Food, medicines and medical ethics

This page outlines how, in 2001, the Government responded to the Royal Commission on Genetic Modification's recommendations about food, medicines, and medical ethics.

Food and consumer information

8.1 FAA monitor research studies on stock feed and act where any indicate a need for assessment in relation to human health

Directed the Ministry of Agriculture and Forestry to:

  1. plan a programme to monitor research into the health aspects of GM stock feeds, similar to that currently being carried out by the Ministry of Health in respect of the effects of genetically modified food on human health
  2. assess what action might be required in the future and to assess the costs of such action, should the monitoring programme indicate negative health effects
  3. determine what legislative tools and risk management strategies would be necessary in order to act on such findings.

8.2 Government facilitate development of a voluntary label for GM-free foods

Directed the Ministry of Consumer Affairs to scope what would be required for an interdepartmental working group to facilitate the development of a voluntary “GM free” labelling system, and to proceed with the facilitation if it can be resourced from within baselines.

8.3 FAA disseminate information on the labelling regime for GM foods [Amended A18 Food Standard] and consumer rights in relation to foods at restaurants and takeaway bars

Agreed to Strategy which would give effect to Recommendation 8.3 of the Commission.

8.4 FAA to produce and distribute consumer information on the use of gene technology in the production of food

Directed the Ministry of Health and the Ministry of Agriculture and Forestry and the Food Safety Authority, once it is established, to update existing web-based information for consumers on the use of gene technology in the production of food.

Food/medicine interface issues

9.3 Products be clearly defined in legislation as medicines, pharmaco foods, functional foods or dietary supplements

Agreed with the intent of Recommendation 9.3, which is to ensure clear and consistent regulation of the foods and medicines interface.

Agreed that the clarification of the foods/medicines regulatory interface be progressed through the existing Trans-Tasman Therapeutic Goods Project (estimated completion date: 2004/05) and the planned development of a “functional foods” standard by Australia New Zealand Food Authority (estimated completion date: 2003).

9.4 Imported medicines and pharmaco foods that include live GMOs be approved for use only by Medsafe (and not by ERMA also)

Directed officials (Ministry for the Environment lead) to report on options to reduce duplication and to streamline the approval processes under the Medicines Act and the HSNO Act for medicines by April 2002 as part of the report to POL on a HSNO amendment bill.

9.5 ACVM applications for GM animal remedies include full information on the efficacy and form of the genetic modification; and that such information be included as one of the categories of relevant risks and benefits under s19 of that Act

Noted that the Director-General of Agriculture and Forestry could readily achieve the Commission’s intent by requiring information on the efficacy and form of genetic modification under existing provisions of the ACVM Act.

Directed officials to alter the operational arrangements issued under the ACVM Act to reflect the intent of Recommendation 9.5.

9.6 As protocols identify useful therapeutics for serious disease control, advance approvals from ERMA and Medsafe be sought for importation of live GMO vaccines

Agreed with the intent of Recommendation 9.6 of the Commission, which is to minimise the risk in case of serious disease outbreak.

Directed officials to explore the possibility of implementing a risk management strategy for epidemics of animal or human infectious diseases, and to report to POL and Cabinet by 30 June 2003.

Medical ethics

9.1 There be formal medical ethical oversight of all gene therapy

Agreed to accept the intent of Recommendation 9.1 that new medical technologies involving genetic modification should only be introduced into a clear legislative and ethical framework that is sound and based on current risk management methodologies.

Agreed to accept that the introduction of a new somatic cell gene therapy product should be referred an appropriate ethics body.

Agreed that clinical trials in humans of somatic cell gene therapy products will continue to be permitted as these studies are already subject to oversight by the Gene Technology Advisory Committee and Institutional Ethics Committees.

Agreed that each application to conduct germ cell line genetic manipulation should be referred to an appropriate ethics body, in addition to a safety and efficacy evaluation by an appropriate technical committee.

Noted that much work is required to implement this recommendation and officials will report back to POL by April 2002 as part of the Bioethics Council project.

9.2 Toi te Taiao: Bioethics Council develop ethical guidelines for xenotransplantation involving genetic modification technology

Agreed to accept and broaden Recommendation 9.2 so that prior to the application of xenotransplantation technology to humans, the Bioethics Council, or some other national expert/ethics committee with Māori representation, in consultation with expert technical advisory bodies, is required to consider:

  1. xenotransplantation of tissues or organs to humans, irrespective of whether it utilises genetically modified animals or not
  2. transplantation of genetically modified tissue or organs within a species.