3. Gaps in HSNO Act coverage

3.1 Summary

Genetic modification of human cell lines

A cell line is an established population of cells derived from tissues that will grow and divide indefinitely in the laboratory given the appropriate growth medium and space. Although the genetic modification of animal cell lines currently requires approval under the HSNO Act, the same modification of human cell lines does not. This is because humans, their tissues and their cells are specifically exempt from coverage under the HSNO Act through being excluded from the definition of an organism. Similarly, the Medicines Act covers clinical trials of new medicines involving human participants, but does not currently include laboratory research using human cell lines.

Two options have been identified to ensure that genetic modification of human cell lines for research purposes is subject to appropriate regulation. The first option would involve amending the HSNO Act to include applications for the development (genetic modification) of a human cell line or the importation of genetically modified cell lines. The other option is to address this matter in the Ministry of Health’s current review of human cell and tissue research, possibly with guidelines to cover the genetic modification of human cell lines in the interim.

New organisms regenerated from tissues

Neither the importation of tissue samples nor any development activity (other than genetic modification) requires a HSNO approval. Improvements in cloning and related technologies since the commencement of the HSNO Act mean that it is now possible to produce an animal not currently in New Zealand (a new organism) from imported tissue using a surrogate mother, without a HSNO approval, thereby bypassing the usual requirements to fully evaluate the effects of introducing that new species of organism into New Zealand.

In addressing this gap it is proposed that the focus of the HSNO oversight remain the same; that is, on the nature of the new animals produced and their potential effects on the environment, not on the technologies themselves nor on any other direct use of the tissues.

Two options have been identified for amending the HSNO Act to include new animals produced using cloning and related techniques: either amend the definition of ‘develop’ to cover the regeneration of new organisms, or broaden the definition of ‘new organism’ or ‘organism’ and include a power to make regulations to provide that things are not ‘organisms’ or ‘new organisms’ for the purposes of the Act. It is proposed that the amendments extend to the artificial regeneration of organisms from all tissues, including plant and fungal tissues that are not capable of replicating themselves.

The proposed amendments would not extend to human cloning as the term organism in the HSNO Act specifically excludes human beings.

To view this section in full, please download the pdf