Printed from https://fyi.org.nz/request/17880-informed-consent-20-provisional-consent?unfold=1 on November 22, 2024 09:31

Informed Consent #20 - Provisional Consent

Annie Weston made this Official Information request to Chris Hipkins

Response to this request is long overdue. By law Chris Hipkins should have responded by now (details and exceptions). The requester can complain to the Ombudsman.

From: Annie Weston

Dear Chris Hipkins,

According to Medsafe:

“Provisional Consent is granted to Pfizer for two years from 3 November 2021.”

https://www.medsafe.govt.nz/regulatory/P...

Under Timeframes for Provisional Consent I note:

“Provisional consent, under Section 23 of the Medicines Act 1981, may be granted when it is desirable that the medicine be sold, supplied, or used on a restricted basis for the treatment of a limited number of patients.

Provisional consent is ideally suited to medicines still undergoing clinical assessment but where it is desirable that patients have early access. It is anticipated that the medicine will be used on a restricted basis until the risks and benefits have been quantified and full consent has been granted.”

https://www.medsafe.govt.nz/medicines/po...

Pfizer’s vaccine has clearly not been used on a restricted basis for the treatment of a limited number of patients. I understand also that the vaccine is still undergoing clinical assessment, the risks and benefits haven’t been quantified, and that full consent hasn’t been granted.

Please can you forward me the new legislation that supersedes Section 23 of the Medicines Act 1981.

Yours faithfully,

Annie Weston

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From: C Hipkins (MIN)
Chris Hipkins

Kia ora

 

Thank you for taking the time to write to Hon Chris Hipkins, Minister for
COVID-19 Response, Minister of Education, Minister for the Public Sector
and Leader of the House.

We are receiving a significant amount of correspondence at the moment and
although your email will be carefully considered and noted, it is not
possible to respond to each individual email. However we will endeavour
to respond to your individual queries as soon as we can.

In the meantime, information about the COVID-19 Protection Framework can
be found here:
[1]https://covid19.govt.nz/traffic-lights/c...
and guidance for businesses can be found here:
[2]https://www.business.govt.nz/covid-19/
Current locations of interest are set out
at [3]https://www.health.govt.nz/our-work/dise...
encourage anyone who has been at one of the locations of interest at the
time specified to self-isolate and call Healthline on 0800 358 5453. 

 

You can find the nearest testing centre to you
at [4]https://www.healthpoint.co.nz/covid-19/ and your nearest
vaccination centre at
[5]https://www.healthpoint.co.nz/covid-19-v.... You can also book
your vaccination at [6]https://bookmyvaccine.covid19.health.nz/ or by
calling 0800 28 29 26.

 

To get your My Vaccine Pass online head to
[7]https://mycovidrecord.health.nz/ or for help over the phone you can
call 0800 222 478 between 8am and 8pm, 7 days a week. Those pharmacies
giving COVID-19 vaccines can also help with My Vaccine Pass face to face,
and can be found here:
[8]https://www.healthpoint.co.nz/covid-19-v...
.

We appreciate that this is a challenging time. If you need to talk, you
can call or text 1737 at any time. Mental health and wellbeing resources
are also available
at [9]https://www.health.govt.nz/our-work/dise...
about the financial support available to individuals and businesses can be
found
at [10]https://covid19.govt.nz/business-and-mon....

We also understand that there are several other aspects to the response
that are very important to people. You can find more information about:

o Managed Isolation and Quarantine (MIQ)
at [11]https://www.miq.govt.nz/, including how to request an emergency
allocation
at [12]https://www.miq.govt.nz/travel-to-new-ze...
make a complaint or request a review of your application by
emailing [13]https://www.miq.govt.nz/about/contact-us....
o Travel with Australia
at [14]https://covid19.govt.nz/travel/quarantin...
you are in Australia, please register
at [15]https://www.safetravel.govt.nz/ and if it is an emergency,
contact the Consulate on +64 99 20 20 20.
o Vaccine data and statistics
at [16]https://www.health.govt.nz/our-work/dise...
Medsafe’s vaccine safety monitoring reports
at [17]https://www.medsafe.govt.nz/COVID-19/vac...
o The Government’s plan to reconnect New Zealand with the rest of the
world
at [19]https://covid19.govt.nz/reconnecting-new....

Please remember to take care, and be kind. We have beaten COVID-19 before,
and we can do it again.

Ngā mihi,

Office of Hon Chris Hipkins

Minister for COVID-19 Response | Minister of Education | Minister for the
Public Sector | Leader of the House | MP for Remutaka

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References

Visible links
1. https://covid19.govt.nz/traffic-lights/c...
2. https://www.business.govt.nz/covid-19/
3. https://www.health.govt.nz/our-work/dise...
4. https://www.healthpoint.co.nz/covid-19/
5. https://www.healthpoint.co.nz/covid-19-v...
6. https://bookmyvaccine.covid19.health.nz/
7. https://mycovidrecord.health.nz/
8. https://www.healthpoint.co.nz/covid-19-v...
9. https://www.health.govt.nz/our-work/dise...
10. https://covid19.govt.nz/business-and-mon...
11. https://www.miq.govt.nz/
12. https://www.miq.govt.nz/travel-to-new-ze...
13. https://www.miq.govt.nz/about/contact-us...
14. https://covid19.govt.nz/travel/quarantin...
15. https://www.safetravel.govt.nz/
16. https://www.health.govt.nz/our-work/dise...
17. https://www.medsafe.govt.nz/COVID-19/vac...
18. file:///C:\Users\TasolaM\AppData\Local\Microsoft\Windows\INetCache\Content.Outlook\556O8F80\Updated%20Document1.docx#_msocom_1
19. https://covid19.govt.nz/reconnecting-new...

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