Court Report NZDSOS V MCNZ: Part 2

Introduction

New Zealand Doctors Speaking Out with Science (NZDSOS) were in court September 23 and 24, 2024 to challenge the Medical Council of New Zealand (MCNZ) on two issues. Part one dealt with the MCNZ Guidance Statement and the second part of the case related to off label prescribing.

Off-Label Prescribing (with Respect to Ivermectin)

NZDSOS argued that this is something that doctors do every day, and it is not the role of the MCNZ to determine what medicines doctors do, or do not, prescribe for individual patients.

The situation is that the MCNZ regulates doctors, Medsafe regulates medicines and doctors are the ones who, in conjunction with their patients, make the decision to prescribe.

NZDSOS effectively asked the judge to confirm that doctors have the ability to do what they are trained to do – prescribe medicines for patients.

If a medicine is considered so unsafe or risky that it shouldn’t be widely prescribed or if there are other reasons to limit the prescription of a medicine, there is a legal pathway via s 48 of the Medicines Act to do this.  The MCNZ had the ability, through the Minister of Health, to use this pathway to limit or prohibit the prescription of ivermectin but it elected not to use it.

Instead MCNZ has sanctioned the doctors who prescribed, authorised, recommended or discussed this, without any basis or explanation for doing so.  This is evidenced by Voluntary Undertakings proposed by MCNZ and/or signed by doctors which included the statements:

By taking actions against doctors regarding ivermectin the MCNZ has effectively inserted itself into the doctor-patient relationship. 

It should be noted that ivermectin is a long-standing, safe medication so the risks are minimal.

The MCNZ legal argument was that they could rely on recommendations (with no regulatory status) by Medsafe and the Royal NZ College of GPs to sanction prescribing by doctors.

The RNZCGP had issued an Update on 3 September 2021 and Medsafe had issued an Alert Communication on 6 September 2021 noting that ivermectin had not been approved for use in c-19 and suggesting that there may be risks. 

Ivermectin was already an approved medication and did not need to be further approved for doctors to be able to prescribe it.  That is what off-label prescribing involves – an approved medicine being used for a different purpose and individual doctors weighing up risks and benefits with individual patients engaging the informed consent process.

What were the officials saying about a doctor’s ability to prescribe ivermectin?

In contrast to the actions taken by the MCNZ against doctors who prescribed, recommended or imported ivermectin, when questioned under OIA, Medsafe and others repeatedly affirmed that doctors could prescribe ivermectin and that there was no prohibition.

On 15 February 2021 Chris James of Medsafe wrote: “Section 25 of the Medicines Act 1981 permits authorised prescribers to prescribe approved medicines for unapproved uses.”

On 15 September 2021 Dr Ashley Bloomfield said, when speaking about various medicines to treat covid 19: “In the meantime, any of these medications can be prescribed by a doctor if they are indicated and if available here. Even if there’s not an approval through Medsafe, they can be prescribed off‐label.”

On 21 September 2021 Gill Hall from the COVID-19 Health System Response noted: “At present, the only approved medication for COVID-19 is dexamethasone tablets.  For your reference, medical practitioners are permitted to prescribe any medicine for a particular patient in their care at their discretion; however, unapproved medicines have not been evaluated by Medsafe for safety and efficacy.” 

On 26 October 2021 Chris James of Medsafe reiterated his earlier stance: “Under Section 25 of the Medicines Act 1981, and within certain controls, authorised prescribers can prescribe any medicine (including ivermectin) for the treatment of a patient under their care. This includes prescribing an unapproved medicine, or an approved medicine for an unapproved indication (“off-label” use).” 

On 23 December 2021 Rachel Read of Pharmac stated: “Medicines listed on the Pharmaceutical Schedule without restriction (open listed) can be prescribed for the treatment of any conditions, including COVID-19, where a prescribed feels it is appropriate.  However, patients may need to pay for the cost of the medicine if it is not listed on the Pharmaceutical Schedule for their condition.”

On 8 August 2022 Chris James of Medsafe stated: “Medical Practitioners, under section 25 of the Medicines Act 1981, can prescribe medicine for a patient under their care. The Code of Health and Disability Services Consumers’ Rights places obligations on prescribers to ensure that all treatment meets ethical and professional standards. In prescribing an unapproved medicine or an approved medicine for an unapproved purpose, a prescriber must consider these requirements and should ensure a process of informed consent with the patient is carried out.”

Summary

NZDSOS stated that doctors should be able to be doctors and make the medical decisions that their training enables them to.  The MCNZ’s position was that other authorities could step into the consulting room and dictate what doctors could prescribe without going through any official process.

We are reminded of the MCNZ’s similarly arbitrary assessment of the safety of the newly developed mRNA vaccine platform as “zero risk” (covered in part 1 of this article, and here with a bit more bile. Independent media platform The Centrist has also covered this story and have been with us all the way through the case, providing legal nouse and financial support. We are most grateful and highly recommend their work).

The warning against ivermectin use seems to satisfy the same political directive – to get jabs in all arms, with no competitor treatments to be allowed. We hope the judge can see the similar patterns here.