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SOP To HASNO (GM Organisms) Bill

Hon Marian Hobbs

20 December 2001 Speech Notes

Supplementary Order Paper to the Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Bill - Medicines Act Amendment.

Mr Speaker, I move that Standing Order 256 be suspended to permit the Finance and Expenditure Committee, in its consideration of the Hazardous Substances and New Organisms (Genetically Modified Organisms) Amendment Bill, to have authority to consider and, if it thinks fit, adopt the amendments set out on Supplementary Order Paper 231.

Mr Speaker, the purpose of the HSNO Amendment Bill, which I introduced earlier this month, was to constrain the release of genetically modified organisms into the environment, to allow time to implement the Government’s response to the Royal Commission on Genetic Modification.

This Supplementary Order Paper is consistent with this objective. It amends the Medicines Act to restrict certain new biotechnical medical procedures until a framework has been developed to ensure the potential risks to public health and safety, and the unique ethical issues these procedures raise, are properly considered. The procedures in question are germ cell line gene therapy and clinical xenotransplantation in respect of human beings. This SOP does not cover animals.

Germ cell line gene therapy is the genetic modification of eggs, sperm or early embryos in such a way that the modification is able to pass on to future generations. This potential for inheritance of the genetic modification poses unprecedented safety and ethical concerns.

Clinical xenotransplantation (which does not necessarily involve genetic modification) involves the insertion of living animal cells, organs or tissue into humans. This procedure poses a risk of passing on new retroviruses (that had previously been restricted to animal species) into the transplant recipient, and into the wider human population. HIV/AIDS is an example of a retroviral infection that is thought to have crossed the species barrier from animals to humans. In addition to this safety concern, the ethics of balancing the needs of an individual against risks for the community require further consideration.

When the content of this SOP becomes law, the Governor-General may, by Order in Council, exempt classes of clinical practices otherwise prohibited by these amendments to the Medicines Act on the recommendation of the Minister of Health. The Minister may also consider an individual application to carry out a regulated procedure and exempt that particular procedure from the prohibition. The Minister of Health, in her consideration of exemptions will take into consideration the risks to health or safety of the public, as well as ethical, cultural and spiritual implications.

This is in accordance with the recommendations of the Royal Commission on Genetic Modification.

Part of the Government’s response to the report of the Royal Commission on Genetic modification includes establishing the Bioethics Council to advise and provide guidelines, and promote dialogue on the cultural, ethical and spiritual issues associated with biotechnology. Mr Speaker, I would expect that the Bioethics Council will also play a role in the consideration of the ethical issues of medical biotechnology and the Minister of Health will look to the council for advice on these issues.

The Medicine Act amendments in this SOP will expire on 30 June 2003 but the Governor-General may, by Order in Council, extend the expiry date to no later than 30 June 2005. This allows time for a comprehensive approach to be developed to deal with germ cell line therapy and xenotransplantation and to cover a range of new and emerging technologies for assisted human reproduction, human cloning, research on embryos, and for example developing animal / human hybrids. It is also expected that this work will take into account policies on use of human tissue. Human biotechnology is moving quickly and it might well be that the comprehensive approach will take into account other new and emerging technologies that have not yet been anticipated.

The Medicine Act amendments create an offence for non-compliance and allow fees to be charged for applications to the Minister of Health.

Clause 96A of the Supplementary Order Paper defines “biological material”, as the whole or part of any organ, bone, tissue, cell, blood or body fluid. While the definition of biological material in this Supplementary Order Paper includes blood and body fluids, the definition of xenotransplantation specifically refers only to “living” biological material.

The xenotransplantation part of the amendment is designed only to regulate:

- the implantation or transplantation into humans of living animal cellular material;

- the injection or infusion of human body fluids that have been exposed outside of the body, for example in a medical device, to intact living animal cellular material; and

- the implantation or use of medical devices containing living cellular material of animal origin.

The amendment does not restrict medical use of animal materials that are recognised as non-living, such as plasma, albumen, purified proteins, hormones, enzymes, or of medical devices such as heart valves manufactured from acellular pig or bovine material, or of surgical implanted material such as demineralised bone or pig skin used in the treatment of burns patients where the manufacturing process of the material has killed any cellular material that may be present.

I invite the Select Committee to consider whether “living biological material” should be further clarified in the bill to avoid capturing these and other similar procedures.

Mr Speaker there is a gap in our law in the area of xenotransplantation and biotechnical medical procedures. This government is committed to putting a legislative framework in place and in the meantime restrict some clinical practices to protect the health and safety of New Zealanders.


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