Dear Ministry of Health,

The Ministry of Health's (MoH) website in About Us states that you are the lead agency in the NZ health sector for Strategy, Policy, Monitoring, Regulation and Data and Analytics based on high quality intelligence, surveillance, research, evidence and science advice.

This OIA seeks to:
1) Identify whether the MoH has the policies and procedures in place to change their advice and regulation if new information arrives, and
2) Seeks to inform stakeholders throughout NZ that have concerns, about the steps they might take and evidence that they can present to enable the MoH to have a scientific conversation according to its procedures in such "new information" events - rather than (say) adopting a defensive posture about defending a previous decision.

OIA 1) Are there documented policies or procedures for assessing new information about a health policy or practice in the MoH, that would lead to a formal review of the evidence, and a potential change in approach? Please provide the documents that describe this policy or procedure.

There may be many such documents - eg a procedure as a result of a decision by another regulatory body (eg MedSafe), or a request/warning from a professional body, a warning on a product (tool or certified technique/guideline), a Ministerial or Health NZ initiative (screening programme), or a set of findings in the medical literature that flag that a safety issue or unintended consequence of a practice needs attention, or surveillance/epidemiological/ACC reporting identifies an issue, or a concerned group from the public documents an issue.

OIA 2) Please identify all areas (including but not limited to the above) where the MoH has an explicit risk management strategy in place to monitor and respond to feedback and requests from key stakeholders. For example, Health NZ may be able to provide a document from each of its senior leadership team that describes how they manage the risks and safety feedback from their stakeholders. There may also be a central dedicated Evaluation Unit that clinically assesses Health NZ initiatives for effectiveness, and focuses warnings and alarms generated internally and externally. The expected outcome of this is a list/table.

OIA 3) Please provide all Job Titles that deal with emerging warnings and risks and group them within the Health NZ organisational structure so that their role can be assessed in context and their leadership team executive identified. Eg Public Health/Hospital/Primary Health/Stakeholder Management/Executive. The expected outcome of this is a list/table.

OIA 4) Please list the Criteria a suitably qualified Group from the Public would have to meet, in order for the MoH to commence a formal review into a scientifically documented and quantified Issue of Concern. To be clear:
- This Group from the Public would not have any commercial or regulatory relationship with Health NZ - but might be entitled to use the services purchased or supplied by Health NZ or be self/privately funded.
- The Issue of Concern would be regarding a substantial initiative within the NZ Health Sector - such as a Public Health initiatives (eg a screening programme, vaccination - eg Thalidomide, forced medication of the population through consumer products), medical practice (eg Cervical Screening at Greenlane Hosptial), pharmaceuticals (eg ultimately leading to product recalls or severe limitation in the indication). Therefore substantial impact, liability and potential embarrassment.

Such Criteria would have therefore been used and documented in policy papers considered by the MoH Executive team, and at Ministerial level where a significant reversal of policy was involved. There will have been many examples over the years - as illustrated above - so the criteria will be well developed and documented.

If not already provided in the earlier documents, please provide this list of Criteria.

If there is no central list of Criteria, then please provide the last 10 documents considered by the MoH Executive team members (individually or collectively), illustrating any Criteria being applied to such Issues of Concern raised by a Group from the Public. The outcome/decision on each of the 10 documents should be provided.

OIA 5) Are there any Impediments (eg contractual clause with a supplier), that the MoH is aware of that would prevent it from:
- Highlighting a safety issue to the general public or any stakeholder within the NZ health sector in a timely manner (i.e. to avoid further injury)?
- Changing a previously adopted policy?

"No" is an acceptable answer. If the answer is "Yes" then please explain in principle the nature of these restrictions, and why this is acceptable practice to the MoH or the Government. I am not asking for copies of the documentation that might contain/cause such Impediments.

OIA 6) What are the key parameters when the MoH in its analysis of options for policy initiatives (or a change in policy). For example:
- the State uses the cost of a human life saved in assessing the potential harms from not fixing safety issues in its roading network.
- there is an accepted rate of injury for immunisations - used for clinical efficacy measurement but presumably also used for deciding whether to commence a new programme, adopt a new formulation. or to cease (i.e. decide that efficacy is no longer commensurate to risk/injury).
- pharmacology vs surgical solutions - as per the recent increase in funding to Pharmac which displaces some hospital based events.

Please provide a list of parameters used and the acceptable levels of death and injury to be used in business cases prepared or reviewed by the MoH.

Yours faithfully,

Chris Johnston