Hot Topics 64 - Health and the Law - Legal Information Access Centre

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formulations. This facilitates citizen choice and patient informed consent, as many sunscreen products do not use nanoparticulate formulations. Use of sunscreen is only one component of sun safety – along with use of shade and sun protective clothing. It is important to stress the important message that repeated application of sunscreen can protect against the development of sunburn, photoageing of the skin and squamous cell carcinoma precursors. Nevertheless, realistic appraisal suggests that sunscreen application is already not an entirely benign act; it may, for example, increase the risk of basal cell carcinoma, with conflicting results on prevention of melanoma. Such effects may be the result of changed sun exposure behaviour under a belief of ‘protection’. ausTralia-us free Trade agreemenT, BlOOd prOducTs and THe pBs Australia currently has strong claims to being regarded as self-sufficient in supplies of whole blood. Self sufficiency in this area is desirable, particularly given increasing threats of emergent infectious diseases and terrorism, as well as ongoing issues with quality control in remote locations. In recent years, increasing imports of plasma-derived and recombinant (artificially produced) products have occurred (with limited public debate), yet the majority continues to be derived from Australian donations and processed in Australia. Whole blood, plasma and platelets from volunteer donors are collected by the Australian Red Cross Blood Service, and tested for HIV, hepatitis B and C, HTLV-1 and 2, syphilis, and for cytomegalovirus to protect recipients with immune deficiencies. Blood is a scarce global commodity; paid donors in developing countries are becoming an increasingly important source of the world’s plasma. Reviews have consistently found that paid blood donors are more at risk of emergent infectious disease and are more likely to donate in symptomless ‘window’ periods. In short, blood sourced from paid ‘donors’ is less safe. CSL Limited is currently the sole provider of plasma fractionation services in Australia, enjoying exclusive rights under the PFA with the Commonwealth Government, due to end in December 2009. (Plasma fractionation is the separation of plasma into components.) Australia’s Free Trade Agreement with the United States (AUSFTA) came into force on 1 January 2005. Chapter 15 of the AUSFTA (‘Government Procurement’) established an obligation that government contracts for goods and services (such as those involved with blood supply) must be equally open to suppliers in both countries. A specific annex, however, excluded from this obligation ‘the procurement of plasma fractionation services’ in Australia. Nevertheless, in May 2004, the United States Trade Representative and the Australian Minister for Trade undertook an exchange of side letters (a binding part of AUSFTA) on blood products and plasma fractionation services. Central to these obligations is an expiry date for the present contract – the Plasma Fractionation Agreement (PFA) with CSL Ltd – and the creation of a review process to consider opening up blood services to competitive overseas tender. Fortunately the Australian government decided, after consulting with the State governments not to proceed in this direction. If a large overseas company used its economies of scale and legal expertise with complex procurement documents to undercut local providers in a tendering process there could be serious consequences, for example: > plasma donated in Australia could be shipped overseas for fractionation and then returned. In such circumstances, thorough cleaning of equipment between batch runs – though specified in written guidelines – could not be as rigorously monitored as it is locally; > a proportion of Australia’s cheap and comparatively safe blood supply could be siphoned off into overseas markets, where it would be highly valued as a low risk product. Annex 2C of the AUSFTA included provisions establishing a Medicines Working Group comprising high level officials from both countries. US negotiators to the AUSFTA wanted to restrict the evidence-based processes that Australia’s Pharmaceutical Benefits Scheme (PBS) system used to bargain down the cost of new, innovative image u navailable Blood donation at the Australian Red Cross. Tamara Dean, Sydney Morning Herald. Human right to health 21
drugs on cost-effectiveness grounds. Concern exists that this body was involved in driving legislative changes to the PBS in the middle of 2007 that divided it into separate categories for innovative medicines and generic drugs with reduced cost-effectiveness processes between these categories. If this controversial assumption is true then it could be seen as diminishing sovereignty of the Australian people over their health policy. This area suggests that in a globalised economy, trade agreements have become a type of ‘supra-national’ legislation. WHisTle-BlOWing in THe medical prOfessiOn ‘Whistleblowing’ refers to the disclosure to the public of information from within an organisation that suggests a significant danger to public safety or well-being. There is considerable anecdotal evidence of the power of large organisations to place substantial financial and psychological burdens on whistleblowers. The perceived likelihood of reprisals or retaliation occurring (often in the guise of performance reviews) has been found to be a strong determinant of whether employees and colleagues will report wrongdoing. Similarly, there is a widespread belief that those who report corruption or misconduct are likely to suffer for it. People are more likely to report wrongdoing if they believe it will result in few personal costs. Exposing deception or misconduct in scientific research is obviously for the public good, yet this often is countered, regardless of what legal protections are technically available, by the fear of receiving lessfavourable treatment, retribution or even the end of a chosen career and income security for a family. There is little, in terms of institutional governance guidelines, on how best to implement or fund the legislative protections afforded to whistleblowers. Few academic institutions seem interested in teaching whistleblowing seriously in any formal sense, for example as an accepted (if last resort) component of governance structures. In the context of whistleblowing about scientific misconduct, complete instruction in and recall of image u navailable Whistleblower Toni Hoffman, Senior ICU nurse, outside Bundaberg Hospital, Qld after hearing news of Jayant Patel’s arrest, March 2008. Photo: John Wilson. relevant bioethical, legal and international human rights principles will not themselves motivate action. Motivation, involving the generation of emotion to encourage performance of an act, also requires convictions, or a sense of conscience, derived from previously established virtue. One suggestion is that such conscience arises most readily from direct proximity to individual patient suffering. Finding a virtue-based justification for whistleblowing in relation to misconduct concerning scientific research is conceptually difficult. One potential source of standards for such concepts is the UNESCO Universal Declaration on Bioethics and Human Rights and its associated database. Article 18 of this declaration provides: ‘1. Professionalism, honesty, integrity and transparency in decision-making should be promoted, in particular declarations of all conflicts of interest and appropriate sharing of knowledge.’ Article 14 provides: ‘2. Taking into account that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief and economic, or social condition, progress in science and technology should advance: (a) access to quality health care and essential medicines, especially for the health of women and children, because health is essential to life itself and must be considered to be a social and human good; (b) access to adequate nutrition and water; (c) improvement of living conditions and the environment; (d) elimination of the marginalisation and the exclusion of persons on the basis of any grounds; (e) reduction of poverty and illiteracy’. Whistle blowing, by its very nature, generally is an external manifestation of poor internal procedures through which potentially unethical, dangerous, unprofessional, unsafe or illegal behaviour may be reported and dealt with. A timely recent example of this has concerned the US Food and Drug Administration (FDA), where whistleblowers such as Dr David Graham have indicated that FDA scientists have been discouraged by supervisors from raising questions about drug safety and sometimes have been prevented from sharing their concern with FDA advisory committees. Most states in Australia (including NSW) have legislation that is designed to protect whistleblowers from unjust reprisals. Nonetheless, managers may disguise such activities as performance reviews. Whistleblowers, despite their courage and desire to apply principles of the public good in the face of obstacles, continue to be persecuted by the organisations they are trying to improve. 22 HOT TOPICS 64 > Health and the Law
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