Ministry of Health roles and obligations, relating to liability waiver for Pfizer

ASE made this Official Information request to Ministry of Health

Response to this request is long overdue. By law Ministry of Health should have responded by now (details and exceptions). You can complain to the Ombudsman.

From: ASE

Attn Ministry of Health,

Regarding a prior OIA Request, reference # H2021111261, portions of indemnity agreements have been released. Regarding these agreements, particularly the agreement with Pfizer,

• This agreement assigns "liability for adverse effects associated with use of the vaccine" to ACC.

How was ACC consulted as part of this negotiation process?

• This agreement says "The liability associated with claims not covered by ACC is relatively low-risk".

What liability is this referring to? How was this risk assessed?

• This agreement says "The potential economic and social benefits of a vaccine are uncertain. The Ministry of Health is beginning work on economic modelling in this area. The potential benefits depend on many factors including how long and in what population groups the vaccine gives protection, and how and when herd immunity can be achieved."

What evidence is there that these treatments can, or ever could, provide "herd immunity" as a benefit? What evidence is there that these treatments are "safe and effective", and that long-term benefits exceeds long-term risks?

This clause appears to hold The Ministry of Health to an obligation to conduct cost/benefit analyses regarding these treatments. Is that correct? As recently as October 2021, The Ministry of Health has responded to requests for a cost/benefit analysis, stating, "Your request for a cost benefit analysis is refused under section 18(e) of the Act, as the information does not exist." Why have such cost/benefit analyses not been done?

• This agreement states "Medsafe is developing a strategy for monitoring the vaccine once it is being used. This may include adverse reaction reporting, active monitoring (via SMS text and real time analysis), requirements on companies to provide adverse reaction information globally, and sharing monitoring data with other regulators to identify safety issues. This monitoring will allow Medsafe to take timely action if a safety issue emerges."

Aside from pre-existing monitoring systems, what is the current state of such monitoring strategies which have been developed specifically for this purpose, and how has that evolved? What signals, thresholds and other quantifiable metrics have been put in place to raise concerns, and what policies are in place to act if/when those events happen?

What monitoring systems have been proposed or considered, but not implemented? Why have such monitoring systems not been implemented?

• This agreement states "they are developing it in accelerated clinical trials that are less likely than non-accelerated trials to detect uncommon adverse effects or possible contraindications", and "most trials will be shorter in length and study fewer people than what is typical. The impact is a reduction in the known safety profile of the vaccine".

Given these acknowledgements, what is the basis of claims that no shortcuts have been taken to ensure safety?

eg, "The vaccines have been developed very quickly but without taking any shortcuts in the necessary processes or compromising safety." - https://www.health.govt.nz/our-work/dise...

eg, "Study designs and regulatory approaches will vary between COVID-19 vaccine applicants, but most trials will be shorter in length and study fewer people than what is typical. The impact is a reduction in the known safety profile of the vaccine" - ibid

eg, "No shortcuts" in granting approval -
- https://covid19.govt.nz/assets/resources...
- https://covid19.govt.nz/assets/resources...
- https://covid19.govt.nz/assets/resources...
- https://covid19.govt.nz/assets/resources...
- https://covid19.govt.nz/assets/resources...
- https://covid19.govt.nz/assets/vaccine_t...
- https://covid19.govt.nz/assets/resources...
- https://covid19.govt.nz/assets/resources...
- https://covid19.govt.nz/assets/resources...

eg, NZ Vaccine Facts: Are vaccines safe? - https://www.youtube.com/watch?v=lFOiK73T...

nb, what data does The Ministry of Health hold, to substantiate the claims in that video that "evidence shows that if you get a double dose, you're far less likely to […] pass the virus on to others"? Is the The Ministry of Health aware of US CDC statements since early August 2021 that "what [vaccines] can’t do anymore is prevent transmission"? How has this information guided The Ministry of Health?

• This agreement states "For example, RNA vaccines like BNT162 have not previously been approved for human use in New Zealand and will require a careful risk-benefit assessment as part of the regulatory approval process."

With The Ministry of Health very actively "encouraging" (ie coercing) everyone older than 12 to be subject to this treatment, and "offering" it to children aged 5 and older, and (as of this writing) boasting about 92% of people being "fully vaccinated" and 95% of people "partially vaccinated", what "careful risk-benefit assessment" has been completed?

As recently as December 2021, when asked about risk-benefit assessments, The Ministry of Health cited a paper stating: “The benefit risk balance of Comirnaty (COVID-19 mRNA Vaccine) for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older, is not clear”, and specifically regarding young children, "Safety and efficacy have not been established in children under 16 years of age."

• This agreement states "A key aspect of our communications and engagement approach is to recognise and acknowledge that public expectations of potential vaccines may be unrealistic, and to actively manage these expectations as part our stakeholder and public communication. This will help to mitigate the risk of any claims relating to an ineffective vaccine or negligent misstatement."

To what extent has The Ministry of Health been obligated to "actively manage [public] expectations" of these treatments, or otherwise "mitigate the risk of any claims relating to an ineffective vaccine or negligent misstatement"? Please cite all examples of this contractual obligation having influence over Ministry of Health messaging, policies, or any other activities.

How exactly does The Ministry of Health define "ineffective vaccine"? How has that definition changed since this agreement was drafted? How can The Ministry of Health consider a vaccine to be effective (or even called a "vaccine") if it does not protect against infection, does not protect against disease transmission, does not confer herd immunity, selects for vaccine-evasive variants, provides efficacy only in terms of symptom suppression, provides that efficacy only for a period of months (with the possibility that duration of efficacy shortens with additional treatment, while risks and consequences of adverse effects may accumulate), has unknown long-term safety consequences, and appears to confer negative efficacy within months, particularly to new vaccine-evasive or vaccine-preferential variants?

What parties does The Ministry of Health consider to be "stakeholders" in these matters? Does The Ministry of Health consider the general public to be a stakeholder that The Ministry of Health has an obligation to represent in these matters? How does The Ministry of Health balance the public health of the general public against other stakeholders, as this clause requires?

• This agreement states "This vaccine candidate is an RNA vaccine. Due to the relative newness of this platform, and truncated clinical trials (which means a reduced ability to identify rare or long-term side effects), we are unlikely to want to immunise the entire population using solely this vaccine candidate."

With The Ministry of Health very actively "encouraging" (ie coercing) everyone older than 12 to be subject to this treatment, and "offering" it to children aged 5 and older, and (as of this writing) boasting about 92% of people being "fully vaccinated" and 95% of people "partially vaccinated", please explain how current policies are aligned with the intention and rationale of this contractual clause.

Thank you
ASE

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From: OIA Requests


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Kia ora,

 

Thank you for your request for official information received on 12 January
2022.

 

The Ministry of Health has consolidated this request with your earlier
request for official information under reference number: H202200226.  

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 10 February 2022, being
20 working days after the day your request was received.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame.

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

show quoted sections

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From: OIA Requests


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Tēnā koe ASE,

 

Thank you for your requests under the Official Information Act 1982 (the
Act) to the Ministry of Health (the Ministry) on 12 January 2022 for
information regarding the COVID-19 response. Each point of your request is
answered in turn.

 

A list of all advisory boards, panels, and any other groups or individuals
providing information or advice to The Ministry of Health in regards to
COVID-19 and related matters.

 

For each of those boards, panels, and any other groups or individuals, in
what capacity are they engaged with The Ministry of Health; eg what is
their defined role, purpose, scope.

 

For each of those boards, panels, and any other groups or individuals,
what advice have they provided to The Ministry of Health, and how has that
advice been actioned or not actioned?

 

A full disclosure of all conflicts of interest (including, but not
necessarily limited to financial and economic conflicts of interest,
professional and employment conflicts of interest, political and
ideological conflicts of interest), by all persons who are in those
advisory boards, panels, and any other such groups.

 

No list exists detailing all who contribute to the Ministry’s COVID-19
health response. As such, these parts of your request are refused under
section 18(g)(i) as the information requested is not held by the Ministry
and there are no grounds for believing it is held by another agency
subject to the Act. Please note, the Ministry receives advice on matters
relating to COVID-19 from a wide range of teams and groups across the
Ministry. The Ministry also consult with many individuals, both internally
and externally. The details of expert groups who provide leadership in key
health areas, including some related to COVID-19, is available on the
Ministry’s website
at: [1]www.health.govt.nz/about-ministry/leadership-ministry/expert-groups.

 

As it relates to the earlier part of this request, I would like to know
what policies, rules, guidance and protocols are in place to prevent
conflicts of interest. I would like to know how conflicts of interest are
assessed, monitored, and managed. I would like to know what actions have
been taken to assure that conflicts of interest do not adversely affect
public health advice that The Ministry of Health is receiving. I would
like to know what protocols are in place to ensure that The Ministry of
Health is holding itself accountable to its own rules.

 

Information relating to conflicts of interest is publicly available on the
Office of the Auditor-General’s website
at: [2]oag.parliament.nz/2020/conflicts/docs/conflicts-of-interest.pdf.

 

Regarding a prior OIA Request, reference # H2021111261, portions of
indemnity agreements have been released. Regarding these agreements,
particularly the agreement with Pfizer,

 

This agreement assigns "liability for adverse effects associated with use
of the vaccine" to ACC.

 

How was ACC consulted as part of this negotiation process?

 

This agreement says "The liability associated with claims not covered by
ACC is relatively low-risk".

 

What liability is this referring to? How was this risk assessed?

 

What evidence is there that these treatments can, or ever could, provide
"herd immunity" as a benefit? What evidence is there that these treatments
are "safe and effective", and that long-term benefits exceeds long-term
risks?

 

This clause appears to hold The Ministry of Health to an obligation to
conduct cost/benefit analyses regarding these treatments. Is that correct?
As recently as October 2021, The Ministry of Health has responded to
requests for a cost/benefit analysis, stating, "Your request for a cost
benefit analysis is refused under section 18(e) of the Act, as the
information does not exist." Why have such cost/benefit analyses not been
done?

 

Aside from pre-existing monitoring systems, what is the current state of
such monitoring strategies which have been developed specifically for this
purpose, and how has that evolved? What signals, thresholds and other
quantifiable metrics have been put in place to raise concerns, and what
policies are in place to act if/when those events happen?

 

What monitoring systems have been proposed or considered, but not
implemented? Why have such monitoring systems not been implemented?

 

Given these acknowledgements, what is the basis of claims that no
shortcuts have been taken to ensure safety?

 

nb, what data does The Ministry of Health hold, to substantiate the claims
in that video that "evidence shows that if you get a double dose, you're
far less likely to […] pass the virus on to others"? Is the The Ministry
of Health aware of US CDC statements since early August 2021 that "what
[vaccines] can’t do anymore is prevent transmission"? How has this
information guided The Ministry of Health?

 

With The Ministry of Health very actively "encouraging" (ie coercing)
everyone older than 12 to be subject to this treatment, and "offering" it
to children aged 5 and older, and (as of this writing) boasting about 92%
of people being "fully vaccinated" and 95% of people "partially
vaccinated", what "careful risk-benefit assessment" has been completed?

 

How exactly does The Ministry of Health define "ineffective vaccine"? How
has that definition changed since this agreement was drafted? How can The
Ministry of Health consider a vaccine to be effective (or even called a
"vaccine") if it does not protect against infection, does not protect
against disease transmission, does not confer herd immunity, selects for
vaccine-evasive variants, provides efficacy only in terms of symptom
suppression, provides that efficacy only for a period of months (with the
possibility that duration of efficacy shortens with additional treatment,
while risks and consequences of adverse effects may accumulate), has
unknown long-term safety consequences, and appears to confer negative
efficacy within months, particularly to new vaccine-evasive or
vaccine-preferential variants?

 

What parties does The Ministry of Health consider to be "stakeholders" in
these matters? Does The Ministry of Health consider the general public to
be a stakeholder that The Ministry of Health has an obligation to
represent in these matters? How does The Ministry of Health balance the
public health of the general public against other stakeholders, as this
clause requires?

 

With The Ministry of Health very actively "encouraging" (ie coercing)
everyone older than 12 to be subject to this treatment, and "offering" it
to children aged 5 and older, and (as of this writing) boasting about 92%
of people being "fully vaccinated" and 95% of people "partially
vaccinated", please explain how current policies are aligned with the
intention and rationale of this contractual clause.

 

The agreement that you are referring to were business cases released in
response to OIA request H2021111261. These were sent to the requester by
the Ministry for Business, Innovation and Employment (MBIE) not the
Ministry of Health. You should direct your questions regarding the
contents of the business cases to MBIE.

As you have noted in your request, the New Zealand Government has granted
Pfizer indemnity from any claims that may arise from use of their COVID-19
vaccine (Comirnaty). It is important to note, it is not unexpected for
pharmaceutical companies to seek indemnities from governments in
circumstances where clinical trials are restricted, or where a purchase
agreement is concluded before full trials are completed. Further details
about indemnity granted to Pfizer are commercially sensitive and withheld
under section 9(2)(b)(ii) where its release would likely unreasonably
prejudice the commercial position of the person who supplied the
information.

 

Furthermore, while the Act allows New Zealanders to ask for information
from Ministers and government agencies, there is no requirement for
agencies to prove an opinion. Parts of your questions and the statements
that support them appear designed to engage in a debate about the
Government’s COVID-19 vaccination programme, rather than a request for
official information. As such, the remaining parts of your request are
refused under section 18(g) of the Act.

 

Under section 28(3) of the Act, you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [3][email address] or by calling 0800
802 602.

 

 

Ngā mihi

 

OIA Services Team

 

[4]Ministry of Health information releases

[5]Unite against COVID-19

 

 

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References

Visible links
1. http://www.health.govt.nz/about-ministry...
2. https://oag.parliament.nz/2020/conflicts...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/

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From: ASE

Attn Ministry of Health;

Thank you for your response, dated 9 Feb 2022.

As per your response, it would seem that you do not hold data regarding conflicts of interest among persons who provide advice to The Ministry of Health via advisory boards, panels, and any other such groups. Is that correct? If that is correct, please explain why this information is not held. If that is incorrect, please provide the information requested, so far as it is practicable to do so.

The request for information included: “As it relates to the earlier part of this request, I would like to know what policies, rules, guidance and protocols are in place to prevent conflicts of interest. I would like to know how conflicts of interest are assessed, monitored, and managed. I would like to know what actions have been taken to assure that conflicts of interest do not adversely affect public health advice that The Ministry of Health is receiving. I would like to know what protocols are in place to ensure that The Ministry of Health is holding itself accountable to its own rules.”

Your response to that was: “Information relating to conflicts of interest is publicly available on the Office of the Auditor-General’s website at: [2]oag.parliament.nz/2020/conflicts/docs/conflicts-of-interest.pdf.”

While I appreciate that the Office of the Auditor-General's "Managing conflicts of interest: A guide for the public sector" should form the basis of how conflicts of interest are assessed and managed within The Ministry of Health, the requested information has not been provided.

Your response states: “The agreement that you are referring to were business cases released in response to OIA request H2021111261. These were sent to the requester by the Ministry for Business, Innovation and Employment (MBIE) not the Ministry of Health. You should direct your questions regarding the contents of the business cases to MBIE.”

As it was revealed in the response to that request, the liability waiver granted to Pfizer states, “The Ministry of Business, Innovation and Employment and the Ministry of Health recommend that the Minister of Finance approve the giving of the indemnity in favour of Pfizer/BioNTech on the terms contained in the Term Sheet in Annex I.” (page 18), and was signed by Maree Roberts on behalf of The Ministry of Health (page 18), and further indicates (page 24) that the contract was entered into on behalf of The Ministry of Health. As such, it appears that The Ministry of Health is very much a party to these liability waivers, and as such I expect that The Ministry of Health can provide the requested information.

Nonetheless, if The Ministry of Health believes that the requested information is held by Ministry for Business, Innovation and Employment (MBIE), then The Ministry of Health is under obligation to transfer the request, or relevant part of the request to MBIE promptly, and in any case not later than 10 working days after the day on which the request is received, as per Section 14 of The Official Information Act 1982. There has been no indication that The Ministry of Health has complied with this obligation.

Your response states: “It is important to note, it is not unexpected for pharmaceutical companies to seek indemnities from governments in circumstances where clinical trials are restricted, or where a purchase agreement is concluded before full trials are completed.”

As such clinical trials are restricted and/or full trials have not been completed, what is the basis for The Ministry of Health's claims that these "vaccines" are safe, effective, and that no shortcuts have been taken in approving their use? Further, what basis is there for "vaccine mandates" and "vaccine passports" when such clinical trials are restricted and/or full trials have not been completed? How does it serve the interests of public health to encourage, promote, and "mandate" "vaccine candidates" (as they are referred to in the liability waiver and/or other documentation relating to purchase agreements) which are not fully tested for safety and efficacy?

Your response states: “Parts of your questions and the statements that support them appear designed to engage in a debate about the Government’s COVID-19 vaccination programme, rather than a request for official information.”

I assure you that no part of my request was intended to engage in debate, and you have not cited any specific part(s) of the request that do so.

As significant parts of this request have not been substantively addressed, and since The Ministry of Health appears to have violated its obligations under Section 14 of The Official Information Act 1982,

I am awaiting further substantive responses to the information which was requested, and is now overdue, and I am filing a formal complaint with the Office of the Ombudsman. I hope that you can provide the requested information before the Ombudsman has to resolve the matter.

Thank you,
ASE

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From: OIA Requests

Thank you for your Official Information Act request. This is
an automatic reply to let you know we received it.

In accordance with the Act, we'll let you know our decision within no more
than 20 working days. If you'd like to calculate the timeframe, you can
use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. This
means we may take some time in responding to your request. The Ministry
regularly updates information about the COVID-19 situation and publishes
OIA responses considered to be of public interest:
[2]https://www.health.govt.nz/about-ministr...

Please also refer to the Unite Against Covid-19 website for copies of
papers, minutes, and key advice for the decisions the Government has made
relating to COVID-19.

Sometimes we may need to clarify aspects of a request. You can expect to
hear from us soon if that is the case here.

Ngā mihi,

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [3][email address]

 

 

 

 

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References

Visible links
1. http://scanmail.trustwave.com/?c=15517&a...
2. https://www.health.govt.nz/about-ministr...
3. mailto:[email address]

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