As we approach phase 2 of the Royal Commission of Inquiry into c-19 (RCI), it is worth revisiting what happened regarding the use of s23 of the Medicines Act 1981 relating to provisional consent in May 2021.
Provisional Consent in NZ under the Medicines Act 1981
Provisional consent in New Zealand, as defined by the Medicines Act 1981, is a mechanism that allows for early access to new medicines under specific conditions. Section 23 of the act empowers the Minister of Health to grant provisional consent for the sale, supply, or use of a new medicine. It is typically granted when it is deemed desirable for a medicine to be available on a restricted basis for the treatment of a limited number of patients.
The original purpose of provisional consent was presumably to protect New Zealanders from medicines with no (or limited) safety or efficacy data but allow them to be used in desperate situations, such as a terminal illness.
As the Pfizer C-19 vaccine rollout started in NZ, lawyer Sue Grey and other astute citizens observed that under s23 of the Medicines Act 1981 provisionally consented medicines could only be used on a restricted basis for the treatment of a limited number of patients. Yet, the Labour government of the day was recommending that the whole population (healthy and otherwise) receive a medicine with only provisional consent.
As five million New Zealanders did not equate to ‘a limited number of patients’, a legal case was mounted to challenge the use of provisional consent. The case was heard in the High Court in Wellington on 12 May 2021. Ellis J released her judgement on 18 May 2021 and agreed with the applicants that the whole population could not be construed as ‘a limited number of patients’.
Ellis J did not provide the relief sought by Sue and her team which was to halt the rollout of the vaccine, instead she advised the government to do something about the provisional consent.
I have also found that it is reasonably arguable that the provisional consent granted to the Comirnaty vaccine was ultra vires s 23 of the Act, and I would urge the Crown now to consider that question carefully.
There must have been internal communications as the very next day following the release of the judgement there was new legislation in front of parliament recommending changes to the Medicines Act.
Indeed David Parker, then Attorney General noted how well the different branches of the government worked together.
I think this is a good example of the different branches of Government showing respect for each other in respect of what are important issues.
[It is a shame the judicial branch of government did not show respect for the people of New Zealand.]
The Medicines Amendment Bill then had three readings in one day on 19 May 2021 and gained Royal Assent on 24 May 2021! No time for public comment or input and it is not clear how many MPs actually had time to read and digest the judgement and the proposed bill.
The amendment removed the words “on a restricted basis for the treatment of a limited number of patients”.
During her presentation of the bill on 19 May 2021 then Health Minister Dr Verrall stated:
The amendments in the bill are consistent with the policy intent of section 23, which is for New Zealanders to have timely access to safe and effective medicines where there is a public health need.
The bill does not affect existing requirements related to safety, quality, and efficacy of the medicines in assessment of the therapeutic benefits and risks.
In both these sentences she mentions the safety, efficacy and quality criteria.
If one reads the provisional consent requirements under s23 of the Medicines Act, reports about safety, efficacy and quality are specifically excluded from being required. (These are points (i), (j) and (k) of s21(2).)
(i) reports of any tests made to establish the safety of the medicine for the purposes for which and in the manner in which it is intended to be used:
(j) reports of any tests made to control the strength, quality, purity, or safety of the medicine and of the method of testing:
(k) any reports relating to the efficacy of the medicine:
She was disingenuous to state “The bill does not affect existing requirements related to safety, quality, and efficacy…” because there were no requirements in the first place.
So, under the provisional consent, New Zealanders were being mandated to take a medicine for which there was no requirement for safety, efficacy or quality.
In direct contrast, the marketing and propaganda the population was exposed to repeated ‘safe and effective’ ad nauseam. This was a lie.
At no point have the products that have been repeatedly injected into New Zealanders been either safe or effective.
As an aside, during discussions at the readings, there was some incredulity on behalf of National MPs that there had been no legal advice sought or given and no questions from anywhere or anyone regarding the use of provisional consent in such a way. David Parker stated, “This first came to the attention of the Government upon the filing of the court proceedings, not before.”
Really? How could that happen if competent people were involved?
This article was originally published by the New Zealand Doctors Speaking Out With Science.
