The increasing costs of medicines and their implications for patients, physicians and the health system.

Most new medicines entering the market are high-cost speciality drugs. These drugs can cost tens to hundreds of thousands of dollars per course of treatment and in some cases millions of dollars per dose. Approximately half of all spending on medicines is projected to target only 2-3% of patients, raising important questions about resource allocation. While there is no doubt that breakthrough innovations have transformed clinical care in some disciplines, it is also true that cost is becoming one of the primary barriers to treatment access and that many new medicines do not provide value commensurate with their prices. This article examines pricing trends, the reasons for high prices and their implications for access and clinical practice.

Cost-Related Non-Adherence to Prescribed Medicines: What Are Physicians' Moral Duties?

As the price of pharmaceuticals and biologicals rises so does the number of patients who cannot afford them. In this article, we argue that physicians have a moral duty to help patients access affordable medicines. We offer three grounds to support our argument: (i) the aim of prescribing is to improve health and well-being which can only be realized with secure access to treatment; (ii) there is no morally significant difference between medicines being unavailable and medicines being unaffordable, so the steps physicians are willing to take in the first case should extend to the second; and (iii) as the primary stakeholder with a duty to put the individual patient's interests first, the medical professional has a duty to address cost-barriers to patient care. In articulating this duty, we take account of important epistemic and control conditions that must be met for the attribution of this duty to be justified.

Do doctors have a responsibility to help patients import medicines from abroad?

Almost any medicine can be purchased online from abroad. Many high-income countries permit individuals to import medicines for their personal use. However, those who import medicines face the risk of purchasing poor-quality products that may not work, or that may even harm them. Many people are willing to accept this risk for the opportunity to purchase more affordable medicines. This is especially true of individuals from low socioeconomic backgrounds who already struggle to afford the medicines they need if they are not subsidised by insurers or if copayments are high. As medicine prices and out-of-pocket healthcare spending continue to climb, the online marketplace provides an important alternative for individuals in high-income countries to source medicines. In this article, I argue that doctors have a responsibility to help patients access medicines online and I propose a framework that can be used to facilitate responsible personal importation.

'First ensure no regret': a decision-theoretic approach to informed consent in clinical practice.

Decision theorists recognise that information is valuable only insofar as it has the potential to change a decision. This means that since acquiring more information is time-consuming and sometimes expensive, judgements need to be made about what information is most valuable to acquire, and whether it is worth acquiring at all. In this article I apply this idea to informed consent and argue that the most valuable information relates not to what the best treatment option may be but to possible futures a patient may regret. I conclude by proposing a regret-minimisation framework for informed consent that I contend better captures the true nature of shared decision making than existing formulations.

How therapeutic advances have transformed the medical landscape: a primer for clinicians.

Novel medicines are entering the market rapidly and are increasingly being used alone or in combination to treat illnesses of every sort. While transforming the lives of many patients, these new therapies have also forced us to reconsider the way we evaluate, use and fund medicines. This article offers a primer to help practitioners understand how the therapeutic landscape is changing and how this might impact the evidence generation, access to interventions, patient experience and quality of care.

Personal Importation and the Law: Protecting Patients Who Import Medicines for Legitimate Health Care Needs.

Australians who cannot access medicines locally are able to find most medicines for sale online. Australia's therapeutic goods legal regime permits individuals to purchase medicines directly from overseas suppliers via the Personal Importation Scheme. Individuals can either import medicines for their own use or that of an immediate family member. For some patients, importing medicines is the only way they can access the medicines they need due to lack of availability or affordability in Australia. This article analyses the therapeutic goods law to clarify offences that may apply to those who import medicines for their own use or that of an immediate family member. Considering the findings, legislative amendments are recommended for the purpose of protecting patients who import medicines for legitimate health care needs.

Are my religious beliefs anyone's business? A framework for declarations in health and biomedicine.

Conflicts of interests (COI) are typically divided into those that are financial and those that are not. While there is general agreement that financial COIs have a significant impact on decisions and need to be declared and managed, the status of non-financial COIs continues to be disputed. In a recent BMJ feature article it was proposed that religious beliefs should be routinely declared as an interest. The article generated over 41 responses from the medical community and health researchers, which put forward diverse and opposing views. In this paper, we analyse the discourse to shed further light on the reasons put forward for and against declaring religious beliefs. We argue for a middle path in which only material beliefs should be declared, and then only when there are no extenuating circumstances. To this end, we present a framework to help evaluate the materiality of interests that can be used for both financial and non-financial interests.

Death, dying and donation: community perceptions of brain death and their relationship to decisions regarding withdrawal of vital organ support and organ donation.

Despite brain death (BD) being established as a definition of death for over 50 years, the concept remains controversial. Little is known about public perception of death determination in decision-making about withdrawal of organ support and organ donation (OD), and the importance of the 'Dead Donor Rule' (DDR). We examined perceptions about death in a BD patient and their relationship to decisions about withdrawal of vital organ support, OD and the DDR, using an online survey of 1017 Australian adults. A BD patient scenario was presented, followed by a series of questions. Statistically significant differences in responses were determined using repeated measures analyses of variance and t tests. Seven hundred and fourteen respondents (70.2%) agreed that a hypothetical BD patient was dead. Those disagreeing most commonly cited the presence of heartbeat and breathing. Seven hundred and seventy (75.7%) favoured removal of 'life support', including 136 (13.3%) who had not agreed the patient was dead. Support for OD was high, but most favoured organ removal only after heartbeat and breathing had ceased. Where OD was in keeping with the patient's known wishes, 464 (45.6%) agreed that organs could be removed even if this caused death. Forty-one (20%) of those who had indicated they considered the patient was not dead agreed to organ removal even if it caused death. Australian public views on BD, withdrawal of 'life support' and OD are complex. Emphasis on prognosis and the impact of significant brain injury may be more appropriate in these situations, rather than focussing on death determination and upholding the DDR.

Unconventional Practice, "Innovative" Interventions and the National Law.

This column explores a recent health profession disciplinary case which throws light on the problems of unconventional interventions by medical practitioners under the Health Practitioner Regulation National Law Act 2009 (Qld). The case involved "innovative" practices which were later found to have been scientifically unsupported, dangerous to patients and grounds for cancelling the health practitioner's registration. This column looks at common features of these kinds of cases in Australia and then examines recent attempts by the Medical Board of Australia to draft policy guidance around the use of unconventional practice in medicine. This column concludes with a number of changes to improve the effectiveness of the proposed policy.

'Treat them into the grave': cancer physicians' attitudes towards the use of high-cost cancer medicines at the end of life.

The prescribing of high-cost cancer medicines at the end of life has become a focus of criticism, due primarily to concerns about the safety, efficacy and cost-effectiveness of these medicines in this clinical context. In response to these concerns, a number of interventions have been proposed - frequently focused on improving physician-patient communication at the end of life. Underpinning these strategies is the assumption that the prescribing of high-cost cancer medicines at the end of life is primarily the result of poor communication on the part of cancer physicians. In this paper, we explore the factors perceived by cancer physicians to be driving the use of high-cost cancer medicines at the end of life. Drawing on semi-structured interviews with 16 Australian oncologists and haematologists, we demonstrate that these physicians believe that the use of high-cost medicines at the end of life is driven by multiple factors - including individual, interpersonal, socio-cultural and public policy influences. We conclude that these factors, and their interactions, need to be taken into account in the development of public policy and clinical interventions to address the use of high-cost medicines at the end of life.

Caution needed in introduction of provisional approvals for medicines.

The Australian government recently released its response to the Review of Medicines and Medical Devices Regulation, accepting most recommendations. One recommendation involves the introduction of provisional approvals for perceived life-saving and innovative new treatments, allowing these to be approved on the basis of more limited data on the condition that further safety and efficacy data (including real-world evidence) are collected to determine whether full approval should be granted. However, experience with similar schemes overseas raises significant questions about the safety and efficacy of products made available through these pathways. These uncertainties are compounded by the challenges associated with the collection and use of 'real-world' data and the difficulty of withdrawing products from the market once patients and clinicians become familiar with them. Although there may be good reasons to provide patients with earlier access to medicines on the basis of provisional evidence (including providing treatment options and hope to patients with serious illnesses), we must exercise caution in order to protect both current and future patients from potentially harmful and futile treatments and ensure that healthcare systems use their resources wisely.

The Right to Health: Implications for the Funding of Medicines in Australia.

Australia's health system is characterised by an ongoing tension between a commitment to utility and a commitment to individual rights. This tension is particularly problematic for the Australian Government when deciding which cancer medicines to add to the Pharmaceutical Benefits Scheme in order to make them cheaper for patients. This article investigates how the right to the highest attainable standard of health has influenced decisions about funding high-cost cancer medicines in Australia. It considers the value of the right to health for funders and concludes that resource allocation decisions should not be entirely informed by the right to health. It is maintained that, instead, regard should be had to the cost-effectiveness and affordability of cancer treatments before they are subsidised.

Overcoming entrenched disagreements: the case of misoprostol for post-partum haemorrhage.

The debate about whether misoprostol should be distributed to low resource communities to prevent post-partum haemorrhage (PPH), recognized as a major cause of maternal mortality, is deeply polarised. This is in spite of stakeholders having access to the same evidence about the risks and benefits of misoprostol. To understand the disagreement, we conducted a qualitative analysis of the values underpinning debates surrounding community distribution of misoprostol. We found that different moral priorities, epistemic values, and attitudes towards uncertainty were the main factors sustaining the debate. With this understanding, we present a model for ethical discourse that might overcome the current impasse.

Ethics & evidence in medical debates: the case of recombinant activated factor VII.

We cannot just point to the facts to solve a medical debate. The use of evidence is itself a matter of values. What the evidence tells us to do tends to depend on what we see as important.