Regulatory Impact Statement: Human Tissue Review

Regulatory Impact Statement: Human Tissue Review
Statement of the nature and magnitude of the problem and the need for government action

At present, the human tissue regulatory framework spans a number of acts and regulations (e.g., the Human Tissue Act 1964, Part 3A of the Health Act 1956, which covers trading and collection of blood and controlled human substances). Individually, many of these acts and regulations are considered to be out-of-date (for example, the Human Tissue Act dates from 1964), and collectively they do not comprise a comprehensive or fully effective framework. Increasingly, issues are raised that either fall outside the scope of the current arrangements, or definition of tissue are subject to varying interpretations, such as, the court case relating to the retention of children’s hearts at Greenlane hospital. The Human Tissue Act 1964 does not specifically define human tissue, but covers tissue taken from a human body. The Act defines a human body as “dead human body, but does not include the body of a stillborn child”.

Concerns regarding the current human tissue framework and practice include:

Ongoing developments in new technology and changes to therapies. Advances such as xenotransplantation (transplantation of tissue from one species to another, for example, animal to human) or stem cell technology present new ethical and safety challenges.
Safety issues. Tissue-based therapeutic products including organ transplants, tissue transplants and cellular therapies are currently subject to minimal formal safety requirements.
Public concerns. Public concern has been expressed in a number of areas of human tissue use including, for example, organ donation, and the retention of tissue following post-mortem examinations (eg. retention of children’s hearts at the Greenlane Heart Library).
Ethical issues. Ethical consideration of research and innovative practice proposals is a core part of the health and disability sector. However ethical issues have arisen where the Ministry of Health considers that the legislation could provide better guidance to assist ethical decision-making.
Consistency with work in other sectors. Currently legislation in other areas is being reviewed and this work intersects with the human tissue area. For example, a new Coroners Bill is currently before the Justice and Electoral Reform Select Committee and new legislation has recently been enacted to cover the human assisted reproduction area.

In particular, there are problems with the following current provisions:

Informed consent
The informed consent requirements for use of tissue from deceased people are unclear in the current legislation. Public concern has been expressed in a number of areas of human tissue use including, for example, organ donation, and the retention of tissue following post-mortem examinations (eg. retention of children’s hearts at the Greenlane Heart Library). Areas of particular concern include:

the need for clarity around informed consent for the collection and retention of tissue at a post-mortem examination
the role of family members in giving consent for tissue use after a person has died and concerns about the lack of individual autonomy in this area
the use of ‘lack of objection’ instead of ‘informed consent’ for the use of tissue from deceased persons in current legislation, which is not consistent with the Code of Health and Disability Services Consumers’ Rights
lack of clarity in relation to the donor status on the Land Transport New Zealand driver licence register – many people think the register records consent when in fact it is an indication of wishes only. Some intensive care unit (ICU) staff never access the information on the database, while others routinely use the database to check for donor wishes.

Therapeutic use of tissue
Therapeutic use of tissue includes tissues and whole organs intended for immediate transplantation (such as hearts, kidneys and lungs) and banked tissues for transplantation at a later date (such as cornea, bones and skin). There are 13 providers currently banking tissue (including the New Zealand Blood Service, New Zealand Eye Bank, and 11 District Health Boards).

Currently the tissue-based therapeutic sector is largely self-regulating. Tissue banks and whole organs and tissues for immediate transplantation operate under voluntary codes of practice. There is no national standard applied to the testing of tissues and organs. The lack of formal regulation of tissue-based therapies is unusual internationally. The following issues have arisen around therapeutic uses of tissue:

the lack of formal requirements impacts on the ability to assure the safety of therapeutic products, such as whole organs for transplantation and the ability to track the use of a product should an adverse event occur
the lack of formal international harmonisation which has implications for the sharing of whole organs between Australia and New Zealand
ongoing developments in new technology and changes to therapies. For example, xenotransplantation or stem cell technology present new ethical and safety challenges
ethical consideration of research and innovative practice proposals is a core part of the health and disability sector. However ethical issues have arisen, for example, in relation to the commercial use of tissue.

Non-therapeutic use of tissue
Non-therapeutic tissue use includes tissue used in research, education and audit. It also includes tissue collected during non-coronial post-mortem. The sector is largely self-regulating and there is no consistent standard applied across the different uses of tissue. There are several areas of concern relating to non-therapeutic uses of tissue including:

Consistency/Clarity: With the exception of the two schools of anatomy there is currently a lack of clarity around processes for non- therapeutic uses of tissue. There is also a lack of clarity around the use of tissue from stillborn children and foetuses, stem cells and cell lines.
Guidance on Retention, Storage and Disposal: There is public concern around retention of tissue when the purpose for retention is unclear, such as the retention of Guthrie Cards (a type of genetic screening where blood samples are taken from newborn children for metabolic testing). There is also concern around processes for the disposal of tissue and those involved in human tissue use would like guidance on these issues.
Professional and public confidence: Professional groups have indicated that the lack of a standard creates uncertainty that they are meeting public expectations in using and retaining tissue for research and education.

Statement of the public policy objectives
To ensure that New Zealand has robust, modern and comprehensive human tissue regulation that is consistent across the whole of the human tissue regulatory regime.

Secondary objectives:
To ensure the regulatory framework:

appropriately promotes the cultural and spiritual needs of New Zealanders and the public good associated with the use of human tissue for therapeutic and non-therapeutic purposes
clarifies the consent process for clinicians and the public
addresses the safety of tissue for therapeutic and non-therapeutic use
is flexible enough to respond to advances in technology that cannot be predicted at this stage
streamlines the legislation relating to human tissue
is comprehensive and easily understood by New Zealanders.
promotes public confidence in the use and management of human tissue for both therapeutic and non-therapeutic purposes

Additional public policy objectives for the management of tissue based therapies:

provides consistency with the regulation of other therapeutic products, such as prescription and non-prescription medicines, medical devices, blood and blood products;
ensures a risk-based approach to regulation and ensures that the level of regulation is commensurate with the level of risk posed by a particular tissue-based therapeutic product;
increases the degree of international harmonisation; and
has the ability to control the cost of monitoring and ensure compliance.

Statement of feasible options (regulatory and/or non-regulatory) that may constitute viable means for achieving the desired objectives AND statement of the net benefit of the proposal, including the total regulatory costs (administrative, compliance and economic costs) and benefits (including non-quantifiable benefits) of the proposal, and other feasible options

The key features of the status quo, the proposed options, and the benefits and costs of the options are identified below under relevant broad themes.

1. Informed Consent
Who can give consent and mechanism for recording consent.

Option 1: Status quo
Under the Human Tissue Act 1964, human tissue is not defined. The Act defines a human body as “dead human body, but does not include the body of a stillborn” and the Act covers tissue taken from a human body.

If the deceased recorded their wish to donate then the person lawfully in possession of the body may remove organs or tissue. If wishes are not known, organs or tissues may be removed if there is no objection from family. Family is defined as surviving spouse, surviving de facto partner of the same or different sex, or any surviving relative of the deceased. Current practice is that the family will be asked to consent to donation whether wishes are known or unknown. If the deceased wishes are unknown, a potential donor’s family will always be asked to agree to their deceased family member’s organs being donated. Consent in regard to children is not addressed in the current legislation.

All drivers are required to indicate whether or not they would be willing to donate organs in the event or their death. Information is held on the Land Transport NZ indicative register. Registering a wish to be a donor on a driver licence does not constitute informed consent. It does however provide an indication of what a person’s wishes were. Provision already exists on the National Health Index/Medical Warning System (NHI/MWS) register for the recording of donor wishes. This system was set up to allow DHBs to upload wishes from the LTNZ database. DHBs showed little enthusiasm for the idea and only one upload occurred, more than five years ago. The NHI/MWS information is very out-of date and is never checked by intensivists.

The status quo is not the preferred option for who can give consent because it does not meet the key objectives of a consent framework.

Key definitions relevant to option 2 and option 3
The following definitions are key features of option 2 and option 3:

Human tissue would include whole bodies through to blood, cell lines derived from tissue, stillborn, aborted foetuses, foetal material. It excludes material covered under the Human Assisted Reproductive Technology legislation. It also excludes material shed by the body naturally, for example, hair and urine.

The proposal would only refer to the “immediate family” in relation to a dead person. Immediate family would be defined as
(a) means members of the dead person’s family, whänau, or other culturally recognised family group who –

were in a close relationship with the person; or
in accordance with the customs or traditions of the community of which the person was part, responsibility for, [or an interest in] the person’s welfare, and best interests; and

(b) to avoid doubt, includes a person whose relationship to the dead person was, or was through, that of spouse or de facto partner (whether the partner and dead person were of the same sex or different sexes), child or step-child, brother or step-brother, sister or step-sister, parent or step-parent or guardian, or grandparent.

The proposal would include reference to ‘the person with lawful responsibility for the tissue’. The person with ‘lawful responsibility for the tissue’ would be the Chief Executive, or equivalent, of the particular institution (District Health Board (DHB), funeral home, school of anatomy etc), with the ability for this responsibility to be delegated as appropriate. The new legislation would set out definition and the role of the “person with lawful responsibility for the body”.

Prior to the removal, use, retention and return/disposal of tissue from a deceased child (under the age of 16 years), consent would be required from a person with guardianship of the deceased child having made reasonable attempts to consult with all other guardians of the child, consistent with the Care of Children Act 2004. When a child dies and there is no guardian then someone who is ‘immediate family’ may give consent to the removal, retention, use and disposal/return of the child’s body, organ/s or tissue.

The proposed definitions are comprehensive and would ensure that all uses of tissue are captured under the proposed framework. They provide the health and research sector with greater clarity around the scope of the legislation and their role and responsibilities in terms of human tissue. The definition of family would recognise the complexity of modern families. The definition of tissue would promote public confidence by ensuring comprehensive coverage of the uses of tissue. The proposals also promote public confidence in those that manage human tissue by providing greater clarity around their roles and responsibilities.

Option Two: Consent of the deceased to be the primary consent
Under this option, the deceased’s formally recorded consent would be the primary consent or a person nominated by the deceased to give consent on their behalf (could be an executor of the will). In practice the family would be consulted but legally they could not override the wishes of the deceased. However, if the immediate family believed their wishes should take precedence over the known views of the deceased and it appeared that to proceed with the donation would cause extreme distress, then it is expected that the person with lawful responsibility for the body would not proceed with removal of the organs and tissues. This is consistent with current practice.

Where the wishes of the deceased are unknown the decision to donate or not would fall to the immediate family. If the immediate family is divided on whether to proceed, then it is expected that the person with lawful responsibility for the body would not proceed with removal of the organs and tissues. This is consistent with current practice. The ‘person with lawful responsibility for the tissue’ must have taken “reasonable steps” or “made reasonable efforts” (or words to this effect) to determine whether consent had been given prior to removing tissue.

This option would require the establishment of a national consent register, on which a ‘yes’ or ‘no’ to donation would be entered. A ‘yes’ on the consent register would allow donation to proceed. Similarly a ‘no’ to donation would not allow donation to proceed. Any consent register would need to be run by the health system, as LTNZ does not have the expertise or resources to be able to ensure that consent to donation is properly formed. If the preferred option is to establish a donor consent register, the NHI/MWS systems should be used to record donor consent.

The Human Tissue Act 1964 would be repealed and replaced with new legislation.

Costs and Benefits to Government
Clarifying the consent framework for human tissue in relation to the collection, use, retention and disposal of tissue taken from deceased people will enhance public confidence in the health system. This option is consistent with a health consumer’s right to informed consent as expressed in the Code of Health and Disability Services Consumers’ Rights (the Code), which would enhance the public and clinicians’ understanding of the system.

There are practical difficulties in recording the deceased’s consent and in ensuring that consent was informed. This would require a dedicated register and an on-going public education campaign for the entire population to work effectively.

[Paragraphs outlining the financial implications of establishing a consent register have been removed on the grounds that they are the subject of Budget 2006 discussions.]

There is no evidence from international literature that this type of register improves the rate of donation. As the Land Transport New Zealand register’s 2.9 million recorded wishes cannot be taken as informed consent and a consent register would have to start from zero. There is a risk that donor rates may drop in the short term as numbers on the register are likely to be low initially and families may assume that the absence of an entry on the register means that their family member did not wish to donate. It is difficult to justify the cost of a consent register that targets all New Zealanders given the small number of potential donors (only around 100 potential deceased donors each year). There is, therefore, limited potential for a register to increase donation rates.

Costs and Benefits to Research/Health sector
This option would provide the sector with greater clarity around who can give consent and when organs/tissue can be used. There may be administrative costs, in terms of costs associated with aligning organisational policies with the consent requirements under the new legislation. There are also likely to be costs in printing new consent forms and there may be additional costs in the record keeping and staff training requirements.

Costs and Benefits to Society
This option would promote the cultural and spiritual needs of New Zealanders and the public good associated with the use of human tissue for therapeutic and non-therapeutic purposes. For example, a new definition of family recognises the complexity of contemporary families, Mäori whänau, hapu and iwi relationships, and the relationships within other cultures such as Pacific peoples. The proposals would also provide clarity in regard to who can give consent (the role of the family) and how consent must be recorded.

Option Three: Deceased’s wishes important consideration
Under this option, discussion about donation with the family must give important consideration to the deceased’s wishes, where known. However, the decision to donate would stay with the immediate family. The Human Tissue Act 1964 would be repealed and replaced with new legislation. In the rare situation where the family has a fundamental opposition to following the known wishes of the deceased, the wishes of the family would prevail.

This option involves improvements to the Land Transport Safety NZ indicative register, that is, the addition of an ‘undecided’ option and more information provided on organ donation and the Land Transport New Zealand database. The information on organ donation sent out with driver licensing forms should be reviewed and updated, with a view both to increasing donation professionals’ confidence in the decisions recorded on the register, and to stimulating family discussions on organ donation and more information on organ donation and the Land Transport New Zealand register should be available through PHOs and other appropriate organisations.

Costs and Benefits to Government
Clarifying the consent framework for human tissue in relation to the collection, use, retention and disposal of tissue taken from deceased people will enhance public confidence in the health system.

This option requires modifications to the current Land Transport New Zealand register to ;work effectively. The proposed modifications to the Land Transport New Zealand register are estimated to cost in the range of $90,000 to $190,000 (GST exclusive) with further costs for promoting organ donation. Under this option there would also be additional costs, estimated at $300,000 (GST exclusive) per annum for producing promotional material on organ donation and distributing it via other agencies, such as PHOs, retail pharmacies, and DHBs. These costs cannot be met within existing Vote Health baselines without reprioritising existing outputs.

There is an existing association between driver licensing and organ donation in New Zealand. The driver licensing process provides means of finding out the donor wishes of a very large percentage (89.5 percent) of the adult population at least once every ten years. It is not possible, however, to include non-drivers (10.5 percent of the adult population) on the register and Land Transport New Zealand has no authority or funding to collect information on anyone who does not have a licence. While licence holders can change their entry on the register at any time, at no cost to the licence holder, by contacting Land Transport New Zealand, there is no practical means of assuring that a wish that can be up to ten years old is still accurate.

Costs and Benefits to Research/Health sector
This option will provide the sector with greater clarity around who can give consent and when organs/tissue can be used. It is also more consistent with current practice.

Costs and Benefits to Society
This option would promote the cultural and spiritual needs of New Zealanders and the public good associated with the use of human tissue for therapeutic and non-therapeutic purposes. For example, a new definition of family recognises the complexity of contemporary families, Mäori whänau, hapu and iwi relationships, and the relationships within other cultures such as Pacific peoples. The proposals would also provide clarity in regard to who can give consent (the role of the family) and how consent must be recorded.

This option balances the expectation that a deceased individual’s stated wishes would be taken into account with the reality that the family would be present and will expect to be involved in the donation process (having been involved in decision-making about the now-deceased up to this point). It also recognises that a family overriding the known wishes of the deceased is a rare event and that there are different cultural perspectives in New Zealand on the role of the family in making such decisions.

This option does not meet many New Zealanders’ expectations regarding individual autonomy and the right for their wishes about donation to be respected after death.

What will require consent & requirements for recording consent

Status Quo
The Human Tissue Act 1964 focuses largely on the activities of schools of anatomy and what they are permitted to do. The person lawfully in charge of the body may authorise the body of a deceased person to be used for anatomical examination if a lack of objection can be established and if there is no reason to believe that the surviving spouse or any surviving relative of the deceased person objected. Consent is either given in writing or orally in the presence of at least two witnesses. Similarly, the person lawfully in charge of the body must establish a lack of objection before removing tissue for therapeutic purposes or for the purpose of education or research. Consent is either given in writing or orally in the presence of at least two witnesses and if there is no reason to believe that the surviving spouse or any surviving relative of the deceased person objected. The Act also states that where a record is held on a health computer system, the person lawfully in charge of the body may rely on that record, unless the person has reason to believe that the request was subsequently withdrawn. Currently, hospitals and schools of anatomy formally record consent to tissue donation and maintain a record of this. The Ministry of Health does not currently record information about tissue donation. Indicative wishes in relation to organ donation (rather than consent) are recorded on the Land Transport NZ register. Some ICU specialists refer to this in their discussion with families about donation, while others do not because of concerns about the validity and currency of the data. Schools of anatomy require consent from both the deceased and the family and this is generally in writing.

Preferred option
The removal, retention and use of any human tissue from a deceased person would require informed consent. Consent would need to include information on: retrieval/collection; all proposed uses (including education, research, commercial use, export); retention; and return/disposal. The consent framework would be consistent across all uses of tissue, including therapeutic uses (transplantation) and non-therapeutic uses (e.g. education and research). It is proposed that the legislation recognise some limited circumstances where the public good associated with the use of tissue outweighs the requirement for consent. These circumstances are research that has received the approval of an ethics committee or for professionally recognised quality assurance programmes, external audit or evaluation activities aimed at improving the quality of services. This would be in line with the exceptions to consent in the Code of Health and Disability Services Consumers’ Rights. The consent framework established in legislation would not cover the retrieval, use, retention or disposal of tissue where this covered by the Coroners Act 1988 or where it is undertaken for criminal justice purposes, including for the purposes of crime prevention, or criminal investigation or prosecution.

Anatomical examination and public display would require formally recorded consent from both the individual and their immediate family, that is, consent must be given in writing or orally in the presence of two witnesses. Organs and body parts would require formally recorded consent from the individual or their family, that is, consent must be given in writing or orally in the presence of two witnesses. Samples taken for microscopic or similar analysis would require consent but this would not need to be formally recorded.

Costs and Benefits to Government
Clarifying the consent framework for human tissue in relation to what requires consent and how the consent is to be recorded will enhance public confidence in the health system by making the requirements explicit and transparent in legislation. For example, greater clarity around the requirements for recording consent would reduce the likelihood of a Greenlane Heart Library (retention of children’s hearts without consent) occurring again.

Costs and Benefits to Health/Research sector
This option would provide the sector with greater clarity around what requires consent and how that consent should be recorded. As identified in the BCCS, this might result in increased administrative costs if consent forms have to be changed.

Costs and Benefits to Society
This option would make the requirements for what requires consent explicit and transparent.

2. The Therapeutic Use of Tissue

Option 1: Status quo
Currently the safety of whole organs for transplantation are set out in the Guidelines for Organ and Tissue Donation. These Guidelines have no legal status. The Guidelines cover the criteria used to identify a potential donor and the criteria that exclude a potential donor (for example, fungal or viral infections or HIV).

Tissue banking providers currently operate under voluntary codes of practice and standards. Most agencies in New Zealand, from national organisations to local hospitals, appear to have adapted or followed the American Association of Tissue Banks (AATB) standard.

Maintaining the status quo does not meet the policy objectives for the management of tissue-based therapies.

Option 2: Regulating under the Health Act 1956
Creating an entity structure under the Health Act 1956, which would lead to tissue being regulated in parallel to the current system for blood and blood products under the New Zealand Blood Service. This option would give particular entities the authority to collect controlled human substances (such as corneas or skin) and prohibit trade in controlled human substances. The Minister would appoint an entity, for example, to be responsible for tissue banking, and would specify the functions of that entity.

This approach would require the development of standards or guidelines that tissue entities would be required to meet. While feasible, this option would not be consistent with the regulation of other therapeutic products and would not increase international harmonisation. This option does not meet all of the policy objectives.

Option 3: Regulating under the Health and Disability Services (Safety) Act 2001
Developing standards for tissue-based therapies under the Health and Disability Services (Safety) Act 2001, which would lead to providers and manufacturers of such therapies being audited for compliances with standards approved by the Minister of Health. Tissue banks, hospitals and other services undertaking these activities would then be independently audited against standards approved under the Safety Act, and pending the outcome of the audit, certified to provide tissue-based therapeutic services.

The providers currently covered by the Safety Act are hospitals and rest homes. The focus is largely on the service provided. The main focus of tissue-based therapies is on the safety of the product. While feasible, this option would not be consistent with the regulation of other therapeutic products and would not increase international harmonisation. This option does not meet all of the policy objectives.

Option 4: Regulating tissue-based therapies under the Australia-New Zealand joint regulatory scheme (Preferred Option)
Under this option, therapeutic uses of human tissue would be regulated under the Joint Therapeutic Products Agency. Regulation of other therapeutic products, such as medicines, medical devices, complementary and alternative medicines and some aspects of blood are to be regulated under the Joint Agency. The joint regulatory scheme would operate on a full cost-recovery basis. Under the proposed scheme New Zealand will have an equal say at the Ministerial level on the Ministerial Council, which oversees the scheme and appoints members to the expert advisory committees. New Zealand officials will ensure that there are appropriate New Zealand experts on any expert advisory committees established by the Joint Agency, including interim committees. In addition, the risks of change will be addressed via the change management process for moving to the Joint Agency environment, and the process to establish and apply the rules that the Agency will operate under.

Tissue-based therapies would be regulated under a risk-based system where the level of regulatory control of a therapeutic product is based on the relative safety of the product and the seriousness of the condition for which it would be used. The auditing and licensing of tissue banking services and high-risk tissue-based therapies are essential public health activities that will ensure safety requirements are met.

All tissue-based therapeutic products, including whole organs and cell-based therapies, would be regulated under the joint regulatory scheme. Such products would be subject to compliance with minimum national standards relating to good tissue practice. Tissue-based therapeutic products would be classified according to risk, with the level of regulation commensurate with the risk posed. Three classes of therapeutic products would be established (Class 1 being the lowest risk and Class 3 being the highest risk) see Appendix 1. Implementation of this option would be over a three to five year time period.

Costs and Benefits to Government
New Zealand will have robust and modern regulation of therapeutic uses of tissue to ensure therapies are as safe as possible. The auditing and licensing of tissue banking services and high-risk tissue-based therapies are essential public health activities that will ensure safety requirements are met. There would be consistency with the regulation of other therapeutic products (such as medicines, medical devices and blood). Efficiency gains would be achieved from developing a joint framework with Australia rather than New Zealand having to cover all the areas of expertise and knowledge. As fees would be approved by the Ministerial Council under the Joint Agency, not by independent contracted auditors under the Health and Disability Services (Safety) Act, this allows greater control over the cost of monitoring and compliance,

Costs and Benefits to Tissue-based therapeutic product sector
The preferred approach to regulation of the therapeutic sector would provide greater certainty to providers around the level of assurance and monitoring expected by government and the public. Consistent standard definitions and quality management across the sector would assist in the transfer of tissues between banks.

Formally regulating tissue-based therapies would create new costs for providers. Costs would be incurred regardless of who the regulator is. It is expected that the major providers of tissue for therapeutic uses (the National Eye Bank and New Zealand Blood Service) who already meet international quality standards, would face few costs in bringing their services up to the standard required under the joint regulatory scheme. The cost to DHBs who have small collections of tissue (mainly bone banks) of meeting the required standard may be higher. The costs would reflect the size of the organisation and the level of risk ascribed to the functions being undertaken. However, until the code of Good Manufacturing Practice (cGMP) and any other relevant standards are finalised it is not possible to accurately estimate the costs to the sector of meeting the required standards.

There will also be costs associated with an application for a licence and audit for providers of all banked tissue e.g. blood, skin, corneas and providers of high risk tissue-based therapies such as tissue combined with non-tissue, and cell-based gene therapy. The Ministry of Health is not aware of any therapeutic tissue-based activities that would fall into class 3 activities currently being undertaken in New Zealand. Based on initial advice from Medsafe’s auditors the Ministry of Health estimates the total annual audit and licensing costs for current tissue related activities under the Joint Agency and joint regulatory scheme to be less than $0.3 million per annum (GST exclusive). This is based on 13 providers currently banking tissue (including the New Zealand Blood Service, New Zealand Eye Bank, and 11 District Health Boards. The estimated audit and licensing costs for blood and tissue under the trans-Tasman Joint Agency and joint regulatory scheme are indicative only and will become clearer once work has been completed on the cost recovery model under the Joint Agency and joint regulatory scheme.

The preferred option is for the costs of regulatory compliance to be absorbed by DHBs as part the cost of carrying out their normal business. However, the estimated audit and licensing costs for blood and tissue under the trans-Tasman Joint Agency and joint regulatory scheme are indicative only and consideration will need to be given to how the costs will be met by DHBs and small agencies if the actual costs are materially higher than estimated. The ability for the New Zealand Blood Service and the National Eye Bank to pass on the costs of meeting the audit and licensing requirements to DHBs and private providers needs further investigation to ensure consistency with current regulation around charging for blood (which allow for costs arising from collection and processing to be passed on but not on the raw and ingredient of blood).

The financial risks associated with the transition to formal regulation will be addressed via the change management process for moving to the Joint Agency environment and the process to establish and apply the rules that the Joint Agency will operate under.

Costs and Benefits to Society
The preferred option would provide greater public confidence in the management and safety of tissue-based products.

3. Non-therapeutic tissue use of tissue and blood

Development of a standard:

Status Quo
While organisations may have their own internal policies surrounding oversight and management of non-therapeutic tissue use, there is no legislation or national policy to give guidance. Maintaining the status quo would not meet the public policy objectives.

Preferred Option: Requirement for a standard in legislation
Under this option the new Human Tissue legislation would require a standard for the non-therapeutic use of tissue to be approved by the Minister of Health. This would be provided for via a regulation making power in the legislation. In addition, the standard would include requirements for ethical approval of research using human tissue. While it is common practice to seek ethical approval for research using human tissue, there is no legislation that requires this. The standard would be a minimum standard covering the collection, use, retention, and disposal/return of all human tissue for non-therapeutic purposes. The Director-General of Health would be given the power to enforce the standard.

Additional provisions for Schools of Anatomy:

Status Quo
Under the Human Tissue Act 1964, the Minister of Health authorises the establishment of schools of anatomy. That authority may be revoked at any time. In addition, the Minister may from time to time appoint one or more members of the Police as an Inspector of any school of anatomy and they must make a quarterly return to the Minister of all bodies which have been removed for anatomical examination, including the name and age of the person. The Minister also issues licences to practise anatomy to any medical practitioner employed to teach in a school of anatomy.

Preferred option (covered by the new Human Tissue legislation)
Schools of anatomy would be covered by the proposed non-therapeutic tissue and blood standard. In addition, it would

Retain authorisation of schools of anatomy by the Minister of Health.
Remove the requirement for licensed anatomists.
Include a smaller inspection role for a person authorised by the Director-General of Health to carry out this role, who may be a member of the Police or another person deemed appropriate by the Director-General of Health. This person would report any irregularities to the Minister of Health rather than mandatory reporting of all bodies removed for anatomical examination as currently happens.
Prohibit anatomical tissue from being held on premises that are not authorised schools of anatomy unless the tissue has come from an authorised school of anatomy and has been authorised in writing by the ‘person with lawful responsibility for the tissue’ in that school of anatomy.

Import and Export of tissue
Status Quo
The import and export of human tissue is largely unregulated in New Zealand. This does not meet the public policy objectives of promoting public confidence in the management of tissue and promoting the cultural and spiritual needs of New Zealanders.

Preferred option
The import and export of tissue would continue to be permitted for quality assurance, peer review, diagnostic, and transplantation purposes where adequate safety levels could be assured. However, more comprehensive oversight of the import and export of human tissue is proposed. Requirements in relation to the import and export of human tissue would be implemented using a code of practice but the new Human Tissue legislation would include a regulation making power that enables the prescribing of standards/requirements on the import and export of human tissue, if this is considered necessary. The Ministry of Health would enforce this on an exceptions basis.

Sale and Purchase of Human Tissue
Status Quo
Current New Zealand law prohibits the sale and purchase of some human tissue:

The Health Act 1956 prohibits trade in blood and blood products and requires the New Zealand Blood Service to recognise the gift status of blood, although it does allow the Minister of Health to authorise the sale and purchase under special circumstances.
The Human Assisted Reproductive Technology Act 2004 prohibits the sale and purchase of gametes and embryos, although allows some cost recovery for those involved in surrogacy arrangements.
Other tissue, such as organs for transplantation, cannot be sold or purchased as a matter of common law.

Preferred Option
The sale and purchase of tissue (includes blood) from both living and deceased people would be prohibited but with provision for exemptions where desirable (ie. it is in the public interest to allow the sale or purchase of tissue).

It is anticipated that the exemptions provision would be used to authorise entities such as the NZBS, DHBs, and private hospitals to purchase tissue, if necessary, for the purposes of audit, diagnosis or treatment or to receive payment to cover expenses incurred in the collection, transport or processing of tissue. Researchers may also seek authorisation to purchase tissue from entities or imported cell lines for research purposes under this provision. The Government’s current policy of allowing welfare assistance for living donors would not be affected by this provision. These proposals are consistent with current practice.

Controlled Activities
Status quo
The Human Tissue Act 1964 is narrow in scope and does not provide a mechanism for managing the ethical, safety, and cultural issues arising from new and challenging uses of tissue (e.g. xenotransplantation, imported embryonic stem cell lines).

Preferred Option
Create a provision for a category of ‘controlled activities’ to enable the control of activities (eg., xenotransplantation) which raise cultural, safety and ethical risks (based on similar provisions in the Medicines Act 1981 relating to Specified Biotechnical Procedures).

Costs and Benefits of the preferred options for non-therapeutic use of tissue
Government
Costs would be met within existing Vote:Health baseline funding for the development of a standard for the non-therapeutic use of tissue (estimated at $80,000 (GST exclusive)) and the development of a code of practice on the import and export of tissue (costs unknown). The proposals for non-therapeutic use of tissues would promote public confidence in the oversight and management of the non-therapeutic use of tissue. There would be a cost to the Ministry of Health in enforcing a standard.

Health/Research sector
A minimum standard will provide guidance and clarity on the management of tissue for non-therapeutic purposes. The research institutions, universities and DHBs consulted indicated that a high level standard would be consistent with current practice and that the majority of costs are likely to be administrative. The business compliance costs are detailed in the Business Compliance Cost Statement. Feedback indicated that standards/guidelines on the management of tissue, export/import of tissue, and sale and purchase of tissue will increase professional confidence by providing clarity and consistency and allow for monitoring and transparency of the processes around tissue use.

Costs and Benefits to Society
The preferred option for regulation of non-therapeutic uses of tissue will provide donors and/or their families with greater confidence in those under taking research, non-coronial post-mortems and education on human tissue and in the safety of therapeutic uses of tissue. It will meet the expectations of New Zealanders that tissue-related matters are well managed.

Statement of consultation undertaken
In March 2004, the Ministry published a Discussion Document on the Human Tissue Review. This Discussion Document formed the basis of public consultation, including a series of public meetings and hui, which was undertaken in May - August 2004. In many cases, the Ministry was pro-active in contacting interested parties and informing them that late submissions would be accepted. All late submissions were included for the purposes of the Ministry’s submissions analysis. The Ministry received 125 submissions from a range of health professionals, researchers, organ donation advocacy groups, health sector organisations, consumer groups, Maori organisations, religious groups, and interested individuals.

In late September 2004, a Summary of Submissions document was publicly released, with copies posted to submitters, the Health Select Committee, members of the media, and other interested parties.

The key themes that emerged from the public consultation process are:

Respect for tissue and tissue donors through appropriate practices and procedures around the collection, use, retention and disposal of tissue and preserving the gift status of tissue.
Informed consent and individual autonomy were central themes. There was a range of views expressed during consultation about who could give consent to organ/tissue donation (the family or an individual prior to their death). This was the most contentious issue during the public consultation process. New Zealand’s organ donor rate was also a key concern raised throughout the Human Tissue Review.
The need for respect for families/whanau and cultural differences came through in many submissions, particularly from Maori and Pacific peoples. From a clinical perspective, the need to care for grieving families at the time of organ donation was highlighted.
Value of tissue for treatment, research, and education – many submissions highlighted the valuable uses of tissue, and caution was expressed about putting requirements in place that prevented public benefit being accrued from the use of tissue. However, the importance of robust oversight mechanisms was also highlighted.
The importance of public confidence in the systems and people that manage tissue was highlighted.
A consistent approach across the different types and uses of tissue was highlighted as being desirable because of: the similarity in processes needed eg. for seeking consent; similar ethical considerations eg. protection of human participants; desire to have streamlined systems that are easily understood; and similarity in safety considerations across different types of tissue for therapeutic purposes.

These concerns have been addressed through the proposals for a new regulatory framework for human tissue and tissue-based therapies, including options for a clear consent framework that is consistent across the therapeutic and non-therapeutic uses of tissue, that clarifies the role of the family in relation to tissue donation, and that acknowledges the valuable uses of tissue in treatment, research, and education, with safeguards. The proposals also include provisions to ensure the safety of tissue-based therapeutic products and to regulate the non-therapeutic use of tissue.

Government departments/agencies consulted

The following government agencies were consulted on this proposal: the Treasury; Department of the Prime Minister and Cabinet; Ministry of Justice, Te Puni Kokiri; New Zealand Police; Ministry of Transport, Ministry of Pacific Island Affairs, Ministry of Economic Development; Ministry of Research, Science and Technology; Land Transport New Zealand; Ministry of Culture and Heritage; Office of Disability Issues, Ministry of Women’s Affairs; Ministry of Consumer Affairs, New Zealand Defence Force, Office of the Health and Disability Commissioner, Office of the Privacy Commissioner; Office of Disability Issues, Ministry of Social Development. The major concerns raised were:

The Ministry of Transport supports the status quo (no change to current system of recording organ donor wishes on the LTNZ driver licence database) because option two and option three require significant and costly changes to Land Transport NZ’s IT systems and operational processes for no direct benefit to licence holders, or improvements to licensing processes. The status quo is not the preferred option for who can give consent because it does not meet the key objectives of a consent framework.

The Health and Disability Commissioner supports option 2 (wishes of the deceased to be primary consent and national consent register) because it is consistent with the principle of informed consent. The Ministry of Justice supports a framework that gives primary recognition to the deceased’s consent to organ/tissue donation but doubts whether a new stand-alone register is cost effective if the new Act, and practice continues to rely heavily on the input of other family members. The concerns are dealt with by not putting forward a preferred option.

Treasury supports option 3 (wishes of the deceased an imported consideration, family decides) because it is the least costly option and it is anticipated that relatively small gains would be achieved under the more costly alternative. The concerns are dealt with by not putting forward a preferred option.

Business Compliance Cost Statement

The main compliance costs of research institutions (Crown Research Institutes, universities, and private research institutes) are likely to be the administrative costs of meeting the requirements in new legislation. Some institutions may need to improve their record keeping systems in order to meet the requirements for formally recorded consent. They may also need to undertake some staff training around the new requirements, particularly in the standard for the non-therapeutic use of tissue. The extent of the costs cannot be quantified at this stage, as they will depend on the exact requirements for the proposed standard, which has yet to be developed. It will also depend on how aligned the affected parties’ current practice is with the proposed standards. There are 9 Crown Research Institutes, 5-6 universities, and 2-3 private research institutes who are likely to use human tissue for research purposes.

The main compliance costs of funeral homes are likely to be the administrative costs of meeting the requirements for formally recorded consent in new legislation. Funeral homes may need to improve their record keeping systems in order to meet the requirements for formally recorded consent. They may also need to undertake some staff training around the new requirements. There are 180 funeral homes in New Zealand.

The Ministry of Health will provide guidance on the implementation and interpretation of the legislation, and in particular, guidance on what is expected in terms of the information to be provided about organ/tissue donation before consent can be recognised as informed consent. This may include providing model examples of consent forms.

Appendix 1 - Classes of therapeutic products

[Note in the period since Cabinet considered this Regulatory Impact Statement there has been ongoing development of the following risk framework]

The level of regulation will be classified and commensurate with the risks posed by the therapies to the individual and the community as follows:

Class 1 products require compliance with relevant standards of good tissue practice. Such standards may be specific to the type of HCT/P in question and will be developed in consultation with stakeholders.

Class 2 products require compliance with the relevant cGMP (that includes standards for good tissue practice) and licensing of the manufacturer by the Joint Agency (as is currently required for tissue banking).

Class 3 products will generally require compliance with the relevant cGMP (that includes standards for good tissue practice), licensing of the manufacturer by the Joint Agency and submission of documentation to the Joint Agency for full assessment of quality, safety and efficacy. Products will be licensed and entered on a register of therapeutic products. This is considered to be commensurate with the increased risk that heightened manipulation entails. However, the other features of the manufacture may actually decrease risk, and this will be taken into account when aligning the level of regulation to the classification of products.

Exemptions
There will be no regulation of HCT/Ps that are removed and reimplanted in the same patient in a single surgical procedure. In addition, the legislation will include exemptions from the requirements for Class 3 HCT/Ps to be licensed and entered on a register of

Related information:

Human Tissue Review Cabinet Papers

Regulatory Impact Statements page