Helen Kroger (Victoria, Liberal Party) Share this | Link to this | Hansard source

I write today to place on the public record the critical need for publicly funded nitric oxide therapy to treat critical care infants. This therapy is used to treat hypoxic respiratory failure, HRF, which affects about 500 newborn babies each year. I would like to note that Senator Connie Fierravanti-Wells raised the issue of nitric oxide therapy in estimates only last week, and, disappointingly, the witnesses knew nothing about it. Nitric oxide therapy is available and could provide much-needed help, but it is not listed on the PBS. It is a safe, proven and effective treatment that has a clear role in the management of critical respiratory failure in newborns.

Exactly a month ago, I wrote to the Minister for Health and Ageing, Ms Roxon, about my concerns. As of today I have not received a response from the minister or her department. In my letter I urged the minister to investigate the situation and consider how this therapy could help newborn babies with respiratory failure. My office has been contacted by two key stakeholders in this area. The Australian and New Zealand Neonatal Network wrote to me, seeking assistance for critically ill babies and young children, which their members care for. Associate Professor Dr Kei Lui, director of newborn care at the Royal Hospital for Women in Sydney, wrote to me as the spokesperson for the group in August, and expressed the critical need for appropriate funding for HRF. In correspondence with my office, she recently said:

I strongly believe that critical care babies who need this Inhaled Nitric Oxide (INO) treatment should have access to it under a federal funding scheme. Withholding or rationing a life saving treatment due to local budgetary constraints is unacceptable to health care providers and the families of babies who need it. Access to a life saving treatment should not be a lottery.

Earlier this month I met with Lorna Meldrum, the general manager of IKARIA—and Lorna and her colleagues are here in the gallery this evening; I note their attendance, and thank them for coming. IKARIA is the Australian provider of the drug INOmax, which is nitric oxide for inhalation. Lorna advised me that the drug is currently used around Australian in over 20 hospital neonatal units. She expressed her concern that, due to the hourly cost of nitric oxide treatment, it is potentially being rationed within the hospital system. IKARIA has been advised that the drug cannot be subsidised through the PBS and MBS because it is classified as a designated ‘orphan drug’ and should be funded through the hospital budget.

In Australia, orphan drugs are defined as drugs which treat diseases or conditions affecting no more than 2,000 individuals at a time. Whilst other orphan drugs are eligible for public subsidy consideration under the PBS, MBS or the Life Saving Drugs Program, IKARIA has been advised that INOmax does not meet the criteria as INOmax treatment is only administered in a public hospital setting and requires technology to deliver it. INOmax is only ever used within a hospital, and therefore should fall under the hospital budget.

Hypoxic respiratory failure is a serious condition that occurs when the cells in a baby’s body are unable to receive enough oxygen. Nitric oxide has been used by Australian specialists to treat HRF for a number of years prior to its approval by the TGA. Prior to the introduction of nitric oxide, there was no other pharmaceutical product available, and the only alternative form of treatment was heart-lung bypass surgery. Mortality rates reported in the pivotal nitric oxide registration trials indicate that 11 per cent to 17 per cent of newborns receiving conventional treatment died before discharge from hospital. This equates to 65 to 85 babies dying each year. It is important to note, however, that management of hypoxic respiratory failure has improved since these trials were conducted which is likely to have an effect on the mortality rates.

In the pivotal nitric oxide registration study, referred to as the NINOS study, the incidence of primary outcome, defined as death or the requirement of a heart-lung bypass, was reduced by almost one-third in babies who were treated with nitric oxide. Treatment duration varies, depending on the baby’s response and needs. This therapy allows medical professionals to determine if it will be effective in opening up the blood vessels in the lungs within the first four hours. If no response is seen in the first four hours of treatment, it can be stopped, capping the cost at a mere $300.

The truth is that at such a dramatic time for newborns and parents, especially mothers who have only just given birth, the cost of life-saving therapies should not be a consideration they are burdened with. The benefits and risks of nitric oxide have been extensively analysed in clinical trials. Nitric oxide has received both TGA and FDA approval for the treatment of full-term and near-term babies with HRF associated with pulmonary hypertension. Nitric oxide therapy causes few side effects. During treatment with nitric oxide all babies remain under constant supervision and are monitored within the neonatal intensive care unit to minimise the risk of side effects. A recent published detailed analysis by the prestigious Cochrane Collaboration concluded with the following summary:

Inhaled nitric oxide is safe and can help some full-term babies suffering respiratory failure who have not responded to the usual methods of support. Trials have shown that inhaled nitric oxide can increase the level of oxygen in babies’ blood and reduce the need for extracorporeal membrane oxygenation, a highly technical and invasive therapy. Unfortunately, these benefits of inhaled nitric oxide care are not seen in babies whose respiratory failure is due to a diaphragmatic hernia. Inhaled nitric oxide has not shown any short- or longer-term adverse effects.

Dr Lui estimates that the average cost of this treatment per case is around $10,000. However, treatment duration varies depending on a baby’s responses and needs. There seems to be a simple solution to this circumstance: if INOmax cannot be funded through the PBS then it should be funded through the hospital system. But, of course, politics gets in the way of the good, made even more difficult by the recent deal between the Prime Minister and the Independents. Let me just recap on one recent example of the confusion and outrage this deal has caused. Reports just after the deal was struck said that the government had freed up almost $2 billion of its health and hospitals funding in a new round of spending for regional Australia. One of the most publicised examples was Blacktown Hospital in Western Sydney, where a $150 million, 100-bed upgrade, including new renal and cancer units, was put on hold so that federal funding could be redirected—all in the name of politics, I might add. The Daily Telegraph reported:

WESTERN Sydney's most urgent hospital upgrade has been dumped from a funding priority list because of the political deal between the NSW independents and the Gillard Government to divert health money ...

I thought it important to conclude with two brief examples of how this therapy can literally save a life. Baby Nagirrah was born by caesarean after doctors discovered major complications. He was struggling to breathe properly and needed treatment immediately. His parents feared the worst but he was put on life support and successfully treated. Within a week he was be able to be taken off ventilation and go home with his parents. His mother reflected afterwards: ‘I was worried sick that my baby boy would pull through but his improvement was so dramatic he was taken off the ventilator in less than a week.’

This is potentially a life-and-death decision and Minister Roxon should immediately act to fix the problem and fund this life-saving treatment.

Claire Moore (Queensland, Australian Labor Party) Share this | Link to this | Hansard source

Last week in this place the Parliamentary Group on Population and Development hosted the launch of the State of World Population 2010 report, an annual report which is produced by the United Nations Population Fund, the UNFPA. The title of the 2010 report is From conflict and crisis to renewal: generations of change. In her foreword to the wonderful document the Executive Director of the UNFPA, Ms Thoraya Obaid, who has visited the Australian Parliament on a number of occasions and was actually here for a couple of our previous launches, makes a statement about one particular topic which was chosen for the 2010 report. She said:

This report coincides with the 10th anniversary of Security Council resolution 1325, which called on parties to armed conflicts to take measures to protect women and girls from gender-based violence and called for greater involvement by women in negotiating and implementing peace agreements. But this report is not only about the resolution. It is also about the special challenges women face in conflict or in humanitarian emergencies and about how women themselves are responding, healing wounds, moving forward, and not just helping the communities return to the status quo but also building new nations on foundations of equal rights and opportunities.

The report covers a couple of well-known communities across the globe, all of which have been victims of horrific conflict or humanitarian crisis. We have stories from Haiti, which look at the horror of the recent earthquake response. We also have issues about East Timor and a particularly devastating chapter about Bosnia-Herzegovina 15 years after the actual conflict. We saw quite a bit of media coverage at the time, but it is 15 years after the hostilities ceased and this chapter is about the ongoing pain and damage that women are suffering who were the victims of systematic rape during that conflict. They lost partners, they lost families and they were used in a systematic process of power domination during that conflict. So, 15 years on, we have the cases of women who were working to respond to that to provide counselling and services to their own community, which is making a genuine difference.

The State of World Population 2010 report is a confronting document but it is also permeated by hope. The stories talk about how women have made real differences to their communities. I call upon members to read this report if they can. It comes out every year. Each year it has a different theme and focus, but this year in particular it focuses on post-conflict resolution. As Mr Obaid said, it also coincides with the 10th anniversary of United Nations Security Council resolution 1235, which came about as a result of years of lobbying by women and friends of women to ensure that the particular impact of conflict on women is acknowledged and there are true efforts made by countries across the globe to ensure that women’s needs are actually responded to.

In October 2000 the Security Council of the United Nations unanimously passed resolution 1325 and for the first time recognised the impact of conflict on women and girls, their increased vulnerability to sexual violence during conflict and their exclusion often from peace agreements, negotiations and post-conflict reconstruction. UN Security Council resolution 1325 recognises the importance and the reality of women’s experience of conflict in peace processes and in conflict resolution, rather than looking at women as only the victims of war or, in many cases, actual combatants. There is documented proof that, in many of the recent conflicts—and I believe also in historical focus as well—women are actual combatants, and that is often overlooked. One of the key challenges for us now is rebuilding communities and recognising women who have been taking active roles in the conflict and rebuilding their communities, re-educating and resettling.

It did not just finish in 2000; there have been subsequent actions by the UN, allowing this document to have real life rather than just being put on a shelf and referred to on occasions such as this. Since that resolution in 2000, three additional resolutions have been adopted in order to ensure accountability and leadership. Resolution 1820, which was passed in 2008, called for an end to widespread conflict related sexual violence and for real accountability in order to enable impunity for women. Resolution 1888, passed in 2009, continued the focus on strengthening leadership and institutional capabilities within the UN and in member states to end conflict related sexual violence. This resolution also called for the appointment of a special representative to monitor and report on efforts made and the ongoing issues. The position was adopted and was filled by Ms Margot Wallstrom that same year. Resolution 1889, passed in 2009, called for the establishment of global indicators to measure progress on 1325 implementation. This is a real document. It has action. Together, the women, peace and security focus is now taken up with what we call the four Ps: prevention of conflict; protection of women and girls during conflict; participation of women in peacekeeping, peace-making, peace-building and political decision making; and the prosecution of gender based war crimes.

Australia has been a strong supporter of this process and has made a number of statements along the way, putting forward our support. The Australian government made a statement on this 10th anniversary of resolution 1325. There was a UN process around the anniversary of 1325. Senator Alan Eggleston, who is representing our parliament at the UN at the moment, delivered a statement to the Interactive Dialogue on Women, Peace and Security. Australia is a co-sponsor and proud supporter of ‘Women, Peace and Security’, and it has restated its commitment to continue to ensure the protection needs of women and girls are met, including in complex emergencies; to uphold and enforce a zero tolerance approach to sexual abuse and exploitation; to train and deploy Australian peacekeepers to the highest professional standards; to support UN nominations and recruitment policies promoting gender equality; to ensure women in the Australian military are deployed to all operational theatres, selected for command positions and promoted to star rank; to increase the proportion of women in the Australian police force and the Australian protective services; and to ensure Australia’s laws and national security frameworks protect the human rights of women and girls in accordance with our international obligations.

We also as a nation have committed to finalising, in accordance with resolution 1325, an Australian national action plan on 1325. Currently there are only 18 nations in the world who have actually completed a plan. Australia has not completed a plan, but it has committed to doing so. That work is being drafted at the moment. We have committed to supporting access to justice, including women- and girl-focused legal aid and law enforcement; strengthening the role of women in conflict prevention, resolution and peace-building; increasing financial support to UN GenCAP and ProCAP initiatives; and rolling-out Addressing conflict-related sexual violence: An analytical inventory of peacekeeping practice.

All those actions are specific commitments that our country has made. In that way, we are responding to the need that was put forward to the UN to ensure that resolution 1325 was passed. In the decade leading up to 2000, when the UN finally passed 1325, there were a number of international conflicts which provided documented evidence of the horrific violence that was perpetrated on women in fields of conflict. It is not new; I am sure that, if you do a history on war across all the generations, you will find that women, in particular, have been victims of war. The situation in some of the African states and Bosnia and Herzegovina, as I pointed out earlier, was particularly looked at, and the UN had no other recourse but to act. Australia was part of ensuring that that occurred.

We need to celebrate the 10th anniversary of 1325. We also need to ensure that the action continues. We cannot allow this resolution to just be noted as something that communities have signed to. We need to have ongoing action, and I am sure that that is something we all expect.