Likely to be Potentially Capable and Placing the more more regulator within sustainable attractive to attractive to the Ministry at and on staff and on lower than 2nd the the tier is likely to international international make it less stage due to stage due to attractive to staff visibility of visibility of and on the independence independence international arrangements arrangements stage as it may be and the although this perceived as not separate is offset by equal with peer appointment being outside regulators. This of the chief the legal perception would executive Crown (other need to be Engagement therapeutic mitigated by domestically product strong branding and regulators and internationally tend to be independence. is likely to be operationally Engagement easier as the independent domestically and regulator and close to internationally is would be part central likely to be easier of the Crown. government) as the regulator be part of the Crown. A new entity A new entity Positive Arrangements for form along form along operational regulatory with a new with a new independence culture regulatory regulatory would need to be scheme scheme visible in order to provides a provides a set the new sound sound regulator on a platform to platform to positive path establish a establish a under this model positive positive given its similarity regulatory regulatory in many respects culture. culture to the status quo.
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
regulatory-impact-statement-therapeutic-products-regulation-analysis-specific-issues-options.docx