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
From: OIA Requests
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
show quoted sections
From: OIA Requests
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
show quoted sections
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/
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
From: OIA Requests
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/
From: OIA Requests
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/
Things to do with this request
- Add an annotation (to help the requester or others)
- Download a zip file of all correspondence