Reclassification of Medicines How New Zealand compares with

Why did we do this analysis? n To investigate concerns of risk-averse behaviour by

Sources of Data n The Association of the European Self- Medication Industry (AESGP) –

What countries were compared? n Countries with established and comparable regulatory regimes n Countries

Medicines reviewed n Ingredients were selected by the AEGSP and published in their tables

Findings – OTC in NZ n 155 ingredients listed by the AESGP are OTC

Findings – prescription in NZ n 48 ingredients listed by the AESGP are Prescription

Conclusions n Amongst comparable countries, New Zealand leads in having the largest number of

Future consideration n But – the analysis suggests there are suitable candidates that the

Examples n 14 OTC medicines in NZ are Rx in Australia n n Why?

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Reclassification of Medicines How New Zealand compares with other countries – March 2012

Why did we do this analysis? n To investigate concerns of risk-averse behaviour by Medsafe in switching classification status of medicines n Analysis conducted in December 2011

Sources of Data n The Association of the European Self- Medication Industry (AESGP) – January 2011 n Selected Regulatory Authorities schedules of medicines – December 2011 n World Self-Medication Industry (WSMI) website n No changes to the source data as at 28 March 2012

What countries were compared? n Countries with established and comparable regulatory regimes n Countries selected for this analysis: n EU countries: n n Belgium, UK, Portugal, Finland, Sweden, Denmark, France, the Netherlands, Ireland, Italy, Austria, Germany, Spain, Greece Specific Non-EU countries: n Australia, the USA, Canada, Switzerland, Norway, Singapore, Japan

Medicines reviewed n Ingredients were selected by the AEGSP and published in their tables n available at www. wsmi. org/otc. htm n Presumably these are medicines of interest to the AEGSP and WSMI n For this analysis, “Restricted Medicine” category in NZ has been grouped with prescription medicines n Ingredients not registered in NZ have been excluded from the analysis

Findings – OTC in NZ n 155 ingredients listed by the AESGP are OTC in New Zealand 131 of the 155 OTC medicines in New Zealand are prescription medicines in one or more other countries n Only 24 are OTC in all countries n n Most comparable country to NZ is Australia, with only 14 of these ingredients classified as Prescription medicines

Findings – prescription in NZ n 48 ingredients listed by the AESGP are Prescription status in New Zealand None are OTC in all 21 comparable countries n 7 are also prescription status in all 21 comparable countries n n Most switched country is the UK where 18 of the 48 are available OTC n Australia has 6 of the 48 prescription medicines in NZ available OTC

Conclusions n Amongst comparable countries, New Zealand leads in having the largest number of medicines available OTC 14 more than the next least restrictive country (Australia) n 68 more than the most restrictive (the USA) n n Concerns of risk-averse behaviour are not upheld by the evidence

Future consideration n But – the analysis suggests there are suitable candidates that the MCC could consider or review, and this work may serve as a waymarker for identifying such candidates n For example: n 6 Rx medicines in NZ are available OTC in Australia n Bacitracin, clobetasone, dihydrocodeine, flavoxate, fluconazole, butoconazole

Examples n 14 OTC medicines in NZ are Rx in Australia n n Why? 18 Rx medicines in NZ are available OTC in the UK n Clemastine, codeine, pramocaine, domperidone, adenosine, oxybuprocaine, acrivastine, clobetasone, dihydrocodeine, mebeverine, fluconazole, sumatriptan, tranexamic acid, flunisolide, hydroxyzine, tamsulosin, azithromycin, simvastatin

n Thank you