House debates

Monday, 30 May 2011

Private Members' Business

Pharmaceutical Benefits Scheme

Debate resumed on motion by Mrs Moylan:

That this House:

(1) recognises the provision of affordable medicines through the Pharmaceutical Benefits Scheme (PBS) is central to Australia's health system;

(2) acknowledges that since its inception, the PBS is an uncapped program;

(3) agrees that evaluations of pharmaceuticals for listing under the PBS should be transparent, evidence based, and not subject to capricious political interference;

(4) notes that:

(a) before recommending medicines for listing on the PBS, the Pharmaceutical Benefits Advisory Committee (PBAC) conducts a rigorous evaluation to determine the comparative clinical and cost effectiveness of the proposed medicine;

(b) the three tiers of major applications for PBS listings are designed to promote an efficient Government approval process; and

(c) positive recommendations by the PBAC have nearly always been approved by the Minister for Health;

(5) deplores the Government's new policy that:

(a) despite positive recommendations by the PBAC, all applications for listing will be further scrutinised by Cabinet;

(b) listing of medicines can be deferred indefinitely;

(c) no new PBS listings will occur unless offset savings are found; and

(d) until the budget returns to surplus, these measures will remain in place;

(6) recognises that:

(a) in scrutinising applications, the PBAC already determines value for money; and

(b) under the Government's new policy, access to medicines will be limited and medications which could improve the treatment of chronic or common conditions will remain financially unaffordable for many Australians; and

(7) condemns the Government for prioritising a return to surplus above the wellbeing of Australians

12:57 pm

Photo of Judi MoylanJudi Moylan (Pearce, Liberal Party) Share this | | Hansard source

I thank the member for Moore, who is not in the chamber at the moment, for seconding the motion and also for his sensible contribution so far to this discussion as a member of parliament and as a medical practitioner. On 25 February this year the Minister for Health and Ageing announced the deferral of listing of a number of Pharmaceutical Benefits Scheme medications that had received a positive recommendation from the Pharmaceutical Benefits Advisory Committee. In subsequent interviews the minister justified the deferral on economic grounds, saying that, until the budget returns to surplus, positive recommendations will not be listed on the PBS unless offsets can be found. Under this system a recommendation by the PBAC to the minister will be referred to cabinet and then referred to a subcommittee consisting of the Treasurer, the Minister for Finance and Deregulation and the Prime Minister if the Prime Minister is available. The committee will then decide on the listing according to the budget bottom line rather than their primary obligation to make available to every Australian citizen best-practice medicine.

Although the minister said that medications that are new or could save lives may be listed by the government, the process will add further unnecessary layers of paper shuffling in what can only be described as a cumbersome and inefficient process. Further, it puts the health of many Australians at risk by denying them best-practice medicine. The ingenuity of mankind will ensure that new and more effective medications are regularly being discovered. My grandfather would likely not have lived until his mid-70s had it not been for the discovery of insulin. Sick and bedridden, he lay for months with his severe malady and was saved from an early death only through the discovery and the availability of insulin. By leaving decisions as to which medications should be listed on the Pharmaceutical Benefits Scheme to a subcommittee of cabinet, on the basis of the budget bottom line, instead of to the expert members of the PBAC, the government risks putting the lives of many Australians in jeopardy. Interference with the recommendation of the expert panel is almost unprecedented. There have been a couple of cases, such as Viagra, but in the past it has been very rare that cabinet has not accepted the recommendations of the PBAC.

This system risks setting up a two-tier system of health where those on low or middle incomes are unable to afford access to best practice medicine. The minister for health has not placed a time limit on when positive recommendations would be considered, except for the blanket statement that the process will continue at least until the budget is in surplus. Given the way we are going, I do not think we can look forward to that any time soon. The government has already spent all of the extra income and budget revenue that the resources boom has delivered to Australia, and then some. It has recklessly squandered taxpayers' money on harebrained schemes such as the now failed insulation program and the botched GroceryWatch and Fuelwatch schemes.

To make up for this maladministration of finances, they are now looking to deny Australians reasonable access to best practice medicines, based on the recommendations of its own expert body. The AMA vice-president, and a former member of the government's expert independent Pharmaceutical Benefits Advisory Committee, Steven Hambleton, was accurate in his appraisal that the government is politicising the drug approval process. In an article by Sue Dunlevy in the Australian on 10 March 2011, Dr Hambleton said that the new rules were about 'overt rationing of health care', and I concur.

Among the greatest concerns is the sheer lack of transparency. The decision to defer is arbitrary. Cabinet, especially ministers concerned with finances, lacks the expertise to adequately judge which medicines should and should not be deferred in the process and undermines the role of the PBAC. Brendan Shaw, from Medicines Australia, said the government should accept the independent advice to list medicines on the PBS. He said:

The Government's own expert committee has said making these medicines available is cost effective, is value for money and is the right thing to do. It's unclear what expertise or experience cabinet ministers have at their disposal to override the decisions of their own expert committee. The Government has brought politics into what was an effective and depoliticised process in a highly-sensitive area where people's health and indeed their lives are at stake.

The cost of medicines has already been subject to an economic evaluation by the PBAC; there is no need for further analysis. This policy that the government has implemented is short-sighted, as products which could have cost the government less have already been deferred. There are examples piling up of patients suffering conditions such as schizophrenia, chronic disabling pain, lung disease and blood clots having to forgo best treatment or having to pay up to $100 per month, instead of the PBS co-payment of $34.20. As I said, it sets up a two-tier system, because those who are on low or middle incomes are unlikely to be able to afford the full cost of these medications.

I think this further diminishes the government's commitment to its mental health policy that has just been announced, because conditions such as schizophrenia can be treated. There are amazing new medications coming onto the market and, in many cases, they allow somebody suffering from severe mental illness to fully participate in the workplace and in the community. Without those medications, these people are unable to properly function in society. So I think it is false economy and false savings and it is not the best outcome for those whose lives are put in jeopardy through not being able to access best practice medicine.

In February, the government saved $30 million, for example, by delaying subsidies for seven new medicines, including Duodart, a treatment for benign prostate cancer; a new schizophrenia medication, Invega Sustenna; and a lung medication, Symbicort. Withholding new improved medications can have a significant impact on the quality of life for many Australians and indeed, as I said, on their capability to fully participate in the workforce. It is therefore a false saving. I call on the government to reverse this policy and to allow the PBAC to resume its premier position of providing critical advice to cabinet on what medications should be listed. Clearly, this is not a matter for ministers of this government to decide entirely; they should be guided by this expert panel. As I said, in the past there have been very few occasions when the recommendations of that expert panel have not been listened to or taken heed of by cabinet and where those medications have been refused a listing.

The government is deciding on the basis of the budget bottom line. But, as I said, we have seen an awful lot of squandering of money on schemes which, at best, could be called harebrained schemes, which have failed. I would have thought that this government has a primary responsibility to ensure the good health and quality of life for every citizen in this country. On that basis, I would hope that the minister would reconsider this decision on the listing of medicines and the recommendations of the PBAC.

1:06 pm

Photo of Jill HallJill Hall (Shortland, Australian Labor Party) Share this | | Hansard source

I will start by saying that I know the member for Pearce is a person who has genuine concern about issues of health and social wellbeing of people living in Australia. But, on this particular issue, I cannot agree with all that she has had to say. Firstly, I would like to go through a little bit of the history of the PBS. It was established in 1948 and it has supplied approximately 140 life-saving and disease-preventing drugs.

The PBS was a Labor scheme which was introduced by Ben Chifley as part of his plan at that stage to look at a nationalisation of the health scheme, and that was found to be unconstitutional. But the PBS scheme came into being. It is a scheme which subsidises the supply of drugs to Australians. It is a scheme that has served our country very well. It is a scheme that I am extremely supportive of and it is a scheme that has increased in cost over a number of years. In 1956, I think the co-payment was 5s, or 50c, and it is now up to $34.20. I note that there was a massive increase in the co-payment for PBS drugs under the former Howard government, when the cost to consumers absolutely skyrocketed.

In the first year the scheme was introduced, it cost the Australian government £149,000. It now costs $6.5 billion. It is interesting to note some of the actions of the opposition when they were in government. Former Treasurer, Peter Costello, was very proactive in increasing the costs to Australians of the PBS co-payment.

We on this side of the House respect the independence of the Pharmaceutical Benefits Advisory Board. The role of the PBAC is to make recommendations to the government. In 2001 the former government inserted another layer, stating an exception that, where a drug was going to cost more than $10 million, it should then be referred to the cabinet. The referral of recommendations from the PBAC to cabinet was actually brought into being under the Howard government. This is not something new; it was a Howard government initiative.

The member for Pearce was right in saying that not only did they defer the listing of a drug—it was Viagra—but they rejected it. One of the uses of Viagra is for sexual dysfunction—and that can even be caused by other medications—but another is for pulmonary hypertension. I had a constituent who suffered from pulmonary hypertension. She was having difficulty walking from the door of my office into my office. She saw me quite a few years ago. She was pointing out to me just how important that drug was for keeping her alive, yet the previous Howard government had refused to list it.

We can go through and look at a variety of issues around the PBAC and the listing of drugs, but the most important thing is to ensure that there is a drug available to treat all conditions. The deferral by the minister was based on the fact that these drugs would probably be very nice to have listed on the Pharmaceutical Benefits Scheme—they do offer some benefits; I have spoken to a number of the companies that produce some of these drugs, and I know that there is an argument for listing some of them—but they are not groundbreaking drugs. They are not new drugs. There are drugs available currently that provide treatment for those conditions. To put before the House that there is no treatment available for people suffering from these diseases is not quite honest.

The minister was reluctant to have to defer—and I emphasise defer, not reject, as was the situation with Viagra—some of these drugs under a provision that was put in place by the Howard government. The reason she chose to do this was that there were some drugs available. She believes it is absolutely imperative that some drugs that are not listed should be listed. When she was faced with the choice of continuing the Bowel Cancer Screening Program or placing a drug on the PBS where there was already a drug available to treat the condition, she decided that the Bowel Cancer Screening Program, which saves life, will be funded now, and $137 million over four years has been put into that program.

Government is about choices. The government has not rejected those drugs from being listed. I know that drug companies can come back and provide additional information that shows that if they are not listed there is no other treatment available. I look at something like Fragmin, from Pfizer, for blood clotting. There are already warfarin and heparin, which Australians can use to deal with those sorts of illnesses. A number of drugs were listed. There was Nplate for a rare bleeding disorder, Xolair for severe asthma, and Duodopa for Parkinson's disease. It could be demonstrated there was no substitute drug currently available for these. There was Galvus MET for type 2 diabetes; Epiduo Gel for severe acne; Prevenar, a pneumococcal vaccine; Mentorix, which is also a meningococcal C vaccine; and Prevnar, which was listed in the budget. There were a number of new drugs listed.

For those opposite to stand in this House and say that this is the first time this has happened and that it is something specific to this government is very misleading. It was the Howard government that put in place the requirement for drugs that were going to cost the PBS over $10 million per year to be referred to cabinet. The Howard government was the first government to use this mechanism. It has been used in the past. It was the Howard government that not only deferred but rejected the listing of Viagra. I put my full support behind the PBS and the work of the PBAC. I do not think this is contrary to its purpose.

1:16 pm

Photo of Mal WasherMal Washer (Moore, Liberal Party) Share this | | Hansard source

I thank the member for Pearce for bringing this important motion before the House. Judy, you have always been a good social operator in these areas. Minister Roxon has announced that in the future all decisions about drugs to be listed on the Pharmaceutical Benefits Scheme, or PBS, and recommended by the Pharmaceutical Benefits Advisory Committee, the PBAC, will have to be passed by cabinet regardless of price.

The past process for getting drugs listed on the PBS was for the drug to undergo scrutiny by the PBAC, a committee independent of government, which Minister Roxon herself had said was one of the most rigorous in the world for assessment of a drug's clinical and cost effectiveness. This process historically evaluated new medicines for listing and negotiated prices. Any drug that was estimated to cost more than $10 million in any year needed to have approval from federal cabinet, a process that often led to delays of up to 12 months. This same process now has full cost recovery from industry for the PBAC assessment, whereas previously it was based not on cost recovery but on recognising the integrity of the PBAC recommendations and getting medicines to the patients in need.

The major worry is that patients will not get the medicines they need when they need them, an essential commitment of the National Medicines Policy that every government must embrace. In this climate, international manufacturers of new medicines may decide not to bring their medicines to Australia, a disaster for therapy in a modern medical world. Drugs still pending cabinet decision are drugs for bowel cancer, deep vein thrombosis, hyperhidrosis, schizophrenia, pain relief and asthma management, an anticoagulant and a synthetic hormone.

There should be extreme consumer concern that new and innovative drugs may be blocked from subsidy because of this government's ruling that causes indefinite deferral. For those in this House concerned about mental health, two drugs—one, known as Invega, for schizophrenia and the other, Consta, for treatment of bipolar disorder—have been indefinitely delayed despite PBAC approval. Several other new advances in approved mental health drugs for the treatment of severe mental health disorders are in the Australian regulatory pipeline but face an uncertain future.

The Prime Minister and cabinet announced that they would bring the budget into surplus by 2012, so they are using that reason to delay the listing of innovative medicines. I have always argued that unless we treat the consumer with the best therapies available to achieve evidence based, best practice outcomes, we will all ultimately pay more. For example, the drug for schizophrenia, Invega, deferred despite PBAC approval, is reported to have savings of up to $52 million per year in treatment costs. Apart from costs, there is no question that keeping people with mental illness working and living useful productive lives in the community is a moral duty. According to the latest ABS figures from 2009, mental illness costs Australia around about $20 billion a year. That includes the cost of lost productivity and labour force participation. Mental disorders were identified as the leading cause of healthy years of life lost due to disability. These new measures which block patient access to new medications on the PBS potentially affect every person with an illness in this country. This amounts to bad policy and bad medicine. I implore my Labor political friends to address the caucus to reverse this truly dreadful budget decision that for the first time has politicised the provision of medicines to the Australian community.

1:20 pm

Photo of John MurphyJohn Murphy (Reid, Australian Labor Party) Share this | | Hansard source

I am very pleased to speak on this motion moved by the member for Pearce, although with great respect to my friends the member for Pearce and the member for Moore I do not support parts (5), (6) and (7) of the motion. It is important to clarify, firstly, that the government had agreed to list seven new medicines and vaccines on the Pharmaceutical Benefits Scheme and National Immunisation Program and defer the listing of seven other drugs. Understandably, the government is concentrating on listing drugs for serious conditions and where alternative treatments are not available. The drugs that will not be listed at this time will still be reconsidered and are mostly for conditions where existing treatments are already available on the PBS. Further, 52 new and amended listings and new brands of existing listings were also listed on 1 April.

I have always supported equitable access to necessary and life-saving drugs at an affordable price. Indeed, let me remind the opposition of some of my long and hard-fought community campaigns to have necessary and life-saving treatments listed. In 2006 I raised my very serious concerns with the Howard government's refusal to list the life-saving breast cancer drug Herceptin on the PBS for people with HER-2 early onset breast cancer. Despite the undeniable benefits of   this life-saving drug with very few side-effects, the PBAC rejected the listing of Herceptin on the cost-effectiveness basis. From the beginning of the campaign in 2001 until the listing of the drug in 2006, many women were going to extraordinary lengths to pay for the drug, at approximately $60,000 a year. One woman told me of her weight loss to reduce the cost of the treatment as she would need less Herceptin in each dose. This was occurring in times of economic prosperity and it was an absolute disgrace. It was only after a very long national campaign led by individuals and support groups, including a petition in my electorate that alone collected over 12,000 signatures, that the former Minister for Health and Ageing, Tony Abbott, announced that he would consider listing the drug. The decision was only made in light of the overriding human element, aside from a list of criteria presented to the PBAC.

My community also campaigned strongly to extend the PBS eligibility of Alimta to include mesothelioma sufferers. In support of the late Bernie Banton's fight to get equitable access to affordable treatment for this condition, I initiated another petition in my local community that received overwhelming support. At the time, Alimta was a treatment provided on the PBS only to lung cancer patients, some of whom were smokers. It was unconscionable that victims of asbestos related mesothelioma were denied the same access to affordable care. Moreover, different states provided different subsidies. Although Bernie Banton was receiving his treatment free of charge, he did not believe it was right that other victims of asbestos, including workers, children and people who washed asbestos laden clothes, would have to pay $18,000 to $20,000 a year for treatment. Again, it was not until after a very strong and long public campaign, led by the late Bernie Banton, that the former Howard government extended eligibility for Alimta to sufferers of mesothelioma.

More recently, last year, I raised my concern about the availability of the life-saving drug Soliris for sufferers of paroxysmal nocturnal haemoglobinuria. One of the youngest known sufferers of this rare disease, Whitney Lane, lives in my electorate of Reid. The disease affects roughly 100 Australians and the average life expectancy from diagnosis is just 10 years. Soliris had been recommended by the PBAC for funding under the Life Saving Drug Program; however, the introduction of new PBAC guidelines meant the treatment underwent further consideration. The fact that treatment costs $480,000 per annum per patient and that it is required for 12 to 16 days without failure I believe means the government has to ensure proper scrutiny and planning. Following the positive review of the PBAC under the new funding conditions and criteria, Soliris was listed for PNH sufferers. The government also ensured that the cost of the treatment was capped, irrespective of the number of new sufferers, and took the appropriate measures to ensure public money was providing a very good cost-effective benefit to the community.

The Labor government believes in providing better health and hospital services for our country and is endeavouring to put the 'care' back into the healthcare system that was so sorely lacking under the former Howard government. We will continue to ensure that the PBS remains sustainable so that it continues to provide low-cost medications to Australians, ever mindful of the responsibility that the funding is targeted to make sure patients and taxpayers are getting value for money.

On a positive note, I thank the member for Pearce for putting the motion on the Notice Paper so that we could debate it. Notwithstanding that, I cannot support parts (4), (5), (6) and (7).

Photo of Sid SidebottomSid Sidebottom (Braddon, Australian Labor Party) Share this | | Hansard source

Order! The time allotted for this debate has expired. The debate is adjourned and the resumption of the debate will be made an order of the day for the next sitting.