Kia ora Penny,

  

Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health - Manatū Hauora on 29 May 2026.
You requested:

 

"All internal briefing papers, policy documents, or ministerial advice
prepared by the Ministry of Health or Health New Zealand regarding the
implications of the New Zealand-India Free Trade Agreement's
pharmaceutical provisions - specifically the mutual recognition of GMP
inspections and acceptance of FDA/EMA/MHRA approvals - for Medsafe's
independent regulatory review process, during the period 1 January 2024 to
date.

All correspondence, meeting records, or briefing documents relating to any
consultation between the Ministry of Health and Helen Clark - in any
capacity including but not limited to her role as Chair of GAVI -
regarding pandemic preparedness, vaccine procurement frameworks, or the
NZ-India FTA pharmaceutical provisions, during the period 1 January 2024
to date.

The current operative legal framework, including any Cabinet decisions,
Director-General of Health directions, or emergency health legislation
provisions, that would govern vaccine procurement and authorisation in New
Zealand in the event of a declared Public Health Emergency of
International Concern (PHEIC) by the World Health Organization -
specifically:

a. The process by which the Director-General of Health can authorise
emergency vaccine procurement outside normal Pharmac competitive tender
processes.

b. The role of Medsafe in reviewing vaccines under emergency
authorisation, and whether FDA, EMA, or MHRA approval can substitute for
independent Medsafe review under emergency conditions.

c. Any changes to this framework made following the COVID-19 pandemic
response, including any changes made in anticipation of or following the
NZ-India FTA.

Any advice provided to MFAT by the Ministry of Health or Medsafe regarding
the pharmaceutical provisions of the NZ-India FTA, during the period 1
January 2024 to 26 April 2026.

Any internal assessments or briefings regarding the 2026 Bundibugyo Ebola
outbreak in the Democratic Republic of Congo and Uganda, including any
assessment of risk to New Zealand and any contingency planning for vaccine
procurement, prepared during the period 1 May 2026 to date."
 

The reference number for your request is H2026083266. We will endeavour to
respond to your request as soon as possible and in any event no later than
29 June 2026 being 20 working days after the day your request was
received. If we are unable to respond to your request by then, we will
notify you of an extension of that timeframe.

 

If you have any queries regarding your request, please feel free to
contact the OIA Services Team on [1][email address]. If any
additional factors come to light which are relevant to your request,
please do not hesitate to contact us so that these can be taken into
account. 

 

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: [2][email address] or by calling 0800
802 602.

 

Ngā mihi, 
 
OIA Services Team

Ministry of Health | Manatū Hauora

 

M[3]inistry of Health information releases

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