Giant trade deal will not drive up cost of meds: Govt

Australians will be shielded from any increase in the cost of government-subsidised medicines under the terms of a massive trade deal covering 40 per cent of the global economy, Trade Minister Andrew Robb has promised.

Negotiators from 12 nations including Australia, the United States, Japan, Canada, Vietnam and Mexico concluded talks on the controversial Trans Pacific Partnership agreement after the US agreed to an Australian compromise to protect the Pharmaceutical Benefits Scheme in the face of demands for an extension of data protection for biologic medicines.

AMA officials and other health campaigners had raised concerns that intellectual property provisions proposed during the course of negotiations would have forced up the price of prescription medicines, costing consumers and the Government billions of dollars, and possibly allowed corporations to block public health measures such as anti-smoking laws.

But Trade and Investment Minster Andrew Robb said the final deal recognised Australia’s existing medicines regime and included carve-outs to protect health and environmental policy from action taken under investor-state dispute settlement (ISDS) provisions.

“Importantly, the TPP will not require any changes to Australia’s intellectual property laws or policies, whether in copyright, pharmaceutical patents or enforcement,” Mr Robb said. “Australia’s five years of data protection for biological medicines will remain unchanged. The TPP will not increase the price of medicines in Australia.”

The US had been pushing for at least eight years of data exclusivity for developers of biologic medicines, which are derived from biological sources such as human cells, blood, proteins and antibodies, and are used to treat diseases including cancer and rheumatoid arthritis.

Australian law currently provides for a five-year period of data exclusivity, and the extra years were potentially worth billions to pharmaceutical companies by delaying the entrance of lower-cost rivals the while adding hundreds of millions to the cost of the PBS.

The issue threatened to derail the deal, but US negotiators accepted an Australian counter-proposal to accept the five-year protection period where it exists while giving countries the option to opt for eight years if they so choose.

Prime Minister Malcolm Turnbull hailed the signing of the trade a “very big win”.

Public health campaigner Professor Mike Daube said the provision in the deal preventing tobacco companies from suing countries for anti-tobacco laws was “a quite remarkable and historic development”.

“It’s a huge achievement for public health, and possibly the biggest international setback for the tobacco industry that we have ever seen,” he said. “Tobacco has rightly been singled out as the pariah industry.”

There had been fears that tobacco and alcohol producers would use ISDS provisions to try and prevent governments from implementing public health measures – tobacco companies are already using ISDS provisions in Australia’s trade agreement with Hong Kong to challenge the legality of tobacco plain packaging laws.

The Government has expressed confidence that the finalised deal will prevent this, but intellectual property law expert Professor Matthew Rimmer sounded a more cautious note.

“Drug companies, junk food and soda companies, and alcohol manufacturers could still challenge government policy and regulation,” Professor Rimmer told Fairfax Media. “There is concern that the general defences for public health policy are limited.”

A major gripe of critics has been the secrecy surrounding the negotiations, which Professor Rimmer said had not served public health policy well.

Among those concerned about the health implications of the completed TPP is medical charity Medicins Sans Frontieres, which warned it would limit the access of people in developing countries to vital drugs.

The charity said millions relied on the ability of pharmaceutical companies in places like India to manufacture drugs coming off patent for a fraction of the cost of name brand producers, and the precedent set by the trade deal would impede this.

“The big losers in the TPP are patients and treatment providers in developing countries,” US Manager of MSF’s Access campaign Judit Rius Sanjuan told Fairfax Media. “Although the text has improved over the initial demands, the TPP will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies.”

Adrian Rollins

Tobacco cuts a deadly swathe through China

While tobacco companies and their deadly products are under siege in Australia and many other developed countries, the death toll from cigarettes in emerging markets is soaring as they make huge inroads into markets like China and Indonesia.

A study in the peer-reviewed journal Cancer has highlighted the heavy human cost that has resulted, reporting that smoking now causes almost a quarter of all cancers in Chinese men.

The authors of the study said that since the 1980s there had been an explosion in the number of men in China who smoke, to the point that the vast Asian country now produces and consumes around 40 per cent of all the world’s cigarettes.

Already, smoking is estimated to cause 435,000 new cancers each year in China (83 per cent of them in men), and researchers warn this will be only the tip of the iceberg as the effects of increased smoking rates now feed through in coming decades.

“The tobacco-related cancer risks among men are expected to increase substantially during the next few decades as a delayed effect of the recent rise in cigarette use, unless there is widespreasd cessation among adult smokers,” the research team, led by Professor Zhengming Chen of Oxford University and Professor Liming Li of the Chinese Academy of Medical Sciences, said.

The team analysed the results of a survey of more than 510,000 Chinese men and women conducted between 2004 and 2008, and a follow-up survey conducted after seven years found around 18,000 new cancers among those interviewed.

Underlining the dangers of tobacco, the survey found 68 per cent of men smoked, and they were at 44 per cent greater risk of developing cancer than non-smokers, particularly cancer of the lung, liver, stomach and oesophagus. The increased risk accounted for 23 per cent of all cancers found in people aged between 40 and 79 years.

But, in a result that should spur efforts to get people to quit the habit, the study found the excess risk of cancer had virtually disappeared 15 years after a smoker stubbed out their last cigarette.

Professor Zhengming said getting smokers to dump cigarettes would be the most potent and cost-effective strategies to avoid cancer and premature death “over the next few decades”.

The results came as Assistant Health Minister Fiona Nash dismissed complaints by tobacco companies about an increase in the excise charged on their products in Australia, and reaffirmed the nation’s commitment to defend the country’s world-leading plain packaging laws against legal challenge in international forums including the World Trade Organisation.

Senator Nash said the heavy tobacco excise had helped reduce the proportion of Australians who smoke daily to an all-time low of 12.8 per cent.

Cigarette manufacturers have complained that plain packaging, the hefty excise and other Government measures are fuelling an illegal trade in tobacco, but the Minister said such “scaremongering…[was] no reason to roll back sensible health policies”.

Adrian Rollins

[Correspondence] E-cigarettes: the need for clear communication on relative risks

The Lancet Editorial1 criticises our Public Health England commissioned evidence update report2 on the basis of perceived flaws in one of the 185 references we used, ignoring the rest of our 111 page document, which addresses population effects of e-cigarette use, regulations, attitudes as well as concerns over its safety. The Editorial focuses on the estimate of risk reduction and protests strongly against the media reassuring smokers that switching to e-cigarettes provides substantial health benefits, but it provides no data to counter our estimate, nor any reason as to why The Lancet believes that the message smokers can benefit from switching to vaping is an undesirable one.

A change in legislation could increase heart transplant numbers

More hearts could become available for transplant if key terms were altered in transplant legislation, experts say.

According to an Ethics and Law article published in the Medical Journal of Australia, the current legislation has resulted in only 39 hearts being procured from 189 donors (21%) during the first 6 months of 2015.

Associate Professor James Tibballs, Deputy Director of the Intensive Care Unit at Royal Children’s Hospital in Melbourne, and Dr Neera Bhatia, Lecturer at the Deakin University School of Law in Melbourne believe this could change.

They write in their article that the law defines death as either “irreversible cessation of all functions of the brain” (brain death) or “irreversible cessation of circulation of blood in the body” (circulatory death).

Tibballs and Bhatia write that the problem is the legislation doesn’t define irreversible or how to determine irreversibility.

“The fact that a transplanted heart can function and sustain life in a recipient must mean that the circulation of the donor had never ceased irreversibly and therefore that the donor of the heart was never dead until his or her heart was removed.

“The question is thus posed — how is it possible to procure the heart of a donor under the premise of circulatory death and yet expect it to sustain life in a recipient?”

They say this legal grey area means a transplant surgeon could possibly be committing a criminal act by transplanting after circulatory death.

They have provided a possible alternative, being: “Retain the present definition of brain death as irreversible cessation of all function of the brain, but to omit the requirement for irreversibility in the definition of circulatory death and to redefine it as cessation of circulatory function with cessation of higher brain function”, they suggested.

They feel that with such an alteration could increase heart transplant numbers and improve outcomes for the organ donation program.

“Otherwise, Australia’s improving organ donor program is at risk of adverse publicity and damage if doctors, hospitals and our organ procurement agencies are perceived as procuring organs from patients not legally dead,” they write.

A podcast with Associate Professor Tibballs and Dr Bhatia is available at www.mja.com.au/multimedia/podcasts and iTunes. Also available as a video at www.mja.com.au/multimedia

Latest news:

NSW prison smoking ban allows staff to continue with the habit

New Zealand started it, Northern Territory followed and now most of Australia has banned smoking in prisons. New South Wales is the latest to have joined the ranks to ban smoking in correctional facilities. However, NSW’s recently introduced ban isn’t without controversy, as prison officers are exempt.

An Australian Institute of Health and Welfare report ‘The health of Australia’s prisoners 2012’, released mid-2013, found that four out of five prisoners reported that they smoke, with 78 per cent saying they smoked daily.

Smoking bans in prisons are complex, and around the world have been controversial and difficult to implement. New Zealand introduced a blanket ban on smoking in correctional facilities in July 2011, but the New Zealand High Court ruled that the ban was unlawful in December 2012. After a lengthy legal battle, Correctional Services amended legislation which reinstated the blanket ban.

New Zealand Corrections Department Chief Executive Ray Smith said that, since the introduction of smoke-free prisons the work environment had improved for staff and prisoners with better air quality and fewer fires.

“Implementing smoke-free prisons was always going to be a serious challenge, and it has gone incredibly well and without major incident. We are the first national prison service to achieve this,” Mr Smith said.

Prisoners were given 12 months to quit smoking before the blanket ban was introduced in July 2011.

Northern Territory prisons have been smoke-free since July 2013, modelling their approach closely on New Zealand’s successful introduction of smoke-free prisons. The Northern Territory introduced a 12 month plan prior to the ban to encourage staff and inmates to quit smoking. Better access to services to help staff and inmates to quit smoking was provided and a comprehensive rather than a partial, smoking ban was introduced.

Much of the rest of Australia followed in Northern Territory’s footsteps with Queensland, Tasmania, and Victoria introducing total bans on smoking in correctional facilities. South Australia is trialling bans at the Adelaide Remand Centre later this year while the ACT has committed to phasing out smoking in prisons, but continues to be elusive with a timeline for the ban. Western Australia currently has no intention to ban smoking from correctional facilities, but they have banned smoking indoors.

NSW’s ban on smoking at correctional facilities was introduced mid-August, but a loophole in the legislation allows staff who live in correctional centres to smoke in designated areas, a move likely to be resented by many prisoners who are being forced to quit.

Inmates’ families have been told by NSW Corrective Services that they won’t be permitted to smoke anywhere on the grounds of a correctional centre which includes car parks or inside their cars during visits.

The smoking ban legislation was amended to allow smoking areas to be declared for staff living in NSW’s 84 prison residences by the Minister for Corrections David Elliot a week before the implementation.

A Corrective Services spokesman told the Sydney Morning Herald that staff who live on Corrective Service NSW sites will be able to smoke while off duty in a designated area outside their accommodation and not visible from any correctional centre.

Monarch University researcher Anita Mackay, who has studied smoking bans in prisons around the world, said that she hasn’t come across a situation where there is a complete ban for imprisoned people, while staff are able to smoke. Given that the justification is to protect the health of staff, it doesn’t really align.

Kirsty Waterford

Medicinal Cannabis may no longer be a pipe dream

Political momentum to allow medicinal cannabis crops to be grown commercially in Australia is building, with a Senate Committee unanimously endorsing a Bill which would remove current restrictions.

All members of the Senate Legal and Constitutional Affairs Committee have recommended that the Regulator of Medicinal Cannabis Bill be passed into law, with amendments.

The Bill was introduced last year by Greens Senator Richard Di Natale and co-sponsored by Liberal Senator Ian McDonald, Labor Senator Anne Urquhart and Independent Senator David Leyonhjelm.

Greens Leader Richard Di Natale, who previously worked as a GP, said the Senate Committee’s unanimous endorsement of his Private Member’s Bill was a significant step towards achieving medicinal cannabis reform.

“The next step is to secure sufficient time in the Parliament to bring this Bill to a vote,” Senator Di Natale said.

“I call on [Prime Minister] Tony Abbott to allow this Bill to be debated during Government business. Given that the Bill has co-sponsors from all sides of politics, I hope that we can work together to make this happen.”

Senator Di Natale said the Committee recommended some amendments to strengthen the Bill, which he and his co-sponsors would consider, but stressed this should not be used as an excuse for major delays.

“This issue is not about politics, it’s about getting medicine to people who need it. We have an opportunity to relieve the pain and suffering of many Australians if we can just come together and show Parliament at its best.”

Senator McDonald has predicted the Regulator of Medicinal Cannabis Bill is likely to pass Federal Parliament by the end of the year.

The Committee’s recommendations are designed to amend the Bill to resolve all conflicts with various pieces of existing legislation including the Therapeutic Goods Act and the Narcotics Act, as well as State and Territory laws.

The AMA believes medicinal cannabis should be regulated in the same ways as other therapeutic narcotics.

The Senate report has acknowledged the legislative conflicts that arise from regulating medicinal cannabis differently to other therapeutic narcotics.

The AMA is wary of more complex regulation for medical practitioners, and would favour simple solutions to the complex issues considered by the Senate Committee.

Odette Visser

Medibank’s too private actions rile doctors and patients

AMA President Professor Brian Owler says that Medibank Private’s recent actions – highlighted by its contentious list of 165 ‘preventable events’ and its rocky contract negotiations with Calvary Health – have nothing to do with quality.

Medibank Private and Calvary eventually signed a contract, but no details were made public.

The AMA acknowledges that commercial elements of the contract should remain confidential, but any arrangements to do with the list of ‘preventable events’ are in the public interest. Keeping them secret only fans suspicion and undermines trust.

“Medibank is using the cloak of quality to cut costs, to not pay for treatments and procedures, and this is going to put an enormous strain on our hospital system – not just in terms of the private system, but the public system as well”, Professor Owler said.

“We know that there will be patients that won’t be able to be readmitted should they develop problems with their wound or other complications, and they will have to go to the public hospitals.

“There are other patients that won’t be able to afford the out of pocket expenses that Calvary will have to charge, and they will have to be going to public hospitals as well.”

Professor Owler is warning that, if the issue was not stopped by the Government, it has the ability to threaten the balance between the public and private system right across the country.

“We’ve already seen Bupa and NIB line up behind Medibank Private,” he said.

The AMA disputes that Medibank Private’s list of ‘preventable events’ can be addressed as a quality issue, with studies showing a similar approach taken overseas has not produced any change in outcomes, and questions the various items that are on the list.

“Medibank is continuing to be mischievous with the truth, and they continue to refer to complications as ‘mistakes’,” Professor Owler said.

“These are not mistakes, these are complications that are unfortunate, but part of everyday medical practice.

“While there is a degree of preventability, they are not mistakes, they cannot be completely prevented.

“Medibank Private is unfairly punishing the hospital, blaming the doctors and the nurses that are working and caring for patients in those private hospitals, and going to put an enormous strain on the public hospital system.

“The idea that the Government does not have a role in this dispute is ludicrous.

“First of all, this dispute is in part the creation of this Government.

“It was this Government’s policy that actually put Medibank Private on the stock exchange, and created the biggest private health insurer where the responsibility was now the shareholders, and concentrating on returns to investors.

“The Government also has about $6 billion of skin in the game; they pay for the private health insurance rebate, they support private health insurance, and this move by Medibank Private continues to undermine it.”

In welcome news, the Government has fast-tracked a review of preventable events being conducted by the Australian Commission on Safety and Quality in Health Care, and Medibank Private has indicated it will cooperate with this review.

John Flannery

Latest news:

Big Tobacco after data on Aussie kids’ attitudes

A global tobacco giant has been accused of using freedom of information laws to obtain taxpayer-funded research showing Australian school children and teenagers’ attitudes to smoking and alcohol.

Public health advocates are concerned that ‘Big Tobacco’ may use the data to hone their marketing of cigarettes to teenagers, as well as to fight plain packaging laws, which are now being implemented across the globe.

British American Tobacco (BAT) is trying to access data from the Victorian Cancer Council Australian Secondary Students’ Alcohol and Drug Survey.

The lawyer seeking the Victorian information for BAT was recently successful in obtaining the Cancer Institute NSW research into adults’ attitudes to smoking, by using the FOI Act.

According to the Sydney Morning Herald, the Institute felt legally compelled to disclose the data, which effectively gave Big Tobacco access to millions of dollars worth of taxpayer funded research for the price of an FOI application.

The information was then used by the tobacco company last year in Britain to contest plain packaging laws.

The Victorian Cancer Council is currently fighting the FOI application in the Victorian Civil and Administive Tribunal.

Victorian Cancer Council CEO Todd Harper said that they are doing everything they can, and are concerned that handing over the data would breach confidentiality and have a chilling effect on future research.

“If this information were to be used for commercial purposes, for instance to hone or localise tobacco or alcohol marketing and pricing strategies to appeal to the young, provision of such information would be highly detrimental to Victoria’s children,” Mr Harper said.

A spokesperson for BAT told the Sydney Morning Herald that the company was seeking information to bolster its case that instead of Australian youth smoking rates going down because of plain packaging, that they’re going up.

“Any evidence to prove the latter needs to be highlighted so that other countries around the world don’t make the same mistake. Any such evidence is also relevant to the Government’s Post Implementation Review into plain packaging, which is still underway,” the spokesperson said.

“In this context, any such request for an FOI to obtain this information is both reasonable and legitimate. Importantly none of the FOI applications sought any personal data or information in respect of children or adolescents,” the spokesperson said.

In a statement provided to Medical Observer the company said that “it is illegal to sell tobacco to children and tobacco advertising has been banned for decades. Children are not, and never will be, our audience and we have always made this clear.”

The survey collects information from students aged 12-17 about their smoking and drinking practices, including what brands they prefer.

The Assistant Minister for Health, Fiona Nash, said the Government would not back away from plain packaging regardless of tactics by tobacco companies to discredit it.

“If tobacco companies are obtaining research on young people through state FOI legislation to increase their sales to children, then I am appalled,” Ms Nash said.

Professor of Health Policy at Curtin University Mike Daube said the FOI application for the school survey data takes the tobacco industry into new lows.

“The companies claim that they have no interest in children – yet they are going to extraordinary lengths to access research data about children and tobacco, alcohol and drugs,” Professor Daube told the Sydney Morning Herald.

“This use of FOI legislation by the world’s most lethal industry raises another issue of enormous concern. If Big Tobacco can use FOI to harass a Cancer Council, what is to stop them using FOI to obtain information from any researchers employed by universities, or to tie them up in endless legal battles?”

Kirsty Waterford

Transplantation of the heart after circulatory death of the donor: time for a change in law?

Australia has an increasing shortfall in transplantable hearts. Over the past decade, the number of all donors per million population increased from 10.0 in 20051 to 16.1 in 2014.2 However, the number of heart donations per million population over the same period has declined slightly from 3.8 to 3.4, with an annual average of 3.3.3 Procurement of organs has always been conducted according to the dead donor rule — that is, after death of the donor — but this practice is being challenged.

The law defines death in all Australian jurisdictions (eg, in s 41 of the Human Tissue Act 1982 [Vic]) as either “irreversible cessation of all functions of the brain” (brain death) or as “irreversible cessation of circulation of blood in the body” (circulatory death), but it does not define irreversible or how to determine irreversibility (Box). Exceptionally, circulatory death is not defined in Western Australian legislation.

Although the procurement of organs such as livers, kidneys and lungs is permitted after either brain death or circulatory death according to Acts in all jurisdictions, the procurement of hearts has traditionally only been from brain dead donors with functioning hearts. The definition and diagnosis of brain death is not without controversy4,5 and may explain in part why more reliance is being placed on circulatory death, which reduces availability of hearts.6,7 Alternatively, organ procurement from patients after circulatory death may be perceived as more realisable than after brain death. Indeed, circulatory death as the source of solid organs has increased from 10% of 204 donors in 2005 to 28% of 378 donors in 2014.1,2 More total organs have been procured (from 726 to 1193) but the number of hearts has increased only slightly from 72 of 204 donors (35%) to 79 of 378 donors (21%) over the same period.1,2 Only 39 hearts were procured from 189 donors (21%) during the first 6 months of 2015.8

Organ donation and procurement after circulatory death

In the practice of organ donation after circulatory death (DCD), life-sustaining treatment such as mechanical ventilation is commonly withdrawn because of a devastating neurological injury that has not progressed to brain death. The withdrawal of treatment from the donor is staged to facilitate organ transplantation to recipients. The procurement of organs is specified in the Australian national DCD protocol published by the Organ and Tissue Authority9 and enacted through the DonateLife network. It is not declared why the heart is not included in the protocol’s list of organs that may be procured.

Expeditious organ procurement may be commenced after death has occurred — defined in Australia as 2–5 minutes after cessation of the donor’s circulation,9 and after 2 minutes in United States.10 The donor’s arrested heart has not usually been procured. However, to increase the availability of hearts, routine procurement after circulatory death is proposed but not yet sanctioned in the current national DCD protocol.9 It is probable that the protocol is under review given that the Organ and Tissue Authority lauded St Vincent’s Hospital in Sydney, where two adults were transplanted with hearts procured after circulatory death in 2014.11 In those cases, the donor hearts were reanimated and kept beating and warm inside a container (ex-vivo Organ Care System, TransMedics) pending transplantation.12

This practice poses ethical,13 legal and medical problems. Foremost of the medical difficulties is the poor condition of the procured heart after it has ceased to circulate blood in the donor. However, the heart can be resuscitated with the aid of extracorporeal techniques, as was performed for the two adult recipients at St Vincent’s Hospital.11,12

Heart transplantations after cardiac death have been performed in three infants in North America14 but were followed by consternation and a medical call for a moratorium on all organ procurement after cardiac death and the accusation that doctors and hospitals were biased towards organ procurement.15 The basis for the opposition was that the infants may not have been dead and possibly were conscious at the time of organ procurement. Of the three infants, one was declared dead 3 minutes after cessation of cardiocirculatory function before the process of organ procurement was initiated, and two were declared dead after 75 seconds.14

Medical interpretation of the legal definition of death

The source of the problem of heart transplantation after circulatory death is the medical interpretation of the legal definition of circulatory death. From a medical point of view, in other contexts, death is not necessarily defined by cessation of the circulation, unless it is of sufficient duration to result in brain death. It is not rare, for example, to be able to resuscitate a victim from a short duration cardiac arrest with complete neurological recovery or to sustain the circulation of a patient for lengthy periods by an extracorporeal circulation with subsequent intrinsic cardiac recovery.

The fact that a transplanted heart can function and sustain life in a recipient must mean that the circulation of the donor is never ceased irreversibly and therefore that the donor of the heart is never dead until his or her heart is removed.

The question is thus posed — how is it possible to procure the heart of a donor under the premise of circulatory death and yet expect it to sustain life in a recipient? Put differently, should the procurement of the heart be a criminal offence in such cases, because its procurement is the cause of death of the donor?

A possible argument to justify heart procurement for transplantation after circulatory death is that legal irreversible cessation of the circulation may be interpreted medically as “will not be resuscitated” rather than “cannot be resuscitated”. However, that interpretation does not appear to be open to the medical profession. From a legal point of view, the meaning of legislation is governed by statute law. In the jurisdiction considered here, it is the Interpretation of Legislation Act 1984 (Vic) and Acts Interpretation Act 1901 (Cwlth) that apply, but these are not helpful in defining “irreversible”.

If a word or phrase is not defined in an Act, resort is made to common law interpretations, which may be described as literal or purposive. The literal interpretation of legislation was defined by Justice Higgins in the High Court of Australia as:

The fundamental rule of interpretation, to which all others are subordinate, is that a statute is to be expounded according to the intent of the Parliament that made it; and that intention has to be found by an examination of the language used in the statute as a whole. The question is, what does the language mean; and when we find what the language means, in its ordinary and natural sense, it is our duty to obey that meaning, even if we think the result would be inconvenient or impolitic or improbable.16

The literal approach may be too restrictive if a word or phrase has more than one meaning. In such instances, legal resort is made to a reputable dictionary — in Australia, usually the Macquarie Dictionary. Since that dictionary defines “irreversible” as “not reversible; that cannot be reversed”, a legal and hence medical interpretation of irreversible cannot logically be “will not be resuscitated”. Doctors cannot simply redefine the meaning of words in legislation to suit their practice.

Notwithstanding that the natural and ordinary meanings of words are the starting points in interpreting Acts,17 a purposive interpretation may be considered when a literal approach produces ambiguity or inconsistency (Acts Interpretation Act, s 15AA). Such an interpretation would be one that best achieves the purpose or object of the Act, whether expressly stated or derived from the content of the Act.

In Victoria, the stated aim of the Human Tissue Act is to make provision for removal of human tissue for transplantation and, among other aims, to provide a definition of death. The purpose of defining death is not declared but s 26 of the Act allows a designated officer and medical officers to remove tissue for transplantation only when the proposed organ donor has fulfilled the definition of death under s 41. In other words, a purpose of the Act is to prevent tissue and organ procurement from a donor who is not dead. Thus, heart procurement for transplantation under the practice of DCD is not possible under either a literal or purposive interpretation of the Act.

A similar problem with the interpretation of legislation has occurred in the United States, where death is defined in the Uniform Determination of Death Act 1982, on which Australian legislation has been modelled. The US Act also defines circulatory death as “irreversible cessation of circulatory and respiratory functions”. In a purposive approach, Bernat18 has proposed that as doctors diagnose death by permanent cessation of circulatory and respiratory functions, this satisfies the requirements of death statutes and does not violate the dead donor rule. Bernat also proposes that “permanence is a perfect surrogate indicator for irreversibility” and thus permits heart donation after DCD. This argument is similarly not sustainable. The Macquarie Dictionary defines “permanent” as “lasting or intended to last indefinitely; remaining unchanged; not temporary; enduring; abiding”. Clearly, a heart that has ceased functioning in a donor and functions later in a recipient has not ceased functioning irreversibly or permanently. Moreover, permanent cessation of the circulation is not the legal definition of death, and the concept, wrong that it is, is similarly not available to doctors to justify heart transplantation after circulatory death.

Another putative justification for heart procurement after DCD is that, whereas the heart may have stopped irreversibly in the donor’s body, it is able to function in that of the recipient. This is also a spurious argument, because the only reason that the heart stops in the donor is the elective, and hence reversible, withdrawal of life-sustaining treatment such as mechanical ventilation. The heart had obviously been functioning well in the donor’s body before its procurement.

Possible solution

This potential problem of heart procurement being the cause of the donor’s death arises because death has been mistakenly defined in the legal sense as cessation of the circulation, without any reference to brain function. A possible alternative would be to retain the present definition of brain death as irreversible cessation of all function of the brain, but to omit the requirement for irreversibility in the definition of circulatory death and to redefine it as cessation of circulatory function with cessation of higher brain function. Under this proposition for the redefinition of circulatory death for the purpose of transplantation, procurement of a heart for the purpose of its transplantation could proceed without legal risk and without risk of retained consciousness of the donor.

Conclusion

Organ transplantation is ethical whether after brain death or circulatory death, and it is proper to maximise organ procurement, but only as permitted by law. We have shown that heart transplantation after DCD does not conform to present statute law. When the way forward is not clear in a medicolegal conundrum such as this one, legislation needs to be refined. Otherwise, as some legal academics have argued,19 procurement of a heart after cardiac death for transplantation under present legislation does not conform to the dead donor rule. This may be a potential criminal offence, an accusation that may need to be made in order to encourage law reform. Alternatively, the dead donor rule, which would arguably be violated in heart transplantation after circulatory death, needs societal, legal and medical debate followed by revision or abandonment.13 Otherwise, Australia’s improving organ donor program is at risk of adverse publicity and damage if doctors, hospitals and our organ procurement agencies are perceived as procuring organs from patients not legally dead.

Australian statute law governing procurement of organs for transplantation

Jurisdiction

Act

Provision

NSW

Human Tissue Act 1983

s 33

Qld

Transplantation and Anatomy Act 1979

s 45(1)

Transplantation and Anatomy Act 1983

s 24(2)

Death (Definition) Act 1983

s 2

Tas

Human Tissue Act 1985

s 27A

Vic

Human Tissue Act 1982

s 41

Human Tissue and Transplant Act 1982∗

s 24(2)

ACT

Transplantation and Anatomy Act 1978

s 45

Transplantation and Anatomy Act 2014

s 23

∗Note: circulatory death is not defined in Western Australian legislation.

[Correspondence] Corticosteroid therapy for pneumonia

We read with interest the article by Claudine Blum and colleagues1 on the effects of adjunct prednisone therapy for patients with community-acquired pneumonia, particularly in view of our own concern on the subject.2 We fear the study suffers a major flaw.