decision was not robust since he went on to advise the Ministry of Health to apply for an Exemption.
The Minister of Health acceded to Medsafe’s request and HFA and SSF have been singled out as the only substances that are used for a claimed therapeutic purpose, that are delivered via ingestion, but are not subject to any of the normal scrutiny and safeguards that all other medicines are.
As only medicines or related products can be exempted from the Medicines Act, the act of exempting the chemicals is an admission that the chemicals would otherwise been considered medicines. Exempting them from the Act has put New Zealand in the position of having medicines added to the drinking water, but these medicines have been given special status to sit outside the normal rule of law, without any sound reason being provided for doing so.
NHNZ’s Appeal on the Declaratory Judgement and the Appeal on the Judicial Review were both was heard in July 2016. The Court of Appeal ruled against New Health New Zealand in both cases.
Case has now (November 2017) been heard at the Supreme Court and we await a decision.