Does Medsafe have to follow the medical process known as informed consent?

Erika Whittome 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). The requester can complain to the Ombudsman.

From: Erika Whittome

Dear Ministry of Health,

The NZ Medical Council has guidelines on informed consent here https://www.mcnz.org.nz/assets/standards..., and these guidelines say that the risks and benefits for a treatment are to be highlighted by health professionals to the patient.

1. Does Medsafe follow these guidelines on informed consent?
2. Does Medsafe come under this jurisdiction of informed consent from the NZMC OR from another governing body?
3, Who is the regulatory body for Medsafe in the event that Medsafe do not follow the informed consent guidelines?

Yours faithfully,

Erika Whittome

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From: OIA Requests


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Kia ora Erika,  

  

Thank you for your request for official information. The reference number
for your request is: H2022016442.  

  

As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/  

  

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

 

Ngā mihi 

  

OIA Services Team 

M[2]inistry of Health information releases 
U[3]nite against COVID-19 

 

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From: OIA Requests


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Tēnā koe Erika, 

 

Thank you for your request under the Official Information Act 1982 (the
Act) to Manatū Hauora (the Ministry of Health) on 8 November 2022. You
requested: 

 

“The NZ Medical Council has guidelines on informed consent
here [1]https://scanmail.trustwave.com/?c=15517&...

and these guidelines say that the risks and benefits for a treatment are
to be highlighted by health professionals to the patient. 
 
1. Does Medsafe follow these guidelines on informed consent? 
2. Does Medsafe come under this jurisdiction of informed consent from the
NZMC OR from another governing body? 
3, Who is the regulatory body for Medsafe in the event that Medsafe do not
follow the informed consent guidelines?” 

 

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority
and is responsible for the regulation of therapeutic products in New
Zealand. Medsafe administers New Zealand legislation in relation to
medicines. It is not a healthcare provider.  

 

As Medsafe is not involved in the provision of healthcare to any
individual patient, it does not perform any informed consent process or
require any oversight by the Medical Council of New Zealand. 

 

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 

M[3]inistry of Health information releases 
U[4]nite against COVID-19 

 

 

 

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References

Visible links
1. https://scanmail.trustwave.com/?c=15517&...
2. mailto:[email address]
3. https://www.health.govt.nz/about-ministr...
4. https://covid19.govt.nz/

Link to this

From: Erika Whittome

Dear Ministry of Health,

This is a very interesting Ministry of Health response which says that Medsafe does not perform any informed consent process.

If Medsafe does not perform any informed consent process, then....

1 Are Medsafe allowed to discourage informed consent?

2. Are Medsafe allowed to discourage the consideration of risks of a medicine which are outlined in a medicine's safety report?

Many Medsafe safety reports for Comirnaty say, "Medsafe advises people NOT to make any decisions about vaccination based on information contained in this report. "
eg https://www.medsafe.govt.nz/COVID-19/saf...

Yours sincerely,

Erika Whittome

Link to this

From: OIA Requests


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89K Download


 

Kia ora

  

Thank you for your request for official information. The reference number
for your request is: H2023019798

  

As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/  

  

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

 

Ngā mihi 

 

OIA Services Team 

M[2]inistry of Health information releases 
U[3]nite against COVID-19 

show quoted sections

References

Visible links
1. http://www.ombudsman.parliament.nz/
2. https://www.health.govt.nz/about-ministr...
3. https://covid19.govt.nz/

Link to this

From: OIA Requests


Attachment Outlook vcvfa3ff.png
80K Download

Attachment H2023019798 Response.pdf
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Kia ora Erika
Please find attached a letter regarding your request for information

Ngā mihi 

  

OIA Services Team

Manatū Hauora | Ministry of Health

M[1]inistry of Health information releases 
U[2]nite against COVID-19 

show quoted sections

References

Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/

Link to this

Things to do with this request

Anyone:
Ministry of Health only: