Nicola Roxon (Gellibrand, Australian Labor Party, Shadow Minister for Health) Share this | Hansard source

The purpose of the National Health Amendment (National HPV Vaccination Program Register) Bill 2007 is to amend the National Health Act to ensure and to establish that the National Human Papilloma Virus Vaccination Program Register can operate. As many in this House would know, Labor was instrumental in pushing the government to include Gardasil, the first vaccine available to treat some strains of HPV, on the National Immunisation Program. Of course we will support these measures to establish the register as they will enhance the efficiency of the National HPV Vaccination Program.

By way of background, HPV is a sexually transmitted infection mostly affecting women between 20 and 24 years of age. Almost all abnormal pap smear results are caused by HPV. In 98 per cent of cases HPV clears by itself; in rare cases, if the virus persists and is left undetected, it can lead to cervical cancer. We know that, sadly, cervical cancer does kill around 200 women in Australia each year.

Gardasil was developed by former Australian of the Year Professor Ian Frazer, and is the first vaccine available that protects against some of the cancer causing strains of HPV, notably HPV strains 16 and 18, which cause around 70 per cent of all cervical cancers. Members would recall that late last year CSL Ltd, the Australian manufacturer and distributor of Gardasil, applied to the Pharmaceutical Benefits Advisory Committee for Gardasil to be listed on the National Immunisation Program. As the vaccine was originally on the market at a cost of $460 for a course of three shots, CSL was seeking to have this cost met by the government, rather than borne by Australian families.

PBAC knocked back the application of CSL in November 2006 citing a number of reasons including that it was not cost effective for taxpayers to fund Gardasil at the price originally proposed by the manufacturer, but PBAC also at that time raised some other concerns about a lack of information on how long the vaccine remained effective. It was also reported that PBAC was not convinced by CSL’s claims about the protection that the vaccine would provide over a lifetime.

I am proud to say that Labor, including my colleague the former shadow minister for health Julia Gillard, led the outcry from health stakeholders, patient groups and pharmaceutical companies that PBAC’s decision required urgent review. Comments by the Prime Minister about driving a hard bargain with manufacturing companies gave credence to the then shadow minister’s concern that PBAC, in making its original decision, had been overly influenced by the government’s focus on cutting the cost of its subsidised medicines program. It is all well and good for the minister to say that he respected PBAC’s integrity and process and therefore would not overrule the decision, but this response ignored the absolute need for the Australian government to do everything that it could, within our health system, to reduce the incidence of cervical cancer.

Eventually, but only after prime ministerial intervention, the minister saw the sense and requested that PBAC reconsider or consider a new application from CSL in which the main initial concerns raised by PBAC were addressed. As we now know, Gardasil was subsequently approved for inclusion in the NIP at the extraordinary PBAC meeting in late November.

On 29 November 2006, the government announced that it would fund free the HPV vaccine for females between 12 and 26. The establishment of the HPV register was also announced at that time. Obviously, despite the ups and downs of that process, we do welcome this result, and the availability of this vaccine is going to provide very welcome protection for many Australian women.

Let me turn now to the legislation before us, which inserts a new section 9BA into the National Health Act providing for the establishment of a National HPV Vaccination Program Register. Broadly speaking, the establishment of the register will assist in the administration of the vaccination program itself, provide a means to monitor participants in the program and assist in monitoring and evaluating the effectiveness of the HPV vaccine in preventing certain cervical cancers. According to the new subsection 9BA(3), the purposes of the register are to ensure the successful implementation of the program and, in doing so, facilitate the establishment and maintenance of an electronic database of records for monitoring vaccination of participants in the program.

It is intended that the register will collect information about the vaccination program, including personal identifying details, details about the doses given and the immunisation provider. Labor acknowledges that there will be some people in the community who will have privacy concerns around the collection of such data. On this issue I note that the bill provides for women or the parents of girls to have information removed from the register following a request in writing—an ‘opt off’ register reflecting the arrangements that have been in place in Australian state and territory based Pap test registers for between eight and 18 years, depending on which state or territory you live in. No information about sexual history will be sought or recorded, and the bill precludes the release of personal information except to a vaccination provider or prescribed bodies, either through regulation or as prescribed in the Health Insurance Act. Labor is satisfied on this basis that the bill adequately addresses privacy concerns. Of course, the public interest in the maintenance of this register certainly is a significant factor in the balancing that is always required in these matters.

The register will help to monitor the effectiveness of the program in preventing certain cervical cancers by allowing for future cross-referencing of data against Pap smear and other cervical cancer registers maintained by states and territories. The register will also allow for the maintenance of records tracking the HPV vaccination status of eligible persons for the purposes of certifying the completion of the course of vaccination and establishing mechanisms to advise eligible persons, or the parents or guardians of children, if doses of HPV vaccine have been missed or if booster doses are required in the future. The register will allow for the provision of information on new developments associated with the program to vaccination providers, eligible persons, and parents or guardians of children, promoting general health and wellbeing. Finally, the legislation provides for payments to general practitioners who enter information on the register.

According to the explanatory memorandum, there is no financial impact arising from this bill. Funding for the register was approved by the Prime Minister on 20 February 2007 as part of an additional $103.5 million over five years allocated for the implementation of this program. A total cost of $8 million to $11 million has been allocated to build and operate the register over three years.

As I said earlier, Labor supports this bill and the program that is now in place. Of course, we support measures that are aimed at the promotion of the health and wellbeing of Australians. As I said earlier, Labor is proud of the strong support it gave early to Gardasil in its ability to treat HPV and argued for it to be put on the National Immunisation Program, so we are keen for its implementation to be as efficient as possible and for its evaluation to be as thorough as possible.

We would encourage the government to move this legislation through parliament quickly, as I believe is intended. While we understand that the short time frame from the November 2006 announcement to the commencement of the vaccination program in April this year meant that it was difficult to establish the register before immunisations commenced, we believe the register needs to be operational as soon as possible. We understand that state based immunisation programs and individual GPs are currently capturing vaccination data at a jurisdictional or surgery level while they wait for the register to be implemented. Obviously there are some risks around data being mislaid or not making its way onto the register. A uniform national approach to capturing this data is preferable and obviously much needed, particularly given the privacy issues that have been flagged. Even more significantly, until this register is operational, the impact of the program on cervical cancer prevention cannot be effectively assessed. With the funding already allocated, the government should move swiftly to set up this register.

Labor would also appreciate some clarification from the government on some eligibility rules around the National HPV Vaccination Program. As members would be well aware, this program has been very widely advertised in media across the country. Those advertisements have heavily promoted the government’s intention to fund free HPV vaccine to all 12- to 26-year-olds. Public information has stated that the HPV National Immunisation Program would be targeted on an ongoing basis for 12- and 13-year-old girls, to be delivered through schools, in addition to a two-year catch-up program for 13- to 18-year-old girls, also delivered in schools, with vaccines to the 18- to 26-year-old age group to be delivered through general practice and community based programs.

While it has been widely noted that not all schools will be vaccinated in this first year—rather, there will be a systematic rollout—no similar qualification has been placed on the community based vaccination of women between 18 and 26. As local members, we are concerned that we are increasingly receiving reports from constituents who have examples of women attending community clinics and their GPs being told that only women in certain age brackets are being immunised in this particular year. We are still trying to get to the bottom of these reports. Obviously there may be people who are not within the specifications, but it seems that at this stage a number are. We are not sure whether this is an issue of the shortage of the requisite volume of vaccine or a practical problem of GPs finding the time and resources in their busy schedules to have these consultations within the correct time frames for young women seeking immunisations. Because there are a range of different ways these vaccines can be provided, we do not know whether it is a problem with the rules the government has set or whether it is a distributional or access problem, particularly with regard to the differences that may exist within some of the community health sectors in different states and territories.

When you consider that some medical services, such as university medical clinics, may have a large number of women on their books who fall within the 18- to 26-year-old age group and that each of these women will need three shots prior to June 2009, when the cut-off for free vaccinations comes into effect, you would understand why some services might seek to streamline their immunisation programs. I know that some people from the department are here, and I would be appreciative of an answer and some clarification on that. Obviously some constituents are very concerned that, if they cannot access it now, by the time they are able to access it they will fall outside the right age categories or the cut-off times. It would be helpful if the government could look into these issues with some urgency and provide us with that information so we can assure or explain to constituents the process to make sure that they get the coverage they are entitled to.

As I have said, given that the vaccination process involves three injections over seven months at a total cost of over $400, if it is not accessed through the HPV Vaccination Program it is a serious cost issue for many families. It is an affordability issue where some families will be forced to make a decision between concern for the health of their daughters and other financial pressures that they have. Obviously the government’s decision has been made. This is a program that is available, and we need to make sure that the rollout is accessible to as many people as possible. After such an extensive advertising campaign has been run we do not want to unnecessarily worry young women, particularly, who want some assurance of knowing that they have been immunised against HPV and who do not want to feel that they have missed out because their local service might not have been able to access the program at the right time.

For the benefit of the staff who are here, I can tell you that these reports have come from many different states. They have come from Queensland, Victoria, South Australia—they are the ones that I can remember off the top of my head—but we have had queries from many constituents. My colleague who is speaking next will know whether this has been an issue in Western Australia. It would be helpful if some proper information could be provided so that we can assist our constituents in making sure that they get the coverage they deserve. As I have said, Labor supports this bill.

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