WHAT IS THE GOVERNMENT HIDING THIS TIME ‘THERAPEUTICS PRODUCTS BILL’?
What are you not being told as to why the government reintroduced the Therapeutics Products Bill. The message they give NZrs is that they are just making sure of the quality and the efficacy on therapeutics. Balancing the risks and benefits. Making sure they are a different product category to medicines and medical devices. That are they hiding, not telling the public of New Zealand.
The Govt sought an urgent law change to the Medicines Act which related to the Pfizer COVID19 rollout legality. The govt needed to urgently fix the Medicines Act so that they could roll out the 4th COVID19 jab legally. After a High Court ruling on the decision to grant provisional approval to rollout Pfizer COVID19 jabs.
The Court concluded it was ‘reasonably arguable that the limited use provision (Off Label Medicine) under sect.23 of the Medicine Act was problematic as it encompassed a limited number of people that could receive the dose 4 of Pfizer jab, not the whole population
The Judge said “While I doubt that this is a much ‘limited’ class of persons than ‘ALL New Zealanders’ a class of that size seems well beyond what is contemplated by a straight forward purpose” referring to Sect 23 of the Medicines Act.
Health Minister Andrew Little acknowledged the Judges ruling saying ‘The Medicines Act’ was due for a change. He said The Medicines Amendment Bill will be passed with urgency tomorrow”. Six products were currently used as an off-label medicine under sect 23 of the Medicines Act. 2 types of contraceptives, 2 pandemic flu vaxes, and a Pfizer Jab, also an electrolyte solution used in hospitals.
25/5/2022 Chris Hipkins Minister for COVID19 Response and Andrew Little Minister of Health made a ‘Regulatory Impact Statement to amend the Medicines Act 1981 allowing for Off-Label Medicines (Mass COVID19 Jabs-unlimited).
The 4th dose of COVID19 jab was an off label medicine classification, it had not been approved in large cohorts, thus a mechanism had to be implemented to allow for use. This would also allow the dosage timing between jabs to be shortened from 6 months to 3 months.
The COVID Technical Advisory Groups had recommended that people over 65 and Maori and Pasifika over the age of 50 years old. Thousands of people.
This giving the Director General of Health the ability to make decisions regarding the admin, supply and the implementation of the 4th Pfizer Jab and other jabs that may be introduced that had not been approved, could only be used as off-label- limited use.
Whilst being outside Medsafe regulations of the medicines process this would provide an enduring sound legal basis for the provision of any further dosed of COVI19 jabs, the 4th dose and future ones. Thus future-proofing off label medicines even if there is no epidemic notice in place.
This was just one of the options the other was the Therapeutic Products Bill which became the preferential option rather than amending the Medicine Act, as it would provide regulatory mechanisms to ensure the future proofing of the 4th dose of Pfizer jab and any other off label jabs that will follow.
What does it mean when a medication is off-label? It is used for a disease or medical condition that it is not approved to treat. Can only be cause for a limited amount of patients not the whole population of NZ.
You must be prescribed an off-label medicine by a doctor by doctors prescription. Out of several options discussed the government stated they found it necessary to introduce the Therapeutic Products Bill to pass it into legislation so they could deploy an unlimited jabbing of people across NZ.
So the real reason for the Therapeutic Products Bill is the jab unlimited people with an off-label unapproved medicine where off label medicines are usually for a limited number of the population. As with all medicines, vaccines can be used outside of Medsafe approval (this is called ‘off label’) if they are prescribed by an authorised prescriber.
27th May 2022 -Currently a fourth dose is considered “off-label” Pfizer’s 4th jab had not been approved by Medsafe, due to the absence of an application from Pfizer. The only way for the approximately 834,000 at-risk people to access the fourth dose is on prescription via a General Practitioner (GP) on an individualised basis.
Thus raising concerns over the ability to maximise uptake of the vaccine in these groups, due to equity of access, cost and timeliness of implementation. Documented by Caroline Flora Associate Deputy Director-General System Strategy and Policy Ministry of Health.
When publicly explaining the reasons for the introduction to the Therapeutic Products Bill they deliberately left some very important information out, that being the real reason for introducing the Bill, however the government told the people of New Zealand “they were just making sure of the quality and the efficacy on therapeutics. Balancing the risks and benefits. Making sure they are a different product category to medicines and medical devices.”
That are they hiding, not telling the public of New Zealand. The Government did not tell the public about why they really introduced the Therapeutic Product Bill, it was so they could legally jab more arms with an off-label unapproved Pfizer jab- more guineapig for another Pfizer jab, which has little to zilch results as yet.
https://wakeupnz.org Carol Sakey