Journal of law and medicine
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Recent legal developments have highlighted the need for greater support from the Federal Government for the authority of the Therapeutic Goods Administration (TGA) to ensure, by pre-approval assessments and post-approval regulation, the safety of listed medicines in Australia. One of these developments concerns the impact of ongoing civil litigation in Australian courts led by Pan Pharmaceuticals stakeholders to recover compensation from the government for the losses they incurred following the TGA's post-listing shut-down of that pharmaceutical manufacturing company in 2003. Another factor is the recently announced governmental policy to outsource to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) safety assessments of foreign drug manufacturers whose products will be used in Australia.
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Organ procurement is possible under statutes defining death as either irreversible cessation of all functions of the brain or irreversible cessation of the circulation, thus fulfilling the "dead donor rule". However, present practice does not conform strictly to these conditions. Clinical guidelines for the diagnosis of whole-brain death are equated, with coma, to absence of brain-stem reflexes which essentially means the absence of spontaneous respiration which is clinically interpreted as "dead enough" or "as good as dead" for the purpose. ⋯ State and national ethical guidelines on this practice conflict and it appears proscribed under State guardianship legislation which requires actions in the best interests of the donor, not the recipient. Considerations should be given to organ procurement in situations where the donor is dying or in which survival is impossible. Simple abandonment of the "dead donor rule", however, is not feasible since organ procurement would be the direct cause of death.
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A doctor who is treating a patient in an Australian hospital may make a pre-emptive decision not to attempt to resuscitate that patient in the event of the patient's sudden demise. This decision is commonly referred to as a not-for-resuscitation (NFR) order. This article examines what resuscitation is, and what it means to withhold attempts at resuscitation from a patient. The medical, legal and ethical doctrines relating to death and dying are synthesised into a set of robust guidelines for making NFR decisions.
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This column considers some of the imperatives and barriers which may impact on a medical practitioner who apologises to a patient following an adverse event in New South Wales. It also considers the inclusion of the apology provisions in ss 67-69 of the Civil Liability Act 2002 (NSW) and the extent to which those provisions may protect apologising practitioners from liability.
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Selim v Lele (2008) 167 FCR 61; [2008] FCAFC 13 was a decision of the Federal Court which interpreted s 51(xxiiiA) of the Australian Constitution. This section accords the federal government, among other things, power to make laws with respect to the provision of "medical and dental services (but not so as to authorise any form of civil conscription)". The Federal Court decided that the phrase "civil conscription" was analogous to "industrial conscription". ⋯ The specific question in Selim v Lele was whether the imposition of standards and prohibition of "inappropriate practice" under the Health Insurance Act 1973 (Cth), ss 10, 20, 20A and Pt VAA, amounted to civil conscription. The court held they did not. The Federal Court also discussed in that context the sufficiency of "practical compulsion" in relation to the s 51(xxxiiiA) prohibition, The constitutional prohibition on "any form" of civil conscription provides one of the few rights protections in the Australian Constitution and may have an important role to play in shaping the limits of health care system privatisation in Australia.