tag:theconversation.com,2011:/uk/topics/medicolegal-394/articlesMedicolegal – The Conversation2020-10-15T06:19:58Ztag:theconversation.com,2011:article/1478462020-10-15T06:19:58Z2020-10-15T06:19:58ZWho pays compensation if a COVID-19 vaccine has rare side-effects? Here’s the little we know about Australia’s new deal<figure><img src="https://images.theconversation.com/files/363573/original/file-20201015-23-y5622.jpg?ixlib=rb-1.1.0&rect=0%2C6%2C1022%2C688&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-vector/vaccine-syringe-vector-background-template-bottles-1744714103">Shutterstock</a></span></figcaption></figure><p>In last week’s federal budget the Australian government <a href="https://www.smh.com.au/politics/federal/morrison-government-grants-indemnity-for-covid-19-vaccine-side-effects-20201008-p5636o.html">announced</a> it had given the suppliers of two COVID-19 vaccines indemnity against liability for rare side-effects.</p>
<p>Although details are unclear, it appears the government would foot the bill for compensation if a member of the public wins legal action against the drug company.</p>
<p>This is in contrast to <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233334">25 other countries</a> with no-fault compensation schemes for rare vaccine side-effects.</p>
<p>Here’s the little we know about Australia’s latest indemnity deal and what we could be doing better.</p>
<h2>What do we know about Australia’s new deal?</h2>
<p>The deal relates to <a href="https://theconversation.com/putting-our-money-on-two-covid-vaccines-is-better-than-one-why-australias-latest-vaccine-deal-makes-sense-145693">two vaccines</a> the government had previously announced it would supply, should clinical trials prove successful.</p>
<p>These are the University of Oxford vaccine, from AstraZeneca, and the University of Queensland vaccine, from Seqirus (part of CSL).</p>
<p>However, it is not entirely clear what this indemnity deal means in practice. The budget papers <a href="https://budget.gov.au/2020-21/content/bp1/download/bp1_bs9_w.pdf">say</a> the government will cover:</p>
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<p>certain liabilities that could result from the use of the vaccine.</p>
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<p>The government <a href="https://thenewdaily.com.au/news/2020/10/09/government-grants-covid-19/">considers</a> further details “commercial in confidence”. </p>
<p>For instance, we don’t know how serious or disabling a side-effect would have to be to qualify or whether there is any cap on the amount of compensation. </p>
<p>We also don’t know what would happen if there were errors involved, or contaminants introduced, while manufacturing the vaccine. These would still be the company’s liability, but it may be hard to determine where boundaries lie.</p>
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Read more:
<a href="https://theconversation.com/putting-our-money-on-two-covid-vaccines-is-better-than-one-why-australias-latest-vaccine-deal-makes-sense-145693">Putting our money on two COVID vaccines is better than one: why Australia's latest vaccine deal makes sense</a>
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<h2>How unusual is this?</h2>
<p>This deal is not entirely new or unexpected. The government has <a href="https://budget.gov.au/2020-21/content/bp1/download/bp1_bs9_w.pdf">provided some indemnity</a> to pharmaceutical companies that make vaccines against smallpox and influenza.</p>
<p>The governments of many other countries have also agreed to indemnify COVID-19 vaccine manufacturers, <a href="https://www.rt.com/news/496801-pharma-not-accountable-vaccine-effect/%20and%20https://www.reuters.com/article/us-health-coronavirus-vaccines-liability/covid-19-era-highlights-u-s-black-hole-compensation-fund-for-pandemic-vaccine-injuries-idUSKBN25H1E8">including</a> governments in the UK, US <a href="https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_1662">and the</a> <a href="https://www.afr.com/politics/federal/vast-majority-of-americans-distrust-trump-on-virus-poll-20200922-p55xv6">European Union</a>. </p>
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<p>The manufacturers <a href="https://www.europeanpharmaceuticalreview.com/news/125517/astrazeneca-receives-protection-from-covid-19-vaccine-liability-claims-report-says/">believe</a> that as the use of their vaccine is for the benefit of society, they should not be held financially accountable for any consequences from a vaccine reaction.</p>
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Read more:
<a href="https://theconversation.com/big-pharmas-safety-pledge-isnt-enough-to-build-public-confidence-in-covid-19-vaccine-heres-what-will-145822">Big pharma's safety pledge isn't enough to build public confidence in COVID-19 vaccine – here's what will</a>
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<h2>So what does this mean for the public?</h2>
<p>If a person in Australia believes they have been injured by a vaccine, including future COVID-19 vaccines, they will need to pursue compensation through the legal system.</p>
<p>Under the latest agreement, it would appear the government, rather than the drug company, would pay that compensation, should the person win their case.</p>
<p>However this is not ideal. The person still has to engage with the legal system, which is both costly and complex, and there’s no guarantee of success. </p>
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<a href="https://images.theconversation.com/files/363570/original/file-20201015-13-1ef3dy7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Woman consulting professional looking woman in office" src="https://images.theconversation.com/files/363570/original/file-20201015-13-1ef3dy7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/363570/original/file-20201015-13-1ef3dy7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/363570/original/file-20201015-13-1ef3dy7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/363570/original/file-20201015-13-1ef3dy7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/363570/original/file-20201015-13-1ef3dy7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/363570/original/file-20201015-13-1ef3dy7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/363570/original/file-20201015-13-1ef3dy7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Under the latest indemnity deal, it seems that people would still need to go through the legal system, with no guarantee of success.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/serious-professional-female-advisor-consulting-client-1256570848">www.shutterstock.com</a></span>
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<p>Compensation may not even be possible via our legal system. That’s because in most cases, it will be difficult to show in court a serious side-effect was due to a fault in the vaccine composition or negligence in the way it was administered.</p>
<p>So in Australia, people with a vaccine injury, either COVID-19 or other vaccine, will likely bear the costs of their injury by themselves, and seek treatment by our publicly-funded or private health systems. </p>
<p>The National Disability Insurance Scheme helps fund therapies for people with a permanent and significant disability but <a href="https://www1.racgp.org.au/ajgp/coronavirus/australia-needs-a-vaccine-injury-compensation-sche">does not cover</a> temporary vaccine-related injuries.</p>
<p>Participants in COVID-19 vaccine clinical trials <a href="https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/">can be compensated</a> for temporary and permanent vaccine injuries.</p>
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<strong>
Read more:
<a href="https://theconversation.com/the-budget-assumes-a-covid-19-vaccine-becomes-available-next-year-is-this-feasible-147557">The budget assumes a COVID-19 vaccine becomes available next year. Is this feasible?</a>
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<h2>What’s happening overseas?</h2>
<p>In the US, people with a rare but serious reaction to a COVID-19 vaccine will be able to access a <a href="https://www.hrsa.gov/cicp">special compensation scheme</a>. This is designed to provide compensation for the use of COVID-19 pandemic medications and vaccines. </p>
<p>However, applicants only have one year from the date they had the vaccine or medicine to request benefits.</p>
<p>The US already has <a href="https://www.hrsa.gov/vaccine-compensation/index.html">a vaccine compensation scheme</a> for vaccines other than COVID-19. This is an example of a <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233334">no-fault</a> compensation scheme. These compensate for specific vaccine reactions, without having to go to court to prove the vaccine manufacturer is liable.</p>
<p>Australia, in contrast to 25 countries including the US, UK and New Zealand, <a href="https://www1.racgp.org.au/ajgp/coronavirus/australia-needs-a-vaccine-injury-compensation-sche">does not have</a> a no-fault vaccine compensation scheme, and does not have the equivalent of the US COVID-19 vaccine compensation scheme.</p>
<h2>How would a no-fault system work?</h2>
<p>There are numerous benefits to a no-fault vaccine compensation system. These include simplified access to compensation, and avoiding a lengthy, costly and complex encounter with the legal system, with no guarantee of success.</p>
<p>Most are government funded. The US government funds it by a flat rate of <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233334">US$0.75</a> for each disease prevented for each vaccine dose.</p>
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<p>Finland and Sweden fund their programs via insurance payments from pharmaceutical companies marketing their products there. </p>
<p>The <a href="https://www.acc.co.nz/">New Zealand scheme</a> includes compensation for vaccine-related injuries, as well as for accidents and treatment injuries. This is funded through a combination of general taxation, and levies collected from employee earnings, businesses, vehicle licensing and fuel. </p>
<p>However, compensation awarded via such no-fault schemes is usually lower than you would receive after a successful liability lawsuit.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/were-all-at-risk-from-scary-medicine-side-effects-but-we-have-to-weigh-the-risks-with-the-benefits-65029">We're all at risk from scary medicine side effects, but we have to weigh the risks with the benefits</a>
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<h2>Where to next?</h2>
<p>To encourage people to receive COVID-19 vaccines for the benefit of the entire community, we need compensation schemes to be in place if there is a rare but serious side-effect. </p>
<p>Should options to increase vaccine uptake include mandates or penalties — such as employment or travel restrictions if not vaccinated — this would make a no-fault vaccine compensation scheme even more essential. </p>
<p>Although it is important manufacturers receive indemnity for “certain liabilities”, we still need to look after our community. That means a compensation system the public can easily access and which provides appropriate support.</p><img src="https://counter.theconversation.com/content/147846/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicholas Wood receives funding from the NHMRC for a Career Development Fellowship</span></em></p>Details are sketchy. But it looks like people would still need to go through the legal system to get compensation. There are better ways.Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1202812019-07-12T04:53:14Z2019-07-12T04:53:14ZThe TGA’s proposed breast implant ban exposes a litany of failures, and fails to protect women<figure><img src="https://images.theconversation.com/files/283810/original/file-20190712-173325-1pt3hyh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It's not just women who are the losers following the latest TGA announcement. People with all types of medical devices need better regulatory protection.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/192268697?src=kjE4cPpyMgy06bxX4_CuVg-1-7&studio=1&size=medium_jpg">from www.shutterstock.com</a></span></figcaption></figure><p>The <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">proposed ban</a> on some textured breast implants <a href="https://www.theguardian.com/australia-news/2019/jul/11/australian-ban-on-textured-breast-implants-recommended-over-apparent-cancer-link">announced</a> by the Australian pharmaceuticals and medical devices regulator earlier this week tells us something very disquieting about the effectiveness of consumer protection. </p>
<p>It will not reassure women living with breast implants concerned about their risk of cancer, or anyone else with an implantable medical device regulated by the Therapeutic Goods Administration (TGA).</p>
<p>It also exposes inadequacies in the regulatory system that have been apparent for years.</p>
<h2>What’s new?</h2>
<p>The proposed ban relates to the import and distribution of certain types of breast implants with a textured surface because of their <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">well documented link</a> with a rare type of cancer known as anaplastic large cell lymphoma. The proposal is unsurprising given bans in Europe.</p>
<p>But Australia’s proposal comes after months of <a href="https://www.abc.net.au/news/2019-04-09/implants-allowed-in-australia-after-crackdown-in-france/10985400">criticism</a> by consumers, medical specialists and legal <a href="https://blogs.crikey.com.au/croakey/2014/03/25/the-tga-a-watchdog-with-dentures/">academics</a> who wanted to see an earlier and better-communicated ban. </p>
<p>The <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">TGA also says</a> it is seeking advice from Allergan, the manufacturer whose implants were the focus of restrictions in Europe.</p>
<p>Yet concerns about the <a href="https://theconversation.com/victims-of-faulty-breast-implants-were-let-down-by-the-tga-13074">safety</a> of a succession of implants and the <a href="https://theconversation.com/pip-breast-implant-controversy-shows-weve-learned-nothing-4896">inadequacy</a> of Australia’s regulatory responses are not new. Advice from Allergan should have been sought a year ago.</p>
<h2>Here’s what we asked the TGA last year</h2>
<p>In responding last year to our queries about implants, the TGA indicated that although importation of the textured implants had been stopped after the ban in France there were <em>no</em> restrictions on implanting those devices in Australia.</p>
<p>The TGA was unaware of how many implants were available for implantation. (Unawareness about what is on the shelf was also <a href="https://www.abc.net.au/news/2017-08-15/potentially-damaging-vaginal-mesh-kits-still-on-hospital-shelves/8805520">evident</a> regarding <a href="https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report">pelvic mesh</a>, a similar regulatory failure). </p>
<p>The TGA was not going to inform potential recipients of the implants, something that is at odds with its new-found <a href="https://www.abc.net.au/news/2019-04-04/medical-implants-overhaul-planned-after-icij-investigation/10964256">recognition</a> that patients are concerned about potential harms.</p>
<p>What we have now is a proposed rather than actual ban. It is driven by criticism rather than TGA initiative and does not provide much reassurance about the TGA’s capacity to prevent harms rather than slowly respond to harms.</p>
<h2>What if you are living with these implants?</h2>
<p>The proposal announced this week is restricted to import and distribution. It does not require removing all breast implants or all textured breast implants. It does however mean that people with the implants listed on the TGA website should be watchful.</p>
<p>The <a href="https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma">TGA lists</a> the affected breast implants on its website, and says the risk of anaplastic large cell lymphoma associated with these is between 1-in-1,000 and 1-in-10,000.</p>
<p>Yet it’s likely many women will experience fear, alongside anger or bewilderment that the TGA has taken so long to act. </p>
<p>Some people will deal with that fear through preemptive surgery: removal of the implants after getting specialist advice. Costs will come out of their own pockets. Some will talk to lawyers.</p>
<h2>What’s the legal issue?</h2>
<p>Uniquely, consumers cannot sue the TGA if it gets things wrong. The TGA has a special <a href="http://www.austlii.edu.au/cgi-bin/viewdoc/au/legis/cth/consol_act/tga1989191/s61a.html">exemption</a> in its Act regarding civil litigation.</p>
<p>However, people who are injured by implanted medical devices can take manufacturers and medical specialists to court. Their challenge is to prove that the devices caused cancer or other injury. </p>
<p>Litigation in Australia with defective <a href="https://www.afr.com/business/health/hip-replacements-metalonmetal-implant-failures-trigger-new-class-action-fears-20181122-h187ha">joint implants</a> demonstrates that manufacturers have deep pockets and will be adversarial when it comes to <a href="https://www.abc.net.au/news/2016-03-31/class-action-over-defective-hip-replacements-settles-for-$250m/7288350">class actions</a> (litigation by groups of injured people) or individual victims. Litigation will often take years. Injury compensation will sometimes be inadequate.</p>
<p>That is one reason why better regulation is fundamental. We need to prevent the injury through timely action by government agencies rather than trying to fix a <a href="https://theconversation.com/failing-medical-implants-are-causing-hundreds-of-thousands-of-people-misery-84230">foreseeable</a> serious harm via legal action once it has occurred (and hope victims have the strength to fight for their rights).</p>
<h2>How engaged is the regulator?</h2>
<p>The <a href="https://www.tga.gov.au/who-we-are-what-we-do">TGA</a> is funded by the businesses it <a href="https://www.theguardian.com/australia-news/2017/nov/08/therapeutic-goods-administration-rejects-claims-it-is-too-close-to-medical-industry">regulates</a>. Like its counterpart the FDA in the United States, it is <a href="https://www.youtube.com/watch?v=UVUHEtrbL7A">underfunded</a> and demoralised. It views its mission through the eyes of those businesses, an example of <a href="https://theconversation.com/vital-signs-when-watchdogs-become-pets-or-the-problem-of-regulatory-capture-111170">regulatory capture</a>. It has been the subject of numerous <a href="https://theconversation.com/tga-all-bark-no-bite-as-labor-botches-response-to-a-series-of-reviews-4640">inquiries</a> about its performance. </p>
<p>Regrettably, the TGA has been described as unresponsive. It is comfortable dealing with the businesses it is supposed to regulate. It is <a href="https://theconversation.com/regulator-silent-on-safety-of-indian-made-generic-drugs-24013">uncomfortable</a> dealing with the public. It faces ongoing criticism about its apparent <a href="https://theconversation.com/medical-watchdog-turns-its-back-on-implant-safety-complaints-5744">indifference</a>. In response to such <a href="https://www.abc.net.au/news/2018-11-26/implant-files-shine-light-on-medical-device-industry/10521480">criticism</a> it belatedly announced an <a href="https://www.icij.org/investigations/implant-files/australia-announces-medical-device-action-plan-to-address-patient-concerns/">action plan</a> regarding oversight of devices. There hasn’t been much action. </p>
<p>In practice, meaningful regulation of devices is being left to <a href="https://www.icij.org/investigations/implant-files/">investigative</a> <a href="https://www.abc.net.au/news/2018-11-26/implant-files-reveal-tga-failures-in-medical-device-trial/10547486">journalists</a>, academics with a specialisation in law and medicine, and consumer advocates. Neither the Coalition nor the ALP have wanted to grasp the TGA <a href="https://theconversation.com/consumers-lose-out-as-tga-reform-turns-into-a-hot-potato-13383">hot potato</a>, but reform is necessary. </p>
<h2>What is needed?</h2>
<p>Our forthcoming research demonstrates the cost of running the TGA is dwarfed by the cost to patients, national productivity and the taxpayer of the TGA’s failures. </p>
<p>TGA legislation needs to be amended, in particular to ensure that the protection of consumers comes ahead of relations between the regulator and business. Independence of manufacturers is imperative. Adequate resourcing is essential. So is a cultural change within the TGA, including meaningful engagement with consumers rather than closed-door consultations with business.</p>
<p>Underpinning those changes we need a comprehensive <a href="https://www.abc.net.au/news/2018-03-27/pelvic-mesh-implants-tracking-medical-devices/9588070">database</a> of implants and incidents, one readily accessible by epidemiologists. </p>
<p>We need trust in the health system and in gatekeepers such as the TGA. Anyone with an implant or considering an implant needs to know that the TGA will actively minimise harms rather than relying on assurances from businesses that have a vested interest in minimising disclosure. Good regulation involves more than a quiet life for regulators.</p><img src="https://counter.theconversation.com/content/120281/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The proposed Australian ban of some types of breast implants is too little, too late. It also reveals regulatory failures that need to be fixed if Australian consumers are to be protected.Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraWendy Bonython, Associate Professor of Law, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/682252016-11-07T23:40:54Z2016-11-07T23:40:54ZAustralian law needs a refresher on the science of HIV transmission<figure><img src="https://images.theconversation.com/files/144765/original/image-20161107-4694-ry4k7e.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Recent improvements in medical management of HIV infection are not well understood in the legal sector. </span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/pic-309710009/stock-photo-image-concept-with-the-result-of-the-hiv-test.html?src=jsZ4xp3vaVRNZ8nFK-ccCw-1-3">www.shutterstock.com </a></span></figcaption></figure><p>Being diagnosed with HIV is a confronting experience. </p>
<p>However the stigma associated with HIV infection – a hangover from its social and medical history – is responsible for an exaggerated perception of transmission risk through sex, and the harms of living with HIV infection. </p>
<p>In our <a href="https://www.mja.com.au/journal/2016/205/9/sexual-transmission-hiv-and-law-australian-medical-consensus-statement">consensus statement published this week in the Medical Journal of Australia</a>, we detail the latest evidence on HIV transmission risk and recent advances in HIV prevention and treatment.</p>
<p>We propose that legal cases relating to HIV transmission should be considered in light of such evidence, and that alternatives to prosecution such as the public health management approach are often appropriate. </p>
<h2>HIV infection no longer a death sentence</h2>
<p>There have been many advances in HIV diagnosis, prevention and treatment since the identification of the first AIDS cases in the early 1980s. </p>
<p>In the initial days of the AIDS epidemic, patients would, after a number of years, develop serious infections and other illnesses due to their immune deficiency, usually resulting in death. When the first treatments became available, they bought time but often at the cost of serious medication side-effects, and complicated treatment regimens involving many tablets each day.</p>
<p>While it remains a serious infection, HIV is now a disease that can be effectively managed through medical treatment, regular health monitoring and healthy lifestyle. For many people with HIV, treatment involves taking only a single pill each day. Those taking antiviral therapy can expect to live a normal life, in good health, with a life expectancy similar to their HIV-negative counterparts. </p>
<p>These great improvements, familiar to those working in health, are not as well understood in the legal sector. </p>
<h2>Prosecutions for HIV infection</h2>
<p>Unlike other diseases, HIV has a long and uneasy relationship with criminal law. In the early years of the epidemic, the stigma around HIV, the fact that it was almost always fatal, and unfounded fears about its potential use as a weapon led to the criminalisation of HIV transmission and exposure. </p>
<p>Since 1991, there have been more than 38 criminal prosecutions for HIV transmission or exposure during sex in Australia. Despite the significant improvements in health and longevity of people living with HIV, the rate of criminal prosecutions has not decreased. </p>
<p>The courts have shown an understanding of the effectiveness of condoms: no one who has used condoms has been convicted. However, people continue to be prosecuted, including for “exposing” others to the risk of HIV infection, even in the absence of actual transmission. This occurs despite the relatively low per-act risk of HIV transmission and the fact that for most people the harms of HIV infection are far less serious than they once were.</p>
<h2>New approaches to limit HIV transmission</h2>
<p>HIV is actually difficult to transmit. <a href="https://www.mja.com.au/journal/2016/205/9/sexual-transmission-hiv-and-law-australian-medical-consensus-statement">Sexual transmission occurs</a> during only about 1% (or less) of penetrative sexual encounters, even when a condom is not used and the HIV-positive person is not on treatment.</p>
<p>HIV prevention messaging in the early days of the epidemic focused on sexual abstinence and condom use. However, prevention messaging is now more nuanced and has expanded to include new ways of reducing HIV transmission risk. A not insignificant number of people at risk of HIV infection choose to have sex without using a condom, which is why developing alternative methods of HIV prevention have been prioritised in recent years. Such research has delivered game-changing results: “treatment as prevention” and “pre-exposure prophylaxis”. </p>
<p><a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1105243">Treatment as prevention</a> refers to the greatly reduced risk of HIV transmission as a result of HIV-positive people taking antiviral treatment, which suppresses replication of the virus in the infected person’s body. When a person with HIV has a very low viral load (unmeasurable levels of HIV in the blood), the risk of sexual transmission becomes <a href="https://www.ncbi.nlm.nih.gov/pubmed/27404185">very low</a>. In fact, there has never been a documented case of HIV transmission from a person with an undetectable viral load.</p>
<p><a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1011205">Pre-exposure prophylaxis</a> describes the use of antiviral medication by an HIV-negative person as a way of preventing HIV infection. Pre-exposure prophylaxis is a <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1506273">very effective means</a> of preventing HIV transmission, with only isolated cases of transmission identified among people applying this approach. This groundbreaking new strategy is available in Australia via limited pilot programs, and is being evaluated for Pharmaceutical Benefits Scheme listing.</p>
<h2>How the law treats people with HIV</h2>
<p>Criminal laws relating to HIV transmission and exposure vary from state to state, but a common factor is that people with HIV are expected to take “reasonable precautions” to prevent transmission. Condom use has long been accepted as meeting this threshold. </p>
<p>The evidence now supports acceptance of treatment as prevention (for the positive partner) and/or pre-exposure prophylaxis (for the negative partner) as meeting the same standard. And the limited harms of HIV infection as a consequence of acts involving low to negligible risk of transmission mean HIV cases generally do not belong in criminal courts.</p>
<p>There is an alternative. All states and territories have health protocols for managing allegations of risky behaviour. This public health approach – involving education, case management and, where required, behavioural orders and isolation – is a much more effective way of protecting public health.</p>
<p>As researchers and clinicians, we are intimately aware of the impact an HIV diagnosis can have. We have all supported patients coming to terms with an HIV diagnosis; many of us having had the painful task of delivering that devastating news. </p>
<p>The criminal law has a role to play, particularly should there ever be a case where a person deliberately transmits HIV. </p>
<p>However, with the advances of recent years in both prevention and treatment, authorities need to be more familiar with latest scientific and medical evidence, and consider alternatives to prosecution such as the public health management approach.</p>
<hr>
<p><em>Elizabeth Crock, <a href="http://www.ashm.org.au/">Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine</a>, co-authored the <a href="https://www.mja.com.au/journal/2016/205/9/sexual-transmission-hiv-and-law-australian-medical-consensus-statement">consensus statement</a>.</em></p><img src="https://counter.theconversation.com/content/68225/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Grulich has given expert evidence in legal cases involving HIV transmission. </span></em></p><p class="fine-print"><em><span>Nothing to disclose.</span></em></p><p class="fine-print"><em><span>David Cooper, David Nolan, Levinia Crooks, Mark Boyd, Michelle Giles, and Sharon Lewin do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>HIV diagnosis is devastating for patients and their families. But the infection is no longer a death sentence, and should not be prosecuted as such say experts.Mark Boyd, Professor, Chair of Medicine, University of AdelaideAndrew Grulich, Professor and Program Head, UNSW SydneyDavid Cooper, Scientia Professor of Medicine and Director, Kirby Institute, UNSW SydneyDavid Nolan, Adjunct Professor, Institute for Immunology and Infectious Disease , Murdoch UniversityLevinia Crooks, Adjunct Associate Professor, La Trobe UniversityMichelle Giles, Associate Professor, Department of infectious diseases and Dept of Obstetrics and gynaecology, Monash UniversitySharon Lewin, Director, The Peter Doherty Institute for Infection and Immunity, The University of Melbourne and Royal Melbourne Hospital and Consultant Physician, Department of Infectious Diseases, Alfred Hospital and Monash University, The Peter Doherty Institute for Infection and ImmunityTrent Yarwood, Infectious Diseases Physician, Senior Lecturer, James Cook University and, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/338452014-12-22T19:18:59Z2014-12-22T19:18:59ZGreat expectations: our naive optimism about medical care<figure><img src="https://images.theconversation.com/files/67327/original/image-20141216-24294-ifo3h9.jpg?ixlib=rb-1.1.0&rect=0%2C310%2C3510%2C2306&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Most people overestimate the benefits and underestimate the harms of medical intervention. </span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/cannnela/4614340819">Barbara M./Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><blockquote>
<p>“It might do me some good and it won’t hurt to give it a go.”</p>
</blockquote>
<p>How often have you heard a phrase like this?</p>
<p>Most people have naïve optimism about medical care. That’s the finding of a systematic review of all available research on common medical treatments we <a href="http://archinte.jamanetwork.com/article.aspx?articleid=2038981&resultClick=1">published</a> today in the journal JAMA Internal Medicine.</p>
<p>We set out to synthesise all the research to date that asked people to quantify the benefits, and/or harms, of common medical treatments, tests and screens (where people are tested for a disease without any symptoms or signs). We also aimed to compare, where possible, people’s expectations with the actual benefits and harms that are derived from research. </p>
<p>Most screening studies were about cancer screening and conclusions were similar regardless of the cancer of focus (breast, cervical, prostate, bowel). </p>
<p>Expectations for various treatments had been studied and included surgery (such as hip and knee replacement, back surgery, cataract surgery), medications (such as those for inflammatory bowel disease, osteoporosis, statins for cardiovascular disease), and other things like cardiopulmonary resuscitation (CPR). </p>
<p>This was a big search: we screened over 15,000 papers to find the 35 studies which met our inclusion criteria. Together these had studied over 27,000 people. </p>
<p>In the majority of studies, most people overestimated benefits and underestimated the harms. There was only one study where the majority of participants underestimated the benefit and one where the majority overestimated the harm. Across most studies, the proportion of people who correctly estimated intervention benefits and harms was generally low.</p>
<p>In other words, people appear to have set a halo around medical care, expecting it to deliver better outcomes than is reality. In marketing terms, we clinicians have a dream sell: our “product” is thought to be far better than it really is. </p>
<p>For the most part, this finding was echoed across various interventions, settings (primary care and hospitals), and countries. </p>
<p>The first question, of course, is why do people have such great expectations about medical management? The answers can only be speculative. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=805&fit=crop&dpr=1 600w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=805&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=805&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1011&fit=crop&dpr=1 754w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1011&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/67329/original/image-20141216-24313-tnoceh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1011&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Why are we so optimistic about medical care? The answers may be patient-related, or clinician-related.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/soozed/9877628084">soozed/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>There may be patient-related factors, such as: assumptions that more health care is better; optimistic bias (when individuals perceive that are at less risk than their peers); and unrealistic expectations may allow psychological needs such as hope and reassurance to be met. </p>
<p>Over-selling is something we come to expect in everyday marketing transactions and we are used to wearing a protective shield of scepticism, if not downright cynicism. But we seem to be generally less sceptical of medical care.</p>
<p>There are also probably clinician-related reasons, such as: clinicians wanting to convey hope and encouragement; the <a href="http://www.bmj.com/content/328/7438/474">strong drive</a> to do something rather than nothing, and the related fear of litigation; and clinicians themselves sometimes being unaware of the true effectiveness or benefit-harm trade-offs of interventions. </p>
<p>But there may also be more subtle factors such as the regression-to-the-mean-effect. This means that as even when an intervention is ineffective, clinicians often see patients improve anyway and this can lead to the false belief that the intervention provided was responsible for the improvement.</p>
<p>Greed on the part of some clinicians who are less scrupulous is probably involved too, especially in largely fee-for-service environments. </p>
<p>But clinicians’ enthusiasm for their speciality is also likely to be a larger contributor. To the man with a hammer in his hand, the world looks like nails. Surgeons are more likely to recommend surgery, radiotherapists radiation oncology, physiotherapists to suggest physiotherapy, and so on. </p>
<p>The next question is does this matter? </p>
<p>Very much so. Overly optimistic expectations undoubtedly contribute to the ever increasing use of health services and the growing problem of over-diagnosis, where disease labels are given even though the latent disease might not have ever caused symptoms, and over-treatment, where unnecessary treatments given. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=800&fit=crop&dpr=1 600w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=800&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=800&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1005&fit=crop&dpr=1 754w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1005&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/67331/original/image-20141216-24294-ifkj6s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1005&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Every intervention has benefits and harms and both should be acknowledged and communicated.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/tojosan/4308897037">Tojosan/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span>
</figcaption>
</figure>
<p>There seems to be a <a href="http://www.ncbi.nlm.nih.gov/pubmed/17353491">vicious cycle</a> in which people have overly optimistic expectations about interventions and request them from their clinicians, who then provide them because it was requested, even if doing so causes the clinician discomfort. Receiving the intervention subsequently reinforces people’s belief that the intervention is beneficial and necessary and so the cycle continues. </p>
<p>Many payment systems favour providing an intervention rather than “just” talking with patients and there is the efficiency appeal of ordering a test or writing a prescription rather than taking the time and effort to explain to a patient why it may not be needed.</p>
<p>A third question is what can be done to counteract these unrealistic expectations? </p>
<p>Many groups have a role to play. Every intervention has benefits and harms and both should be acknowledged and communicated. This applies to: </p>
<ul>
<li><strong>researchers</strong> – harms are <a href="http://www.bmj.com/content/348/bmj.f7668">notoriously under-reported</a>, and even in our review, many more studies assessed expectations of benefit than harm, or benefit and harm</li>
<li><strong>journalists</strong> – media stories <a href="http://www.nejm.org/doi/full/10.1056/NEJM200006013422206">often portray</a> interventions in a misleading way</li>
<li><strong>health services and the pharmaceutical industry</strong> – for example, <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1388137/">screening invitations</a> and <a href="http://www.vaoutcomes.org/wp-content/uploads/2012/11/drug_ads.pdf">drug advertisements</a> often present information tilted towards or only about the benefits</li>
<li><strong>clinicians</strong> – conversations between patients and clinicians tend to focus on the benefits of interventions and may not address, or downplay, the harms. </li>
</ul>
<p>Patients, and indeed any individual who is considering a screen, test, or treatment, can also be involved in the solution. Beyond being aware of this tendency to assume that interventions help a lot and harm little, asking their clinician three questions before consenting to any intervention is a good habit to acquire. They are: </p>
<ul>
<li>what are my options?</li>
<li>what are the possible benefits and harms of each option?</li>
<li><a href="http://www.askshareknow.com.au">how likely</a> is it that each of those benefits and harms will happen to me?</li>
</ul>
<p>Asking these questions can trigger a conversation between clinician and patient that hopefully enables an informed decision to be made. </p>
<p>Similarly, the <a href="http://www.choosingwisely.org">Choosing Wisely campaign</a> underway in many countries (and on its way to Australia) provides evidence-based information for the public about interventions that are commonly used, yet may be unnecessary, and encourages a conversation between clinicians and patients. </p>
<p>Modern medicine is slowly moving towards a commitment to true partnerships between clinicians and their patients. Realising that people often come to consultations with preconceptions and expectations is a step closer to achieving this. </p>
<p>In the process of negotiating the best clinical option, clinicians should elicit the patient’s expectations and preconceptions about what they are expecting from the intervention, discuss any misperceptions, and provide accurate information about the benefits and harms of each management option. </p>
<p>Only then can any genuine “<a href="https://www.mja.com.au/journal/2014/201/1/shared-decision-making-what-do-clinicians-need-know-and-why-should-they-bother">shared decision making</a>” start to occur and perhaps the impact of these great expectations lessened.</p><img src="https://counter.theconversation.com/content/33845/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Tammy Hoffmann receives research funding from the NHMRC and book royalties for evidence-based practice books. </span></em></p><p class="fine-print"><em><span>Chris Del Mar receives research funding from the NHMRC, and book royalties.</span></em></p>“It might do me some good and it won’t hurt to give it a go.” How often have you heard a phrase like this? Most people have naïve optimism about medical care. That’s the finding of a systematic review…Tammy Hoffmann, A/Prof Clinical Epidemiology, Bond University; NHMRC Research Fellow, The University of QueenslandChris Del Mar, Professor of Public Health, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/326252014-11-17T19:17:14Z2014-11-17T19:17:14ZJustice for all: how should the law deal with false confessions?<figure><img src="https://images.theconversation.com/files/61014/original/zs2ms8vg-1412660883.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The vulnerability of mentally disordered people warrants a range of strong protections to prevent wrongful convictions</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/ensh/6204837462">Emmanuel Huybrechts/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>Confessions constitute strong evidence of wrongdoing, but not all of them are reliable. So what can the legal system do to ensure justice is done? A US judge is deciding on exactly this matter in <a href="http://www.newsday.com/news/new-york/judgerules-confessions-of-defendant-in-killing-of-etan-patz-won-t-be-made-public-1.9473910">a prominent trial</a> of a man accused of what The New York Times has described as “<a href="http://www.nytimes.com/2014/10/08/nyregion/judge-in-etan-patz-case-to-decide-if-defendant-understood-rights.html?_r=0">one of the most infamous crimes</a>” in the city’s history.</p>
<p>Pedro Hernandez, a 53-year-old man <a href="http://www.nytimes.com/2014/10/01/nyregion/accused-killer-in-etan-patz-case-is-called-unfit-to-confess.html?_r=1">described as being of limited intellect</a> and with a history of mental illness, is charged with the historical murder of Etan Patz. The six-year-old boy disappeared on his way to school in Manhattan in 1979. </p>
<p>The case remained unsolved for 33 years until <a href="http://www.nytimes.com/2012/05/25/nyregion/man-claims-he-strangled-etan-patz-police-say.html/nyregion/pedro-hernandez-indicted-in-killing-of-etan-patz.html">police arrested Hernandez on May 23, 2012</a>. He is said to have confessed after a <a href="http://www.nytimes.com/2014/09/19/nyregion/in-etan-patz-case-detective-says-lengthy-interview-preceded-a-confession.html">long day of “emotional” questioning</a>. </p>
<p>At issue now is Hernandez’s confession; the legal discussion has been about whether it should be admissible as evidence in his trial.</p>
<h2>Inbuilt biases</h2>
<p>There’s a strong body of evidence about confessions. In the past, a number of wrongful convictions have relied on false confessions: the <a href="http://en.wikipedia.org/wiki/Guildford_pub_bombings">Guildford Four</a> and the <a href="http://en.wikipedia.org/wiki/Birmingham_Six">Birmingham Six</a> are the most famous British cases.</p>
<p>While being questioned by police, a suspect may make a false confession while exhausted, intoxicated or withdrawing from drugs or alcohol; they may not understand the purpose of the interview or how their confession will be used in court; or their confession may be influenced by mental illness or intellectual disability.</p>
<p>In the case of Hernandez, it’s suggested he was not read the standard caution until six hours into the police interview in which he confessed to killing Patz. And that he did not understand his right to remain silent.</p>
<p>Most jurisdictions protect the rights of a suspect and generally ensure police caution them about such rights. They also allow the suspect to seek legal advice prior to interview. But research shows the wording of such cautions may require <a href="http://onlinelibrary.wiley.com/doi/10.1002/casp.658/abstract">language skills commensurate with mid-secondary schooling</a>.</p>
<p>Given the prevalence of <a href="http://informahealthcare.com/doi/abs/10.1080/00048674.2010.503650">mental disorders</a>, <a href="http://assets.justice.vic.gov.au/corrections/resources/36d7e731-e819-4ed3-972d-269b829b952d/acquired_brain_injury_in_the_victorian_prison_system.pdf">cognitive impairment</a> and <a href="http://informahealthcare.com/doi/abs/10.3109/17549507.2011.578661">language disorders</a> in the criminal justice system, the caution and language used may be too complex for a significant number of suspects. </p>
<p>An independent observer or an assessment of fitness for interview by a forensic medical officer or psychiatrist are possible safeguards, but both measures still rely on recognition of potential disorders by police.</p>
<p>Researchers who have <a href="http://books.google.com.au/books?hl=en&lr=&id=GtB65IADRjIC&oi=fnd&pg=PR7&dq=gudjonsson&ots=83a6O5BbAM&sig=ASxyGYldKbUCuGGyHZ99yYDj-XY#v=onepage&q=gudjonsson&f=false">investigated the basis of false confessions</a> highlight interrogation techniques and tactics that may increase untrue confessions, as well as characteristics of the person being questioned.</p>
<p>In particular, they propose some people are suggestible, will acquiesce, or are unduly compliant. In the context of an emotionally charged interview, they may be prone to confessing to offences they didn’t commit. Even when subsequently retracted, the confession evidence may be sufficient to result in conviction.</p>
<h2>The law’s disinterest</h2>
<p>In addition to structural and political biases that may be associated with incorrect findings of guilt, retrospective assessments of miscarriages of justice often note that a confession may prevent proper scrutiny of other – potentially exculpating – facts.</p>
<p>Evidence law provides a statutory framework to determine what material can be presented to a judge or jury. As in the Etan Patz case, there may be dispute about the understanding of a caution, the circumstances of interview and whether cognitive impairment or mental disorder resulted in <a href="http://heinonline.org/HOL/LandingPage?handle=hein.journals/mulr32&div=14&id=&page=">unreliable admissions</a>. </p>
<p>At issue here is a strong piece of evidence that may bring to justice the murderer in a shocking and emotional case. But the justice system shouldn’t be blinded by emotion or overlook troubling elements of a police interview and confession, as well as the characteristics of the accused person.</p>
<p>In Australia, the <a href="http://www.alrc.gov.au/inquiries/uniform-evidence-law">Uniform Evidence Law</a> has over recent years provided a robust framework to restrict the admission of evidence to what has been properly obtained. What’s more, the likelihood that evidence is probative (assists the court) must outweigh its potential unnecessarily to prejudice a judge or jury. </p>
<p>Nevertheless, we could still perhaps do more to ensure that vulnerable people are identified and appropriately supported during police interviews.</p>
<p>For Pedro Hernandez, the discussion about the admissibility of his confession may seem abstract and technical, involving mental health professionals and cognitive and psychiatric assessments. But the vulnerability of mentally disordered people warrants a range of strong protections to prevent erroneous convictions. These may otherwise diminish the reputation of the justice system.</p><img src="https://counter.theconversation.com/content/32625/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Danny Sullivan does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Confessions constitute strong evidence of wrongdoing, but not all of them are reliable. So what can the legal system do to ensure justice is done? A US judge is deciding on exactly this matter in a prominent…Danny Sullivan, Adjunct Senior Lecturer in Psychiatry, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/305182014-08-26T04:44:04Z2014-08-26T04:44:04ZDo we need a law to help people try experimental drugs?<figure><img src="https://images.theconversation.com/files/57321/original/mzjmtc4s-1409013619.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">People with life-threatening or incurable diseases may be willing to try experimental drugs and unproven treatments.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/wink/260268486">juicyrai/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span></figcaption></figure><p>People with life-threatening or incurable diseases may be willing to try experimental drugs and unproven treatments, but they face <a href="http://www.abc.net.au/news/2014-08-25/rogue-operators-charge-thousands-ineffective-stem-cell-treatment/5695360">the risk of exploitation</a>. Is the law the best avenue to ensure that they are protected while medical innovation is encouraged?</p>
<p>Protection of vulnerable people is a thread running through many laws, in Australia and elsewhere. In medical law, for instance, children and people with impaired decision-making capacity warrant special attention. </p>
<p>But what of the ordinary person diagnosed with a life-threatening disease? Such people are <a href="http://www.smh.com.au/national/stem-cell-treatment-warnings-after-australian-woman-dies-in-russia-20140728-zxrzt.html">vulnerable to harm</a> and potential exploitation when they <a href="http://www.ideal-collaboration.net/2014/02/what-is-surgical-innovation-a-qualitative-study-of-surgeons-views/">seek access to innovative</a>, experimental or unproven treatments that depart from the existing range of accepted medicine. </p>
<h2>Choice in medical decision making</h2>
<p>Personal autonomy is a well-entrenched <a href="http://www.austlii.edu.au/au/cases/cth/HCA/1992/58.html">guiding principle</a>
in medical decision making in Australia. An adult with the capacity to make decisions may refuse medical intervention if they wish, even if that treatment could preserve their life and be seen by doctors as being in their best interests. </p>
<p>A <a href="http://www.austlii.edu.au/au/cases/nsw/NSWSC/2014/302.html">recent NSW case</a>, for instance, required the courts to comment on the request by a young man, who had suffered quadriplegia since age seven, that his life-sustaining mechanical ventilation stop on his 28th birthday. The court confirmed doctors would be acting lawfully if they did so. </p>
<p>Conversely, <a href="http://www.austlii.edu.au/au/cases/nsw/NSWSC/2012/1609.html">courts rarely compel</a> doctors to provide treatment requested by a patient if that treatment is futile, or hopeless.</p>
<p>But what does hopeless mean in this context? To a dying person, a remote chance may be infinitely preferable to no chance at all. </p>
<p>Consider someone suffering from a rare and probably fatal neurological disorder who wants <a href="http://www.stemcellfoundation.net.au/docs/patient-handbook/the-australian-stem-cell-handbook.pdf?sfvrsn=4">stem cell treatment</a>. Apart from one or two exceptions, <a href="http://exahttp://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/rm01_stem_cell_treatment_quick_guide_131219.pdfmple.com/">such treatments</a> are currently unproven. Even if this person asks for early access to experimental treatment, it’s likely their [doctor will be cautious](http://es](https://www.mja.com.au/insight/2014/13/james-best-peddlixample.com/).</p>
<p>A medical professional may be concerned the treatment would do more harm than good by raising false hopes, or exposing patients to side effects. They may fear the impact of the person being diverted from partly beneficial conventional treatment or palliative care, or financial costs they would incur. Doctors may also worry about being sued if some of these risks eventuate. </p>
<p>Cases like these give rise to the question of whether the law strikes the right balance between encouraging medical innovation, promoting patient autonomy and protecting vulnerable people against harm and potential exploitation by maverick health-care providers. </p>
<h2>UK attempts at legalisation</h2>
<p>While not currently on the Australian law reform agenda, encouraging medical innovation has been the subject of wide public debate in England. It’s driven by the <a href="http://www.telegraph.co.uk/health/saatchi-bill/10870505/The-Saatchi-Bill-can-a-PR-guru-cure-cancer.html">sad personal story</a> of a man with a role in political life and a strong background in advertising. </p>
<p>Lord Maurice Saatchi lost his wife Josephine Hart <a href="http://www.cancerresearchuk.org/cancer-help/about-cancer/cancer-questions/primary-peritoneal-carcinoma"> to primary peritoneal cancer</a>. Writing in the <a href="http://www.dailymail.co.uk/news/article-2241693/Im-going-make-Parliament-cure-cancer-Lord-Saatchi-launches-bid-beat-disease-claimed-wife.html">Daily Mail newspaper</a> in late 2012, he wrote of his intention to introduce a Medical Innovation Bill, saying:</p>
<blockquote>
<p>The aim, in practical terms, is to change the way we treat patients, many of them terminally ill. The Bill’s ultimate goal is to help find a cure for cancer. </p>
</blockquote>
<p>The core of the suggested law reform is a provision that would not consider a doctor as being negligent if he or she departs from the existing range of accepted treatments, provided the decision follows an accountable, transparent process that considers all relevant matters. </p>
<p>The proposed <a href="http://medicalinnovationbill.co.uk/the-new-bill/">Medical Innovation Bill</a> has been through two drafts and a third may soon follow. The revisions all seek to give doctors more clarity and confidence if they wish to innovate. </p>
<h2>The challenge of balance</h2>
<p>Drafting the proposed law is difficult because of fears the reform will have the unintended consequence of protecting maverick, perhaps even exploitative, health providers who offer false hope to vulnerable patients as their lives draw to a close. </p>
<p>Many, including some <a href="http://www.aomrc.org.uk/doc_details/9752-academy-response-to-the-medical-innovation-bill-consultation">doctors groups</a>, particularly the <a href="bma.org.uk%20bmaresponselegislationencouragemedicalinnovation.pdf">British Medical Association</a>, and <a href="http://www.medicalprotection.org/uk/press-release/MPS-responds-to-DH-report-on-Medical-Innovation-Bill%E2%80%93the-Bill-is-still-unnecessary">insurers</a>, have questioned whether the bill is needed at all. </p>
<p>But the <a href="http://www.telegraph.co.uk/health/saatchi-bill/10798826/Saatchi-Bill-People-power-drives-the-fight-to-cure-cancer.html">strong public response</a> in support of the bill suggests the promotion of medical research and responsible innovation by treating doctors has widespread support. Perhaps the focus of the debate should shift to identifying and addressing practical barriers to medical innovation, such as adequate funding of medical research, rather than suspected but unlikely legal barriers.</p>
<p>Resources might be allocated to educating the public and assisting medical practitioners along the pathways to innovative practice, including participation in clinical trials (even trials involving only one person where this is clinically relevant and in the best interest of that patient) and existing ethical, legal and regulatory frameworks concerning medical research and innovation.</p>
<p>One example of this approach is the <a href="http://www.nhmrc.gov.au/media/releases/2013/nhmrc-warns-risks-associated-unproven-stem-cell-therapies-australia-and-overseas">recent publication</a> by the National Health and Medical Research Council (NHMRC) that provides practitioners with information to help them discuss stem cell treatments with patients. </p>
<p>In Australia, as in England, changing the law of medical negligence is probably not the best way to promote responsible medical innovation, even if the aim is to help people diagnosed with a life-threatening disease.</p><img src="https://counter.theconversation.com/content/30518/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bill Madden is employed by and holds shares in a law firm that conducts medical litigation for patients.</span></em></p><p class="fine-print"><em><span>Tina Cockburn does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>People with life-threatening or incurable diseases may be willing to try experimental drugs and unproven treatments, but they face the risk of exploitation. Is the law the best avenue to ensure that they…Tina Cockburn, Associate Professor, Australian Centre for Health Law Research, Queensland University of TechnologyBill Madden, Adjunct Professor, Australian Centre for Health Law Research, Queensland University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/291952014-07-15T04:38:28Z2014-07-15T04:38:28ZRisks versus rights in home birthing: a legal view<figure><img src="https://images.theconversation.com/files/53844/original/nmm8s54k-1405391996.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The legal landscape around rights and responsibilities for home births is growing increasingly complex.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/tom_focus/6381797933/in/photolist-aHWobR-MK25L-mv4XZv-fduoqb-94EcJg-iNpH9k-AwHaw-cZCJSu-6t4Hnw-9f7aPF-bvghrw-bJb4Fx-nhbGtv-iMfqi-7GjUsg-7GjVe6-5PL3xc-6BkEdN-Gdg8U-Gdkzz-bQYotr-6hr9nQ-7fPNHM-adeUNC-9DiuSn-b5EYdK-emy9z-8CptUB-fAdFfB/">Flickr: Thomas</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span></figcaption></figure><p>The ongoing and sometimes emotive debate about risks and rewards of giving birth in hospital or at home is nothing new. What is new is the attention being given to the legal rights and responsibilities of parents and health practitioners.</p>
<p>Consider <a href="http://www.sapolicenews.com.au/component/content/article/4-news/25742-police-probe-babies-death.html">this recent news</a>: South Australian police have announced criminal investigations of the deaths of two babies in home-birth deliveries. Detectives are said to be closely examining evidence given by witnesses during an earlier inquest to determine if perjury was committed or evidence was withheld or concealed. Charges, including manslaughter, may be laid.</p>
<p>This is a highly unusual development.</p>
<p>As a general rule, few health practitioners are subject to criminal charges in Australia, although the number has perhaps been growing in recent years. The <a href="http://www.austlii.edu.au/au/cases/vic/VSC/2013/93.html">imprisonment of Dr James Peters in Victoria</a> is a recent, albeit unusual, example.</p>
<p>Australia has not yet seen the prosecution of a midwife or doctor following a home birth – though we have seen cases come before disciplinary tribunals, coroners’ courts if the child has died, or civil courts if the child or mother is said to have suffered injury for want of reasonable care.</p>
<p>So how do parents wanting home births and their health-care providers now navigate the legal landscape?</p>
<h2>Risk assessment</h2>
<p>Central to legal arguments about home births is the assessment of risks and the provision of accurate information. The latter is crucial to the question of whether a mother’s decision about where she gives birth is well informed.</p>
<p>Only a few weeks ago, a <a href="http://www.coronerscourt.vic.gov.au/resources/d6ca3578-3cc8-4271-a13d-f576090c82ba/thomasfreemantle_420110.pdf">Victorian coroner reported</a> in relation to the death of a child, Thomas Freemantle, following a home birth. The birth was complicated by cephalo-pelvic disproportion, a condition whereby the baby’s head or body is too large to fit easily through the mother’s pelvis. </p>
<p>The parents agreed that medical practitioners had told them of the risks of a home birth given aspects of the mother’s medical history, but argued they were “not sufficiently firm in their advice that Thomas should be born at hospital”.</p>
<p>The coroner’s view was bluntly stated: “high-risk pregnancies demand birth occur in the safest setting – namely, a hospital which can provide emergency and timely, medical support”. He went on to say that “the safety of the child is paramount and … the wishes of the parents always secondary to ensuring the safest birthing process”. </p>
<p>But it may not be entirely true, in the legal sense, to say the wishes of parents are always secondary to ensuring the safest birthing process. While the coroner spoke in favour of unambiguous communication, that does not guarantee a mother will always simply accept the given advice (whether by doctors or midwives).</p>
<h2>The rights of mothers</h2>
<p>An example of advice being given but not accepted can be found in a <a href="http://www.austlii.edu.au/au/cases/vic/VCAT/2014/771.html">decision earlier this month</a>, where a hospital had declined to provide a mother with home birth services under its program because of medical concerns – namely, her age and the number of her earlier pregnancies. </p>
<p>The mother argued the hospital’s refusal was discriminatory and in breach of her human rights, but the Victorian Civil and Administrative Tribunal found the medical advice was sound. Neither argument by the mother, as to discrimination or breach of human rights, succeeded. </p>
<p>This returns us to the earlier suggestion (by the Victorian coroner) that the wishes of parents are always secondary to ensuring the safest birthing process. The mother (having been refused participation in the hospital’s home birth program) simply chose to deliver at home without a midwife in attendance, as she appears to have done on five prior occasions. </p>
<p>The law recognises that a mother, when not clearly lacking the capacity to make decisions, is able to decide where to give birth freely, regardless of advice about the safest birthing process.</p>
<p>Further complications for mothers may arise in assessing the quality of advice provided to them. Not all advice is good advice, not all care is good care. <a href="http://billmaddens.wordpress.com/2014/03/11/home-births-permanent-prohibition-on-provision-of-midwifery-services/">Disciplinary case examples</a> highlight that unfortunate reality.</p>
<h2>Making sense of it all</h2>
<p>So what are the emerging legal trends? While this area of law seems under constant development, perhaps the following can be safely said:</p>
<ul>
<li><p>health practitioners should give clear and sometimes robust advice about the risks of home birth in the context of known medical history, so mothers can make informed choices.</p></li>
<li><p>a mother has the right to choose where to deliver her child, but that does not extend to forcing a health-service provider to allow a home birth service it has decided is unsafe for her or her unborn child, in accordance with accepted clinical practice.</p></li>
<li><p>for those health practitioners and providers who offer services unsafe for the patient or the unborn child, existing civil and disciplinary action precedents may soon be followed by criminal charges.</p></li>
</ul><img src="https://counter.theconversation.com/content/29195/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bill Madden does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The ongoing and sometimes emotive debate about risks and rewards of giving birth in hospital or at home is nothing new. What is new is the attention being given to the legal rights and responsibilities…Bill Madden, Adjunct Fellow, Western Sydney UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/223062014-01-24T03:28:08Z2014-01-24T03:28:08ZHealth-care providers – a different class of criminal?<figure><img src="https://images.theconversation.com/files/39805/original/yyb98bsq-1390522905.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Our legal system already has provisions in place capable of responding to criminal conduct by health-care workers.</span> <span class="attribution"><span class="source">Image from shutterstock.com</span></span></figcaption></figure><p>Should Australian health-care workers face criminal penalties if they wilfully or recklessly neglect or mistreat patients? The United Kingdom is currently <a href="http://www/bmj/com/cgi/doi/10.1136/bmj.g133">grappling with this question</a> after systemic failures in care and treatment of patients at the <a href="http://www.midstaffs.nhs.uk/">Mid Staffordshire NHS Foundation Trust Hospital</a> (MSNFTH) contributed to radically higher death rates than in comparable hospitals elsewhere in the UK.</p>
<p>Australia’s recent experience with the trials of former Bega gynaecologist <a href="http://www.austlii.edu.au/au/cases/cth/HCA/2013/57.html">Graeme Reeves</a> and Bundaberg surgeon <a href="http://www.austlii.edu.au/au/cases/cth/HCA/2012/29.html">Jayant Patel</a> are likely to see similar proposals mooted here. But is this the best way of ensuring patient safety?</p>
<p>Provisions criminalising wilful or reckless neglect or mistreatment of mentally ill and child patients already exist in the UK. Supporters of recommendations in the <a href="https://www.gov.uk/government/publications/berwick-review-into-patient-safety">Berwick review </a> and <a href="http://www.midstaffspublicinquiry.com/report">Francis enquiry</a> into UK patient safety argue that these sanctions should be extended to cover all patients. This would plug a hole in the existing legal framework, they say, where a gross, but unintentional, error can attract criminal sanctions, but a wilful or reckless act or omission cannot. </p>
<p>The Australian regime differs from the UK. In the most serious cases, practitioners can be charged with criminal offences. More commonly, claims of negligence or misconduct are dealt with by professional disciplinary tribunals, or as civil claim in negligence or trespass.</p>
<p>Our forthcoming research examining cases in the UK and Australia where health professionals have been charged with these offences reveals that the trials are long and complex, with low conviction rates, frequent appeals, and comparatively light penalties. </p>
<p>Furthermore, the penalties fail to distinguish between a defendant who made a decision to act – or not act – in a way that was recklessly or wilfully negligent, and a defendant who wilfully or recklessly failed to make a decision about their course of action – sticking their heads in the sand, rather than facing the circumstances.</p>
<p>This is particularly relevant in the context of patients who have given specific instructions, such as <a href="https://theconversation.com/planning-your-endgame-advance-care-directives-4250">advanced care directives</a> (AD), in anticipation of their future care. A practitioner who is aware of a “do not resuscitate” clause in a patient’s AD, and follows the patient’s wishes, could be exposed to the same criminal sanctions as a practitioner who simply refuses to acknowledge that a patient requires resuscitation, panics, or withholds resuscitation regardless of patient wishes. </p>
<p>Such a law is likely to see practitioners engage in defensive medicine, or behave paternalistically, providing futile treatment in contravention of patient wishes and eroding patient autonomy.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/39806/original/btrjhz85-1390523224.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/39806/original/btrjhz85-1390523224.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=422&fit=crop&dpr=1 600w, https://images.theconversation.com/files/39806/original/btrjhz85-1390523224.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=422&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/39806/original/btrjhz85-1390523224.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=422&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/39806/original/btrjhz85-1390523224.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=530&fit=crop&dpr=1 754w, https://images.theconversation.com/files/39806/original/btrjhz85-1390523224.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=530&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/39806/original/btrjhz85-1390523224.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=530&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Whistleblowers who report potential harms need greater protections.</span>
<span class="attribution"><span class="source">Image from shutterstock.com</span></span>
</figcaption>
</figure>
<p>Should health-care providers even be singled out in criminalising this type of conduct? There are many other examples of employees who, if they wilfully or recklessly act or fail to act, can potentially maim or kill many people. Bus drivers, safety inspectors, pilots and engineers are a few that spring to mind. </p>
<p>As the <a href="http://www.brisbanetimes.com.au/queensland/jayant-patel-finally-leaves-queensland-20131122-2y0aq.html">Patel</a> and <a href="http://www.smh.com.au/nsw/butcher-of-bega-graeme-reeves-released-from-jail-20131228-300fo.html">Reeves</a> cases show, health-care providers who act criminally in the course of providing health care are not above the law. Charges of assault and battery, manslaughter, sexual assault, criminal negligence, and fraud can still be laid. </p>
<p>In the UK, the number of doctors charged with manslaughter has <a href="http://jrs.sagepub.com/content/99/6/309.full">soared</a> since the 1990s. Prosecution generates headlines but doesn’t necessarily improve health. That’s because legal requirements for conviction often can’t be met. It’s also because it fosters <a href="http://qje.oxfordjournals.org/content/111/2/353.full.pdf">defensive medicine</a> that is not in the interests of individual patients or the overall health system. We should be wary about demonising doctors and other health-care workers.</p>
<p>The greatest limitation on these laws in terms of achieving patient safety objectives is their focus on harms – the “hits” – at the expense of the “near misses”. It is these “near misses” which allow health-care facilities to respond to safety issues proactively – ideally <em>before</em> anyone is harmed. Without a harm – a dead or injured patient – there can be no offence. </p>
<p>Criminalisation without adequate support for reporting, complaint resolution, and accountability and transparency creates a culture of fear and cover-up within health care. </p>
<p>A more reasoned approach would be to <a href="https://web.archive.org/web/20120320065040/http://www.qphci.qld.gov.au/Default.htm">increase protections for whistleblowers and enhance mandatory reporting</a> of safety breaches. We should ensure that independent statutory authorities are empowered and resourced to conduct own motion enquiries and thorough investigations of complaints, reporting direct to parliament, rather than a minister. </p>
<p>Finally, criminalisation of this type could potentially free employers from liability for the conduct of their employee health-care workers on the basis that the conduct was criminal. </p>
<p>Employers have a responsibility to supervise what goes on in their hospitals. Dysfunctional reporting and quality assurance procedures in a culture focused on financial targets were identified as significant factors in the harm at MSNFTH. Criminalisation of the kind proposed would not have prevented the harm, nor will it bring back those patients who died, or reverse the harms suffered by others. </p>
<p>Australia is yet to experience a scandal on the scale of MSNFTH. To avoid it, a better strategy would be to ensure that our regime emphasises systemic improvement in health-service delivery rather than being driven by moral panics founded on perceptions that every incident has someone who should be punished – preferably with incarceration. </p>
<p>Our legal system already has provisions in place capable of responding to criminal conduct by health-care workers; creating a separate class of offences specifically targeting health-care workers is unlikely to improve patient safety. </p><img src="https://counter.theconversation.com/content/22306/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Should Australian health-care workers face criminal penalties if they wilfully or recklessly neglect or mistreat patients? The United Kingdom is currently grappling with this question after systemic failures…Wendy Bonython, Assistant Professor, School of Law- Torts, Health and Biotechnology, University of CanberraBruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/220762014-01-21T03:31:40Z2014-01-21T03:31:40ZBrain death, pregnancy and ethics: the case of Marlise Munoz<figure><img src="https://images.theconversation.com/files/39465/original/2hcjqtgn-1390260381.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Marlise’s husband and parents say her body is being used as an incubator.</span> <span class="attribution"><span class="source">Image from shutterstock.com</span></span></figcaption></figure><p>In November, 33-year-old Texas woman Marlise Munoz <a href="http://www.nytimes.com/2014/01/08/us/pregnant-and-forced-to-stay-on-life-support.html?_r=0">collapsed</a> at her Fort Worth home after suffering a suspected blood clot in her lungs. She was later declared brain dead. </p>
<p>When the hospital determined that she was 14 weeks pregnant, it continued to support her biological life under a Texas law that prohibits the withdrawal of life support from a pregnant patient. </p>
<p>Marlise’s body is now 21 weeks pregnant; at 24 weeks, doctors will <a href="http://www.wfaa.com/news/local/Lawyers-Munntildeoz-is-not-in-a-coma-shes-dead-241039421.html">attempt to determine</a> whether the fetus can function independently and decide how to proceed. </p>
<p>But is it ethical to keep a brain dead pregnant woman alive to sustain the pregnancy? It’s a tough question to answer, even for those with strong views on abortion, withdrawal of treatment and advance care planning. </p>
<h2>The law</h2>
<p>Similar laws prevail in roughly half the states of the US, albeit in variable form. The Texas law is among the most restrictive: regardless of the progression of the pregnancy, a woman must remain on life-sustaining treatment until she gives birth. </p>
<p>There is <a href="http://www.centerwomenpolicy.org/programs/health/statepolicy/documents/REPRO_PregnancyExclusionsinStateLivingWillandMedicalProxyStatutesMeganGreeneandLeslieR.Wolfe.pdf">considerable variation</a> elsewhere, with factors including the probability that the fetus will develop to the point of birth, and the existence of advance wishes of the mother, playing variable limiting roles. Some states have no relevant legislation, while a small number allow women to state positive wishes about pregnancy in their advance care plans. </p>
<p>Australian jurisdictions have no such pregnancy-triggered restrictions for advanced care planning. </p>
<p>Marlise’s husband and parents have objected to continued life support on the basis of Marlise’s advance wishes that her life not be sustained in such circumstances, and that her body is now being utilised as an incubator.</p>
<p>The hospital considers that it is upholding existing law, but this has been strongly challenged. The <a href="http://www.statutes.legis.state.tx.us/Docs/HS/htm/HS.166.htm">relevant legislation</a> defines life-sustaining treatment as that which “sustains the life of a patient and without which the patient will die”. </p>
<p>But by definition, life-sustaining treatment cannot be provided to someone who is dead, and Marlise’s parents maintain that they were told she was brain dead some weeks ago. </p>
<p>Her husband has since <a href="http://www.latimes.com/opinion/commentary/la-oe-caplan-pope-texas-pregnancy-life-support-20140116,0,3476520.story#axzz2qXeV8XWC">lodged a lawsuit</a> against the hospital in order to have treatment removed.</p>
<h2>Ethical dilemma</h2>
<p>The ethical dilemma in this case arises from the complex interrelation of distinct issues such as abortion, withdrawal of treatment and advance care planning. </p>
<p>To what extent, for example, should the now well-recognised right to refuse treatment in advance, and the right for families to make decisions for loved ones who have lost decision-making capacity, be modified by the rights of the developing fetus? </p>
<p>And how do we balance the interests of the state in preserving the life of the fetus against <a href="http://healthland.time.com/2014/01/10/why-the-dad-has-no-say-in-dismal-texas-brain-death-case/">those of the father</a>, who may be forced to care for a new infant in the absence of its mother, and with possibly significant medical problems?</p>
<p>The question of fetal status is often overlooked, or presupposed, when pro-abortion advocates invoke women’s rights over their bodily integrity as the only consideration relevant to abortion. Given what abortion amounts to, it cannot be ethically or legally legitimate in the absence of an account that explains why fetuses do not deserve the same moral consideration as children and adults. </p>
<p>The legislatures of states such as Texas that insist on sustaining the life of the severely compromised mother, to maximise the chances that the fetus survives, reflect the belief that no such account holds water. This, in turn, reflects the greater religious influence on politics in these jurisdictions than in Australia, where a number of states and territories have <a href="http://www.abc.net.au/news/2013-11-22/tasmania-removes-abortion-criminal-code/5109554">liberalised abortion law</a>.</p>
<p>Some people may see the recently introduced <a href="https://theconversation.com/zoes-law-will-changing-foetuses-legal-status-endanger-abortion-rights-18096">Crimes Amendment (Zoe’s law) Bill 2013</a> in New South Wales as a threat to abortion rights. The Bill would criminalise grievous bodily harm to a fetus of 20 weeks gestation or more by recognising the fetus as a legal person. </p>
<p>However, similar <a href="http://www.austlii.edu.au/au/legis/qld/consol_act/cc189994/s313.html">1996 legislation in Queensland</a>, albeit not explicitly bestowing legal personhood on the fetus, has not impeded access to abortion. And the Bill explicitly exempts “anything done by or with the consent of the pregnant woman that causes the destruction of or harm to a fetus”.</p>
<h2>Life of the fetus</h2>
<p>There are <a href="http://www.ncbi.nlm.nih.gov/pubmed/3392814">precedents</a> for maintaining the biological life of a brain-dead mother to sustain the pregnancy. Over 30 years ago, a 27-year-old woman who was 22 weeks pregnant was sustained, albeit in a brain-dead state, for nine weeks before the delivery of a normal, healthy baby. </p>
<p>Interestingly, the ethicists <a href="http://www.ncbi.nlm.nih.gov/pubmed/3392814">reporting on the case</a> stated that maternal autonomy ceased with her death and that even a refusal expressed before death should not override the obligation to save endangered fetal life.</p>
<p>If Marlise’s husband’s lawsuit is successful and her life-support is switched off, it would mean that not even the restrictive law in Texas is sufficient to provide the protection for the fetus that some Texans and others would like. </p>
<p>There have been <a href="http://www.centerwomenpolicy.org/programs/health/statepolicy/documents/REPRO_PregnancyExclusionsinStateLivingWillandMedicalProxyStatutesMeganGreeneandLeslieR.Wolfe.pdf">calls</a> for women to receive better information about what their state advance care planning laws stipulate in relation to pregnancy. But the more fundamental need is to continue working towards greater coherence, across national and international jurisdictions, on how we should value the life of the fetus. </p><img src="https://counter.theconversation.com/content/22076/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Malcolm Parker receives funding from the Australian Research Council.</span></em></p>In November, 33-year-old Texas woman Marlise Munoz collapsed at her Fort Worth home after suffering a suspected blood clot in her lungs. She was later declared brain dead. When the hospital determined…Malcolm Parker, Professor & Head of Ethics, Law and Professional Practice, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/89712012-08-24T06:25:36Z2012-08-24T06:25:36ZHigh Court orders a retrial after upholding Jayant Patel’s appeal<figure><img src="https://images.theconversation.com/files/14613/original/4h28t646-1345780176.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Dr Jayant Patel (centre), walks with his wife Kishoree (right) and defence barrister Michael Byrne (left) to the Brisbane Supreme Court on Friday.</span> <span class="attribution"><span class="source">Dave Hunt/AAP</span></span></figcaption></figure><p>The High Court has handed down its decision on Jayant Patel’s appeal against his conviction on three counts of manslaughter and one count of grievous bodily harm. </p>
<p>It unanimously upheld Patel’s appeal on the basis that there was a miscarriage of justice, and has ordered a retrial. He has been granted bail ahead of a retrial.</p>
<h2>Issues of contention</h2>
<p>There were two grounds on which Patel’s lawyers based their appeal. The first was that miscarriage of justice occurred because the prosecution brought its case under the wrong section of Queensland’s Criminal Code (section 288). That section seems only to apply to the actual performance of surgery: requiring that surgery be performed with a reasonable standard of care and skill. It doesn’t seem to apply to a decision to recommend surgery in the first place. </p>
<p>By day 43 of Patel’s trial, the issues had been narrowed down to whether the surgery should have been performed at all. On this basis, Patel’s defence argued that section 288 couldn’t apply because it didn’t concern the decision to recommend the surgery. The trial judge and the Court of Appeal held that it did. And the High Court agreed, dismissing this aspect of Patel’s appeal. </p>
<p>The second ground of appeal was that the prosecution radically changed its case on the 43rd day of the trial. This meant that a lot of irrelevant evidence had already been put before the jury and was likely to have influenced the jury’s verdict, resulting in a miscarriage of justice. </p>
<p>During the trial, Patel’s team sought to discharge the jury for this reason, but failed. And the Court of Appeal rejected their appeal on this ground. But the members of the High Court unanimously upheld Patel’s appeal, and have ordered a retrial.</p>
<h2>The court’s reasoning</h2>
<p>The reason for the High Court’s decision is that, before the Crown had narrowed its case down to the decision to operate at all, evidence had been presented that Patel had been incompetent and grossly negligent in the way in which he had carried out the surgery, and in the post-operative treatment he supervised. </p>
<p>By the time these claims had been abandoned, however, that irrelevant evidence had already been placed before the jury. This was likely to have influenced their decision on the much narrower issue of whether the surgery should have been undertaken at all. Regardless of whether the allegations had a strong basis, once it is conceded that they are not relevant to the case, they should not go before the jury.</p>
<h2>Broader implications</h2>
<p>The court’s decision on the first ground (that section 288 could apply to decisions to carry out surgery at all) is most important in terms of legal implications. The wording of the section seems to restrict the meaning of “surgical treatment” to the act of carrying it out, because it says that the person must have reasonable skill and use reasonable care “in doing such act”. The words “in doing such act” seem to refer to the act of doing the surgery, not to any decision to do it in the first place. </p>
<p>But the High Court, perhaps surprisingly, found that the provision is “not ambiguous” (Heydon J) and that those words do capture “the formation of a judgement about whether surgery should be recommended”. </p>
<p>Indeed, Heydon J goes further and holds that they also include “advice not to undergo particular forms of surgery”. This seems to be a natural consequence of the High Court’s finding, because, as the trial judge noted, if the word “act” included the recommendation of the surgery, the only way in which the duty to exercise reasonable care and skill could be satisfied by Patel is by advising against the surgery. </p>
<p>This has the odd implication that a decision not to do surgery is itself surgical treatment, and it also means that under this section, what the law would normally classify as an omission (a decision not to undertake surgery) is an act. It also means that “undertaking” includes a decision not to undertake surgery, which is perhaps another oddity. </p>
<p>The joint judgement made it clear, however, that there could be no responsibility for a death or grievous bodily harm without the physical act of surgery. This means that, according to the joint judgement, the only decisions caught would be those which recommend surgery and then proceed with it, when the recommendation is grossly negligent. </p>
<p>Although perhaps strained, the upshot of the decision is that it is now clear beyond doubt that a person can be prosecuted for gross negligence for recommending surgery that should not have been recommended, even if the surgery was itself carried out competently.</p><img src="https://counter.theconversation.com/content/8971/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew McGee does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The High Court has handed down its decision on Jayant Patel’s appeal against his conviction on three counts of manslaughter and one count of grievous bodily harm. It unanimously upheld Patel’s appeal on…Andrew McGee, Lecturer, Faculty of Law, Queensland University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/38452011-10-20T19:35:25Z2011-10-20T19:35:25ZVioxx withdrawal: making sense of the fight for compensation in Australia<figure><img src="https://images.theconversation.com/files/4600/original/4825051772_5205c60302_b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Vioxx was withdrawn from the Australian market in October 2004 and there's an ongoing compensation case.</span> <span class="attribution"><span class="source">DaGoaty/Flickr</span></span></figcaption></figure><p>The enormous medical impact of modern pharmaceuticals has on occasion been matched by some large-scale litigation regarding adverse events. The Vioxx litigation in Australia and <a href="http://www.merck.com/newsroom/vioxx/">elsewhere</a> is one such recent example. </p>
<p>The Federal Court last week <a href="http://www.theage.com.au/national/drug-company-wins-appeal-over-vioxx-lawsuit-20111012-1ll84.html">overturned a ruling</a> that could have seen up to 1500 former Vioxx users who suffered heart attacks or other forms of cardiovascular disease claim compensation from Vioxx’s manufacturer Merck.</p>
<p>In Australia, <a href="http://www.msd-australia.com.au/content/corporate/index.html">Merck Sharp & Dohme (Australia) Pty Limited</a> recalled Vioxx in October 2004; it was <a href="http://www.abc.net.au/news/2011-10-12/vioxx-compensation-decision-overturned/3554542?section=business">reported as the biggest drug recall in history</a>. </p>
<p>The <a href="http://www.tga.gov.au/safety/recalls-medicine-vioxx-041001.htm">Therapeutic Goods Administration (TGA) notice</a> indicates the decision followed a then-recent clinical study showing increased risk of cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment (on the 25mg dose).</p>
<p>The withdrawal raised many questions – was the manufacturer of Vioxx negligent? Was Vioxx defective? Is compliance with the TGA regime a sufficient defence to claims by consumers?</p>
<h2>Local litigation</h2>
<p>The Australian litigation began in 2006. Mr Peterson was the applicant in a representative proceeding alleging the use, by him and others, of Vioxx contributed to various kinds of cardiovascular disease. </p>
<p>His claim, heard before Justice Jessup, succeeded in 2006, although various aspects of <a href="http://www.austlii.edu.au/au/cases/cth/FCA/2010/180.html">that decision</a> were the subject of an appeal by Merck and cross appeal by Mr Peterson.</p>
<p>Earlier this month, the <a href="http://www.austlii.edu.au/au/cases/cth/FCAFC/2011/128.html">Full Court of the Federal Court of Australia considered & reversed</a> a number of crucial findings made against Merck in the <a href="http://www.austlii.edu.au/au/cases/cth/FCA/2010/180.html">2010 decision</a>, where Mr Peterson had succeeded.</p>
<h2>Why the different outcome? </h2>
<p>The main issue regarded cause – was the evidence enough to meet the legal test for causation, such that Mr Peterson could show Vioxx caused his myocardial infarction. </p>
<p>The trial judge said yes, but all three members of the Full Court took the opposite view.</p>
<p>Tort lawyers will focus in particular on the court’s acceptance of the principle that in common law, negligently increasing the risk of harm is, alone, insufficient for a conclusion of causation by material contribution to that harm. </p>
<p>This issue isn’t limited to litigation about medicines – judgments from the High Court of Australia are expected soon on similar problems in cases regarding asbestos exposure and the development of ill health.</p>
<p>The court appears to have accepted that the use of Vioxx doubled the risk of myocardial infarction. But a small, absolute risk may be doubled without making it a likely source of injury. </p>
<p>While it was possible that Vioxx consumption was a cause of Mr Peterson’s infarction, he was, by reason of his age, gender, medical issues and history of smoking, within a cohort of which 25% was expected to suffer a heart attack within five years. </p>
<p>Mr Peterson may simply have been the unlucky one. </p>
<h2>Some caveats</h2>
<p>The court was careful to point out that there may be other people who used Vioxx, in a different position to Mr Peterson, who would perhaps be able to prove Vioxx was the probable cause of their condition.</p>
<p>Notwithstanding the causation finding against Mr Peterson, the court held that Vioxx had a defect within the meaning of s 75AC Trade Practices Act. </p>
<p>The defect was one which affected some people, not all. It said, in some people, by a mechanism not known, Vioxx increased the risk of myocardial infarction and the product provided no information, advice or warning about this effect. </p>
<p>But the state of scientific or technical knowledge at the time when the goods were supplied by Merck, was not such as to enable that defect to be discovered.</p>
<p>The court was unwilling to assume from the wording of the Therapeutic Goods Act that the company had the intention to abrogate the common law rights of individual consumers. </p>
<p>Mere compliance with the TGA system wasn’t enough to exhaust the manufacturer’s obligation to exercise reasonable care. </p>
<p>The Vioxx story in Australia may well have a third chapter to be written, as Mr Peterson may choose to seek leave to appeal to the High Court of Australia. </p>
<p>Other consumers of the medication who are in a different position to Mr Peterson may wish to pursue their claims.</p><img src="https://counter.theconversation.com/content/3845/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Bill Madden is an adjunct fellow, University of Western Sydney School of Law. He is also a lawyer employed by Slater & Gordon, a law firm that represented Mr Peterson in the Vioxx litigation, but was not involved in the conduct of the litigation. The views expressed are personal views and not those of Slater & Gordon.</span></em></p>The enormous medical impact of modern pharmaceuticals has on occasion been matched by some large-scale litigation regarding adverse events. The Vioxx litigation in Australia and elsewhere is one such recent…Bill Madden, Adjunct Fellow, Western Sydney UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/22222011-08-29T08:13:49Z2011-08-29T08:13:49ZMonday’s medical myth: osteoarthritis can be ‘cured’<figure><img src="https://images.theconversation.com/files/3055/original/Algo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">There aren't any miracle cures but there are a number of treatments that can reduce its severity.</span> <span class="attribution"><span class="source">Flickr/Algo</span></span></figcaption></figure><p>Switch on daytime television on any given day and you’d be forgiven for thinking there was a cure for the debilitating and dreaded condition, osteoarthritis. </p>
<p>Unfortunately, there’s not. And that’s not from want of trying. With the exception of the common cold, no everyday health problem has been as extensively studied with such little result.</p>
<p>Osteoarthritis is the most common form of arthritis, <a href="http://www.aihw.gov.au/publication-detail/?id=6442468397&libID=6442468395">affecting around 1.6 million Australians</a>. The hallmark of osteoarthritis is loss of cartilage which lines major joints – this causes the classic symptoms of pain and stiffness in the affected joints. </p>
<p>Or does it? One of the major frustrations in osteoarthritis research is the absence of <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2805%2971086-2/abstract">research showing the correlation</a> between the state of joints on X-rays and the degree of pain and disability the operator of the joint experiences. </p>
<p>To work out what creates the pain in osteoarthritis, researchers need to look beyond the joint.</p>
<p>Many studies using magnetic resonance imaging (MRIs) suggest the <a href="http://www.ncbi.nlm.nih.gov/pubmed/16713310">bone marrow around the joint</a> is a potent source of pain. And further away, in the spinal cord and brain, there may be <a href="http://www.ncbi.nlm.nih.gov/pubmed/19714588">abnormal processing of pain signals</a>. </p>
<p>When you add the standard physiological, genetic and psychological complexities common to all types of long-term pain, you begin to see why finding durable, meaningful relief from osteoarthritis pain is so difficult. </p>
<p>What osteoarthritis sufferers don’t need is to be presented with a steady stream of fake and cynical products which reflect none of this hard-won knowledge. </p>
<p>Tabloid media, particularly television, often feature products promising relief from arthritis pain. <a href="http://www.youtube.com/embed/G2nZbJLS2C4">This story from A Current Affair</a> is fairly typical of the genre. The product is usually presented as an infomercial, with no critical analysis from the reporter. A couple of testimonial cases are then wheeled out for breathless adoration. </p>
<p>There is also invariably some type of pseudoscientific angle presented as an explanation for the miraculous healing powers of the product. It’s often cast as a “secret breakthrough” discovered by a lone misunderstood genius, who is persecuted by vested interests in the pharmaceutical industry. </p>
<p>So how does this type of misinformation make its way onto our television screens and magazines?</p>
<p>The <a href="http://tgacc.com.au/codeList.cfm">Therapeutic Goods Advertising Code</a> contains what would be robust protection for consumers – if it were adequately policed.</p>
<p>But the Code is held in such low regard by product manufacturers and distributors that some <a href="http://www.tga.gov.au/industry/cm-post-listing-compliance-reviews.htm">don’t bother to follow the Code</a>. Others don’t do their research to understand the Code before tipping thousands of dollars into promoting their questionable devices or pills. </p>
<p>Many of the less scrupulous operators simply ignore TGA sanctions, or <a href="http://www.tgacrp.com.au/index.cfm?pageID=13&special=complaint_single&complaintID=1844">make the minimum required changes to their advertising</a>, while maintaining claims about efficacy. </p>
<p>Cynics can chuckle that there’s no great harm in condoning this thriving industry built on deceptive advertising. They may even say it’s a tax on gullibility. </p>
<p>But it makes things much harder for those of us whose careers involve trying to steer these osteoarthritis sufferers towards the <a href="http://www.mja.com.au/public/issues/180_05_010304/seg10357_fm.html">proven interventions that can reduce their disability and pain</a>. </p>
<p>There aren’t any miracle cures for osteoarthritis but there are evidence-based measures to treat the condition or reduce its severity. These include:</p>
<ul>
<li><p>peer-led education groups; </p></li>
<li><p>carefully tailored weight loss; </p></li>
<li><p>cognitive-behavioural treatment; </p></li>
<li><p>judicious medication use; and </p></li>
<li><p>joint replacement.</p></li>
</ul>
<p>These measures aren’t glamorous and challenge sufferers’ beliefs about their pain and their lifestyle. This type of change is hard for individuals to contemplate, and difficult to resource and implement. </p>
<p>For the average Australian without much scientific background, it’s easy to see the attraction of a simple and compelling story about a miraculous cure. </p>
<p>So what’s the solution? </p>
<p>Well, for a start, health-care professions should do more to educate consumers about dodgy arthritis products and avoid lending our professional credibility to endorsing them.</p>
<p>And the government needs to step in with some ruthless regulation.</p><img src="https://counter.theconversation.com/content/2222/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Michael Vagg does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Switch on daytime television on any given day and you’d be forgiven for thinking there was a cure for the debilitating and dreaded condition, osteoarthritis. Unfortunately, there’s not. And that’s not…Michael Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist, Barwon HealthLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/16852011-08-19T04:20:18Z2011-08-19T04:20:18ZYou want to see your teen’s medical records, but should you have the right?<figure><img src="https://images.theconversation.com/files/2604/original/Ed_Youdon.jpg?ixlib=rb-1.1.0&rect=10%2C17%2C629%2C392&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Teens have a right to confidential and private health care. </span> <span class="attribution"><span class="source">Ed Yourdon</span></span></figcaption></figure><p>If your teenage daughter was sexually active and wanted to go on the pill, you’d want to know, right? Well, think back to when you were her age – would you have told your parents? </p>
<p>These questions were the subject of a recent <a href="http://www.jahonline.org/article/S1054-139X(11)00055-3/abstract">Melbourne study of parental views</a> of adolescent’s right to confidential health care.</p>
<p>The study, which took place in a specialist Adolescent Medicine clinic, found the majority of parents surveyed (86%) believed they should be informed by their adolescent’s treating health professional about their health problems and behaviours, regardless of whether their child agreed. </p>
<p>For clinicians, confidential care underpins best practice in adolescent health. But so does working with parents and families to support young people who have health problems. </p>
<p>These seemingly opposite approaches raise a number of ethical, legal and health-care issues for health professionals who treat young people.</p>
<h2>Legal framework</h2>
<p>In Australia, confidential health care is a human right enshrined in law. And medical practitioners can be sued for breaching patient confidentiality. </p>
<p>There are many exceptions to this, such as a patient giving permission for their information to be shared – with partners, parents or family members – or when a person is deemed at serious risk of harm to themselves or others. </p>
<p>If a child under 16 years is considered to be at risk of harm then health professionals are mandated by law to notify child protection authorities (except Western Australia, where health professionals are only required to report sexual abuse). </p>
<p>The definition of “risk of harm” varies between jurisdictions, as does the classification of who constitutes a “mandatory reporter”. </p>
<p>While there are many other legal exemptions to confidential health care, these are the most pertinent in the day-to-day clinical care of adolescent patients.</p>
<p>In practice, this means that a teenager who sits in a consulting room with his or her doctor can rely on their doctor to keep confidential any information they disclose unless an exemption applies. </p>
<h2>How old is old enough?</h2>
<p>There is no lower age limit, and this is the case if the young patient has presented themselves to a health service independently, or if they see you while mum or dad waits in the waiting room. </p>
<p>So imagine Maya, aged 15, nervously attending the family GP by herself for the first time, worried about pregnancy following an unprotected but consensual sexual encounter two days earlier with her 15-year-old boyfriend of several weeks. </p>
<p>Unless this incident led the GP to strongly suspect abuse, assault, or imminent risk of harm to self or others, the doctor is legally bound to keep this information confidential – even if Maya’s mother visits the next day for her routine Pap smear and mentions her concern about Maya’s boyfriend distracting her from her school work.</p>
<p>If Maya wanted to discuss emergency or ongoing contraception with her GP, a different legal framework comes into play. The right to consent to your own medical treatment kicks in at the age of legal majority, which is 18 years. </p>
<p>But common law allows for a medical practitioner to assess a legal minor for their competence to consent to their own treatment. If they’re found to be competent, parental consent is <em>not</em> required, and the adolescent can consent to their own treatment. </p>
<p>Maya would need to satisfy her GP that she has a full understanding of any treatment being proposed (contraception, for instance) and that she voluntarily accepts the treatment. </p>
<p>In South Australia and New South Wales, additional legislation provides for younger teenagers to consent to their own treatment.</p>
<h2>Ethical complications</h2>
<p>Nevertheless, in optimal adolescent health care, the family, cultural and psychosocial environments of each patient are considered. Important ethical issues can arise, and these can intersect with legal issues. </p>
<p>What if the GP believed that Maya’s parents would in fact be tolerant of this new turn in her relationship and would want to support her? </p>
<p>What if the GP also felt that for Maya to keep a secret from her parents this would actually cause her more anxiety than the sexual relationship itself? </p>
<p>The ideal consultation would also include an exploration of these issues with Maya. </p>
<p>The opposite might be true – what if the GP believed that family repercussions for Maya’s sexual activity could be serious, perhaps due to religious or cultural beliefs? </p>
<p>The GP might wish to offer Maya other options for support in this context.</p>
<h2>Parents want to know</h2>
<p>In the Melbourne study, 40% of parents wanted to be told of their adolescent’s sexual activity, and this rose to almost 60% if their daughter was pregnant or if their son or daughter had a sexually transmitted infection.</p>
<p>Parental desire to be informed about health behaviours or problems was highest for mental health issues, such as depression (87% of parents), eating disorders (81%) and drug use other than alcohol, smoking or marijuana (78%).</p>
<p>It’s understandable why parents want to be informed when mental illness or substance abuse is involved. </p>
<p>Psychological illnesses and substance misuse can impact on an individual’s insight and capacity to care for themselves, and surrounding support persons are part of a “care team”. </p>
<p>When these issues are identified in confidential consultations with adolescents, the law does not change per se, but the practicalities of health care probably do in most situations. </p>
<p>Managing a mental health condition may require treatment from a number of health professionals and the establishment a support network.</p>
<p>Part of the therapeutic armament would include focused discussions with the adolescent about informing and involving parents or carers, being careful not to breach confidentiality in order to gain trust and build a therapeutic relationship. </p>
<p>This applies whether an adolescent patient is 13 or 19, although the young person’s maturity, educational stage and psychosocial needs must be considered in the context of their family and cultural background.</p>
<h2>Case by case</h2>
<p>Adolescent health care is a challenging area of medicine, not in the least because adolescents are in a “grey area” legally and as individual patients. </p>
<p>There are varying levels of maturity and autonomy that must be assessed for each adolescent and in each clinical situation. </p>
<p>Parents can be the most important source of support for most adolescents and ideally should be involved when their adolescent child has complex or changing health and wellbeing needs. </p>
<p>Nevertheless, the confidential consultation is essential as young people learn to take responsibility for their health and learn to navigate the health system – and the world in general – in their personal quest for maturity and autonomy.</p>
<p><br></p>
<p><em><strong>What role should parents play in their teen’s health care? Share your comments below.</strong></em></p><img src="https://counter.theconversation.com/content/1685/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Melissa Kang does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>If your teenage daughter was sexually active and wanted to go on the pill, you’d want to know, right? Well, think back to when you were her age – would you have told your parents? These questions were…Melissa Kang, Senior Lecturer, Department of General Practice, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/26162011-08-07T20:52:59Z2011-08-07T20:52:59ZPatent controversy: don’t let breast cancer gene genie out of the bottle<figure><img src="https://images.theconversation.com/files/2693/original/InsectoPerfecto_Flickr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A test case is slated to challenge Myriad's claim for breast cancer genetic mutations next February.</span> <span class="attribution"><span class="source">TheAlieness GiselaGiardino²³/Flickr</span></span></figcaption></figure><p><em>The US Court of Appeals for the Federal Circuit has <a href="http://www.nytimes.com/2011/07/30/business/gene-patent-in-cancer-test-upheld-by-appeals-panel.html?_r=3&nl=todaysheadlines&emc=tha25">found Myriad Genetics is entitled to patents</a> on two sets human genetic mutations used to predict if women have an <a href="http://www.bracnow.com/">increased risk of breast and ovarian cancer</a>.</em></p>
<p><em>The case has been closely monitored here for two reasons:</em> </p>
<p><em>1) The Australia <a href="http://www.comlaw.gov.au/Details/C2011B00012">Patent Amendment (Human Genes and Biological Materials) Bill 2011</a> is currently with the Senate and Community Affairs Legislation Committee, whose report on the Bill is due on August 25.</em> </p>
<p><em>2) The Federal Court of Australia is slated to hear an Australian test case (discussed below) in February 2012.</em></p>
<p><em>Dr Luigi Palombi, who has <a href="http://theconversation.com/who-owns-the-rights-to-the-human-body-its-patently-obvious-835">previously written about the Patent Amendment (Human Genes and Biological Materials) Bill 2011 for The Conversation</a>, gives his response about the implications of the decision for Australia:</em></p>
<p>The US decision is disappointing because it doesn’t provide a definitive resolution of the real question – should naturally occurring genes be patentable subject matter? </p>
<p>There were three judges hearing the case and effectively they’ve come to three different decisions. </p>
<p>While two of them held that isolated genomic DNA is patentable subject matter, one of the two only came to that view because she believed it was a matter for Congress, not judges, to change the policy first implemented by the US Patent Office allowing this kind of patenting.</p>
<p>What is puzzling is that all three judges invalidate Myriad’s patent claims to <a href="http://www.bracnow.com/">its BRCA genetic test</a>.</p>
<p>Effectively, what the judges are saying is that the process of producing a genetic test result using patented DNA doesn’t result in an invention.</p>
<p>This is because the process of comparison involved in coming to a test result is merely a mental one that doesn’t transform anything physically. </p>
<p>As a mental abstraction, it’s not patentable subject matter.</p>
<p>That puts Myriad in the unusual situation of having a patent over the BRCA1 and BRCA2 genetic mutations linked to breast and ovarian cancers but not over their practical use in a genetic test.</p>
<p>Of course, having a patent monopoly of the genetic mutations means that anything anyone can usefully do with them is subordinate to Myriad’s gene patents, so it might be argued that the company has the BRCA test market cornered in any event. </p>
<h2>Legal implications of the decision</h2>
<p>The decision turns patent law on its head because it means that the prize is given for the discovery not for the invention (a new, tangible and practical use of the discovery). </p>
<p>The second problem is, Myriad’s scientists discovered and linked genetic mutations to breast and ovarian cancers, but that’s a long way off an invention. </p>
<p>If there was any invention by Myriad (assuming it was also novel and involved an inventive step), it was in the development of a diagnostic test.</p>
<p>So, the result is less than ideal.</p>
<p>The majority decision, in my opinion, is irrational, contrary to scientific fact and little more than a knee-jerk reaction to the fear mongering of the American biotechnology industry.</p>
<p>It claims that without gene patents it will not have any incentive to undertake necessary research. Of course, this is a lie. </p>
<p>The truth is that much of the research work that led to the discovery of the BRCA 1 gene was conducted by <a href="http://web.mit.edu/invent/iow/king.html">Professor Mary-Clare King</a> over 16 years. And that research was publicly funded. </p>
<p>Indeed, this is the case for much of the research described in Myriad’s patents as an “invention”. </p>
<p>This work was undertaken by researchers at the University of Utah while receiving funding from the United States government, which is why the government is named as a co-patentee on some of the US patents. </p>
<p>And this is true even in Australia. For instance, in 2009 the Walter and Eliza Hall Institute received $55.2 million of its $74 million budget from Australian and US taxpayers. Only a meagre $1.6 million came from royalties it receives from gene patents.</p>
<p>It’s revealing that even though the US government is a co-patentee with Myriad, it argued in an amicus brief filed with the US Federal Circuit that the patent claims to the BRCA gene mutations were <em>not</em> patentable subject matter.</p>
<p>The US decision, unfortunately, raises more questions than it answers and what this means is that this case is on its way to the US Supreme Court. </p>
<h2>The Australian test case</h2>
<p>This US decision is not binding for the Australian courts, but obviously Myriad’s Australian lawyers will seek to rely on it as persuasive authority when the test case reaches trial in February 2012.</p>
<p><a href="http://www.cancervoicesaustralia.org.au/default.htm">Cancer Voices Australia</a> and Mrs D'Arcy, a woman who had breast cancer, are seeking to invalidate three of the 30 patent claims in one of Myriad’s four Australian patents over BRCA1 and BRCA2 mutations and their uses in genetic tests.</p>
<p>The case will determine the legality of patent claims to isolated BRCA1 and BRCA2 genetic mutations under Australian patent law. </p>
<p>Ironically, the US decision takes a backward step in the debate because leading Australian scientists like Professor Ian Frazer have argued that we should not be granting patents on isolated genomic DNA.</p>
<p>Professor Sir John Sulston, a Nobel prize winner, agrees. </p>
<p>Now, while the Australian test case is important, I believe that it’s more efficient if the Australian Parliament draws the discovery-invention line based on policy rather than basing it on what judges say. </p>
<p>I find myself concurring with Judge Moore, one of the majority judges in the US decision, not because her decision is permissive of the status quo, but because the policy underpinning this issue is better resolved through the parliamentary process than through the courts. </p>
<p><em><strong>Read <a href="http://theconversation.com/patent-controversy-what-the-us-decision-about-breast-cancer-gene-patent-means-for-australia-2618">an alternative view</a> of the US Court of Appeals decision.</strong></em></p>
<p><strong><em><a href="http://theconversation.com/who-owns-the-rights-to-the-human-body-its-patently-obvious-835">Read Dr Palombi’s argument for Australia’s Patent Amendment (Human Genes and Biological Materials) Bill 2011</a></em></strong></p>
<p><strong><em><a href="http://theconversation.com/patent-amendment-bill-could-kill-access-to-new-medicines-637">Read the argument against Australia’s Patent Amendment (Human Genes and Biological Materials) Bill 2011</a> by Douglas Hilton, Director and Julian Clarke, Business Development Manager of the Walter and Eliza Hall Institute (WEHI).</em></strong></p>
<p><em><strong>Leave your thoughts about gene patenting below.</strong></em></p><img src="https://counter.theconversation.com/content/2616/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Luigi Palombi does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The US Court of Appeals for the Federal Circuit has found Myriad Genetics is entitled to patents on two sets human genetic mutations used to predict if women have an increased risk of breast and ovarian…Luigi Palombi, Director, Genetic Sequence Right Project, Australian National UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/26792011-08-04T04:58:13Z2011-08-04T04:58:13ZOrgans for sale? The ethics of paying living kidney donors<figure><img src="https://images.theconversation.com/files/2654/original/Flickr_PACOM.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Reimbursing for costs is standard in research but large payments present problems. </span> <span class="attribution"><span class="source">Flickr/PACOM</span></span></figcaption></figure><p><em>The Commonwealth Government is <a href="http://www.theage.com.au/national/doctors-urge-compensation-on-kidney-transplant-20110803-1ibpb.html?skin=text-only">considering a proposal</a> from K<a href="http://www.abc.net.au/rn/breakfast/stories/2011/3280698.htm">idney Health Australia</a> to reimburse living kidney donors for reasonable expenses incurred during the donation process, such as loss of income or travel expenses.</em> </p>
<p><em>Meanwhile, senior research fellow at the University of Dundee in the United Kingdom, Sue Rabbitt Roff, <a href="http://www.bmj.com/content/343/bmj.d4867.extract?sid=01f9c699-e631-460b-85b5-aa350d290a47">has argued in the British Medical Journal</a> that in order to raise live organ donation rates, donors should receive an average annual income.</em> </p>
<p><em>So what are the ethical implications of paying for organs? Associate Professor Malcolm Parker, University of Queensland’s head of Medical Ethics, Law and Professional Practice explains:</em> </p>
<p>Reimbursing living kidney donors for lost income is a reasonable proposal. Clearly, it’s directed towards increasing the organ donation rate to make it somewhat more attractive for living donors to at least consider this route. </p>
<p>The question that arises is whether payment could be construed as a coercive incentive. But if there’s a limit on the payment and it’s restricted to lost income and other associated costs, that argument becomes weak. </p>
<p>Payments are not unheard of in medical, psychological and pharmaceutical research trials – the reimbursements are designed to cover expenses that the participant has incurred in the process of getting to and participating in the trial. </p>
<p>Clearly, there’s more involved in becoming a live organ donor but similarly, I think many people support the idea of reimbursements for costs incurred, up to a limit. </p>
<p>Such a scheme could increase the rate of live organ donors to some extent but given the invasiveness of the procedure and the lifelong implications, I expect any increase would be modest. </p>
<p><strong>What do you make of Sue Rabbit Roff’s argument that live donors should be paid the equivalent of an annual income for donated kidneys?</strong></p>
<p>This payment would obviously be a lot higher than just reimbursing for costs incurred and time off work so it may well prove to be a greater incentive. </p>
<p>In this scenario, the question of coercion comes more into view and you have to ask whether this will persuade certain people, particularly people with low income, to consider donating their kidney when otherwise they wouldn’t.</p>
<p>And does that amount of money, or that degree of compensation, render their decision somehow coercive or involuntary?</p>
<p>There’s no in-principle answer to that – coercion won’t necessarily occur. But in certain cases you might find that someone who is desperate for money will become involved, when otherwise they wouldn’t have. </p>
<p>This is certainly not the first time that payment for organs has been proposed. </p>
<p>The prevailing view is that we shouldn’t have an organ market because it should be an altruistic arrangement. But there has certainly been pressure mounting over the years to find ways to increase the number of organ donors. </p>
<p><strong>How is the cash for organ idea playing out internationally?</strong></p>
<p>There’s a market for organs – it’s perfectly clear that’s happening. It’s also clear that there are vulnerable groups who are more subtly coerced or blatantly exploited. </p>
<p>The far extreme of that is criminal activity where people are abducted and have their organs removed. That’s not a common occurrence though we know it does happen. </p>
<p>We’re aware of the Chinese situation – where executed prisoner’s organs are used – and this probably occurs in other countries as well. </p>
<p>We hear that the Chinese are attempting to regulate this practise more strongly but it’s difficult to know exactly where they’re at. </p>
<p>So there are markets and activities occurring around the world which are different from the standard altruistic practise of organ donation. </p>
<p>These underground activities are different from the proposed compensation of wages lost or even an annual income – they’re somewhere along that continuum but not quite at that far down the end. </p>
<p><strong>More broadly, how can we increase rates of organ donation in Australia – is an opt-out policy, where consent is assumed, the answer?</strong></p>
<p>No. Where the organ donation rates are significantly higher than Australia’s, it’s more a result of the quality of the processes that have been instituted in hospitals and other healthcare institutions, such as the introduction of transplant coordinators, financial supports, and so on, rather than the adoption of an opt-out system. </p>
<p>Spain, for example, has the highest rate of organ donation in the western world and this likely comes down to the processes in place rather than whether they’ve got an opt out system. </p>
<p>I wouldn’t predict an opt-out organ donation system would have a huge impact in Australia.</p><img src="https://counter.theconversation.com/content/2679/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Malcolm Parker curretnly receives funding from the Australian Research Council and the Australian Teaching and Learning Council.</span></em></p>The Commonwealth Government is considering a proposal from Kidney Health Australia to reimburse living kidney donors for reasonable expenses incurred during the donation process, such as loss of income…Malcolm Parker, Associate Professor & Head of Ethics, Law and Professional Practice, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/26082011-08-01T20:56:44Z2011-08-01T20:56:44ZA healthy prescription: doctors, own up to medical mishaps immediately<figure><img src="https://images.theconversation.com/files/2596/original/Faunce_2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Transparency in the relationship between doctors and patients will lead to fairer outcomes for victims of medical mishaps. </span> <span class="attribution"><span class="source">AAP</span></span></figcaption></figure><p>An expansion of the fiduciary duties of doctors towards patients could provide better protection to those suffering from medical mishaps. Such an expansion would require doctors to promptly disclose adverse events. </p>
<p>A New South Wales District Court is <a href="http://www.smh.com.au/nsw/woman-to-sue-after-sponge-left-in-her-body-20110731-1i6fv.html">currently hearing a case about a surgical pack</a> allegedly left inside Helen Caroline Anne O'Hagan’s abdomen for more than 15 years. </p>
<p>It’s claimed surgeon Dr Samuel Sakker negligently failed to remove it during a partial colectomy he performed in August 1992 at the Poplars Private Hospital in Epping, Sydney. </p>
<p>Mrs O'Hagan subsequently experienced cramping, fevers and loss of bowel control but assumed they were related to her chronic abdominal and pelvic problems.</p>
<p>The pack, encapsulated with fibrous adhesions, was discovered after an X-ray in October 2007 revealed the sponge’s embedded radiopaque thread.</p>
<p>Although distressing, such medical errors are not uncommon. Research increasingly shows they relate to system error. </p>
<p>This makes the hunt for individual blame (perpetuated by the common law compensation system) often somewhat farcical. It also supports the case for a “no-fault” compensation system for medical negligence. </p>
<p>What is most concerning about this case, however, is that although the surgical pack was removed in the immediate aftermath of its X-ray discovery by another surgeon, it was three years before he told Mrs O'Hagan that it could only have been put there during Dr Sakker’s operation. </p>
<p>By that time, the statute of limitations on Mrs O'Hagan’s right to claim for medical negligence had expired.</p>
<p>The patient (through her solicitor) had to make a special application to be granted permission to sue the first surgeon for negligence. This was granted by NSW District Court Judge Leonard Levy. </p>
<p>Academics, judges and many in the legal profession have been suggesting that the statutory changes to medical negligence are grossly unfair - they seem designed to prevent patients seeking fair compensation. </p>
<p>These changes took place over a decade ago, at the time of the so-called “medical indemnity crisis”. This was blamed on large patient pay-outs at the time but was probably more due to refinancing problems in the medical indemnity insurance industry. </p>
<p>As a result, taxpayers – through a federal government subsidy – now support the private medical indemnity insurance companies of doctors.</p>
<p>This means that such insurance companies make profits from a reduced need to pay money back to the injured, while the injured (through their taxes) have to fund the legal teams that oppose their claims for fair compensation. </p>
<p>Many see the solution as involving the introduction of a <a href="http://theconversation.com/ending-the-vaccine-blame-game-time-for-a-no-fault-compensation-scheme-1952">“no-fault” compensation scheme for medical error</a>. Under such a scheme, damages claims for medical negligence might not be as large as under common law, but they would be more prompt, affordable and accessible.</p>
<p>A case like Mrs. O'Hagan’s compounds the injustice of the existing system. It creates the appearance that information may have been withheld from a patient until the statute of limitations had expired. </p>
<p>The doctor who held that information back is not currently legally liable.</p>
<p>Doctors have a legal fiduciary duty to protect patients in particularly vulnerable situations. This is a special class of common law obligation. It covers, for example, allegations of sexual or financial abuse of patients by doctors. </p>
<p>When such a claim is made by a patient, the legal onus of proof is on the doctor to disprove it. </p>
<p>The law operates this way to take the pressure off patients because the power in a doctor-patient relationship is particularly stacked against the latter in such situations.</p>
<p>Academics such as myself have for some time argued that the fiduciary duties of doctors should be expanded to include a duty to promptly notify patients of adverse events. </p>
<p>If such an event occurred during a hospital admission, for example, “promptly” could be reasonably interpreted as requiring disclosure before the patient is discharged.</p>
<p>If such a fiduciary obligation had been in place in this case, the patient would most likely have been told immediately by the second doctor that the removed abdominal mass wrapped around a surgical sponge with a radio-opaque tracer could only have been placed in her stomach during an operation. </p>
<p>Making this change could be something that a judge could do in the course of proceedings such as this. </p>
<p>It would involve an incremental expansion of the common law doctrine of fiduciary responsibilities to cover amongst particularly vulnerable situations – not just sexual and financial abuse but also instances where the patient has been injured by medical staff.</p><img src="https://counter.theconversation.com/content/2608/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Thomas Faunce receives funding from the Australian Research Council under Discovery Grants related to regulation of health technologies.</span></em></p>An expansion of the fiduciary duties of doctors towards patients could provide better protection to those suffering from medical mishaps. Such an expansion would require doctors to promptly disclose adverse…Thomas Faunce, ARC Future Fellow, Australian National UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/10612011-06-22T20:46:02Z2011-06-22T20:46:02ZWhy loosening genetic privacy law is a recipe for fear and frustration<figure><img src="https://images.theconversation.com/files/1736/original/Aaron_Goselin.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Specialists can go on a genetic fishing expedition tracking down potential relatives. </span> </figcaption></figure><p>Doctors are supposed to keep patient information confidential unless told otherwise, right? Well, not any longer. </p>
<p>If you’re diagnosed with a genetic disorder, medical specialists are now allowed to contact anyone and everyone they suspect could be your relative. And they don’t need your permission. </p>
<p>Welcome to the brave new world of genetic privacy. </p>
<h2>Guidelines & legislation</h2>
<p>Privacy in Australia is protected through an uneven and increasingly threadbare patchwork of state, territory and commonwealth laws and guidelines. </p>
<p>At the state level, it’s protected through health-specific privacy law and through common law provisions for confidentiality. This covers the doctor’s duty to protect a patient’s privacy – patient information must be safeguarded and not disclosed without the patient’s consent. </p>
<p>At the national level, broad protection is provided by the <a href="http://www.austlii.edu.au/au/legis/cth/consol_act/pa1988108/">Privacy Act 1988</a>, an enactment of the Commonwealth parliament, and is overseen by the <a href="http://www.privacy.gov.au/">privacy commissioner</a>. But the Act can be modified through <a href="http://www.privacy.gov.au/law/act/pid">Public Interest Determinations</a> (PIDs), which are made by the privacy commissioner and not by parliament or the national attorney-general. </p>
<p>This is where the new provisions come into play. The commissioner has issued PID 11 and 11A: <a href="http://www.privacy.gov.au/materials/topics/health#Determinations"><em>Collection and use of contact details of genetic relatives to enable use or disclosure of genetic information</em></a>, which override the existing provisions for patient privacy. The PIDS are founded on <a href="http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/e96.pdf">guidelines</a> developed by the <a href="http://www.nhmrc.gov.au/">National Health & Medical Research Council</a> (NHMRC).</p>
<h2>Privacy failure</h2>
<p>The PIDs allow a medical specialist to disregard a patient’s request not to provide information about a serious genetic condition to a third party. </p>
<p>Ethics aside, this is of great concern for a number of practical reasons.</p>
<p>If specialists diagnose patients with a genetic disorder, they can legally contact anyone – yes, anyone – they believe may be related to the patient.</p>
<p>The Privacy Commissioner has disregarded criticism that this would allow a specialist to grab a phonebook and contact anyone and everyone with the surname Ng or Smith, on the basis that a Smith or Ng had a particular genetic attribute.</p>
<p>The NHMRC guidelines and PIDs explicitly anticipate that large-scale scattergun contact will take place. </p>
<p>This means that many of the people contacted won’t be genetic relatives and, if they are, won’t have the particular genetic attribute. There may have been name changes, adoption, marriage or other circumstances that preclude them from being genetically linked. </p>
<p>Potential genetic contacts of the patient will receive a letter from the specialist indicating that a potential relative has a serious genetic condition and it’s advisable for them to have a test. </p>
<p>The letter won’t identify the relative, who may of course not actually be related to the recipient. The letter won’t even identify the condition, for which the relatives may or may not be at risk, or outline the test the relatives need to clear themselves.</p>
<p>Recipients will presumably contact their general practitioner, asking to be tested. But since the specialist isn’t authorised to identify the original patient or the patient’s condition, the general practitioners can’t know what’s meant to be tested. </p>
<p>Likewise, pathology laboratories have indicated to me that financial and regulatory requirements prevent them from testing for all genetic conditions. </p>
<h2>A recipe for frustration, not better health</h2>
<p>The contact exercise therefore needlessly raises concerns that can’t be allayed. </p>
<p>Rather than increase diagnosis and treatment, it will create suspicion and confusion, with recipients wondering which of their relatives has the mysterious and serious condition (since surely reputable specialists wouldn’t make a mistake or cause unnecessary worry). </p>
<p>The PIDs are distinct from existing law that allows practitioners to breach confidentiality in exceptional circumstances, such as when the doctor is aware the patient has HIV and is engaging in unprotected sex with people who are unaware of that status.</p>
<p>Setting aside the absurdity of the exercise, we come to the ethical question: should people with particular genetic attributes – that may or may not eventually result in disability or death, and may or may not be passed to offspring – have a right not to know? </p>
<p>In some cases, people don’t want to know they have a death sentence, particularly one which may cause death in a few months’ time or in thirty years. </p>
<h2>Making sense of the PIDs</h2>
<p>So, should we be concerned about the specific PIDs and the breach privacy they allow?</p>
<p>From submissions provided to the Commissioner by the NHMRC and the <a href="http://www.privacy.gov.au/materials/types/download/9515/7088">specialist doctor who originally recommended the PIDs</a> (with the encouragement of the Commissioner), it’s clear these provisions wouldn’t be commonly needed – very few patients refuse to share information about their condition with immediate relatives. </p>
<p>Then why introduce the PIDs at all? We might conclude that they’re the result of bureaucratic incapacity within the Privacy Commissioner’s office. Rather than seeking independent advice from a range of sources and fully considering all concerns, the Commissioner seems to have been captured by the interests of a handful of medical specialists. </p>
<p>Scrutiny of the Commissioner’s file, obtained through Freedom of Information, suggests that in making the PIDs, the Commissioner has misunderstood the contact process, has disregarded advice from medical and legal specialists and has uncritically accepted statements by the handful of medical specialists who developed the NHMRC guidelines.</p>
<p>The weakening of medical privacy through the PIDs sets a worrying precedent for future erosion of privacy law.</p>
<p><br></p>
<p><em><strong>Share your views below: Should these PIDs be abandoned?</strong></em></p>
<p><em><strong>Would you want to know if you had a gene that increased your risk of death, tomorrow or 30 years down the track?</strong></em></p><img src="https://counter.theconversation.com/content/1061/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The author has no commercial or personal relationships that pose a conflict of interest in relation to genetic profiling.</span></em></p>Doctors are supposed to keep patient information confidential unless told otherwise, right? Well, not any longer. If you’re diagnosed with a genetic disorder, medical specialists are now allowed to contact…Bruce Baer Arnold, Assistant Professor, School of Law, University of CanberraLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/18892011-06-22T04:36:40Z2011-06-22T04:36:40ZSensaSlim goes SLAPP, public interest crusader cops a legal whack<figure><img src="https://images.theconversation.com/files/1802/original/Screen_shot_2011-06-22_at_1.25.31_PM.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Screen shot at PM</span> <span class="attribution"><span class="source">Malcolm Vickers/Australian Skeptics (Victorian Branch)</span></span></figcaption></figure><figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/1801/original/Screen_shot_2011-06-22_at_1.18.25_PM.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/1801/original/Screen_shot_2011-06-22_at_1.18.25_PM.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=252&fit=crop&dpr=1 600w, https://images.theconversation.com/files/1801/original/Screen_shot_2011-06-22_at_1.18.25_PM.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=252&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/1801/original/Screen_shot_2011-06-22_at_1.18.25_PM.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=252&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/1801/original/Screen_shot_2011-06-22_at_1.18.25_PM.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=317&fit=crop&dpr=1 754w, https://images.theconversation.com/files/1801/original/Screen_shot_2011-06-22_at_1.18.25_PM.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=317&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/1801/original/Screen_shot_2011-06-22_at_1.18.25_PM.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=317&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Claims made for the weight-loss nasal spray..</span>
<span class="attribution"><span class="source">SensaSlim website</span></span>
</figcaption>
</figure>
<p>The <a href="http://theconversation.com/sensaslim-and-me-how-criticism-of-a-weight-loss-spray-landed-me-in-court-1911">SensaSlim company’s recent defamation suit against Dr Ken Harvey</a> of La Trobe University highlights some of the regulatory problems facing complementary products in Australia. </p>
<p>Dr Harvey initiated a complaint against the weight loss advertisements of SensaSlim in March this year with the <a href="http://www.tgacrp.com.au/index.cfm?pageID=2">Complaints Resolution Panel (CRP)</a>, which deals with complaints about breaches of the <a href="http://www.tga.gov.au/industry/legislation-tgac.htm">Therapeutic Goods Advertising Code 2007</a>.</p>
<p>The complaint was also sent to the <a href="http://www.tga.gov.au/">Therapeutic Goods Administration (TGA)</a> (which did not acknowledge it) and the <a href="http://www.accc.gov.au/content/index.phtml/itemId/142">Australian Competition and Consumer Commission (ACCC)</a>, which is now <a href="https://www.comcourts.gov.au/file/Federal/P/NSD940/2011/actions">taking action against the company</a>. The hearing is being held in a Federal Court in New South Wales tomorrow.</p>
<p>There are also <a href="http://www.theage.com.au/national/dodgy-websites-push-diet-spray-20110621-1gdmu.html">allegations the original research which validates the product is fabricated</a>. </p>
<p>Dr Harvey’s complaint alleged SensaSlim’s advertisements breached a number of sections of the Therapeutic Goods Advertising Code 2007; the substance of Dr Harvey’s complaints was that he could find no evidence to justify the sensational claims made for the product. </p>
<p>On the 31 March Dr Harvey was served with a warning to withdraw his complaint. SensaSlim also threatened AusPharm with legal action for publishing an account of the complaint.</p>
<p>When Dr Harvey refused to withdraw his complaint he was served with a defamation claim for $800,000.</p>
<p>Of particular interest is the effect the defamation claim has on the complaint lodged with the CRP. Basically, it stops the CRP investigation in its tracks. </p>
<p>According to <a href="http://www.austlii.edu.au/au/legis/cth/consol_reg/tgr1990300/s42zcaj.html">Regulation 42ZCAJ (2)</a> of the Therapeutic Goods Regulations 1990, “If, after a complaint has been made to the Panel, a proceeding begins in a court about the subject matter of the complaint, the Panel cannot deal with the complaint until the proceeding is finally disposed of.”</p>
<p>This means SensaSlim is free to advertise and promote its products and the CRP cannot investigate it for as long as the defamation action against Dr Harvey continues. </p>
<p>SensaSlim subsequently sent out a newsletter to its members which stated:</p>
<p><em>“This defamation action, which could be in the courts for a year or two or even longer, basically gives an iron clad protection that nobody can raise a complaint against SensaSlim to the CRP and hurt us.</em> </p>
<p><em>There are nine complaints that were received in a three day period two weeks ago. These were not complaints by members of the public, but clever legal crafted arguments by people acting on behalf of our competitors and big pharmaceutical companies. These are the same people who have written to the CHC [Complementary HealthCare Council] to delay and hinder our progress and having our advertisements approved.. and they also wrote to the TGA.</em> </p>
<p><em>But let me say this. We will not allow their dirty tactics defeat us. We had a very big win this week with the determination by the CRP that they cannot adjudicate on any matters pertaining to SensaSlim.”</em></p>
<h2>Regulation of complementary products in Australia</h2>
<p>The preliminary question all this raises is – how are products like SensaSlim approved for use in Australia? </p>
<p>The Therapeutics Goods Administration (TGA) is charged with the responsibility for “listing” about 2000 complementary health products per year on the <a href="http://www.tga.gov.au/about/artg.htm">Australian Register of Therapeutic Goods</a>. </p>
<p>Complementary medicines are regarded by the TGA as relatively low-risk products, so an <a href="http://www.tga.gov.au/industry/ebs-elf-userguide.htm">electronic listing facility (ELF)</a> allows easy and rapid market entry. </p>
<p>Sponsors must pick their ingredients from a computerised drop-down list of substances that the TGA believes are relatively safe; certify that the goods are produced under Good Manufacturing Practice (GMP) requirements; and tick a box that they hold evidence to support the claims made. </p>
<p>On payment of a $600-fee, the computer issues a letter of marketing approval and an “AUST L number”. </p>
<p>In theory, sponsors of listed medicines are restricted to making low-level claims for their products relating to health maintenance, health enhancement or non-serious, self-limiting conditions. </p>
<p>But the TGA conducts very limited post-marketing assessment of AUST L products, the results of which have traditionally been regarded as commercial in confidence. </p>
<p>Following recent Freedom of Information (FOI) requests, the TGA has released some of this data. The <a href="http://www.tga.gov.au/industry/cm-post-listing-compliance-reviews.htm">results are appalling</a> and show that a system relying on trust has failed. </p>
<p>Currently, the complaint system is the main way that these matters can be redressed but the CRP is under-resourced, overloaded and lacks effective sanctions to ensure compliance with its determinations. </p>
<p>There are, at present, several government enquiries into these matters. However, just as many other enquiries have come to nought over the last decade so we are not holding our breath that there will be reform this time around. Any changes are also bitterly opposed by industry. </p>
<p>What’s more, when complaints <em>are</em> made, Regulation 42ZCAJ(see above) encourages strategic litigation against public participation (SLAPP) writs by suspending investigation of the complaint while the litigation plays out in the courts. </p>
<h2>SLAPP - preventing public participation</h2>
<p>Effectively, SLAPP refers to the lodgement of a lawsuit to prevent the publication of criticism or to gag public discussion of an issue. On the face of it, SensaSlim’s legal action appears to be a SLAPP writ although the company has denied this is so. </p>
<p>A famous example of a SLAPP writ comes from the United Kingdom where cryptologist and author Simon Singh was sued for libel by the British Chiropractors Association for saying that many chiropractors advertise “bogus treatments” for childhood illnesses like colic and frequent ear infections, and problems with sleeping and feeding. </p>
<p>Singh eventually won his court action on the basis of the defence of fair comment but had to spend considerable financial resources to defend himself.</p>
<p>A SensaSlim representative has been reported as saying, “This is not about gagging Dr Harvey. We will continue to pursue our right to protect our franchisees and their investment in our product.” </p>
<p>But it’s hard to reconcile this statement with the earlier statement of the company that the writ would provide SensaSlim with “iron clad protection” against CRP investigation.</p>
<p>One of the risks associated with SLAPP litigation is that it can backfire. SLAPP suits often generate counter-publicity so that their attempt to silence public debate fails miserably. </p>
<p>This is referred to as the “Streisand effect”, after Barbara Streisand’s failed attempt to sue a photographer for publishing a photo of her house as part of a coastal erosion project. </p>
<p>The suit generated massive publicity, resulting in over 400,000 internet visits to the photo. </p>
<p>Simon Singh’s legal fight against the British Chiropractic Association had a <a href="http://www.guardian.co.uk/science/2010/mar/01/simon-singh-libel-case-chiropractors">similar effect, with a quarter of British chiropractors having complaints lodged against</a> them for false advertising after he was sued. </p>
<p>A Google search of “SensaSlim Harvey” currently shows over 5600 websites featuring Dr Harvey’s story. Articles have already appeared in major newspapers across the world and in journals such as the <a href="http://www.bmj.com/content/342/bmj.d3728.extract">British Medical Journal</a> and Medical Journal of Australia. </p>
<p>If SensaSlim was aiming to shut down discussion of its advertising the choice to litigate may have become counterproductive.</p>
<h2>Lessons for the future</h2>
<p>Regulation 42ZCAJ (2), which stops the CRP from investigating complaints when litigation commences, is clearly a bad idea. </p>
<p>It needs to go, both because it stops the regulator from being able to function as a regulator and because it is fundamentally anti-democratic.</p>
<p>It maintains the commercial interests of the manufacturer in the face of genuine public concerns about the putative benefits and broader risks of the product in question. </p>
<p>The public needs to be able to rely on the CRP to get on with the job of deciding whether the product has been advertised appropriately and in accordance with the rules. </p>
<p>Sensaslim and companies like it are free to defend themselves in that process and can provide scientific evidence to back their claims. </p>
<p>The effect of the current regulation is to silence the person who is pursing the protection of the public and to stop the regulator from functioning. </p>
<p>It has a chilling effect, which does not serve the public interest.</p><img src="https://counter.theconversation.com/content/1889/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Cameron Stewart receives funding from the NHMRC to look at advertising of pharmaceuticals.</span></em></p><p class="fine-print"><em><span>Ian Kerridge does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The SensaSlim company’s recent defamation suit against Dr Ken Harvey of La Trobe University highlights some of the regulatory problems facing complementary products in Australia. Dr Harvey initiated a…Cameron Stewart, Associate Professor at Sydney Law School, University of SydneyIan Kerridge, Associate Professor in Bioethics & Director, Centre for Values and Ethics and the Law in Medicine, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/19112011-06-20T04:53:05Z2011-06-20T04:53:05ZSensaSlim and me: how criticism of a weight-loss spray landed me in court<figure><img src="https://images.theconversation.com/files/1763/original/Nasal.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Nasal</span> </figcaption></figure><p>On March 18, 2011, I submitted my first complaint about the promotion of SensaSlim to appropriate authorities – the Complaint Resolution Panel (CRP) which hears complaints about alleged breaches of the Therapeutic Goods Advertising Code 2007, the Therapeutic Goods Administration (TGA), which administers the Therapeutic Goods Act 1989 and the Australian Competition and Consumer Commission (ACCC) which administers the Competition and Consumer Act 2010.</p>
<p>This complaint, and at least six others, alleged that the promotion of SensaSlim on the internet, television and in shops breached numerous sections of the above regulations. </p>
<p>Soon after, I received a letter from the SensaSlim Australia Pty. Ltd, titled, “Notice of Intention to Commence Proceedings”. This, and subsequent communications from SensaSlim threatened legal action against both my university and me unless my complaint was withdrawn.</p>
<p>My university could not be joined in the threatened legal action because the conditions of my adjunct appointment were clear – “During the period of this appointment you will receive no remuneration from La Trobe University. Nothing in this offer creates or implies an employment relationship between you and the University”.</p>
<p>I declined to withdraw my complaint and on April 19, 2011 a “Statement of claim” was issued against me in the New South Wales Supreme Court alleging that my complaint was defamatory and claiming “general and punitive damages for libel in the sum of $800,000.00”, plus costs.</p>
<p>This action had the effect of stopping the CRP from hearing all complaints about SensaSlim due to Therapeutic Goods Regulations 1990 42ZCAJ (2) – “If, after a complaint has been made to the Panel, a proceeding begins in a court about the subject matter of the complaint, the Panel cannot deal with the complaint until the proceeding is finally disposed of”.</p>
<p>My own lawyers filed a notice of motion in the NSW Supreme Court seeking orders to have the SensaSlim claim struck out and the proceedings dismissed because it disclosed no reasonable cause for the action.</p>
<p>The case was listed on June 14, 2011 before the Defamation List Judge, Justice Lucy McCallum, in the Supreme Court at Sydney. It was agreed that the initial “Statement of claim” by SensaSlim would be struck out because it had many technical legal errors. </p>
<p>However, SensaSlim’s lawyers wanted to re-submit an amended “Statement of claim” and were allowed to do so, given that they agreed to pay our costs for defending the first one.</p>
<p>This move by SensaSlim keeps the action going and stops the CRP and TGA from acting on numerous queued complaints. Some observers believe this case is an example of a <a href="http://www.pilch.org.au/accesstojustice/publicinterestlitigation/#5">SLAPP (strategic litigation against public participation) writ</a>, which aims to silence criticism because the defendant “succumbs to fear, intimidation, mounting legal costs or simple exhaustion and abandons the criticism.”</p>
<p>The Medical Research Director of SensaSlim, Dr Matthew Capehorn, has now resigned. <a href="http://www.medreach.com.au/wp-content/uploads/2011/06/Dr-Capehorn-to-Dr-Harvey-email.pdf">He stated</a>, “Despite requests, I have never seen evidence of the original clinical trial, and it has never been published in a peer reviewed medical journal. Therefore, the White Paper holds no scientific relevance, until that original trial is published” and “video interviews were put on the SensaSlim website, without my approval or opportunity to review the content”.</p>
<p>As of today, SensaSlim is still listed on the TGA’s Australian Register of Therapeutic Goods, which allows it to continue to be legally sold, it’s still actively promoted on numerous Australian internet sites. And <a href="http://www.sensaslim.com.au/default.asp">Dr Capehorn is still featured spruiking the product.</a></p>
<p>Meanwhile, the <a href="http://www.skeptics.com.au/latest/news/ken-harvey-taken-to-court/">Australian Skeptics have kindly launched a campaign to raise funds</a> to support my continued defence of this legal action. </p>
<p>There are a number of lessons to be drawn from this case study.</p>
<p>First, one might have hoped that university-trained health professionals who promoted this product would have been more discerning in their assessment of evidence for the claims made.</p>
<p>Second, one might have expected that the <a href="http://www.mja.com.au/public/issues/188_01_070108/har10522_fm.html">TGA would have responded to previous calls</a> to look more rigorously at complementary medicines before they are listed on the Australian Register of Therapeutic Goods (ARTG). </p>
<p>This could have saved many people (consumers, stockists and franchisees) from spending large amounts of money on SensaSlim.</p>
<p>Failing that, on receipt of well-documented complaints, surely the TGA could have rapidly removed this product from the ARTG, which would have made continued sales illegal?</p>
<p>Ironically, the TGA have yet to respond to queries and complaints about this product that were sent to them direct. Perhaps the <a href="http://www.theaustralian.com.au/news/nation/pan-class-actions-675m-settlement/story-e6frg6nf-1226028350099">Pan Pharmaceutical class action</a> has made the TGA more cautious about taking such action?</p>
<p>Finally, we are left with the ACCC, which I understand have been investigating this matter for some time but are not yet ready to inform us of their findings.</p>
<p>It seems a sad reflection on the regulators that we are dependent upon complainants, investigative journalists, blogs, skeptics and health professional web sites to get the message out.</p>
<p><em><strong>Do you think the TGA should examine products more rigorously before allowing them to be listed on the Australian Register of Therapeutic Goods?</strong></em></p>
<p><em><strong>Leave your comments below</strong></em></p><img src="https://counter.theconversation.com/content/1911/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ken Harvey receives travel assistance and occasional sitting fees for work on government enquiries in the medicines field. He is the Australian Consumers Association (CHOICE) representative on several government committees and enquiries.</span></em></p>On March 18, 2011, I submitted my first complaint about the promotion of SensaSlim to appropriate authorities – the Complaint Resolution Panel (CRP) which hears complaints about alleged breaches of the…Ken Harvey, Adjunct Associate Professor of Public Health, La Trobe UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/17902011-06-14T04:12:40Z2011-06-14T04:12:40ZIt’s a vision thing: the case for a far-sighted approach to stem cell research<figure><img src="https://images.theconversation.com/files/1626/original/BWJones.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Stem cells have successfully been transplanted to restore sight.</span> <span class="attribution"><span class="source">BWJones</span></span></figcaption></figure><p>In 2002, the Australian federal Parliament passed two Acts to regulate human embryo and stem cell research. </p>
<p>The <a href="http://www.comlaw.gov.au/Details/C2008C00694/Download">Prohibition of Human Cloning Act</a> banned practices that people seemed to be most worried about, like “reproductive cloning” to breed identical people, creating half-human half-animal hybrids, and selling human sperm, eggs and embryos. </p>
<p>These are all still crimes with heavy penalties. </p>
<p>The second piece of legislation – The <a href="http://www.comlaw.gov.au/Details/C2008C00689/Download">Research Involving Human Embryos Act</a> – permitted research on human embryos donated from IVF programs (which would otherwise have to be destroyed), provided the researcher has a licence and reports openly on the research. </p>
<p>This licence-based research has assisted infertile couples to have children and produced human stem cells for use in other research.</p>
<p>In 2005, the <a href="http://www.aph.gov.au/senate/committee/clac_ctte/completed_inquiries/2004-07/leg_response_lockhart_review/report/index.htm">Lockhart Committee</a> reviewed the two Acts and recommended the legislation should be maintained but also allow human embryos to be formed for research by <a href="http://www.sciencedaily.com/articles/s/somatic_cell_nuclear_transfer.htm">somatic cell nuclear transfer</a> (SCNT) (though not by fertilisation). In 2006, the legislation was amended as the Committee recommended.</p>
<p>Since 2005, there have been many developments with “adult” stem cell research. In Australia, a patient’s own stem cells have been transplanted to the cornea to restore sight. In the UK, a patient’s diseased windpipe was replaced with one grown from her own stem cells.</p>
<p>There have also been developments with embryo research. Australian researchers were the first in the world to study Huntington’s disease in <a href="http://stemcells.nih.gov/info/basics/basics3.asp">human embryonic stem cells</a> (hESCs). </p>
<p>In the US, a human retina was created from human embryonic stem cells; and the first clinical trial recently started to treat patients with severe spinal injury with human embryonic stem cells. </p>
<p>Some laws have been changed in other countries to assist embryo research. New York State now permits federal funds to be used to pay women who donate eggs for research. And in the UK, the law allows scientists to use animal eggs to incubate a human nucleus to produce stem cells for research </p>
<p><a href="http://stemcells.nih.gov/news/newsarchives/stemfactsheet.asp">Pluripotent human stem cells</a> have now been derived without embryos (IPS cells) – in other words, embryonic stem cells can now be made without the embryos. </p>
<p>In 2011, the <a href="https://legislationreview.nhmrc.gov.au/2010-legislation-review-committee">Heerey Committee</a> reviewed the federal legislation again after consulting stakeholders and the wider community. Its report has been delivered to the Minister but it is yet to be publicly released. </p>
<p>So there have been exciting developments in human stem cell research, both with adult stem cells and also embryonic stem cells. </p>
<p>Most embryonic stem cells used in research to date have come from embryos donated from fertility treatment programs but there are still reasons to create embryos for research to obtain tissue-matched cells. </p>
<p>These are issues for ongoing community discussion.</p>
<p><br></p>
<p><strong><em>Loane Skene is a panelist on today’s University of Melbourne’s <a href="http://www.ideas.unimelb.edu.au/">Festival of Ideas</a> event, The Genetic Revolution III: Legal, Ethical and Moral Dimensions. The Festival of Ideas runs until 18 June</em>.</strong></p>
<p><em><strong>See our other Festival of Ideas coverage:</strong></em></p>
<p><em><strong><a href="http://theconversation.com/determined-to-be-different-what-we-do-changes-the-wiring-of-our-genes-1726">Determined to be different: what we do changes the wiring of our genes</a> by keynote speaker Matt Ridley</strong></em></p>
<p><em><strong><a href="http://theconversation.com/weve-cracked-the-genetic-code-now-what-1791">We’ve cracked the genetic code, now what?</a> by David Weisbrot</strong></em></p><img src="https://counter.theconversation.com/content/1790/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Loane Skene has had past ARC grants and other funding on the regulation of genetic testing. She was a member of the Lockhart and Heerey committees. She is a member of the NHMRC Australian Health Ethics Committee and the ASSCR and the ISSCR. She teaches in the area of law and genetics and has had PhD students in this area. </span></em></p>In 2002, the Australian federal Parliament passed two Acts to regulate human embryo and stem cell research. The Prohibition of Human Cloning Act banned practices that people seemed to be most worried about…Loane Skene, Professor of Law & Adjunct Professor, Faculty of Medicine Dentistry and Health Sciences, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/17912011-06-13T20:59:18Z2011-06-13T20:59:18ZWe’ve cracked the genetic code, now what?<figure><img src="https://images.theconversation.com/files/1625/original/California_Institute_for_Regenerative_Medicine.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Hard laws and regulations are needed to protect our genetic information.</span> <span class="attribution"><span class="source">California Institute for Regenerative Medicine</span></span></figcaption></figure><p>The rapid development of genetic science and technology holds hope for greatly improved health outcomes, with better diagnostics, treatments and cures, as well as the beginning of <a href="http://www.ornl.gov/sci/techresources/Human_Genome/medicine/pharma.shtml">pharmacogenomics</a> and truly personalised medicine. </p>
<p>The <a href="http://www.ornl.gov/sci/techresources/Human_Genome/project/about.shtml">Human Genome Project</a> spent US$3.2 billion in an international effort to sequence fully the first human genome, culminating in the joint announcement by Bill Clinton, Tony Blair, Francis Collins and Craig Venter in 2000. </p>
<p>A decade later, we can do this for as little as $2500, and the $500-or-less genome is imminent. It’s likely we’ll soon have a smartphone app to access details of our own genome, or the ability to link to cloud computers which store the three billion base pairs of our own DNA. </p>
<p>Of course, the expertise to translate this mass of complex information — and its interaction with environmental factors — into sensible health and medical advice will be considerably more expensive and elusive.</p>
<p>There is currently strong public support for human genetic research, genetic testing, and other applied uses of DNA technology, such as forensic testing and analysis by law enforcement authorities. </p>
<p>At the same time, it is understandable that there is an underlying social anxiety about the ability of governments to regulate these developments and protect the public. </p>
<p>Specifically, we must develop and implement sound and effective policy to:</p>
<ul>
<li><p>ensure the protection of personal privacy, while understanding and respecting that DNA, and potential abnormalities, are shared among family members;</p></li>
<li><p>guard against stigmatisation and unlawful discrimination;</p></li>
<li><p>maintain the highest possible ethical standards; and</p></li>
<li><p>promote access and equity in the distribution of the benefits of advances in genetic science and medicine. </p></li>
</ul>
<p>Initial concerns and controversies in the media have related mainly to aspects of medical research and <a href="http://www.theherald.com.au/blogs/jeff-corbett/dna-privacy/1757436.aspx">private insurance coverage</a>. </p>
<p>However, the potential reach of genetic information is enormous and growing, with ethical, legal and social concerns arising in a wide variety of contexts. </p>
<p>Do employers have the right to order an employee or a job applicant to undergo genetic testing, or to provide predictive genetic information? </p>
<p>Should applicants for individually risk-rated insurance (such as life insurance) be required to supply known genetic information for underwriting purposes? </p>
<p>Can the federal government require potential immigrants to undergo genetic testing for health or identity purposes? What about schools, nursing homes and sporting associations? </p>
<p>Can DNA be used to determine an individual’s ethnic or racial identity, or whether they can be recognised legally as an Indigenous person? </p>
<p>To what extent should genetic information be used in the criminal process? </p>
<p>If a defendant has biological markers that predict poor behaviour (addictive personality, risk-taking or “warrior” genes, for instance), is <em>“my genes made me do it”</em> an adequate defence? Or might it actually be an aggravating factor? </p>
<p>The challenge is to develop policies, standards and practices that promote the intelligent use of genetic information, while providing a level of security with which the community feels comfortable. </p>
<p>This will involve some “hard law” and regulation, but it will be even more important to develop a broad mix of strategies. These must include community and professional education, and the development of official standards and industry codes that reflect emerging international best practice in this area. </p>
<p><strong><em>David Weisbrot is a panelist on today’s University of Melbourne’s <a href="http://www.ideas.unimelb.edu.au/">Festival of Ideas</a> event, The Genetic Revolution III: Legal, Ethical and Moral Dimensions.</em></strong></p>
<p><em><strong>See our other Festival of Ideas coverage:</strong></em></p>
<p><em><strong><a href="http://theconversation.com/determined-to-be-different-what-we-do-changes-the-wiring-of-our-genes-1726">Determined to be different: what we do changes the wiring of our genes</a> by keynote speaker Matt Ridley</strong></em></p><img src="https://counter.theconversation.com/content/1791/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>David Weisbrot does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The rapid development of genetic science and technology holds hope for greatly improved health outcomes, with better diagnostics, treatments and cures, as well as the beginning of pharmacogenomics and…David Weisbrot, Professor of Legal Policy, United States Studies Centre, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/10192011-06-07T03:51:32Z2011-06-07T03:51:32ZSing for your supper: why Australia should reward corporate informants<figure><img src="https://images.theconversation.com/files/1418/original/anolobb_flickr_PBS.jpg?ixlib=rb-1.1.0&rect=0%2C232%2C480%2C326&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Laws rewarding informants could help crack down on fraud regarding medicines.</span> <span class="attribution"><span class="source">anolobb/Flickr</span></span></figcaption></figure><p>Federal and state governments in Australia appear much less successful than their United States counterparts in recovering taxpayers funds lost to suspected large-scale corporate fraud. </p>
<p>For instance, there are petrol companies in Australia that seem to raise and lower their prices in sync with each other, especially prior to weekends – negatively impacting government departments that fund fuel costs. </p>
<p>The Australian Competition and Consumer Commission (ACCC) waits for whistleblowers to come to it to provide documentary evidence of illegal collusion, but no one does. </p>
<p>Then there are defence contracts for rusty warships, dud helicopters, submarines and aircraft where the possibility of kickbacks to people in high places seems worth investigating – if only we had a better mechanism to encourage insider information. </p>
<p>With all the fuss about a resource rent tax there are inevitable queries about whether the giant corporations mining our iron ore, coal and gold are actually declaring all they pull out of the ground and have to pay royalties upon. </p>
<p>Then, there’s the possibility of systematic corporate fraud in relation to the billions of dollars of annual government expenditure – at both State and Federal levels – on medicines and health care. </p>
<p>There is suspicion, for example, that corporations running private hospitals may be systematically billing Medicare improperly. </p>
<p>Recent litigation around the drug Vioxx showed the extent to which the pharmaceutical industry can encourage drug representatives to make misleading statements to improperly encourage prescriptions. This extended to creating “fake” medical journals to promote their products. </p>
<p>So, what, if anything, can be done about this and what lessons can the United States give us in dealing with large scale corporate fraud on taxpayers? </p>
<h2>US Anti-Fraud laws: Letting informants sue via no-win no-fee lawyers</h2>
<p>The so-called <a href="http://www.fas.org/sgp/crs/misc/R40785.pdf">“Qui Tam” provisions in the US False Claims Act 1986 (FCA) </a>create a private-public enforcement partnership that drives the highly sucessful American anti-fraud regime. </p>
<p>The name Qui Tam is an abbreviation of a Latin legal maxim roughly meaning “he who sues on behalf of himself also sues on behalf of the state”. </p>
<p>The laws allow private citizens (called “relators” under the legislation) the right to provide documents establishing fraud to a no-win-no-fee lawyer. </p>
<p>This may lead to the initiation of a lawsuit under seal, that is, a lawsuit that is not initially disclosed to the defendant.</p>
<p>This is very different from the situation in Australia where governments expect informants to come to regulators without the promise of reward despite the emotional distress and job insecurity they will inevitably experience.</p>
<p>In the U.S., a provider of information critical to a successful anti-fraud case is compensated for efforts in the public interest with a small percentage of whatever proceeds (including triple damages) the government recovers from the civil suit. </p>
<p>The U.S. model has private practice law firms work synergistically with federal or state justice department officials. </p>
<p>The relator and his/her counsel contribute valuable manpower and financial resources to the government action. </p>
<p>This is a highly successful model that has not been applied in Australia. </p>
<p>Instead, in Australia regulators sometimes take details of fraud from private firms who have been contacted by informants and leave both the firm and informant without financial compensation for their efforts. </p>
<p>For the informant, this can result in intimidation, loss of livelihood, friends, family and stress.</p>
<p>The U.S. False Claims enforcement partnership has proven extremely cost-effective, recouping $15 for every dollar spent on Qui Tam investigations and litigation. </p>
<p>Qui Tam laws act as potent deterrents for fraudulent activities as they amplify the threat of detection and prosecution. </p>
<p>They also create incentives for compliance with government requirements and conditions. </p>
<p>Frivolous or “parasitic” Qui Tam claims are prevented by statutory bars on individuals who have made no material contribution to uncovering the fraud or providing the factual basis of the case. </p>
<p>A relator cannot base a Qui Tam action on publicly disclosed allegations, unless the relator is the original source of that information.</p>
<h2>Compensating anti-fraud informants in Australia</h2>
<p>The time is right to get Qui Tam, False Claims Act-type legislation into Australia. </p>
<p>Over the past 20 years, anti-competitive behaviour has increasingly been regarded as a serious crime by Australian regulators. </p>
<p>No-win-no fee advertising from law firms is common and litigation funding companies are permitted to back public interest class actions. </p>
<p>What’s more, the Australian High Court now supports the right of any person to bring an action, not to vindicate a private right, but to prevent the violation of a public right or to enforce the performance of a public duty.</p>
<p>Litigation funding companies in Australia already accept the risk of paying the other side’s costs if a case fails, in return for a set share of the proceeds if it succeeds. </p>
<p>These arrangements have withstood challenges in Australian courts, in part due to the fact that they fulfill public policy imperatives such as access to justice, particularly in public health-related class actions. </p>
<p>Treble damages have been considered previously as a deterrent for insider trading and regulators, in general, are in favour of them.</p>
<p>The key strengths of allowing informants of corporate fraud in Australia to sue via private legal firms operating in conjunction with government regulators include: </p>
<ul>
<li><p>the large amounts of public monies recovered;</p>
<ul>
<li>the encouragement it provides for good corporate practice; </li>
<li>the incentives it provides to informants from within the private sector; </li>
<li>the compensations it fairly affords such informants; and </li>
<li>various mechanisms that ensure only presumptively meritorious claims are processed. </li>
</ul></li>
</ul>
<p>If designed carefully, Australian Qui Tam anti-fraud laws could provide a mechanism for sustained and diligent oversight of claims by the pharmaceutical, medical device and health care industries on the public purse without significantly impeding their growth. </p>
<p>Australian Qui Tam or False Claims legislation could also play a significant role in reducing fraud and false claims in relation to other large investments or redistributions of public monies in public health-related fields, such as a carbon tax or carbon credit trading scheme. </p>
<p>The debate about whistleblowers in Australia has to move on from laws protecting them against unfair repraisals, towards laws allowing fair financial compensation for the personal loss and distress caused by their public service.</p>
<p>This piece is <a href="http://www.mja.com.au/public/issues/194_09_020511/fau11387_fm.html">based on an article published in the Medical Journal of Australia </a>in May 2011</p>
<p><strong>_Do you think informants on corporate fraud in Australia should be able to sue and receive compensation using private practise lawyers working in conjunction with government regulators? _</strong></p>
<p><em><strong>Leave your comments below</strong></em></p><img src="https://counter.theconversation.com/content/1019/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Thomas Faunce receives funding from the Australian Research Council under a Discovery Grant project focused on exploring applications of the US False Claims legislation in Australia.</span></em></p>Federal and state governments in Australia appear much less successful than their United States counterparts in recovering taxpayers funds lost to suspected large-scale corporate fraud. For instance, there…Thomas Faunce, ARC Future Fellow, Australian National UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/6372011-05-31T04:11:21Z2011-05-31T04:11:21ZPatent amendment bill could kill access to new medicines<figure><img src="https://images.theconversation.com/files/1404/original/4004791663_0d10fc20ae_b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Banning patents on biological agents could see capital for innovative medicines dry up. </span> </figcaption></figure><p><a href="http://theconversation.com/who-owns-the-rights-to-the-human-body-its-patently-obvious-835">Read the argument for the proposed legislation</a> </p>
<p>No one can deny that improved medical treatments and equity of access to them are essential to improving our community’s quality of life. Unfortunately, the<a href="http://www.aph.gov.au/senate/committee/legcon_ctte/patent_amendment/index.htm"> current patent amendment bill</a> threatens to block these goals.</p>
<p>Research translation involves optimizing the production of new medicines and lengthy pre-clinical and clinical testing to determine whether new medicines are safe and effective. </p>
<p>The community should demand nothing less. In many cases, the process of translation takes years or decades and many hundreds of millions of dollars.</p>
<p>This places research translation beyond the reach of academia, philanthropy and government, leaving only the private sector capable of making investments on the scale required. </p>
<p>This reality means that we must work with the private sector if we want the potential of life-changing discoveries to be realized. </p>
<p>It also means that the private sector must be able to generate a return on its investment. </p>
<p>The protection afforded by patents is an important mechanism by which investors are provided time to reap that return, so they can make investments in new medicines.</p>
<p>Given the central role the <a href="http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/">Patents Act</a> plays in enabling investment and bringing new therapies to market, we must demand that any proposed amendments to the current act are clear in their intent; precise in their effect; and that the burden of proof that the benefits of the amendments vastly outweigh their potential disadvantages is overwhelming.</p>
<h2>What is the problem advocates of the amendment seek to fix and what solution do they propose?</h2>
<p>Quoting from the explanatory memoranda <a href="http://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22legislation%2Fems%2Fs814_ems_46594cb2-74f1-4de5-834a-d5b1aea4edac%22;rec=0">(1)</a> _“The purpose of this Bill is to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature.”</p>
<p>Quoting from the proposed amendment itself <a href="http://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22legislation%2Fbills%2Fs814_first%2F0001%22;rec=0">(2)</a> ; the solution is to expand the definition of non-patentable inventions from <em>“human beings, and the biological processes for their generation” to additionally include “biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature”</em>, with biological materials defined as <em>“DNA, RNA, proteins, cells and fluids”</em>.</p>
<h2>The “straw-man” - patents stifle creative medical research</h2>
<p>First, let us consider whether the patenting of biological material, or indeed any other patents has hindered medical and scientific research. </p>
<p>In our combined experience - having worked for decades in major centres of medical research in Australia, the United States and Europe - the answer is a resounding no. </p>
<p>The vast majority of Australian medical researchers continue their programs without concern for patents. </p>
<p>With more than 11,000 patents being issued every year and more than 75,000 researchers in Australia, if patents, of any type, hindered public research, we would expect to see a myriad of infringement notices and court cases. </p>
<p>Where are they? The answer is they have not occurred because overwhelmingly research takes place without paying any heed to patents. It is a non issue. </p>
<p>Advocates of the amendment paint a picture of the devastating impact of patents on medical research, which is a complete distortion of reality. This argument is a straw man.</p>
<h2>The dangerous fallacy that banning patents on biological materials will enhance access to life-saving diagnostics and treatments</h2>
<p>We all agree that broad access to new ways of diagnosing, treating and curing diseases is desirable. </p>
<p>However, it is naive in the extreme - and ultimately placing patients’ lives at risk - to be advocating that this will be achieved by banning the patenting of biological materials. Quite the reverse! </p>
<p>By banning patents on biological agents, the capital required to transform innovations into products as varied as <a href="http://www.medicinenet.com/statins/article.htm">statins</a>, <a href="http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/bqctaxol/$File/bqctaxol.pdf">taxol</a>, <a href="http://www.cancer.org/Treatment/TreatmentsandSideEffects/GuidetoCancerDrugs/filgrastim">filgrastim</a>, <a href="http://www.medicinenet.com/sargramostim/article.htm">sargramostim</a>, <a href="http://www.cancer.gov/cancertopics/druginfo/rituximab">rituximab</a>, <a href="http://www.herceptin.com/index.jsp?aq=f&sourceid=chrome&ie=UTF-8&q=Herceptin">Herceptin</a> and <a href="http://www.gardasil.com/">Gardasil</a> will dry up. </p>
<p>As capital dries up, the pipeline of new products that treat the untreatable and prevent the unpreventable will slow to a trickle, and with it will dissipate the hopes of patients.</p>
<h2>The way forward</h2>
<p>The amendments currently being considered, and which will exclude biological materials from consideration from the patent act, fail three tests.</p>
<p>Their intent is misguided; their effect is far-reaching and unpredictable; and while there is no evidence that they will lead to improvements in patient care, there is a major concern that the reverse is true. </p>
<p>The amendments should be withdrawn immediately and, if not withdrawn, resoundingly defeated in Parliament.</p>
<p>There are very real challenges facing the health care sector - challenges such as the high cost of new genetic tests and new pharmaceuticals prohibiting widespread availability; and the escalating cost of healthcare as a percentage of Gross Domestic Product (GDP). </p>
<p>These are important issues but they are issues that can be dealt with by mechanisms, such as invoking Crown use provisions, compulsory licensing or Commonwealth acquisition. </p>
<p>Likewise, if access to affordable diagnostic tests is a major concern, then surely this can be addressed via an arrangement similar to the Pharmaceutical Benefits Scheme (PBS). </p>
<p>The PBS sets a precedent for controlling drug prices and this approach could extend to diagnostics. Let’s focus on real solutions to real problems.</p>
<p><a href="http://theconversation.com/who-owns-the-rights-to-the-human-body-its-patently-obvious-835">Read the argument for the proposed legislation</a> </p>
<p><em><strong>Do you think patenting of genetic and biological materials should be permitted?</strong></em></p>
<p><strong><em>Leave your comments below</em></strong></p><img src="https://counter.theconversation.com/content/637/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Douglas Hilton receives funding from the NHMRC, Australian Stem Cell Centre, CSL, HEARing-CRC, National Collaborative Research Infrastructure Strategy and National Institute of Health (USA).</span></em></p><p class="fine-print"><em><span>Julian Clark does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Read the argument for the proposed legislation No one can deny that improved medical treatments and equity of access to them are essential to improving our community’s quality of life. Unfortunately, the…Douglas Hilton, Director, Walter and Eliza Hall Institute & Professor of Medical Biology , Walter and Eliza Hall InstituteJulian Clark, Business Development Manager, Walter and Eliza Hall InstituteLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/8352011-05-30T21:02:32Z2011-05-30T21:02:32ZWho owns the rights to the human body? It’s patently obvious<figure><img src="https://images.theconversation.com/files/1245/original/AAP_DNA_research.jpg?ixlib=rb-1.1.0&rect=8%2C212%2C1239%2C1117&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The Bill seeks to close the loophole opened by the US Patent Office 30 years ago.</span> <span class="attribution"><span class="source">AAP</span></span></figcaption></figure><p><a href="http://theconversation.com/patent-amendment-bill-could-kill-access-to-new-medicines-637">Read the argument against the proposed legislation</a></p>
<p>Patents are only to be for granted inventions - that’s the intent of the <a href="http://www.austlii.edu.au/au/legis/cth/consol_act/pa1990109/">Patents Act 1990</a>, it has been the law for nearly 400 years, and it’s also what <a href="http://www.wto.org/english/tratop_e/trips_e/t_agm3_e.htm">Article 27.1 of TRIPS</a> says in black and white.</p>
<p>About 30 years ago, a new patent office practice was established by the <a href="http://www.uspto.gov/">United States Patent and Trademark Office</a>, the <a href="http://www.epo.org/">European Patent Office</a> and the <a href="http://www.jpo.go.jp/">Japan Patent Office</a>. </p>
<p>The change essentially meant that naturally occurring biological materials, such as DNA and amino acids or proteins, which have been isolated (removed from their natural environment), could be considered to be inventions. </p>
<p>This practice was subsequently adopted in Australia and its implementation resulted in the granting of thousands of patents over isolated biological materials from a variety of sources, including viruses, bacteria, human genome and plant genomes. </p>
<p>However, the legality of this practice was never tested, either in a United States or Australian court – until 2009 in the former and 2010 in Australia. </p>
<p>This only happened when the legality of patents granted to <a href="http://www.myriad.com/">Myriad Genetics</a> over the <a href="http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA">BRCA 1 and BRCA 2</a> genes and their use in genetic tests were challenged.</p>
<p>In the United States, a Federal Court judge held in March 2010 that the US patents, insofar as they claimed the BRCA 1 and BRCA 2 genes as inventions, were invalid. </p>
<p>The judge held that the isolation of a naturally occurring biological material was not the equivalent of transforming that material from a product of nature into a product of humankind. </p>
<p>His decision has been appealed and the appeal was heard a few weeks ago. You can listen to the legal arguments <a href="http://oralarguments.cafc.uscourts.gov/Audiomp3/2010-1406.mp3">here</a>. </p>
<p>Whatever the outcome of that appeal, it is likely that the case will go to the US Supreme Court for final determination.</p>
<p>In Australia, a test case is proceeding through the Federal Court and a tentative trial date has been set for September 2011, but there is a strong possibility that that date will change.</p>
<h2>Patent Amendment (Human Genes and Biological Materials) Bill 2010</h2>
<p>The <a href="http://www.aph.gov.au/senate/committee/legcon_ctte/patent_amendment/index.htm">Patent Amendment Bill</a> going through the Australian Parliament seeks to define what an invention is in the context of biological materials which are (and this next bit is important) <em>identical or substantially identical to what exists in nature</em>. </p>
<p>In other words, it seeks to close the loophole which the US patent office practice opened 30 years ago.</p>
<p>The intent of the Bill is to make it clear that a naturally occurring biological material isolated from its natural environment is not patentable matter, that is, it is not an invention. </p>
<p>This is a scientific fact. As an example, imagine a cotton ball – removing a cotton ball from a cotton plant doesn’t make the cotton ball an invention. It is absurd to suggest it does. </p>
<p>The Bill does not prevent the patenting of modified biological materials if they are substantially different to those that exist in nature. </p>
<p>So, the modified protein which is at the heart of the <a href="http://www.gardasil.com/">Gardasil</a> vaccine would not be affected. Neither would the monoclonal antibody which is at the heart of <a href="http://www.herceptin.com/index.jsp?aq=f&sourceid=chrome&ie=UTF-8&q=Herceptin">Herceptin</a>, nor the modified human insulin which is at the heart of <a href="http://www.novolog.com/">NovoLog</a>. </p>
<p>These are biological materials but each have been modified so they function in a way that unmodified proteins do not and their enhanced function is sufficient to distinguish them from their naturally occurring parent proteins.</p>
<p>Further, the Bill does not prevent the patenting of vaccines, medicines, diagnostics and therapeutics that use biological materials as their active ingredient. </p>
<p>So, even if the Bill becomes the law, it will still be possible to apply for a patent for a vaccine containing a biological material identical to one existing in nature, such as a vaccine using a live attenuated viral strain. </p>
<p>All the Bill does is prevent the patenting of the naturally occurring biological material itself, not the product which uses such a material to produce a new and inventive efficacious result, which is what a new vaccine does.</p>
<p>Ultimately, the Bill merely applies patent law as it was always intended to be applied. </p>
<p>Even the US government acknowledges the USPTO’s practice was wrong in law. In October 2010, the US Department of Justice, on behalf of the US government, filed an <a href="http://www.genomicslawreport.com/wp-content/uploads/2010/11/Myriad-Amicus-Brief-US-DOJ.pdf">amicus (friend of the court) brief</a> in the Myriad BRCA US patent appeal.</p>
<p>The brief said that having reviewed the “longstanding practice of the [U.S.] Patent and Trademark Office” relating to “patents for isolated genomic DNA”, the Department of Justice found the practice to be contrary to “settled principle under [U.S.] Supreme Court precedent”.</p>
<p>The main reason for the opposition to the Bill is that it will achieve its stated aim. </p>
<p>Those who oppose it have either obtained patents on isolated biological materials which are identical or substantially similar to those that exist in nature (pharmaceutical and biotechnology companies, universities and certain research institutions) or have participated in procuring such patents (patent attorneys and intellectual property lawyers) or are financially benefiting from them. </p>
<p>Their opposition is an over reaction because the Bill will not actually stop the patenting of new and inventive diagnostics, medicines and therapeutics which contain or incorporate these biological materials. </p>
<p>It will merely prevent the patenting of the biological materials existing in nature or those derived from such materials that function in exactly the same way.</p>
<p>The argument that this Bill will bring the Australian biotechnology sector to its knees is complete and utter nonsense. </p>
<p>It is regrettable that some of Australia’s leading scientists have publicly opposed it when all it seeks to do is ensure that only true inventions are rewarded with a patent monopoly.</p>
<p><a href="http://theconversation.com/patent-amendment-bill-could-kill-access-to-new-medicines-637">Read the argument against the proposed legislation</a></p>
<p><strong>_Do you think human genes and other biological materials should be allowed to be patented? _</strong></p>
<p><strong><em>Leave your comments below</em></strong></p><img src="https://counter.theconversation.com/content/835/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Luigi Palombi receives funding from the ARC.</span></em></p>Read the argument against the proposed legislation Patents are only to be for granted inventions - that’s the intent of the Patents Act 1990, it has been the law for nearly 400 years, and it’s also what…Luigi Palombi, Director, Genetic Sequence Right Project, Australian National UniversityLicensed as Creative Commons – attribution, no derivatives.