Human Tissue Bill introduced in Parliament

The Labour-led government has taken a major step forward in addressing New Zealand's low rate of organ donation with the introduction of the Human Tissue Bill in Parliament today, Health Minister Pete Hodgson said.

The Bill encourages an environment of informed consent of potential donors balanced with protections for family rights and cultural values. It is hoped that these legal protections and the creation of an Organ and Tissue Donor Register will help increase the rate of organ donation in New Zealand, which lags behind the rate of other OECD nations.

"The decisions surrounding organ donation are among the most difficult that individuals and their families will face," Pete Hodgson said. "It became clear during the Human Tissue Review that gaps in current law were making it difficult for families to work through organ donation decisions. The result has often been a default position of not to donate.

"For example, the Current Driver Licensing Register is only an indication of a person's wishes, not legal consent for donation. This has often left grieving families unsure about what to do.

"It is hoped that the creation of a new Register that provides legal consent and the work of Organ Donation New Zealand to improve awareness will lead to the increase of informed choices to donate."

"We believe the Bill will ensure that the public and clinicians fully understand the consent process for donating human tissue. There will also be clear mechanisms in place for the use and management of human tissue for non-therapeutic purposes.''

The Human Tissue Bill will replace the Human Tissue Act 1964, which has become increasingly out of date. The existing regulatory framework for human tissue spans a number of acts and regulations, which creates confusion.

The new bill specifies who can give consent for the collection and use of human tissue and takes into account many of the views expressed by the public during consultation on the Human Tissue Review.

"This Bill aims to ensure a balance between respect for the autonomy of the individual, and the cultural and spiritual needs of their family. It also recognises the public good associated with the use of human tissue for therapeutic and non-therapeutic purposes such as research and education," Pete Hodgson said.

"The Bill will be considered by the Health Select Committee alongside Dr Jackie Blue's Private Member's Bill on organ donation. The two main differences between the bills are the Government bill's wider scope and its recognition of the of the wishes of the deceased person's family.

"I'm confident that the Select Committee will consider the two bills in the constructive fashion that has characterised discussion of these issues to date. The government will hold off work on the implementation of an organ donation register until we hear back from the Select Committee.

"Specifically, I am seeking the Committee's consideration of the international evidence surrounding donor registers to ensure that our register can maximise organ and tissue donations."

Below: Questions and answers on the Human Tissue Bill

Human Tissue Bill (A Government Bill)

What is the Human Tissue Bill?

The Human Tissue Bill provides a framework for regulating the collection, storage and use of tissue and organs, primarily from the deceased. It also regulates trading in tissue, export and import of tissue, and the use of tissue for non-therapeutic purposes (e.g. audit, anatomical examination, research and post mortem). Once enacted, the Human Tissue Bill will repeal and replace the Human Tissue Act 1964.

Why is the law being changed?

The current regulatory framework for human tissue spans a number of acts and regulations. This creates confusion, and there are gaps in the framework that regulates the use of human tissue. Increasingly, issues are raised that either fall outside the scope of the current arrangements or are subject to varying interpretations.

In 2004, the Ministry of Health undertook a review of the regulation of human tissue and tissue-based therapies (the Human Tissue Review). The Bill aims to address concerns raised during public consultation for the Human Tissue Review, including:

•A lack of clarity around the informed consent requirements for the collection and retention of tissue. Public concern has been expressed in a number of areas of human tissue use including organ donation and the retention of tissue following post-mortem examinations.

•The role of family members in giving consent for the collection and use of tissue from a person who has died and the lack of individual autonomy in this area.

•A lack of clarity in relation to the donor status on the National Register of Driver Licences – many people think the register records consent when it is an indication of wishes only, and the register is not routinely accessed by many health professionals involved in donation.

What does the Bill do?

•The Bill captures the key themes that emerged from the public consultation process on the Human Tissue Review, including: respect for donors and for organs and tissue informed consent and individual autonomy respect for families/whanau and cultural and spiritual differences the value of tissue for treatment, research and education.

•The Bill makes informed consent the fundamental principle underpinning the lawful collection and use of human tissue from deceased people.

•In general, the Bill 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 Bill does close a gap in current regulation by requiring consent to the analysis of human tissue (including DNA analysis) taken from living people.

•The Bill specifies who may give consent for the collection and use of human tissue (including for a purpose not covered by the original consent). Under the Bill, the primary consent will be that of the deceased, if formally recorded before he or she died, or of someone nominated by the person to consent on his or her behalf.

• Penalties of up to one years’ imprisonment or a fine, or both, are provided in the Bill as a deterrent to collecting, storing or using tissue without ‘appropriate consent’.

•The existence of appropriate consent would be sufficient for organ or tissue donation to be lawful. However, in practice, there may 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.

•Standards will be established for the non-therapeutic use of human tissue (e.g. research, education, audit, anatomical examination) and for the import and export of human tissue.

•The Bill prohibits trading in human tissue, with provision for the Minister of Health to exempt some activities, for example, recouping administrative costs associated with collection and use of tissue.

Is consent always required?

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

The Bill 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 related to a major public health risk), and professionally recognised quality assurance programmes, or external audit or evaluation activities, aimed at improving the quality of services. This is consistent with provisions in the Code of Health and Disability Services Consumers’ Rights 1996 for tissue taken from living people.

What about the organ and tissue donor register?

The Bill gives recognition to a national organ and tissue donor register. Such a register would need to be established to support the consent framework in the Bill. The Bill requires medical practitioners, donor agencies and others involved in the collection and use of tissue to take “all reasonably practicable steps” (including checking the register) to ascertain whether consent has been given. Why not use the existing Drivers License Register? 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 Bill.

What impact will a new register have on organ and tissue donation rates?

International evidence is inconclusive regarding the impact of registers on organ and tissue donation rates, which tend to fluctuate from year to year. Evidence points to increased public awareness about organ and tissue donation, improvements in processes around donation and improvements in co-ordination between agencies as being most likely to lead to improvements in donation rates. Organ Donation New Zealand, which was set up last year, has initiatives underway in this area and welfare assistance for living donors is available.

How is the Government Bill different from the Member’s Bill (Dr Jackie Blue)?

The key differences are: 

•The Government Bill is broader in scope and has a more comprehensive consent framework.

•The Government Bill aims for a balance between respect for the wishes of the deceased person and the cultural and spiritual needs of their family, whereas, the Member’s Bill (the Human Tissue (Organ Donation) Amendment Bill) does not acknowledge the needs of the deceased person’s family.

Other sources of information

Ministry of Health website: www.moh.govt.nz/human tissue Organ Donation New Zealand: www.donor.co.nz/ New Zealand Eye Bank: www.savesightsociety.org.nz/htmls/eyebank.html New Zealand Blood Service: http://www.nzblood.co.nz

ENDS

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