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Human Tissue

Human Tissue Review
Questions and Answers


  1. Why is the review being done?
  2. What is the process for the Review?
  3. How do people get more information about the consultation process or the Review in general?
  4. What is human tissue?
  5. What are the therapeutic uses of tissue?
  6. What are the non-therapeutic uses of tissue?
  7. What provisions currently govern this area?
  8. What are some of the problems with the current provisions?
  9. What doesn't the review cover?
  10. What does the Review say about consent for the post-mortem retention of tissue?
  11. Is the review linked with the recommendations from the Gisborne cervical screening inquiry?
  12. What does the review say about organ donation and the government response to the petition recently considered by the Health Select Committee?
  13. How does the Review fit with the Code of Health and Disability Services Consumers' Rights?
  14. Where does xenotransplantation fit into the Review?
  15. What is the Gillick test of competence?
  16. What penalties can be imposed under the Health and Disability Services (Safety) Act?
  17. Will ICU bed numbers be increased in order to improve donation rates?
  18. What provisions exist around stem cells and pre-implantation genetic diagnosis?
  19. Who were your Maori advisors?
  20. Will tissue be included in the Trans-Tasman Joint Therapeutic Products Agency?

1. Why is the review being done?


New and emerging technologies, gaps in the existing legislative framework, and changes in societal attitudes have led to the review being undertaken. Increasingly, issues are being raised which fall either outside the scope of current arrangements or into areas that are subject to varying interpretation.

The goal is to put a new regulatory framework in place that:

  • promotes both the cultural and spiritual needs of New Zealanders as well as the public good associated with the use of human tissue for therapeutic and non-therapeutic purposes.
  • addresses safety issues around therapeutic and non-therapeutic use of tissue
  • is flexible enough to respond to advances in technology that cannot be predicted
  • streamlines the legislation relating to human tissue, and
  • is comprehensive and easily understood by New Zealanders.


2. What is the process for the Review?


The Ministry of Health prepared a Discussion Document for public consultation.
The consultation process ran until 4 June 2004. The Ministry will analyse all the submissions made and begin preparing advice to the Minister of Health and Cabinet on the new legislative framework. It is anticipated that new legislation will be introduced to the House by the end of this year. The public will have further opportunities to contribute to the development of legislation through the Select Committee process. This is likely to be undertaken during early 2005.

3. How do people get more information about the consultation process or the Review in general?


  • Refer to the Ministry's website for more information about the Review, an electronic version of the Discussion Document and an electronic template of the consultation questions (www.moh.govt.nz)

  • For additional paper copies of the Discussion Document or other queries about the Review please contact the Ministry by emailing humantissue@moh.govt.nz or telephone 04 496 2244.

4. What is human tissue?


The Discussion Document proposes that human tissue be defined as:

  • the whole body or part of a body
  • bone
  • a whole organ such as the heart
  • parts of organs, such as heart valves
  • other tissue, such as corneas or skin
  • tissue specimens
  • foetal material
  • cellular material
  • cell lines.

The Ministry is seeking comment on the definition of human tissue.

The definition of tissue excludes:

  • donated blood and blood products as defined in the Health Act 1956
  • human sperm and eggs and human embryos that are outside the human body
  • x-rays or other images of tissue
  • secreted substances such as breast milk
  • animal tissue (except as described in relation to xenotransplantation).

5. What are the therapeutic uses of tissue?


The therapeutic uses of tissue described in the Discussion Document are:

  • human tissue and cells, and cellular and tissue based therapies (this includes organ and tissue transplantation, and cellular therapies such as stem cell therapies)
  • gene therapies – these types of therapies are currently the subject of research and are not available as treatments.
  • xenotransplantation – the use of live animal tissue in the treatment of humans (refer below).

6. What are the non-therapeutic uses of tissue?


The Discussion Document considers the following non-therapeutic uses of tissue:

  • anatomical examination
  • education and training
  • research
  • determining the cause of death, or gathering more information about an illness, through a post-mortem examination. (Note the Review considers non-coronial post-mortem examinations only)
  • An example of the non-therapeutic use of tissue is the research done by the Human Brain Bank in Auckland which uses tissue donated with consent to research the causes and potential ways of treating neuro-degenerative diseases of the brain such as Alzheimer's, Parkinson's and Huntington's diseases.

7. What provisions currently govern this area?


The use of human tissue for therapeutic and non-therapeutic purposes is governed by:

  • Human Tissue Act 1964 – governs the collection of tissue from deceased persons for therapeutic use, anatomical examination, education and research. It also provides for non-coronial post-mortem examinations, schools of anatomy and inspectors of anatomy.

  • Code of Health and Disability Services Consumers' Rights 1996 – sets out the rights of consumers of health and disability support services and the responsibilities of providers. The Code applies to living people.

  • Operational Standard for Ethics Committees 2002 – provides the operating procedures for health and disability ethics committees.

  • Hazardous Substances and New Organisms Act 1996 – provides coverage of the genetic modification of human cells and tissues outside the human body.

  • Supplementary Order Paper to the Human Assisted Reproductive Technology Bill 1996 – proposes a framework for the regulation of assisted human reproductive procedures and research.

  • Health (National Cervical Screening Programme) Amendment Act 2004 – allows for the Health (Retention of Health Information) Regulations 1996 to be extended to specimens as well as other types of health information
  • Health Information Privacy Code 1994 – provides protection for health information relating to identifiable individuals
  • Medicines Act 1981 – is concerned with the safety of medicines and medical devices. The safety regime in the Medicines Act applies only to tissue that meets the definition of a medicine or medical device. It does not cover whole human organs and other transplantable tissue that have not been subject to a manufacturing process. The Medicines Act also contains provisions for clinical trials to be undertaken and places controls on xenotransplantation being undertaken in New Zealand.

  • Health Act 1956 – regulates the collection of blood and blood products and contains the ability for other controlled human substances to be regulated.

  • The Health and Disability Services (Safety) Act 2001 applies a system of standard setting, audit and licensing to health and disability support services. This Act contains the ability for tissue services to be added to the safety regime, but they are not currently governed by this Act.

8. What are some of the problems with the current provisions?


The regulation of tissue for both therapeutic and non-therapeutic use has grown over time and is spread across a large number of acts and regulations. This patchwork does not provide a comprehensive framework for this sensitive and evolving area.

Some of the issues with the current coverage are:
  • Informed consent to use tissue after a person has died
    Informed consent is a central issue in the Review. There are important gaps in the Human Tissue Act 1964 around the need for consent to be given for tissue to be retained after a non-coronial post-mortem examination.

    The Act only covers consent for the post-mortem examination itself, but sometimes it is important for tissue to be retained after the examination for further testing, or perhaps for research. It is important that the law is clear about consent requirements in these situations. There are also difficulties with the terms used in the Human Tissue Act to refer to who may give consent for tissue to be used after a person has died, these terms do not cover the complexity of contemporary family relationships and aren't consistent across the different uses of tissue.

    The Human Tissue Act also doesn't use the term 'informed consent', it uses the phrase 'lack of objection' and the Review proposes that this be updated.
  • Some types of tissue are excluded from the current regime
    Importantly, still-born children are currently excluded from the Human Tissue Act through the definition of a 'body' in that Act. The Review proposes that still-born children be included in the new framework and seeks comment on this proposal.

  • The monitoring and oversight of tissue used for non-therapeutic purposes isn't comprehensive
    Under the Human Tissue Act, anatomical examination and the activities of schools of anatomy are the only areas subject to monitoring and oversight.

  • Some aspects of the use of tissue for therapeutic purposes aren't subject to formal regulation
    The use of tissue-based therapeutic products has the ability to improve the quality of life for many people. Procedures such as organ donation are now established practice, while some tissue-based therapies are only research possibilities. As this area continues to develop, the Review proposes that safety arrangements be formalised for existing practice and designed to anticipate future developments. Safety arrangements would draw on existing guidance developed by professionals working in these areas.
  • Whether the current system New Zealand has for organ and tissue donation for therapeutic use is the best system for this country
    The legislative system for organ and tissue donation is contained in the Human Tissue Act 1964. The Review is seeking peoples' views on whether changes to this system would improve the process and rate of organ and tissue donation.

  • How legislation can be 'future-proofed' for new developments in technology
    It is important that the new regulatory framework for human tissue is able to respond to developments in science and technology that cannot necessarily be predicted at the moment. While providing exciting opportunities for diagnosis and treatment of disease, it is likely that new uses of tissue will arise that challenge the cultural, spiritual and ethical views of New Zealanders, and our mechanisms for regulating the safety and quality of therapeutic products. The Review seeks comment on how a regulatory framework can be designed with future uses of tissue in mind.

9. What doesn't the review cover?


The definition in Question 4 describes the types of tissue that are excluded from the Review. The review also does not cover the:

  • coronial system and coronial post-mortem examinations
  • genetic modification of human cells and tissue
  • the creation and use of human reproductive tissues and cells (in-vitro embryos and gametes). The Review does include, however, the collection and use of foetal tissue and the use of embryonic cells and cell lines for non-reproductive purposes
  • human tissue collected as part of forensic investigation.

These areas are covered, or are about to be covered, by other laws and regulations. It is our intention to take other regulations into consideration so we can ensure some consistency with how we operate within these areas. As noted in Question 13, the Review is also not covering service or resource allocation issues associated with organ and tissue donation for transplantation.

10. What does the Review say about consent for the post-mortem retention of tissue?


The lack of clear provisions for the retention of tissue after non-coronial post-mortem examinations has been highlighted in New Zealand (Greenlane Heart Registry) and overseas.

The Discussion Document proposes to address this particular issue in two ways:

  • by including stillborn children within the regime (currently still-born children are excluded from the Human Tissue Act), and
  • by making the law clear about the consent requirements for a post-mortem examination to be undertaken and the consent requirements for tissue to be retained from that post-mortem examination (currently the law is silent on consent for tissue retention at post-mortem).

11. Is the review linked with the recommendations from the Gisborne cervical screening inquiry?


Yes, one aspect of the Review is to extend the Health (Retention of Health Information) Regulations 1996 to require the retention of specimens.

Currently these regulations only apply to more traditional types of health information such as doctor's notes. The Gisborne cervical screening inquiry recommended that legal obligations be put in place to require the retention of records of patients’ cell and tissue test results.

The Health (National Cervical Screening Programme) Amendment Act has recently been passed, one of the changes made was to the regulation-making powers in the Health Act 1956. The regulation-making power now allows for regulations to be made to require the retention of specimens. This will be done by extending the Health (Retention of Health Information) Regulations 1996 and the Discussion Document seeks feedback on a number of matters to do with extending those regulations.

12. What does the review say about organ donation and the government response to the petition recently considered by the Health Select Committee?


A number of organ donation issues are being considered at the moment. The Review is examining the legislative framework for organ donation including consent issues and the role of families.

There is also work being done on service issues, in particular the establishment of a national organ donation agency to give a national focus to organ donation, co-ordinate organ donation and to expand the education of health professionals.

The Ministry of Health is working with the sector on issues around the national agency and to examine issues relating to organ donation, such as the training of health professionals. This was the key recommendation from the Government's response to a Health Select Committee Report on a petition from Mr Andy Tookey and 1,169 others. The Government response also signalled that the Review was happening and that consultation on the legislative framework would begin shortly.

13. How does the Review fit with the Code of Health and Disability Services Consumers' Rights?


The Code of Consumers' Rights applies to living people and the rights in the Code that are most relevant to the Review are:
  • Services may be provided to a consumer only if the consumer makes an informed choice and gives informed consent. For example, a person must agree, after being given sufficient information, to give a sample of tissue (e.g. a biopsy or blood test) or to have a surgical procedure such as the amputation of a limb, or to participate in a live organ donation procedure. (Right 7(1)).
  • Consumers must be fully informed of any proposed participation in teaching or research (including being informed about whether the research requires and has received ethical approval). Consent to participate in research must be in writing. (Rights 6(1)(d) and Right 7(6)).
  • Right 7(5) that allows consumers to use advance directives
  • Right 9 extends all the rights in the Code to occasions when a consumer is participating in, or it is proposed that a consumer participate in, teaching or research

Right 7(10) of the Code states that any body parts or bodily substances removed or obtained in the course of a health care procedure may be stored, preserved or utilised only with the informed consent of the consumer. Separate from the Review, the Government is amending this right to allow some research activities to be undertaken without informed consent, but an ethics committee must have scrutinised and approved the proposal. Professionally recognised quality assurance programmes or external audits or evaluations of services undertaken to improve the quality of the services will also be allowed.

14. Where does xenotransplantation fit into the Review?


Xenotransplantation is the transplantation of live cells, tissue, or organs from another species (e.g. pigs) into humans. Xenotransplantation is not currently happening in New Zealand and under the Medicines Act 1981, no one can carry out xenotransplantation without the Minister of Health's permission. Before giving permission the Minister must be satisfied the health and safety risk to the public is minimal and will be managed effectively, and that any ethical, cultural and spiritual issues have been adequately addressed. The provisions in the Medicines Act are due to expire in June 2005.

The Review considers xenotransplantation in the context of future-proofing the legislation for new and challenging technologies. It also notes that further work on the acceptability of xenotransplantation in New Zealand is to be undertaken by the Toi te Tao – the Bioethics Council.

15. What is the Gillick test of competence?


The Gillick test of competence is a way of measuring the ability of young people under the age of 16 to consent to or refuse health care or treatment.

The Code of Health and Disability Services Consumers’ Rights 1996 states that ‘services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent’, except where legislation provides otherwise (right 7(1)).

In order to give informed consent, a person must
  1. have the information required to make the decision to give consent, and
  2. be able to understand that information. In other words, they must be competent to give their consent.

Under the Guardianship Act 1968, young people over 16 years of age can consent to health care procedures. As with any adult, a health practitioner can overturn their decision if there are reasonable grounds for believing they are not competent for any other reason. Such reasons might include mental or intellectual disability, or undue coercion or interference by a third party.

There is no law or regulation that says that those under 16 are not competent to give consent. Right 7(2) of the Code of Health and Disability Services Consumers’ Rights holds that ‘every consumer must be presumed competent to make an informed choice and give informed consent, unless there are reasonable grounds for believing that consumer is not competent’. Therefore, while some young people under the age of 16 will not be competent to give consent, and the consent of their parent or legal guardian (or the Director-General of Social Welfare or the Courts, in the case of Wards of the State and Courts respectively) will be required in most circumstances, their lack of competency must be established and not presumed.

The test for competency for young people under the age of 16 is the Gillick test. The name comes from a case taken to the Court of Appeal in the UK by a mother who wanted assurances from her local health authorities that her daughters would not be given information about contraception or given contraceptives without her consent. The Court ruled that the health authority could not give such assurances, acknowledging the possibility that young people under the age of 16 can be competent to consent to receive information or treatment. The decision underlined the fact that the test for competency does not rely on age but on maturity and ability to understand health information, and rests on the fact that children are individuals who grow in intelligence, competency and autonomy as they move toward adulthood.

Whether a young person is considered competent depends on the situation and the treatment involved. More serious treatments will require stronger evidence of competence. Questions that a health practitioner will consider in determining whether a young person under the age of 16 is competent include:
  • Does the patient understand why they need the intervention?
  • Does the patient understand what the intervention involves and what it is for?
  • Does the patient understand the probable risks and benefits of the intervention and what the alternatives are?

Where the competency of any person is considered to be diminished, that person retains the right to give consent to the extent appropriate to their level of competency. Competency is therefore not an all or nothing affair.

Where they are not considered to be competent, or to have diminished competence, young people must be given information appropriate to their level of understanding.

Where decisions are made on behalf of a young person, the interests of the young person must be the primary consideration.

There are limited sets of circumstances in which a young person’s competence does not need to be determined, nor consent sought from a parent or caregiver. These include:
  • emergencies where the parent or caregiver cannot be found.
  • abortions, which are not restricted on the basis of age.
  • contraceptives or advice on contraceptives.
  • some blood transfusions.
  • examinations ordered by the Courts on suspicion of child abuse or neglect.
  • cases where the law allows compulsory treatment, for example under the Mental Health (Compulsory Assessment and Treatment) Act 1992.

The proposed Care of Children Bill, which is currently before Select Committee, will reinforce the use of competence rather than chronological age as a guide to the decisions that children and young people are able to make.

16. What penalties can be imposed under the Health and Disability Services (Safety) Act?


The Health and Disability Services (Safety) Act 2001 exists to promote the safe provision of health and disability services to the public, enable the establishment of consistent and reasonable standards for providing health and disability services to the public safely, encourage providers of health and disability services to take responsibility for providing those services to the public safely, and encourage providers of health and disability services to the public to improve continuously the quality of those services.

Under section 54 of the Act, those who:
  1. provide health care services otherwise than in compliance with the service standards mentioned in section 9 of the Act,
  2. provide health services while under a cessation order, or
  3. provide health services in any premises that are under a closing order

commit an offence and can be fined up to $50,000 on summary conviction.

Those who prevent or hinder the monitoring of compliance with the provisions of the Act also commit an offence and can be fined up to $1,000 on summary conviction.

17. Will ICU bed numbers be increased in order to improve donation rates?


The main reason for any increase in ICU bed numbers would be to improve access to intensive care services for those who need it, not to increase organ donation rates.

Although an increase in ICU bed numbers may impact on the number of organ donors, other factors – such as the falling number of serious road accidents and improvements in quality of care for conditions which used to be fatal – are likely to have a greater effect on the number of ICU deaths, and therefore on donation rates.

The Ministry of Health’s Intensive Care Clinical Advisory Group recently recommended that national ICU capacity be increased by at least 70 beds by 2010. New Zealand currently has around 45 ICU beds per million people, which is relatively low by international standards. According to a study by a group of leading intensivists, the percentage of total deaths that occur in an ICU is also relatively low, at 5.1%.

18. What provisions exist around stem cells and pre-implantation genetic diagnosis?


Stem cells

Stem cells are capable of developing into more than one type of tissue. Most adult cells do not have this ability; a liver cell can give rise to more liver cells, but not to blood or skin cells. In contrast, early embryos consist entirely of cells capable of differentiating into every type of tissue in the human body. Stem cells obtained from embryos are called embryonic stem cells. The extraction and use of stem cells, particularly embryonic stem cells, raise complex ethical issues and will be covered by the proposed Human Assisted Reproductive Technology (HART) legislation.

Because stem cells are found in the blood, some aspects of stem cell research are regulated by legislation relating to blood (such as the Health Act 1956). Other aspects of stem cell research may require more intensive regulation and monitoring, given the high degree to which stem cells can be manipulated.

The Review is asking whether the issues raised by stem cell research require protections other than those currently in place.

Pre-implantation genetic diagnosis (PGD)

Pre-implantation genetic diagnosis (PGD) is the genetic testing of embryos before they have been implanted into the womb. In vitro fertilisation (IVF) and related techniques are used to create the embryos to be tested.

PGD will be regulated in New Zealand under the Human Assisted Reproductive Technology (HART) Bill. The HART Bill, currently before Parliament’s health select committee, will provide a legislative framework for the appraisal and use of new assisted reproductive technologies.

Therefore, the legislative framework for human tissue will not address PGD.

19. Who were your Maori advisors?


The Ministry respects and values the points of view held by all New Zealanders. In addition, a special obligation exists under the Treaty of Waitangi to seek Mäori input and feedback on public policy matters. The Ministry’s Mäori Health Directorate had extensive input into the design and direction of the Review. Hui and Mäori focus groups were held in Christchurch, Rotorua, and Hamilton during May 2004. There will be further opportunity for extensive and specific Mäori input into the development of a regulatory framework for human tissue when the matter is before select committee.

20. Will tissue be included in the Trans-Tasman Joint Therapeutic Products Agency?


The Agreement between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products, signed in December 2003, provides for the establishment of joint regulatory scheme for therapeutic products. Regulation in this area is currently the job of Medsafe (New Zealand) and the Therapeutic Goods Administration (Australia).

The text of the Agreement allows for tissue products to be included in the scheme with the agreement of both Governments. This and other regulatory options – involving, for example, the Health Act 1956 or the Health and Disability Services (Safety) Act 2001 – are put forward in the Review as possibilities for New Zealand. The Government of New Zealand is waiting for the results of the Review’s consultation process before making its decision. The Ministry of Health will advise its Minister, who will in turn advise the Cabinet, on which regulatory option is most appropriate.

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