Department Departmental Agency Crown Entity Regulatory Cabinet has agreed that regulator can set and adjust many rules and this will be contained in legislation Cabinet has agreed that regulator can set and adjust many rules and this will be contained in legislation Cabinet has agreed that regulator can set and adjust many rules and this will be contained in legislation Budgetary Cabinet has agreed settings for budgetary independence Cabinet has agreed settings for budgetary independence Cabinet has agreed settings for budgetary independence Operational An internal agreement be needed to provide for operational independence and care would be needed to ensure this capacity was not eroded over time Some feedback that health professionals are less willing to report adverse events to Medsafe because it is part of the Ministry due to Operational independence is provided as a matter of form Operational independence provided as a matter of form.
concern that information about named health professionals would be shared with other parts of the MoH who may be obliged to investigate an individual practitioner’s professional response. Risk that the Ministry’s on regulatory business-as-usual diminishes over time Signal of high levels of Weakest signal – branding as a business unit would strengthen this signal as would a visible commitment to operational independence signal The model automatically brings a signal of independence as Departmental Agencies are operationally autonomous from the host department. These could be supported by provisions in statute eg conferring Strongest signal – independence is clearly signalled as a matter of institutional form, however there is no platform for sending a very strong signal of real and perceived independence (for example, as existed with respect to the
statutorily independent functions on the chief executive if appropriate. establishment of Worksafe) Clear and robust Accountability arrangements for the regulator (separate to for the Ministry, such as financial reporting) would need to be agreed and set out in regulations or agreed as a matter of practice (most likely approach) Some accountability arrangements would come as a matter of form (eg. the requirement to produce an annual report). Others may need to be specified in regulations and/or in the departmental agency agreement Accountability arrangements would be in statute as a matter of institutional form (are contained in the Crown Entities Act)
Capable and sustainable Placing the regulator within the Ministry at lower than 2nd tier is likely to make it less attractive to staff and on the international stage as it may be perceived as not equal with peer regulators. This perception would need to be mitigated by strong branding and independence. Engagement domestically and internationally is likely to be easier as the regulator be part of the Crown. Likely to be more attractive to and on the international stage due to visibility of independence arrangements and the separate appointment of the chief executive Engagement domestically and internationally is likely to be easier as the regulator would be part of the Crown. Potentially more attractive to staff and on the international stage due to visibility of independence arrangements although this is offset by being outside the legal Crown (other therapeutic product regulators tend to be operationally independent and close to central government) Positive regulatory culture Arrangements for operational independence would need to be visible in order to set the new regulator on a positive path under this model given its similarity in many respects to the status quo. A new entity form along with a new regulatory scheme provides a sound platform to establish a positive regulatory culture. A new entity form along with a new regulatory scheme provides a sound platform to establish a positive regulatory culture
over that gained from using technical committees. And there is a risk of confusion between governance and regulatory responsibilities Impact of size Depending on location at 2nd or 3rd tier, may comprise a disproportionately division within the MoH which may fit awkwardly with other MoH functions Would require good working relationship between the chief executive and the responsible manager to ensure independence of regulatory decision-making and operational independence were maintained Would be separate from other MoH functions and easier to manage Would require good ongoing working relationship between the chief executives Size is not out of step with other Crown entities eg, PHARMAC Would require good working relationship between the chief executives of the Crown Entity and the Ministry of Health making
Flexibility to incorporate other functions or for form or other to change over time Other functions can readily be incorporated. Regulatory powers for other regimes are vested in the Director-General of Health and these would simply be delegated within the MoH a change to form would require either legislation (Crown Entity) or an (Dept Agency). Considerable flexibility to evolve the model. Changes would not necessarily be subject to external scrutiny Other functions can readily be incorporated. Regulatory powers for other regimes are vested in the of Health and these would simply be delegated to the chief executive of the Departmental Agency and necessary arrangements reflected in the departmental agency agreement a change to form would require either legislation (Crown Entity) or an (to change to the Departmental model). Whether other matters Other functions can be incorporated through delegation, contract or legislation. a change to form require legislation. How readily other matters could be changed would depend on how the regulator’s functions and powers were designed. The vehicles for change would be Statement of Performance Expectations and Statements of Intent. These are public documents.