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
        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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