Many recipients believe however, that the Allars Inquiry did not adequately address the issue of accountability because the terms of reference did not go to the question of liability

Senate Community Affairs Committee Report on The CJD Settlement Offer TABLE OF CONTENTS CHAPTER 7 PROTECTION OF PUBLIC SAFETY The AHPHP operation and accountability 7.1 Under the second term of reference, the Committee is required to report on whether CSL or CSL Ltd, the National Health and Medical Research Council (NHMRC), the Department of Health and Family Services (DHFS) or any other Commonwealth department, agency or employee failed to adequately protect public safety in relation to the Australian Human Pituitary Hormone Program (AHPHP). 7.2 In their submissions to the Committee, many recipients expressed disquiet at the way the AHPHP was conducted and raised issues of accountability. For example, one recipient submitted: ...all of the agencies that were connected with the Australian human pituitary hormone program are at fault. The revelations of the Allars inquiry are mind-boggling to say the least. The irony of all of this is that no one will ever be made accountable for their improper actions, actions that have left a number of people dead, others at risk and families devastated by a dreadful disease.[1] And: No-one from CSL - whose actions in harvesting the pituitary glands under completely uncontrolled conditions must border on criminal negligence - has ever been held to account. Nor have any members of HPAC, who sought kudos and career advancement ahead of prudent medical practice and patient safety.[2] Further, some recipients concluded that there were breaches of the law by persons involved in the program: We believe that the report completed by Professor Allars, her executive summaries and Dr Lawrence's speech to the House prove beyond any question that there had been significant breaches of the law as it applies to a wide variety of areas. These include the manufacture of the hormone, including the collection of glands, distribution of the hormone by various agencies, including HPAC, CSL and others as detailed in the Allars report, and non-disclosure of possible side effects.[3] 7.3 Other recipients expressed concern that CSL's manufacturing practices were unsafe' and negligent' and that they may have been treated with hormone that was not only potentially contaminated with CJD but hepatitis as well.[4] 7.4 For many recipients lack of knowledge about the future implications for their children is a further source of anxiety: As a human pituitary hormone recipient and as member of the Australian public, I feel that my life, my safety, has been jeopardised. I now have an increased risk of contracting CJD and it is not known to what extent all my 4 children (who were all breastfed) are also at risk of contracting CJD.[5] 7.5 An additional matter raised in submissions was the time taken to notify recipients of the risk of CJD. It was also noted that many recipients had donated blood between the time the program was suspended in 1985 and when the majority of recipients were notified in 1992-93. This had caused concern within the recipient community. 7.6 The Allars Inquiry report provided extensive detail on the government bodies and agencies involved in the AHPHP. Many recipients believe however, that the Allars Inquiry did not adequately address the issue of accountability because the terms of reference did not go to the question of liability. Professor Allars in her submission to the Committee noted: Neither compensation nor the issue of criminal or civil liability of medical practitioners were part of my terms of reference. Consequently I made no recommendation on these issues. I make no comment now.[6] 7.7 In considering whether there was a failure to adequately protect public safety in relation to the AHPHP, the Committee has relied extensively on the findings of the Allars Inquiry. Comments are provided in relation to the particular areas of : the production of the product, including collection of pituitary glands; supervision of the product and program by government agencies including the Health Department, the National Biological Standards Laboratory and the Human Pituitary Advisory Committee; and action taken by the Department following the suspension of the program in 1985 in relation to tracing of recipients, information provided to recipients, epidemiological studies, and blood and organ donation. 7.8 The Allars Inquiry reported that from the commencement of the AHPHP, CSL and HPAC believed that there were two avenues for ensuring the safety of hormone product from viral contamination. Firstly, through the criteria established to exclude the collection of glands from certain cadavers and secondly, through the method of processing the glands.