Human Tissue

Human Tissue Act 2008 Factsheet

The Human Tissue Act regulates the collection and use of tissue, primarily from dead human bodies, and sets up a framework for informed consent for human tissue collection and use. The Act also regulates trading in tissue, the exporting and importing of human tissue and the use of tissue for non-therapeutic purposes (e.g. audit, anatomical examination, research and post mortem).

Although the collection and use of tissue from living people is largely covered by existing legislation and common law, the Act also requires informed consent for:

analysis for the purpose of providing information about a condition or rait of a person (“donor analysis”), where the tissue is not collected in a health care procedure (tissue collected in a health care procedure is covered by existing legislation and guidelines), and
the use for a secondary purpose of tissue collected from a living person after the donor’s death (i.e. for a purpose other than one that the donor consented to while alive).

Once enacted, the Human Tissue Act 2008 repeals and replaces the Human Tissue Act 1964.

More information is provided below:

What does the Act do?

The Act makes informed consent the fundamental principle underpinning the lawful collection and use of human tissue from deceased people.
In general, the Act does not cover consent for the collection and use of tissue from living people because it is covered under existing legislation and common law. However, the Act does close a gap in current regulation by requiring consent to the analysis of human tissue (including DNA analysis) taken from living people outside of a health care procedure.
The Act specifies who may give consent or raise an objection for the collection and use of human tissue (including for a purpose not covered by the original consent). Under the Act, the primary consent or objection will be that of the deceased, if formally recorded before he or she died, or of someone nominated by the person to make the decision on his or her behalf. If there is no nominee consent or objection may be given collectively by the deceased’s immediate family, or by a specified member of the immediate family.
The Act creates penalties of up to one years’ imprisonment or a fine for collecting and using tissue without ‘appropriate consent’.
The existence of informed consent would be sufficient for organ or tissue donation to be lawful. However, in practice, there can be a number of reasons why donation should not proceed - organs and tissue may be unsuitable for donation, the family may be aware that the person changed their mind since recording their consent, or the immediate family may be distressed by a decision to proceed with donation. The Act allows for collection and use not to proceed in these circumstances.
The Act has provision for standards for the non-therapeutic use of human tissue (e.g. research, education, audit, anatomical examination) and standards or requirements for the import and export of human tissue to be adopted by regulation.
The Act prohibits trading in human tissue, with provision for the Minister of Health to exempt some activities, for example, recouping administrative costs associated with the collection and use of tissue.

The consent framework

The Act makes informed consent the fundamental principle underpinning the lawful collection and use of human tissue. It replaces the use of “lack of objection” in the Human Tissue Act 1964 with “informed consent” which is consistent with the Code of Health and Disability Services Consumers’ Rights. By specifying who may give consent or raise an objection for the collection and use of human tissue, the Act provides clarity for organ and tissue donation, and the collection and retention of tissue for other purposes such as a post-mortem examination, research or education and training.

Is consent always required?
The Act provides some exceptions to the general rule that informed consent is required to collect or use human tissue. These exceptions include tissue collected or used under the Coroners Act 2006 or for criminal justice purposes.

The Act also recognises that there are certain limited circumstances where, because appropriate safeguards are in place, the public good associated with the use of tissue outweighs informed consent requirements, including:

research approved by an ethics committee (e.g. for research relating to a major public health risk)
professionally recognised quality assurance programmes
external audit or evaluation activities, aimed at improving the quality of services.

These exemptions to the requirement for informed consent are consistent with provisions in the Code of Health and Disability Services Consumers’ Rights for tissue taken from living people.

Who can give consent?
The Act identifies who can give informed consent for the lawful collection or use of human tissue.
The Act sets out who is able to give informed consent in four different circumstances.

The collection and use of tissue from a deceased person for general purposes including organ and tissue donation and research.
The collection and use of tissue from a deceased person for anatomical examination or public display.
The use of tissue that was collected from a living person, for a secondary purpose, after their death.
The collection and use of tissue from a living person where the Code does not apply and the analysis is for the purpose of obtaining genetic or other information about a particular condition or trait.

The consent framework is slightly different for each of these situations and the Act includes flowchart diagrams in the schedules to clarify the hierarchies of consent for some particular uses of human tissue.

Consent framework for the collection and use of human tissue from a deceased person for general purposes
In this case, the primary consent or objection will be that of the deceased before he or she died, or of someone nominated by the deceased person to consent or object on their behalf. In the absence of consent or objection to donation by the individual, or their nominee, the decision would be made by the immediate family. The Act provides for decision-making by a close available relative of the dead individual if the immediate family is unable to reach a decision.

Informed objection
The Act recognises the ability of decision-makers to raise an informed objection alongside the ability to give informed consent. Both informed consent and informed objection have legal standing and prevent lower-ranked decision-makers in the hierarchy from consenting or objecting.

Cultural context of informed consent
The Act requires decision-makers to take into account the cultural and spiritual needs, values and beliefs of the immediate family of the individual whose tissue is collected. A decision-maker will need to decide what weight to give this perspective and may or may not make a decision that the immediate family would agree with. Individuals who want to make a decision about the collection and use of tissue after their death are encouraged to consider the impact of their decision on their family. Individuals, however, retain the right to make a decision that their family does not agree with.

The Act also requires the person collecting or using human tissue to take into account the cultural and spiritual needs, values and beliefs of the immediate family of the individual whose tissue is collected. It is entirely appropriate for clinicians, researchers and others collecting and using human tissue from a deceased individual to do so with proper recognition of, and respect for, the immediate family.

Authority not to act on informed consent
Nothing in the Act requires someone to collect or use human tissue and a person who proposes to collect or use tissue may decide not to act on informed consent. There may be a number of reasons why collection should not proceed. The organs and tissue may be unsuitable for donation, the immediate family may be aware that the deceased person had changed their mind since recording their consent or the immediate family may be distressed by a decision to proceed with donation. This reflects current practice.

What about the organ and tissue donor register?

The Act does not establish an organ and tissue donor register but does include a clause that permits the establishment of an opt-on register by regulation at a later date.

International evidence indicates that registers are an ineffective tool for increasing organ and tissue donation. Registers are not a significant influence on the number of deceased donors available for transplantation. Other factors such as the religious and cultural views towards death and the body, the predominant cause of death, and the number and efficiency of transplantation co-ordinators make a more significant contribution to the number of organs and tissues available.

Developing clinical expertise, improving co-ordination between agencies and well-designed social marketing are likely to prove more cost-effective in increasing organ and tissue donation. Organ Donation New Zealand has initiatives underway in this area (www.donor.co.nz).

What about the Drivers Licence Register?
When you fill out your driver licence application form, you will be asked the following question:
Would you be willing to donate organs in the event of your death?

There is a box to tick for 'Yes' and one for 'No'.

By ticking the 'Yes' box and signing the form, all you are agreeing to is having the word 'DONOR' printed on your licence card. (It's also recorded on your record on the driver licence database.)

A person’s entry on the current Driver Licensing Register is an indication of a person’s wishes at the time they applied for a drivers licence. It does not meet the requirements for consent in the Human Tissue Act. The requirement to tick either ‘Yes’ or ‘No’ is a useful prompt for individuals to think about organ and tissue donation and to discuss their views regarding consent or objection to donation with their family. It may also guide the family in deciding whether to consent or object to the donation of the deceased person’s organs and tissues.

Organ and tissue donation
Only a very small number of New Zealanders die each year in circumstances that allow them to become organ donors. Organ donation is possible when an individual is determined brain dead prior to their blood circulation ceasing, and this only occurs within an intensive care unit. A 2002 estimate put the number of medically suitable potential donors per year at approximately 100.

In recent years there has been a reduction in brain death rates in intensive care units due to a declining road toll, and continuous improvements in clinical practice and survival rates from trauma. In 2007 there were 38 organ donors in New Zealand.

Due to the less stringent medical requirements for tissue donation there are significantly more potential tissue (skin, eyes, heart valves) donors than organ donors. It is estimated that almost half of all deaths in New Zealand would fit the medical criteria for eye donation. However, logistical issues such as the place and time of death and the availability of appropriate facilities and staff limit the number of potential tissue donors.

For information on organ and tissue donation, including the circumstances in which a person can become a donor, the process of donation, and statistics on donation please see ODNZ’s website – www.donor.co.nz.

It is important to discuss your views about organ and tissue donation with your family. If you die in circumstances that mean you could be a potential donor, your family will be asked whether you have discussed donation and whether you consented or objected to being a donor.

Non-therapeutic Use of Human Tissue Standard

View information on the Non-therapeutic Standard page.

Offences and Penalties

The Act contains a range of penalties for offences that vary according to the seriousness of the offence. The proposed penalties for the most serious offences are up to 1 year in prison or a fine of $50,000. These offences are:

Collecting and using human tissue from bodies without appropriate consent
Unlawful removal of tissue for use for therapeutic purposes or medical education or research
Charging for administered blood or a ‘controlled human substance’ (defined in the Act)
Collecting or using human tissue from a living person with the intention of its DNA or other material being analysed (where this is not covered under the Code of Health and Disability Services Consumers’ Rights 1996) without the consent of the person from whom the tissue was obtained
Trading in human tissue (unless it is an exempted activity).

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Page last updated: 27 June 2008