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Medicines

Under New Zealand law, all medicines must be assessed by Medsafe and approved by the Minister of Health while animal remedies must be approved by the Agricultural Compounds and Veterinary Medicines (ACVM) Unit of the Food Safety Authority for safety. These agencies are responsible for ensuring the quality and effectiveness of these products. Only after they have been assessed can they be distributed and sold in New Zealand.

However, medicines that contain a live Genetically Modified Organism (GMO) also need the approval of the Environmental Risk Management Authority (ERMA) under the Hazardous Substances and New Organisms Act 1996.

There are currently no live GMO medicines available in New Zealand. but there are some medicines made here that use a GMO to produce the substance needed for the medicine. These medicines do not actually contain any genetically modified material. They include medicines such as insulin (formerly derived from animals), human growth hormones and a hepatitis B vaccine widely used in New Zealand. They are known as recombinant DNA medicines.

The Royal Commission on Genetic Modification highlighted the area of GMO medicine regulation as one that needed attention. The Royal Commission felt that the requirement that new medicines made from, or containing new organisms (including GMOs) must obtain both Medsafe or ACVM and ERMA approval resulted in unnecessary duplication and high compliance costs. As a result, the Royal Commission believed, the future importation or development of useful medicines for the prevention and treatment of diseases could be discouraged.

In response, the HSNO Act has been amended to streamline approvals for these medicines.

The changes allow ERMA to delegate the approval of medicines that meet a set of criteria for ‘low risk’ to Medsafe (for human medicines) or the ACVM unit (for animal remedies). To maintain the integrity of the system, ERMA sets guidelines for approvals and regularly audits the decisions.

Medicines containing new organisms that do not fit the ‘low risk’ criteria will still require full ERMA approval, including public consultation.

The HSNO Act has been also amended to speed up the assessment and approval of animal and human medicines, vaccines and pesticides that contain new organisms (including genetically-modified organisms) or hazardous substances, and that may be required in an emergency.

Generally, these products would have to go through full assessment by the Environmental Risk Management Authority (ERMA) – including public notification and consultation – before they could be used here. This means potential delays in bringing in medicines in a health or biosecurity emergency.

Under the amended law, decisions could be made to allow the products to be imported without the level of detailed information or full formal processes required under normal circumstances.

The products would still come under scrutiny by experts who would be required to weigh up the relative risks and benefits in view of the situation at the time.

The fact that a product has been given the go-ahead for release in a health emergency would not affect its status as a new organism or hazardous substance. Once the emergency was over, a normal application would need to be made for the medicine, vaccine or pesticide to be used again.

  • For more information on Medsafe and the regulation of medicines visit the Medsafe website.
  • For more information about the assessment of GMOs, including live GMO medicines, visit the ERMA website.

Last updated: 17 September 2007