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Finance and Public Administration Legislation Committee

HAMBLETON, Dr Steven, Federal President, Australian Medical Association Ltd


Evidence was taken via teleconference

CHAIR: Good morning. Information on parliamentary privilege and the protection of witnesses and evidence has been provided to you. The committee has your submission. I now invite you to make a short opening statement. At the conclusion of your remarks I will invite my Senate colleagues to put some questions to you.

Dr Hambleton : Thank you very much for the opportunity to appear before you today, and thank you for allowing me to speak via teleconference. I am speaking on behalf of the Australian Medical Association. I am the president of that association and I am also a specialist general practitioner in Brisbane.

The issue of transparency of relationships between medical practitioners and health industry companies is an important one for discussion by parliament. Almost every industry has its symbiotic relationships where producers of products rely on the input and feedback of the user of the product to help develop and improve the product and then to buy it. In health it is slightly different. The user is the patient. The purchaser is usually a health insurer. In the case of pharmaceuticals, the purchaser is the taxpayer via the Commonwealth. In health the overriding relationship is and always will be between the doctor and the patient, and any transparency relationship must maintain the confidence in that doctor-patient relationship, which is the paramount one that the AMA will support.

Without good design and implementation transparency could mean that patients choose not to go to a particular doctor for the wrong reasons. Patients need information that is specifically relevant to their clinical circumstances and healthcare decisions that they will have to make. It is our responsibility to make sure that the information is provided in the best possible way, to enable patients to make informed decisions about their healthcare options, taking account of their healthcare provider's involvement with a company, not simply because of their involvement.

The AMA does not shy away from further transparency measures about the relationship that pharmaceutical companies have with medical practitioners. The AMA is an active participant in the Medicines Australia Transparency Working Group. It is also an active participant in the Therapeutic Goods Administration working group to develop consistent industry codes of conduct.

The committee has received other submissions that have pointed out the various flaws in the bill. The bill may have been hastily drafted and is perhaps a bit before its time. In the USA it has taken a long time since the Sunshine Act was passed for any name to be published. The law was passed and then they had to do the work about how to do it and what to do. In Australia we are approaching the issue the other way around. We are designing the transparency arrangement to ensure that it is workable, is useful and meaningful to patients. Once implemented, it can be reviewed and refined as we better understand how patients use the information. The various submissions the committee has received have demonstrated that the industry is making good and solid steps towards uniform codes of conduct and transparency measures. If the bill is passed the work being done now to get the best arrangements in place would have to shift to implementing a system that may not actually make the grade from the patient perspective.

CHAIR: Thank you.

Senator DI NATALE: I want to start by providing a bit of context to the AMA's position. Does the AMA actually accept the published evidence that interactions between health professionals, doctors, and the pharmaceutical industry have a negative impact on prescribing patterns?

Dr Hambleton : Much of this evidence is internationally based—from either the UK or the US. Our system is somewhat different. Certainly we accept that such reports may undermine the confidence of patients in their practitioner. That is why the AMA is moving towards and will move towards much more disclosure. Having said that, we are already governed by our own code of ethics and the code of ethics that is published by the Medical Board of Australia, Good medical practice, which does say that medical practitioners are required to inform their patients about interests that could or could be perceived to affect patient care. If professionals do not do that, there are already consequences which could even affect medical practitioner registration.

Senator DI NATALE: You are concerned about the perception here—and there is no question that that is a reasonable concern—but I want to move beyond perception to reality. There is a vast volume of published evidence; we heard from Dr Ken Harvey earlier about some of that evidence. The interaction between pharmaceutical companies and health professionals does lead to adverse prescribing patterns. I want to get a sense of whether the AMA accepts that.

Dr Hambleton : I think there are two things that the pharmaceutical companies are doing. The first is promoting appropriate prescribing patterns, and we certainly see reports internationally of some adverse prescribing interactions. What I mean by 'appropriate' is that much of the marketing we see in this country—certainly for general practice and possibly for specialist practice—is when a product actually goes on to the PBAC; distributing the information that it is in fact available for use in a certain class of patients. And we have to remember that the PBAC process actually analyses the drug very carefully. TGA tells us that it works, that it does what it says it does and that it has these effects and side effects. PBAC says: 'We have now looked at the drug a second time. It does what it does; at this price it is cost-effective; and there will be benefits for the Australian population if it is used in the area that it is intended.'

Take statins as an example. We spend more money on statins than on any other product on our PBS. The real question is: 'Are we spending enough?'; because, when we spend enough money on statins, we actually improve health outcomes. So, for people who have already had a heart attack, we actually know that prescribing a statin to the right dose reduces the risk of the next heart attack. There is also evidence that primary prevention works for the right class of patients. So the pharmaceutical company advising doctors that this is available and subsidised may actually save lives. If there is a perverse effect on a small group, we need to understand that. We do see evidence overseas that that may be happening and we are moving towards transparency, but we have a different framework for prescribing in this country. It protects patients to a great degree.

Senator DI NATALE: Can I pursue that a little more. Many of the jurisdictions where this has been studied have regulatory processes to determine the cost-effectiveness of particular drugs. Are you suggesting that Australia is somehow different in that the relationship between the industry and doctors has no negative impact? Because I find that quite a remarkable statement.

Dr Hambleton : I think there are great positive impacts. There are probably negative impacts in certain areas. I think the balance is there. I think it would be inappropriate to characterise it as all negative.

Senator DI NATALE: No, I am not at all suggesting that. I am not disputing that there is a role here. I am just putting forward that the interaction can, and in many instances does, lead to adverse prescribing which impacts both the patient and the community more generally because of the cost associated with that prescribing, and I just want to provide some context here. Clearly, if the AMA does not accept that, then there is not much pursuing the point; if you are disputing that baseline assertion, then of course anything that we do in this area would be seen as problematic.

Dr Hambleton : Thank you for clarifying your view. I am sure that there are some circumstances where there is adverse impact. The question is: is it in many circumstances, and how much is the impact? I have no doubt that our systems and regulations in this country are different and will lead to different outcomes.

Having said that, there is an undermining of the confidence in the doctor-patient relationship by reports that we have seen from overseas. We in the medical profession were as shocked as the public was by some of the reports from international shores. We do want to make sure that we do not lose the confidence between the doctor and the patient. We are engaged in processes for increasing transparency for that very reason. But we want to do it in such a way that it is relevant and focused to the individual doctor-patient relationship and we want to build on the frameworks that we have—our own code of ethics and the Medical Board's code of ethics—to make sure that we have a constructive process.

I am sure, as you point out, if there are some areas where there is a problem, this should shine the light on that, and there is nothing like shining the light of public opinion on something to make a change, but the AMA is engaged in that process.

Senator DI NATALE: But the AMA has previously been on record opposing transparency and naming individual doctors.

Dr Hambleton : Yes, that is true, and circumstances have led to a change. I am pleased to lead the AMA at a time when it is changing its view about transparency. It has been as a result of the reports we have all heard and reports we know occur about undue influence and people not following our own code of conduct. So I charged my own ethics committee to have another look at this and their response was, as expected, that, yes, we should engage in the process, we should look at an appropriate mechanism to maintain our own code of ethics and I guess the confidence in the profession by our patients. So we are actively engaged in it. It is absolutely true to say that we opposed it in the past but that has actually changed.

Senator DI NATALE: I am very pleased to hear that. In your submission you say that interactions between medical practitioners and pharmaceutical and medical companies are a necessary part of ensuring patients have access to new and improved medicines. Again, I find that statement peculiar. There are a number of other health professionals who have made a decision that they can get access to objective information not through their interactions with the pharmaceutical industry but through other sources: through the National Prescribing Service, through relevant guidelines, through journal articles and so on. Yet in your submission you seem to indicate that it is necessary for medical practitioners and the industry to engage in a relationship.

Dr Hambleton : Yes, we do say that, and you do point out some other avenues by which information is distributed, and we support all those other revenues. In fact, we expect our members not to just accept information from one source but to seek other sources, and journal articles and MPS publications are important—well, essential—to make sure there is a balanced view. As we know, the medical profession is trained to access information. Unless there is a significant increase in spending by those agencies to distribute information about new products there is going to be a role for pharmaceutical companies to get the information out there. We know that when a product is approved on the PBAC it is significantly better accessible by patients. Using the example of the statins earlier, we know that it saves lives. We need to get the message out. A pharmaceutical company which has got a product that is cost-effective, like any other product should be entitled to distribute information about that product. As I say, the filter of the PBAC is a very important one to guarantee that used appropriately it is cost-effective and may even save the health system money. So unless the other agencies are prepared to significantly increase their budgets to distribute the information, it is going to be an essential partnership to get the information out.

Senator DI NATALE: But, Dr Hambleton, I feel that we are confusing two different ideas here. One is whether the industry should be entitled to do what they do and the second is whether it is necessary and essential that medical practitioners engage with industry. You yourself used the example of statins. There are very clear guidelines accessible to all medical practitioners around the use of statins. Why should it be necessary for a doctor to see a pharmaceutical rep, to go to an industry sponsored conference to get that information? I do not see why that is necessary. I am not arguing the industry's right to do it, but this seems to be a very significant change in the view towards the industry that all doctors should engage with the industry to get up-to-date information. Are you suggesting that those doctors who are not doing that are somehow not being armed with the information they need to prescribe appropriately?

Dr Hambleton : No, I think we agree more than we disagree on what you just said and how you framed the question. I think the industry should be entitled to promote its products and I also agree that it is not essential that doctors engage with industry but they should have the opportunity should they so wish. If we preclude industry from being able to promote, I think we are going to find that the information distribution is going to be a lot slower and the impact and the benefits of some of these products is going to be a lot slower. We have to remember that while there may be some adverse impacts that we agreed do occur in some circumstances, there are great benefits achieved by the interaction. Simply interacting with pharmaceutical companies does not necessarily imply an adverse outcome.

Senator DI NATALE: Thank you for that clarification. The final note in your submission relates to the issue of whether this regulation should apply to other health practitioners. We have heard through previous submissions and through Dr Harvey's submission that it would be appropriate to include medical devices and a whole range of other health professionals. Would you support the notion of expanding the scope of the bill to apply to all health practitioners?

Dr Hambleton : I would agree with some of that. Certainly the bill is limited in its coverage of the industry and how it requires information to be reported and it does only cover pharmaceutical companies and medical practitioners. There are lots of other relationships that warrant transparency. Thinking about pharmacy, for example, the Department of Health and Ageing, in 2006, advised the AMA that only three per cent of PBS prescriptions had the 'do not substitute' box ticked by the doctor on the prescription, yet there are a lot of products going into particular brands. So it is true; the pharmacist does make the most decisions about which brand of medicine is to be dispensed. I do not have anything more up to date than 2006 but the Department of Health and Ageing may be able to help us there. It may well be that brand decisions are not made by the practitioner, and we do need to make sure that we are spending appropriately. If there is a reason a particular brand needs to be prescribed, the medical practitioners are not indicating that except in very small circumstances.

So, yes, transparency would be important on a broader basis. But the principle is the same and is one that we would support—that is, to make sure that doctor-patient confidence is not impaired. Does this bill give us the opportunity to do that? Again, we need to do a lot more work on how the transparency process would operate. We should build on the communication mechanisms and the goodwill we have now, to actively look at how we do this effectively for patients. For example, if we have just a list of patients somewhere on a website that tells that this doctor has this number of patients, that might be relevant to a journalist but it might not be relevant to an individual patient. The patient may turn down the opportunity of seeing that doctor, who may well be the best doctor for them, because of a relationship that is not relevant in their particular health setting.

I agree, in one sense. Yes, we do need to broaden this out, because in the health-care setting there are lots of other areas that warrant transparency. We will certainly actively work towards solving that issue as well.

Senator DI NATALE: Thank you very much, Dr Hambleton. That message has come through the submissions loud and clear. I would suggest that an amendment to that effect would certainly be something we would actively look at.

CHAIR: In relation to what has been outlined, and people's concerns with their submissions, do you have any knowledge of complaints being made from consumers in relation to the lack of transparency on this issue around the medical profession?

Dr Hambleton : The short answer is, yes. We have all seen international reports of concerns that there are individuals who were perhaps more influenced by a relationship with the industry than by the patient in front of them, but I am not aware of any in Australia. The international concerns are so strong that the AMA has changed its view and is of the view that we need to make sure we maintain confidence in the doctor and patient. In Australia, I am not aware of any specific instances.

CHAIR: In the experience from overseas, do the complaints lie in one particular area, to your knowledge?

Dr Hambleton : Senator Di Natale raised an issue and it is not just in the pharmaceutical area; there are other areas where we have seen international concerns. We have all heard the phrase 'key opinion leaders' and we understand the marketing techniques which have been used by some US pharmaceutical and product manufacturing companies. Those sorts of things are concerning. We live in an environment where we have a good medical practice code of conduct and we have a code of ethics for AMA members. We expect our doctors to disclose to their patients if they have an interest for example in the hospital they are referring to. Even my specialist colleagues who write back to me in general practice say, 'I've seen your patient. They need cataract surgery. I have referred them to a hospital in which I have an interest. I have informed them of my interest. That is the sort of thing we would like to see happen in this country, that one-to-one disclosure to patients about the interests doctors might have which may or may not influence a patient's decision to proceed with a particular course of treatment.

CHAIR: So if this bill was amended to be broader than is currently written, would the AMA be more inclined to support it?

Dr Hambleton : I think the principle is correct. I think the timing of the problem and the way the bill is drafted is an issue for us. We would not be able to support the bill even with the amendments, unless it was significantly amended. We are mandating something which we already want to see in this country. Making the relationship with pharmaceutical companies illegal and putting a law around it really sends a message that any relationship is negative. I think that is a bad message to send to the Australian people when we are trying to build confidence in the doctor-patient relationship and to build confidence that the right decision is being made by the practitioner that is only in the best interests of the patient and not in the best interests of a third party, in particular a third party which is not the government or the insurer, or in the best interests of the health system. If the third party is a product manufacturer or a drug manufacturer, or a prosthesis manufacturer, that is something we would not be supporting but I am not sure this bill is capable of delivering that without a significant rewrite. It certainly makes it illegal, which sends completely the wrong message.

CHAIR: In relation to any change if this bill were passed and building in any extra cost to consumers, do you have any concerns there or any estimates of what the costs may be in extra regulation?

Dr Hambleton : Again, any extra regulation, if it increases red tape, is something the AMA has stood against in many fora. We have a first-rate health system. We have some of the best outcomes in the world. We do not want to tie up the doctors at the front line of care in red tape. We certainly do not want to isolate doctors, as we have said already. There are other health professions which warrant transparency measures because at the end of the day if there are increased costs because of red tape or increased costs because of education expenses which are not covered by other avenues, as we have discussed earlier, there is going to be an input cost of the medical care and that input cost will ultimately be transferred to the patients. Again, we do not want to see decreased access to good practitioners making good decisions.

CHAIR: Thank you for that.

Senator RYAN: One of the underlying views around this sort of regulatory approach seems to be overprescribing, particularly of medicines which are said to be not as cost-effective as others—that is another issue with respect to PBS listing. Do you think it would be fair to say that statins and maybe even antihypertensives would not be as widely prescribed now if their pharmaceutical company reps did not have a role with doctors?

Dr Hambleton : I think the short answer is yes, they would not be prescribed as widely, but the long answer is that perhaps even now we are still not prescribing antihypertensives and lipid-lowering agents as much as we should. If we look at the trials which led to the listing of these products, if you pass certain criteria for primary prevention we can show a significant decrease in adverse outcomes. Certainly after you have had a heart attack there is a really clear evidence that statins commenced early and pushed up to the right dose will make a significant difference in short- and long-term outcomes. Sometimes by reviewing the prescribing habits, despite the current promotions that we see, we still find that we are underprescribing—and I know we are talking about potentially overprescribing in certain areas. It is about: which product to what level and for which patient to get the outcomes we need. Lord Darzi advised us at our national conference last year when he came to speak to us that we can get the best outcomes, the most cost-effective outcomes, in our health industry if we close the gap between what we know and what we do. We know these things work. We have to make sure we do them. We have to make sure the message gets out.

Hypertension is another one. That brings up another point. Many of the antihypertensives are listed by the PBAC in a cost-minimisation way. If there are five products on the PBAC that cost $20 a month to be delivered and a sixth product comes on and says, 'We're no better than those, but we're no worse. We want to be listed' generally that is listed at $20 a month. All six—the five existing, plus the new one—cost the same amount. In one sense, if they are equivalent at the level of the patient, it does not matter which one you choose; they are all cost-effective at that dollar figure. What the pharmaceutical companies go after is market share, but that does not actually change the cost to Australia or the cost to the individual patient, because of the way the PBAC is set up. If another antihypertensive comes on the market and says, 'We're not only as good as those things but we have fewer side effects. We're worth more' or, in fact, 'We're a better product because we are more potent' or 'Our effect is better,' it is listed at a higher price. It might be a new product with a higher price, but the higher price is precisely because it works better.

Practitioners are entitled to and are guided by what goes on the PBAC, because there are a whole lot of smart people in that room making very difficult decisions about what works, what the side-effect profile is likely to be, how much use there should be and, importantly, how much it costs Australia. We are buying a health outcome by using that product at that price. That is the message that we need to understand, because a lot of the stuff that is marketed is about brand switching, but it may be a good idea.

Senator RYAN: Is it fair to say that over the 10 or 12 years the statins have been on the PBS, the treatment guidelines have been liberalised? By that I mean: the hurdles for their use have been lowered so that the population using them has grown.

Dr Hambleton : Yes, that is absolutely true. What happens initially with the listing of a product is that the pharmaceutical company will run a trial in a particular subgroup where there is a high likelihood of success. Regarding secondary prevention, for example, you have already had a heart attack; we will collect 10,000 patients—and with statins it is often that number—from various jurisdictions, and we will fairly quickly demonstrate that there is a statistically significant improvement.

Senator RYAN: In a layperson's terms, what we do today with statins would a decade ago, potentially, be called overprescribing, wouldn't it?

Dr Hambleton : There is no doubt about it—yes, absolutely. When the new data comes, we spread the use and decrease the hurdles.

Senator RYAN: It is fair to say that with the trials, the collection of the data and, shall we say—because it has been alleged—influence over things like people writing journal articles that might inform therapeutic guidelines, a lot of the spin is driven by the manufacturers who make quite substantial profits out of this?

Dr Hambleton : Yes, that is another truism. People who fund the trials are often the pharmaceutical companies. Again, when a trial is published in a peer reviewed journal, all those doctors need to declare conflicts of interest to make sure there is not any.

Senator RYAN: Again in layperson's terms, the point is that sometimes this pushing of the boundaries, this funding of research, this marketing spending that gets doctors probably more quickly aware of a product than a government newsletter might, can lead to improved health outcomes for both individuals and across the population by effectively increasing the utilisation of medicines? It does cost more, but you can get better health outcomes; it is not always' inappropriate'.

Dr Hambleton : I entirely agree. Increased use of appropriate medication can save lives and save money, but not—

Senator RYAN: Use also changes over time, doesn't it, Dr Hambleton?

Dr Hambleton : Yes.

Senator RYAN: Like again to use the statin example: people who are accessing them now were not accessing them 10 or 12 years ago. So that boundary of what is considered acceptable use and indeed cost-effective use does change over time.

Dr Hambleton : It does change, but it does need to be driven by evidence. When it is it saves lives and saves money out of either different parts of the health budget or future health budgets.

Senator DI NATALE: Earlier when we talked about the role of the industry in terms of providing information we mentioned other sources of information. One of the agencies that is responsible for providing evidence based information to healthcare professionals is the National Prescribing Service. Do you see that the NPS could have a much bigger role in providing information to doctors and other healthcare professionals?

Dr Hambleton : The short answer is yes. The NPS has been able to build a lot of confidence in the health professions for giving accurate, independent information. When it publishes something on its website we all have confidence that it is actually accurate, peer reviewed and helpful to our day-to-day practice. A good example was the prescription of add-ons to various products that were being offered at the pharmacy. When the NPS published a document suggesting that adding on various things at the point of sale was of no benefit, it gave us a lot of confidence that we were on the right track. NPS is doing a good job. If it increased its work because it had more funding then I suggest it would be beneficial to the healthcare system.

Senator DI NATALE: I want to tease out one more example. You have used the Pharmaceutical Benefits Advisory Committee, the PBAC, as the arbiter of what is good medical practice. I put to you the example of antibiotic use. All of those antibiotics are approved by the PBAC but we all know that in some cases a particular antibiotic, even though it may be approved for use, is potentially more harmful to the community because of the capacity to promote antibiotic resistance. That for me is one clear and very obvious example of why you cannot rely on the PBAC's recommendations for listing as comfort for what is appropriate prescribing. In fact, having the industry promote one antibiotic over another may in fact lead to greater antibiotic resistance over the long term. Perhaps you could respond to that.

Dr Hambleton : That is a good example. I do share your concerns about antibiotic resistance over the long term. The reason I have focused on the PBAC is that I have been a member and the AMA has a lot of confidence in the PBAC process—

Senator DI NATALE: So do we as well. I do not want to imply for a moment that we have problems with the PBAC.

Dr Hambleton : Let us look at how the antibiotics are listed and the restrictions that are imposed by the PBAC to try to limit the prescribing to the desired indication. If we follow the rules—in other words, if we do what Lord Darzi told us—and we apply what we know much more rigorously, we would still get good outcomes. Let us start at the beginning. Many antibiotics are on a unrestricted benefit, which means that they can be used at the discretion of the doctor, and we still hope they choose the appropriate circumstance. Many of them though are on restricted benefits, which tells the doctor that they are only cost-effective if they are focused on the restriction that is in the listing. Things like amoxicillin clavulanic acid should be used when there is suspected penicillin resistance, not in every case. Ciprofloxacin is showing enormous amounts of resistance internationally. In Australia it is on authority prescription, which really focuses the mind on a particular cost-effective use and that is in particular areas of the body—soft tissue, bones, joints and around cartilage, for example—where penicillin resistance is suspected and where you need high levels of penetration. If we followed those rules, as we have done with ciprofloxacin, we can demonstrate in Australia that there is a lot less antibiotic resistance in this country than there is in, say, India and China where there are much fewer restrictions and a lot more prescription and use in veterinary and farming practices. There are rules that guide us, and so it cannot be the only source but it is a quality source, so I think there is a balance there and that is why we are confident in the way things are listed.

CHAIR: There are no further questions. I thank you and the AMA for the submission and taking the time to give your evidence via teleconference this morning. Thank you very much.