Human Tissue Bill
Submission to the Health Select Committee on the Human Tissue Bill - March 2007
The Human Tissue Bill is an important piece of legislation updating old law developed in the 1960s. Considerable work has been done over a number of years to develop a robust framework to govern the use of human tissue on “non-therapeutic” situations - usually diagnostic and research situations. NZORD has taken a close interest in the development of this legislation because of our close interest in protecting the rights and interests of patients and support groups, and an equally strong interest in ensuring there is progress in disease identification and development of therapies and cures. Here is the text of our submission to the Health Select Committee:
NZORD has as one of its prime functions the gathering of information and issues from the 130+ rare disorder support groups in our network, and from our links with over 70 other support groups for common disorders, and presenting these to a range of agencies, policy makers and Parliament.
NZORD does not claim to fully represent these wider networks with this submission. We operate a network rather than a membership organisation. However we believe the submission is consistent with the comments and expressed wishes we have frequently encountered in our detailed discussions on a wide range of health and disability policy issues with many groups over the past 7 years. We believe it is a fair reflection of issues of high interest to many support groups.
Detail of our submission
Overall support for the Bill. We believe the Bill is a good step forward in regulating the collection and use of human tissue in New Zealand. Patients, their families, and support groups have two major interests in respect of the matters covered by the Bill:
- That there is a clear and safe process for the collection and use of tissue, with informed consent and autonomous decision-making underpinning the process, plus ethical controls, to ensure the protection of individual interests and the public interest.
- That the regulation necessary to ensure protection is also balanced against the need for systems to facilitate and enable research into human development and disease. The regulation that is needed must not act to unreasonably restrict research that may offer improvements in the health and quality of life of patients and their families.
We are pleased to note that the Bill provides a good framework for addressing these issues. With just a small number of qualifications about detail of the Bill, mentioned below, we offer our overall support for the Bill.
A hierarchy of concerns needs a corresponding hierarchy of controls. We note the different levels of consent and controls required for the use of bodies for public display or anatomical examination in medical training. In our experience this is consistent with the public interest as well as the way in which such matters are viewed by individual patients and their families. Likewise, we believe that whole organs such as the brain and the heart have significant emotional attachments that require a high level of attention to consent requirements and ethical control for all subsequent uses.
However in our experience there is considerably less concern about some tissue such as skin tissue, pathology material, and for example, lumps/tumours removed in surgery. In particular, we do not think that cell lines derived from human tissue hold such importance that they should require ongoing ethical approval for all use, and a prohibition on trading in them. Nor do we consider pathological samples of such importance that they too should be required to undergo ethical approval for all uses and have a ban on trade in them.
We do support the consent requirements for the collection and use of such materials, which would include consent required for the generation of cell lines or the production of pathology slides, from such tissue. We also support the exemptions outlined in section 27 of the Bill. But we think some of the provisions of Section 54 to 62 of the Bill go too far in restricting trade in human tissue, and Section76 goes too far in requiring ethical approval of all research using human tissue. We have three examples which illustrate the problem:
Pathology samples on slides. We note that there are well established systems for the commercial generation of pathology samples on slides and these are widely used in laboratories for comparisons in teaching, diagnosis and research. In a practical sense they are similar to a consumable item or reference material, even though they are still in fact a sample of tissue. Without the availability of such slides through commercial sources, all of these important areas of activity might be compromised. From a patient/family perspective we believe that once consent has been given for tissue to be used for this purpose there is no valid reason for putting a ban on the trade in items that are essential for laboratories and researchers to use, and which may not be available in adequate quantity or quality unless there is a commercial incentive to make such material available.
We think it is also overdoing things to a considerable degree to have a requirement for ethics approval for all use of these materials. That is the effect of the provisions of Section 76 of the Bill. They are used so frequently that ongoing ethical requirements would be an imposition that would be counterproductive to patient and public interests in the efficient operation of research, diagnostic and teaching settings.
Cell lines. It is important that consent is given for use of human tissue, and this may include the generation of cell lines from the tissue.
However cell lines, once generated from human tissue, have a significantly reduced emotional connection and relevance to patients and their families. True there is DNA retained in them, but they do not contain all of the other connective elements that would make them “whole” tissue and thus worthy of special consideration preventing trade and requiring in the future that there must be ethical approval for all research use, as required by Section 76. Cell lines have been used very much as a consumable item in laboratories for many generations. The availability of these important items occurs also because they are produced and traded commercially. Restriction of their availability by prohibiting trade is not in the wider interests of patients and their families, nor in the public interest.
Tissue banks cost recovery. We suggest that there needs to be an alteration to the provision on trade prohibitions to make it clear that tissue banks can operate cost recovery systems when distributing tissue to researchers here in New Zealand or overseas, and that likewise other researchers can pay to obtain necessary samples for their research projects. Without such a provision there will be difficulties for a wide range of researchers in getting the samples they need, and difficulties for tissue banks if they cannot recover costs of storage, preparation and distribution. Of course one alternative solution may be for government to ensure that all tissue banks are fully funded in their operations so charges become unnecessary. In the absence of such a provision, the only practical solution seems to be allowing cost recovery.
The patient and family interest in this issue, as well as the public interest, is covered by consent to the banking and distribution of tissue for research, and so enabling research into causes and possible treatments of disease. Amending the Bill as we suggest will ensure there are no unintended harmful consequences to the operation of tissue banks and the research work that relies on them, all of which are important parts of the effort to improve human health and well-being.
Section 58 exemption to trade prohibition. We do not consider this exemption to be sufficient protection against the problems we discussed in paragraph 6 in relation to pathology slides, cell lines and tissue banks. We believe there should be exemptions written into the Bill to ensure that the prohibition is specific to certain products, but does not creep down to every conceivable bit of human tissue and its derivatives.