The Council is required, under section 196W, to review all the information that was available to the Repatriation Medical Authority when it determined those Statements of Principles in respect of malignant neoplasm of the prostate. Its review is of "the contents" of those Statements of Principles. The Council takes the view that this is not to be construed narrowly (ie, being confined only to those matters actually contained within the Statements of Principles), but the Council's consideration must also include those matters, if any, that are suggested (either by the information itself or by a submission to the Council) that the Repatriation Medical Authority should have included in the Statements of Principles but did not include. Otherwise, if it were suggested (as it is by the organisations making the request in the current review) that the Repatriation Medical Authority wrongly failed to include a factor in a Statement of Principles, then the Council would not be able to consider the matter.

The Council takes the view that such a narrow interpretation of the Act could not have been intended, and that the entire contents of the Statements of Principles are open for consideration as to what should or should not have been included in them. The process that the Act requires the Council to engage in - in publicly seeking submissions from any interested persons or organisations, and relevant experts in relation to the information available to the Repatriation Medical Authority about that kind of injury, disease or death - indicates that the Council is required to review all the information that was available to the Repatriation Medical Authority with a view to considering all aspects of "the contents" of the Statements of Principles, not merely an aspect of the Statements of Principles that might be raised by the applicants.

While the subject of the review is the contents of the Statements of Principles, subsection 196W(2) makes it clear that the Council must, for that purpose, carry out a review of all the information that was available to the Repatriation Medical Authority when it determined the Statements of Principles.

Section 196K indicates what is meant by the phrase, "the information that was available", by stating that the Repatriation Medical Authority must send to the Council "a copy of all the information that was available to it" when it determined the Statements of Principles. Clearly, the word, "available", in this context, can only mean the information that was actually before the Repatriation Medical Authority at the relevant time rather than all the possible information that the Repatriation Medical Authority might have been able to obtain. To give the phrase the latter meaning would be to impose on the Repatriation Medical Authority a burden under the Act that would be impossible to meet.

Subsection 196C(3) provides further support for this view. That subsection indicates the extent of the information that was available to the Authority by providing that the Authority may rely only on sound medical-scientific evidence that has been submitted to it or that it has obtained on its own initiative or from the Secretary or from a consultant. It then provides that the Authority must consider and evaluate all the evidence "so made available to it". Thus this provision states how the information is made available to the Authority and, in so doing, defines the extent of the "available" information.

The scheme of the legislation, in broad terms, is that the Council reviews the information on which the Repatriation Medical Authority made the Statements of Principles to determine whether or not the contents of those Statements of Principles reflect the sound medical-scientific evidence contained in that information. But, if there is further information that was not before the Repatriation Medical Authority when it determined the Statements of Principles, then that information may be submitted to the Authority to reconsider the Statements of Principles rather than have that information reviewed by the Council.

The explanatory memorandum, incorporated into Hansard on 28 June 1994 (Senate, Debates, vol.S165, p.2177), confirms this interpretation. It states:

Nevertheless, in the context of its review of the information that was available to the Repatriation Medical Authority, the Council takes the view that it is bound to take into account other material that explains, analyses or comments upon the information that was before the Authority. The provisions relating to payment of medical and travelling expenses incurred in respect of applicants obtaining "relevant documentary medical evidence" (sections 196ZN to 196ZP) relate to the obtaining of medical reports and submissions from relevant medical-scientific experts that explain, analyse or comment upon the information that was available to the Repatriation Medical Authority.

It is perhaps useful to make the comment at this point that the Council would find it particularly helpful if submissions, both oral and in writing, were to address the information that was available to the Repatriation Medical Authority by reference to the definition of sound medical-scientific evidence in section 5AB. This should include an analysis of that information by reference to the epidemiological and other criteria referred to in that definition. Sections 196ZN to 196ZP appear to be included in the Act for the purpose of assisting persons to obtain such an analysis from appropriately qualified experts.

Reference was made in some submissions to the fact that, prior to the Repatriation Medical Authority determining Statements of Principles Nos.95 and 96 of 1995, the Repatriation Commission had accepted that a certain amount of smoking would be acceptable as providing a basis for a reasonable hypothesis in cases concerning malignant neoplasm of the prostate. Reference was made to Statements of Principle developed by the Repatriation Commission for the guidance of its delegates prior to the introduction of the current legislation under which the Repatriation Medical Authority and Specialist Medical Review Council operates. Those Repatriation Commission Statements of Principles had no legal standing.

Those Repatriation Commission guidelines have no relevance in this review. One reason for this is that the law has changed. Those guidelines were not required to be determined on the basis of sound medical-scientific evidence. The Act now provides that the Council can only make decisions on the basis of sound medical-scientific evidence.

The phrase, "sound medical-scientific evidence", is defined in section 5AB of the Act, as follows:

It is important to recognise that sound medical-scientific evidence is defined in terms of being "information". Information is essentially knowledge that is communicated or received concerning some fact or circumstance. In the case of sound medical scientific evidence, it is knowledge concerning a particular kind of injury, disease or death that meets the requirements of subparagraph (i) or (ii) of paragraph 5AB(2)(a) and, in the case of information about how that kind of injury, disease or death may be caused, it must also meet the applicable criteria for assessing causation currently applied in the field of epidemiology.

Sound medical-scientific evidence is the basis for determining Statements of Principles for the purposes of both standards of proof, and has the same definition for the purposes of instruments under subsection 196B(2) as it has for the purposes of instruments under subsection 196B(3). The information either meets the definition of sound medical-scientific evidence or it does not. Information cannot meet the definition for one purpose and not for another.

As explained above, it is the assessment of that information in terms of its indications of the relative potential of a factor being a causal factor in each case to which the Statement of Principles applies, by which differences may arise between the factors included in Statements of Principles determined under subsection 196B(2) and those determined under subsection 196B(3). But, a factor cannot be included in either type of Statement of Principles if there is no sound medical-scientific evidence that supports its inclusion as a factor.

Paragraph 5AB(2)(b) refers to the applicable criteria for assessing causation currently applied in the field of epidemiology. For the purpose of this review, the Council has been constituted so as to include two epidemiologists. It is clearly the intention of the Parliament that Councillors are to apply their expertise in considering the matters before the Council. The Act does not state what the current epidemiological criteria are, but leaves it for the Council and the Repatriation Medical Authority to determine given the expertise within both of those bodies. It is relevant that, as far as the constitution of the Repatriation Medical Authority is concerned, the Act expressly requires that one of the members must be a person having at least five years experience in the field of epidemiology (subsection 196L(3)). In relation to appointments to the Council, the Minister is required to have regard to the branches of medical science, expertise in which would be necessary for deciding matters referred to the Council for review (subsection 196ZE(3)).

The Council takes the view that the criteria for assessing causation currently applied in the field of epidemiology include what is commonly known as the Bradford Hill criteria. There are a number of slightly different expressions of those criteria currently being applied, but all of them have similar elements. Not only are the Bradford Hill criteria, themselves, part of the criteria for assessing causation, but the methods by which medical and scientific studies are analysed in relation to the Bradford Hill criteria, must be said to be part of the criteria currently applied in the field of epidemiology. The Council also notes that the explanatory memorandum to the legislation indicated that the Bradford Hill criteria were contemplated by the Parliament as the type of criteria intended to be applied.

Broadly speaking, epidemiology is the study of the distribution and determinants of disease in populations. Studies are often designed to examine the risk of a disease (or death from a disease) in a population together with frequency of one or more other factors in that population. There are many different ways of conducting epidemiological studies, and they each have their strengths and weaknesses depending on the purpose for which the study was established and the manner in which it was designed and conducted. These are matters that are relevant in assessing causation in epidemiology.