Review of the Regulation of Human Tissue and Tissue-based Therapies
Questions and Answers
These FAQs relate to a media release dated 5 April 2004 - "Review of human tissue uses "
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 has prepared a Discussion Document for public consultation.
The consultation process runs until early June when 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 take part in the consultation process?
The Discussion Document has been distributed among health service providers, university departments, researchers, consumer groups, government agencies, and other organisations and individuals with an interest in the regulation of human tissue. It is also available from the Ministry of Health and the Ministry’s website (www.moh.govt.nz).
There are two ways to take part in the consultation process:
- Make a written submission to the Ministry
The discussion document contains specific questions for response.
The Ministry of Health’s website contains a template of the questions raised in the discussion document and people are encouraged to submit responses electronically (www.moh.govt.nz).
Postal submissions can also be sent to the Ministry. When making submissions the Ministry requests that people identify the section of the discussion document that they are commenting on to assist with the analysis of the submissions. The closing date for written submissions is 4 June 2004.
- Attend a consultation meeting or hui
The Ministry is holding consultation meetings, including hui, that are open to everyone.
The meetings will provide an opportunity for people to give feedback on the issues in the discussion document and to raise other issues that they think the Ministry should address in the new regulatory framework.
We encourage people to attend a meeting or hui and ask that they register by completing the form available with the Discussion Document and on the Ministry’s website and return it to the Ministry by 19 April 2004
4. 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.
5. What is human tissue?
The Discussion Document proposes that human tissue be defined as:
- the whole body or part of a body
- a whole organ such as the heart
- parts of organs, such as heart valves
- other tissue, such as corneas or skin
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).
6. 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).
7. What are the non-therapeutic uses of tissue?
The Discussion Document considers the following non-therapeutic uses of tissue:
- 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.
8. 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.
9. 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 have 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.
10. What doesn't the review cover?
The definition in Question 7 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.
11. 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
- firstly by including stillborn children within the regime (currently still-born children are excluded from the Human Tissue Act), and
- secondly 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).
12. 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 cytology and histology 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.
13. 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 to implement 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 Andy Tookey’s organ donation petition. The Government response also signalled that the Review was happening and that consultation on the legislative framework would begin shortly.
14. 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 (eg 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.
15. Where does xenotransplantation fit into the Review?
Xenotransplantation is the transplantation of live cells, tissue, or organs from another species (eg 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.