5. Assessment of GMO Medicines
5.1 Summary
At present, medicines that are or contain a GMO require assessment and approval under both the Medicines and HSNO Acts. The Royal Commission on Genetic Modification recommended that imported medicines and pharmaco foods (see below) that include live GMOs be approved for use by Medsafe without additional approval from ERMA.
In response, the Government directed officials to report on options to reduce duplication and streamline the approval processes under the Medicines Act and the HSNO Act for medicines. It noted that the recommendation was consistent with the precedent set for finished-dose forms of medicines, which are exempt from the hazardous substances part of the HSNO Act. The Government’s response also included consideration of GMO medicines developed in New Zealand as well as those imported into New Zealand.
Four options have been identified for reducing duplication and streamlining approval processes for all medicines that are or contain new organisms (including GMOs). The options are:
- Option 1: retain approval under both the Medicines and HSNO Acts, but clarify the respective roles of Medsafe and ERMA;
- Option 2: approval under the Medicines Act only;
- Option 3: approval under the Medicines Act, with a environmental risk assessment of the medicine provided by ERMA; or
- Option 4: approval under the HSNO Act, with safety, quality and efficacy assessment of the medicine provided by Medsafe.
A similar situation arises with veterinary medicines that are assessed under the ACVM Act and the HSNO Act. Whether or not similar options should be considered in that situation is also discussed.
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