Please find below  my opposition to the LEGALLY BINDING  WHO CA+ International Pandemic Treaty.

I have found that the World Health Organization’s (WHO’s) “Zero Draft” the new agreement on pandemic prevention, preparedness, and response, called WHO CA+, is significantly flawed.  Due to the evidence and information provided below I oppose the WHO CA+ Treaty.

(1)WHO failed miserably in preventing the spread of COVID-19, the WHO CA+ draft would dramatically expand WHO authority to declare a pandemic and, thereby, trigger provisions in the treaty that would re-allocate resources and encourage governments to waive intellectual property rights

(2)New Zealand is already playing an active part in planning the WHO CA+ without consultation of the public of New Zealand’s input. The Government have been deliberately non-transparent as to the WHO CA+ and its purposes, aims, goals as to its intention as to the WHO Pandemic Treaty (Accord)

(3)The proposed Treaty is due to be introduced at the 77^th World Health Assembly in May 2024.  If New Zealand agrees and are compliant to the WHO CA+ this will risk  further increased significant tax payer payments  as to the allocation  to the added expenditure it will cost our country

(4)The World Health Organization has already miserably failed since the pandemic first evolved on many accounts, yet it appears that members of the New Zealand Government are supporting and even promoting the WHO CA+ International Pandemic Treaty (Accord)

(5)The draft of the WHO CA+ clearly focuses on significantly strengthening, expanding the powers of the World Health Organization which I note signed a ‘Partnership Memorandum with the World Economic Forum on 13^th June 2019.

(6)The WHO/ WEF is now  a Public-Private Partnership. The UN was never originally declared as such when it was created.  Obviously through the extraordinary super powers awarded to the WHO would also reward the Multi-stakeholder Corporations that WEF represents., therefore there is a massive conflict of interest that would effectively bring multistakeholder corporations, and those represented by the WEF huge wealth and power in the realms of  global politics and economies. The WEF is the whisperer in the ears of the WHO.

(7)The ZERO draft of the International Pandemic Treaty focuses on hugely expanding the authority, powers of World Health Organization, which give WHO the super powers to trample on ‘intellectual property rights’ and the redistribution of knowledge and technology. The WHO will become the only one, so called source of ‘Truth’, therefore having the ability to shut down the ‘True’ source of Truth., this is very dangerous.

 (8)WHO International Health Regulations 2005 failed miserably when it came to accessing China’s part in the origins of the COVID19 pandemic instead of holding them to account and responsible for their failings under the IHR2005 the WHO now parrots the CCP and even praises the Chinese regime. Therefore cannot be trusted to be such a superior force of authority over all UN Nation States.

 (9)In accordance with the Charter of the United Nations and the principles of International Laws the people of New Zealand have the right to self-determine and manage their own autonomous approach to public health. This is a ‘sovereign’ right, the people of New Zealand are the ‘sovereignty who have that right. The global superior authoritative right does not lay with the WHO to control, cause damage to society, business, infrastructure or medical, technical determinations of the people of New Zealand. The people rights in New Zealand are that of ‘self determination’

(10)The people of New Zealand have in accordance with the Charter of the United Nations and the Principles of International Law the sovereign right to determine, manage their own approach to public health, this notably also means ‘pandemic prevention, preparedness, response and recovery of health systems pursuant to the autonomy of domestic policies, legislations. That is provided that within this domestic jurisdiction the control awarded to the state through the vote of the people in New Zealand ‘causes no harm, damage to the peoples of New Zealand’.

‘(11)Sadly I say there has been much damage done to the peoples of New Zealand through the governments misinformation as to the COVID19 immunizations and the mandating of these. The closures of businesses throughout New Zealand and the loss of work and income.  Also the closure of schools where many children have not returned back to school.

(12)The members of  New Zealand House of Representatives have shown themselves to be  non-transparency upon publicly  exposing the serious harms and deaths of post COVID 19 immunizations. The many law abiding decent people of New Zealand have been deliberately abused by members of the New Zealand mainstream news media that has been paid for by the Governments Journalist Fund.

 (13) A member of Parliament namely Michael Wood character assassinating, labelling people those who are grieved through loss of work and income, loss of businesses as a so called ‘River of Filth’. Amongst those people he called a ‘River of Filth’ and ‘Anti -Vaxers’ were those that had been vaxed and were suffering serious harms post immunization.  As noted, not one member of Parliament has apologised for this cruel emotional harm caused to people of New Zealand by members of the House of Representatives. 

(14)The mandating of COVID19 Immunization. The following  term has often been quoted by members of WHO and WEF,  and even members of NZ House of Representatives ‘No-one is safe until everyone is Safe’. Pfizer Chief Executive has publicly admitted that they did not test their COVID19 immunization for transmission prior to entering the global market place.  Evidence has shown us that those that have been injected with the Pfizer mRNA  Injection have still been infected by the virus.. . Obviously the people of New Zealand have been misled when it has come to mandating of COVID19 immunizations and mandates

(15)It is a huge concern that large Pharmaceutical companies such as Pfizer have and continue to advise the Intergovernmental working group on the WHO CA+ International Pandemic Treaty as to the Zero Draft which is a huge conflict of interest.

(16)It is a deep concern that if the New Zealand Government continues to pursue, support the WHO CA+ International Pandemic Treaty (Accord) it would give the WHO superior authority over NZ Domestic policies. WHO would have the power to declare a pandemic globally whether New Zealand is affected or not and could have the power to reallocate resources.

(17)The Zero Draft of the WHO CA + Pandemic Treaty makes transparency and cooperation mandatory (legally Binding). Uses the word ‘shall’ when referencing facilitating accessing, sharing of research and genomic data, however there are no repercussions for ‘non-compliance’. It is evidently clear that the WHO and those drafting this treaty , and those that support, promote it have learned nothing. There is no reason to believe that China would be compliant with the obligations set out in the WHO CA+ International Pandemic Treaty (Accord)  I also note that the  World Health Organizations failure to quietly abandon investigations into China’s incompetence to comply to the legally binding WHO Health Regulations (IHR 2005)

(18)The WHO CA+ Draft lets China off the hook. Despite China having the largest economy in the world the United Nations considers China as a developing country. Developed countries financially support developing countries when it comes to ‘common but differentiated responsibilities’ among nations. Developed countries would share the greater costs therefore  China will likely be the beneficiary of the WHO CA+ obligation for developed nation parties, among other provisions.

(19)The WHO CA+ Pandemic Treaty Zero Draft calls on the parties to tackle misleading, misinformation or disinformation. Yet the WHO  themselves have been the source of disinformation when they tweeted  “preliminary investigations conducted by the Chinese authorities have found no clear evidence of human-to-human transmission of COVID 19.

I refer to the ‘World Health Organization ‘Preliminary investigations conducted by the Chinese authorities have found no evidence of human to human transmission of the novel coronavirus (2019-n CoV) identified in Wuhan Vina. Twitter January 14^th 2020 ¹⁸

^{https://twitter.com/WHO/status​/1217043229427761152} 

(20)As for the CDC on the efficacy of facial mask wearing that shifted over time, when Anthony Fauci defended flip flop accusations after shifting mask guidance, this has reported changed time and time again. There is much controversy about mask wearing. It is clearly evident that many people wear masks as chin straps. Masks do risk emotional, psychological damage to some extent. Mask wearing is not normalised behaviour so will affect people in different ways.  ^{LINK: Independent, July 29, 2021, https://www.independent.co.uk/news/world/americas/us-politics/fauci-cdc-mask-flip-flop-b1892600.html}

(21)A recent study found that natural immunity acquired by a COVID-19 infection was “associated with lower incidence of SARS-CoV-2 infection, regardless of the variant, than mRNA primary-series vaccination. Yet WHO superior authorities under a legally binding Pandemic Treaty could mandate all populations to be vaccinated, immunized without accountability. This is very dangerous.

LINK:” ^{Hiam Chemaitelly et al., “Protection from Previous Natural Infection Compared with mRNA Vaccination Against SARS-CoV-2 Infection and Severe COVID-19 in Qatar: A Retrospective Cohort Study,” The Lancet, November 11, 202, https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(​22)00287-7/fulltext (accessed February 24, 2023).}

(22)The WHO and UN Member Nation Governments and their  so called experts have been proven wrong far too often, yet the WHO Pandemic Treaty gives WHO the global super power authority to police “disinformation. This seriously infringes on the internationally accepted right to freedom of expression. (UN International  Human Rights and NZ Domestic Human Rights Legislations)

(23)The WHO CA+ Treaty Draft emphasizes ‘Equity’. It is guided by ‘Equity’, which is defined by the absence of unfair, unavoidable or remediable differences among and within countries, including between different groups of people, whether these groups are defined socially, economically, demographically, geographically or references ‘Inequality’. The term ‘Equity’ and ‘Equitable’ appear more that thirty times in the ZERO Draft of the Treaty, however there is no clear definition what this means.

(24)The people of New Zealand have the right to have clear, concise information. (ibid., Art 3,4 (3) ). It is evidential by the ZERO Draft of the WHO CA+ Treaty that it is guided by ‘Equity’, a term that is deeply rooted in ‘Marxist’ ideology and should never be embedded in the guiding principles of any international legally binding commitment of any State, including that of New Zealand.

(25)The ZERO Draft of the CA+ International Pandemic Treaty (Accord- Convention) commits to the term ‘Universal Health Coverage’, this is not clearly defined. I stand to be corrected, but does that mean that the Government provides the peoples of New Zealand health care, is that with or without costs to the peoples of New Zealand, and at what costs must the people of New Zealand pay?. How will this indeed affect tax payers pockets?

(26)Its obvious that if the NZ House of Representatives agree, comply to the WHO CA+ International Pandemic Treaty domestic legislations will have to be amended.  The people of New Zealand are not awarded end decision making rights when it comes to domestic policy making.    I refer to the (Non-Legally Binding Citizens Initiated Referenda), and even if this did become ‘Legally Binding’ the people of New Zealand would have no end decision rights when it comes to Domestic Policies due to the legally binding nature of the WHO CA+ Treaty.. Therefore upon voting for political parties at election time, this means that promises made to the voting public can be over- ridden by the WHO Pandemic Treaty

(27)The WHO CA+ Pandemic Treaty (Accord) incorporates a ‘One Health’ approach framework. This includes ‘Humans, Animals-wild and domestic and all Eco-systems’. This means that the WHO under the WHO CA+ International Pandemic Treaty has massive super superior control over every aspect of life on this planet.

(28)WHO CA+ Treaty under the classification  of ‘Climate Change’ will have the authority to restrict, control food systems, trade and travel, infrastructure, land use and property rights. This is scandalous and extremely dangerous when it comes to the health and wellbeing of New Zealanders.

(29)Those that reside in the NZ House of Representatives are accountable to the people of New Zealand who voted them in to the political positions they hold in the New Zealand House of Representatives. To be responsible and accountable to ALL peoples of New Zealand.  Through researched evidence of viewing speeches in the House and other UN Information that New Zealand Members of Parliament are supporting, promoting and are in agreeance with the WHO ZERO Draft of the CA +.

(30) I also note that at the 77^th gathering of the World Health Assembly the final draft of the CA+ WHO International Pandemic Treaty will be produced, introduced to all UN Member Nation States to determine whether, and which UN Member States agree on the WHO International Pandemic Treaty (Accord)

(31) I therefore request that the NZ House of Representatives transparently accords the peoples of New Zealand open public debate, discussion without political intrusion as to all knowledge, information that is pertained in every ZERO draft of the WHO CA+ Pandemic Treaty as it is produced, introduced.

The draft states that the WHO CA+ “shall be subject to ratification, acceptance, approval or accession by UN Member Nation States, therefore clearly requires advice and consent under the process outlined.^{, “Circular 175 Procedure,” https://2009-2017.state.gov/s/l/treaty/c175/index.htm (accessed February 24, 2023).}

(32)I conclude that the  WHO CA+ International Pandemic Treaty (Accord) is highly problematic and deeply flawed and would allow the global superior powers of the World Health Organization (UN) to have authority over New Zealand’s domestic policies. One size does not fit ALL and there is no evidence of ‘trustworthiness’ as to why the people of New Zealand should support this WHO Treaty proposal.

(33)The ‘Public-Private’ partnership of the World Economic Forum with the UN is a huge conflict of interest as they are  the ‘whisperers in the ear’ of the UN, therefore also  rewarded global superiority political, economical control through the  WHO CA+ International Pandemic Treaty (Accord) agreeance.

Therefore, for all the above reasons , information provided I totally oppose the WHO CA+ International Pandemic Treaty (Accord). I find it to be highly dangerous to the health and wellbeing of ALL peoples of New Zealand. I have cc’d other groups, individuals, organizations, members of parliament the above information-communication t as outlined to the NZ House of Representatives as to opposition of the WHO CA+ International Pandemic Treaty.

I request a response at your earliest. Thank you.

 

Carol Sakey

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These links are reference to my last two video’s on this subject. 2020-2030 Global Sexualization of children (UN). UN Agenda 2030 Global Development Goals (SDGs). Documented in the UN Technical Brief of Anti School Bullying in Schools globally Studies and Surveys of schools students

LINK Several approaches were used for questioning students about themselves, in these UN Surveys, studies  March 2019 https://www.ohchr.org/sites/default/files/Documents/Issues/SexualOrientation/Data/UNESCO.pdf

Several approaches were used for questioning students about themselves, in these UN Surveys, studies  March 2019 https://www.ohchr.org/sites/default/files/Documents/Issues/SexualOrientation/Data/UNESCO.pdf

A first example is provided by the 2015 Youth Risk Behaviour Surveillance System (YRBS), conducted by the Centres for Disease Control and Prevention (CDC) in the USA.  Statistically analysed together with a sub-group of bisexual respondents, another subgroup identified ‘Not Sure: of gender.

Youth2000 survey in New Zealand. This is conducted among 9-13 year olds and, since 2012, has included a question about whether students self-identify as transgender. The sample for the most recent survey (2012) involved students being randomly selected from 91 schools that, in turn, were randomly selected from all eligible schools (those with at least 50 students) from across the country.

The resulting sample – of 8,500 respondents – proved large and representative enough for the implementers to find that 1.2% of students identify as transgender – a figure that is significant enough to enable statistical comparisons (Clark, et al., 2013).

UNESCO-supported study in four countries in Southern Africa, questionnaires used in schools referred to gender non-conforming students as ‘people who are seen as different in terms of gender (boys who look or act like girls; girls who look like or act like boys)’.

Auckland University Sample size 28,000. Conducted 2001, 2008, 2012  9-13 yr olds   www.fmhs.auckland.ac.nz/en/faculty/adolescent-health-research-group/youth2000-national-youth-health-survey-series.html

Source. http://cdc.gov/HealthyYouth/yrbs Global school-based student health survey Type: School-based survey. Country: Global. Population: Adolescents. Age: 13-17 year olds. Sample size: Unknown. Frequency: From 2018. Further information: https://www.cdc.gov/GSHS/

Source: Growing up today study 2 Type: Population-based survey. Country: USA. Population: Children of Nurses’ Health Study participants. Age: 10-17 year olds (2004). Sample size: 10,900. Frequency: Annually since 2004. Further information: www.gutsweb.org

https://www.samhsa.gov/data/data-we-collect/nsduh-national-survey-drug-use-and-health

From 2018. Further information: https://www.cdc.gov/GSHS/

http://www23.statcan.gc.ca/imdb/p2SV.pl?Function=getSurvey&SDDS=3226

Transgender Age: 14-18 year olds (Grades 9-12). Sample size: Varies. Further information: http://cdc.gov/HealthyYouth/yrbs

Age: 12-18 year olds (Grades 7-12). Sample size: 14,400. Frequency: 1994–2008 (longitudinal). Further information: http://cpc.unc.edu/projects/addhealth

School-based survey. Country: Global. Population: Adolescents. Age: 13-17 year olds. Sample size: Unknown. Frequency: 2018. Further information:https://www.cdc.gov/GSHS/

Respondents  were given a  range of gender identity options. EG., whether or not they self-identify as transgender. The following are two examples of best practice questions about gender identity.

Example 2: Question: Do you think you are transgender? This is a girl who feels like she should have been a boy, or a boy who feels like he should have been a girl. (e.g. Trans, Queen, Fa’faffine, Whakawahine, Tangata ira Tane, Genderqueer. New Zealand  www.fmhs.auckland.ac.nz/en/faculty/adolescent-health-research-group/youth2000-national-youth-health-survey-series.html

Intersex Human Rights Australia. (2012). Including intersex in research studies and surveys. Retrieved from https://ihra/org.au/20042/ on-requests-for-research/

Kann, L., Olsen, E. O., McManus, T., Harris, V. A., Shanklin, S. L., Flint, K. H., . . . al, e. (2016). Sexual identity, sex of sexual contacts and health-related behaviors among students in Grades 9-12 – United States and Selected Sites, 2015. MMWR Surveill Summ.

Patterson, J. G., Jabson, J. M., & Bowen, D. J. (2017, April 1). Measuring sexual and gender minority populations in health surveillance. LGBT Health, 82-105.

UNESCO. (2015). From insult to inclusion: Asia-Pacific report on school bullying, violence and discrimination on the basis of sexual orientation and gender identity. Paris and Bangkok: UNESCO.

UNESCO. (2016). Out in the open: Education sector responses to violence based on sexual orientation and gender identity/expression. Paris: UNESCO.

UNESCO. (2019). Behind the numbers: Ending school violence and bullying. Paris: UNESCO.

REFERENCE MADE TO UN AGENDA 2030 SDG 4.

https://www.ohchr.org/sites/default/files/Documents/Issues/SexualOrientation/Data/UNESCO.pdf

https://www.cbsnews.com/news/world-health-organization-removes-gender-dysphoria-from-list-of-mental-illnesses/

: Adolescents. Age: 13-17 year olds. Sample size: Unknown. Frequency: From 2018. Further information: https://www.cdc.gov/GSHS/

. Age: 14-18 year olds (Grades 9-12). Sample size: Varies. Further information: http://cdc.gov/HealthyYouth/yrbs

: School-based survey. Country: Global. Population: Adolescents. Age: 13-17 year olds. Sample size: Unknown. Frequency: 2018. Further information:https://www.cdc.gov/GSHS/

 

BIOGRAPHY: INCLUDED:-

Australian Government. (2013). Guidelines on the recognition of sex and gender. Barton: Commonwealth of Australia.

Clark, T. F., T., B. P., Crengle, S., Denny, S., Dyson, B., Fortune, S., . . . Rossen, F. (2013). Youth’12 Prevalence Tables: The health and wellbeing of New Zealand secondary school students in 2012. Auckland, New Zealand: The University of Auckland

Intersex Human Rights Australia. (2012). Including intersex in research studies and surveys. Retrieved from https://ihra/org.au/20042/ on-requests-for-research/

Kann, L., Olsen, E. O., McManus, T., Harris, V. A., Shanklin, S. L., Flint, K. H., . . . al, e. (2016). Sexual identity, sex of sexual contacts and health-related behaviors among students in Grades 9-12 – United States and Selected Sites, 2015. MMWR Surveill Summ.

Patterson, J. G., Jabson, J. M., & Bowen, D. J. (2017, April 1). Measuring sexual and gender minority populations in health surveillance. LGBT Health, 82-105.

UNESCO. (2015). From insult to inclusion: Asia-Pacific report on school bullying, violence and discrimination on the basis of sexual orientation and gender identity. Paris and Bangkok: UNESCO.

UNESCO. (2016). Out in the open: Education sector responses to violence based on sexual orientation and gender identity/expression. Paris: UNESCO.

UNESCO. (2019). Behind the numbers: Ending school violence and bullying. Paris: UNESCO.

REFERENCE MADE TO UN AGENDA 2030 SDG 4.

https://www.ohchr.org/sites/default/files/Documents/Issues/SexualOrientation/Data/UNESCO.pdf

.https://www.cbsnews.com/news/world-health-organization-removes-gender-dysphoria-from-list-of-mental-illnesses/

29TH May 2019.. video World Health Assembly updated 25th May 2019 ICD-11 updated for 21st Century reflects critical advances in science and medicine. Is reframed as Gender Incongruence NOT Gender Identity Disorder as previous. Is described by a marked incongruence between an individuals experienced/ expressed gender and the assigned sex in pre-pubertal children.

https://www.ohchr.org/sites/default/files/Documents/Issues/SexualOrientation/Data/UNESCO.pdf 20 PAGES

 

 

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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 4^th 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 4^th 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 4^th 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 4^th 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 4^th 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.

27^th May 2022 -Currently a fourth dose is considered “off-label” Pfizer’s 4^th 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://www.newshub.co.nz/home/politics/2021/05/covid-19-government-to-urgently-change-law-after-high-court-ruling-on-pfizer-vaccine-rollout-legality.html

https://www.health.govt.nz/system/files/documents/information-release/ris-fourth-dose-final.pdf

https://wakeupnz.org    Carol Sakey

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FIRSTLY-TO MAKE MY CASE I WILL EXPLAIN WHAT AN ‘OFF LABEL MEDICINE ‘is, later you will find out why I am explaining this ‘An Off Label Medicine is an unapproved drug can be used under certain regulations, legislations.

Under Sect 23 of the Medicine Act 1981 this provides the Minister of Health to grant provisional consent when considered desirable for the medicines to be sold, supplied or used on a restricted basis (LIMITED BASIS) for the treatment of a LIMITED number of patients (People)

June 12^th 2015 The National Library Of Medicine published an article ‘Off-Label drug use as a consent and health regulation issue in New Zealand. ‘Off Label’ described as not yet approved or the status of drugs that have been approved

The NZ Medicines Act 1981 specifically allows for off-label drug use, however this authority is limited-Code of Health & Disability Services Consumers Rights Regulations and Common Law state:- It is required that ‘off-label’ drug use is of an acceptable standard, the patient should be fully informed, the patient must give informed consent.

‘Off Label drug use is an extremely important issue, the current law provides medical practitioner very wide discretionary power without providing classification for what is required of the practitioner in exercising this discretion ’off label’.

SO WHAT HAS THE NZ GOVTS THEREPEUTIC PRODUCTS BILL  GOT TO DO WITH THE REPLACING OF THE MEDICINES ACT WITH ‘OFF LABEL’ MEDICINE?

The Government had unsuccessfully introduced policy proposals for the Therapeutic Content proposals  back in 2011 and 2016. In 2019 the Therapeutic Product proposal was back on the governments table. “Iwi/Maori natural medicines would be exempted from the Therapeutic Product proposal”

A Med-Safe Report in May 2022 refers to the Medicine Act being replaced with the Therapeutic Products Bill to allow for ‘Off Label’ Medicines Chris Hipkins the COVID19 Response Minister and Andrew Little Minister Of Health where the Director General has the ability to make decisions regarding the administration of the COVID19 jabs, the dose and the frequency as the pandemic developed whilst being outside of the established Medsafe Regulations- medicine process.

A legal base for the provision of the medicines process of any further doses of COVID19 Vaccines (Jabs) including Pfizer’s 4^th doses. The 4^th dose had not yet been approved by Med-Safe. The government had recommended that Maori and Pacifika peoples over the age of 50 who are immune-compromised can receive the 4^th Pfizer dose before winter 2022.  NO public consultation was undertaken as to the governments proposal, however the 4^th dose was consistently promoted by mainstream media.

Ministry of Health reported that Pfizer have not yet applied for approval of 4^th dose in NZ, that local jurisdictions have to find their own approval strategies.

2.The Ministry of Health reported as to Maori, Pacific peoples health- cannot be overstated as to the impact of COVID19 that there is a time pressure to maximize immunity when winter illnesses are at their peak. (Specific targeting of Maori and Pacific Island peoples for COVID19 jabs -guineapigs) saying “It would be ideal to enable the broader doses of4th Pfizer doses. Opportunities to administer flu and COVID 19 jabs at the same time.

 To provide their populations with 4^th doses, but they had to find their own legal route.. However Standing Orders cannot be made for an unconsented medicine (A new medicine), this undermines the purpose and consents process under the 1981 Medicines Act

NOTE: Under the Medicines Act 1981 ‘Off Label’ – number of people receiving doses of ‘unapproved Med-Safe medicines are limited. Pfizer COVID19 dose 4 was unapproved and therefore limited as to how many New Zealanders could receive it.

The government ‘WITH URGENCY’ introduced new arrangements, they  were implemented to amend the Medicine Act introduced 7^th June 2022, passed in mid June- recommended by Andrew Little that the Ministry Of Health would be responsible for the implementation of the 4^th dose of Pfizer, utilizing all existing delivery settings, processes & technology that has been used previously for the COVID19 rollout.

Ministry Of Health to monitors new data collection. Andrew Little Minister Of Health will administer the application of the Medicines Act 1981 to ensure ‘off-label’ medicines eg COVID19 Pfizer 4^th Dose practices.( Ria-moh-amat-may.22.pdf)

In a Court hearing-Judge Rebecca Ellis stated when referring of ‘off label’ medicine, “a limited number of people  specified for in Section 23 Medicines Act 1981. This could NOT be stretched to the whole population over 16years old” Andrew Littles response to Judge Ellis was “I will fix the snag” (Intro to the Therapeutic Product Bill)

RNZ reported 18/5/2021 ‘Technical Anomaly Spurs Urgent Law Change for COVID 19 Vaccine. Government URGENTLY’ seek a change of law to ensure COVID19 Vax rollout is LEGAL following the High Court decision of Judge Rebecca Ellis. Judge Ellis ruled it was ‘reasonably argued, that the governments approval of Pfizer vaccine rollout went beyond the Medicines Act 1981 allowed” . This gave  Andrew Little the right to approve medicines for a limited number of patients. However the COVID 19 Vaccine rollout would cover all New Zealanders over the age of 16years. THUS NOT LIMITED AS IN MEDICINE ACT 1981

Chris Hipkins response to Judge Ellis was “this raises no safety issues, it just highlighted a technical anomaly as to the law. NOTE THE GOVERNMENT WAS TECHNICALLY BREAKING THE LAW. AND THEY NEEDED TO COVER THEIR ARSES.

Andrew Little again responded to Judge Ellis “The government will pass legislation under URGENCY to rectify the problems ( THERAPEUTICS PRODUCTS BILL- This will most definitely be passed to save Governments arses)

Six products are potentially affected by Judge Ellis court decision these include Pfizer Vaccines, 2 Flu Vaccines and 2 types of contraceptives and an electrolyte solution

3.On the 30November 2022 the Therapeutic Product Bill was officially introduced by Andrew Little to the House (Parliament). He describes this in his speech in the Beehive “To modernize the way medicines, medical devices (includes COVID Test Kits) and Natural Health products are regulated. Strict rigorous regulations on natural health products eg. Vit C, Vit D etc., etc., you can buy at the supermarket.

The Therapeutic Product Bill if passed replaces the Medicines Act 1981 and the Dietary Supplement Regulation 1985 with one comprehensive  regulatory regime. Andrew Little stated “FIT FOR THE FUTURE’. Enables NZ to take advantages of advances in medicine -gene therapies, AI and machine learning software also vaccines for pandemics. The Therapeutic Product Bill legislation will work alongside, contribute to ‘Pae Ora Health Futures Act’

David Seymour said “Medsafe tended to approve drugs that were approved elsewhere in the world saying “Well, has Medsafe ever declines to approve a drug that the rest of the world is safe”. David Seymour was supporting replacing the Medicine Act 1981 with the Therapeutic Product legislation. He also stated  “the Court were right to uphold the law, however he backs the law change to replace the Medicine Act with the Therapeutic Product Legislation.

As to Judge Rebecca Ellis court outcome David Seymour said “the Court were right to uphold the law, however he backs the law change to replace the Medicine Act with the Therapeutic Product Legislation. National Party COVID19 Minister Chris Bishop said to reporters that National Party support the law change.  .

RNZ Reported 18/5/2021. Technical Anomaly spurs Urgent Law Change. Government urgently seek a change in law to ensure COVID19 Vaccine rollout is LEGAL following a High Court decision. Judge Rebecca Ellis ruled “it was reasonably argued that the government approval of Pfizer Vaccine rollout went beyond the Medicine Act 1981.

NOTE: The Medicine Act 1981 only gave the government the right to approve a limited number of patients, whereas the COVID19 Vaccine Rollout covered everyone in NZ over 16years of age. There are be legal enforcement includes, huge fines, court hearings etc., for those who do not comply to the Therapeutics Legislation (announced Beehive)

SO BASICALLY—THE THERAPEUTICS PRODUCT BILL IS TO SEVERELY RESTRICT  NEW ZEALANDERS ABILITY TO PURCHASE NATURAL HEALTH REMEDIES. FOR THE GOVERNMENT TO COVER ITS ARSE FOR CRIMINALLY BREAKING THE MEDICINES ACT 1981 BY REPLACING THE MEDICINES ACT WITH THE THEREUPEUTIC PRODUCT BILL TO PROMOTE JABS FOR PANDEMICS, MORE HUMAN TRIAL GUINEAPIGS. THE ADVANCEMENT USE OF AI AND GENETIC CELL ADVANCEMENT TRIALS AND DRUGS.

https://pubmed.ncbi.nlm.nih.gov/25096169/

https://i.stuff.co.nz/national/politics/300310925/government-to-introduce-a-new-law-for-vaccine-after-legal-challenge

https://www.medsafe.govt.nz/COVID-19/status-of-applications-asp-ria-moh/amat-may22.pdf

 

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