Trials and tribulations in the removal of dextropropoxyphene from the Australian Register of Therapeutic Goods.

• The Therapeutic Goods Administration determined in November 2011 that dextropropoxyphene should be removed from the Australian Register of Therapeutic Goods. This is consistent with this drug's removal from the market in many other developed countries. • However, dextropropoxyphene is still on the market in Australia owing to a series of appeals made to the Administrative Appeals Tribunal (AAT) by the drug's manufacturer.

The affordability of prescription medicines in Australia: are copayments and safety net thresholds too high?

Objective: To create and report survey-based indicators of the affordability of prescription medicines for patients in Australia.

Method: A cross-sectional study of 1502 randomly selected participants in the Hunter Region of NSW, were interviewed by telephone.

Main Outcome Measure: The self-reported financial burden of obtaining prescription medicines.

Implementing US-style anti-fraud laws in the Australian pharmaceutical and health care industries.

This article critically analyses the prospects for introducing United States anti-fraud (or anti-false claims) laws in the Australian health care setting. Australian governments spend billions of dollars each year on medicines and health care. A recent report estimates that the money lost to corporate fraud in Australia is growing at an annual rate of 7%, but that only a third of the losses are currently being detected.

A methodological framework of preparing economic evidence for selection of medicines in the Chinese setting.

Medicines are becoming a major component of health expenditure in China. Selection of effective and cost-effective medicines represents an important effort to improve medicines use. A guideline on cost-effectiveness studies has been available in China.

The Trans-Pacific Partnership Agreement: challenges for Australian health and medicine policies.

Four formal rounds of Trans-Pacific Partnership Agreement (TPPA) negotiations took place in 2010. They involved over 200 officials from Australia, the United States, New Zealand, Chile, Singapore, Brunei, Peru, Vietnam and Malaysia. Future negotiations officially are set to include three issues with public health and medicines policy implications for Australia and our region: ways to approach regulatory coherence and transparency; how to benefit multinational and small-medium enterprises; and multilateral investor-state dispute settlement.

Developing an equivalent to the National Medicines Policy for medical devices.

While Australia has enjoyed the benefits of a National Medicines Policy (NMP) for many years, there is no equivalent national policy for medical devices. This is despite an established medical device legal framework that spans multiple departments across the Australian Government. The existing NMP offers an effective and proven benchmark for the development of a national medical devices policy.

Policy challenges of nanomedicine for Australia's PBS.

All major pharmaceutical companies are currently investing significantly in the development of medicines with a nanotechnology component. Such research promises therapeutic drugs with greater efficacy and a wider range of clinical indications. Nanomedicines are just beginning to enter drug regulatory processes, but within a few decades could comprise a dominant group within the class of innovative pharmaceuticals.

Three Proposals for Rewarding Novel Health Technologies Benefiting People Living in Poverty. A Comparative Analysis of Prize Funds, Health Impact Funds and a Cost-Effectiveness/Competitive Tender Treaty.

This paper sets out to analyse three different academic proposals for addressing the needs of the poor in relation to new, rather than 'essential' medicines. It focuses particularly on (1) research and development (R&D) prize funds, (2) a health impact fund (HIF) system and (3) a multilateral treaty on health technology cost-effectiveness evaluation and competitive tender. It compares the extent to which each responds to the 'market fundamentalist' philosophy (that we maintain forms a loose theoretical background for the patent-driven approach to pharmaceutical R&D) and begins to analyse their respective strengths and weaknesses.

Normative foundations of technology transfer and transnational benefit principles in the UNESCO Universal Declaration on Bioethics and Human Rights.

The United Nations Scientific, Education, and Cultural Organization Universal Declaration on Bioethics and Human Rights (UDBHR) expresses in its title and substance a controversial linkage of two normative systems: international human rights law and bioethics. The UDBHR has the status of what is known as a "nonbinding" declaration under public international law. The UDBHR's foundation within bioethics (and association, e.

Integrated research into the nanoparticle-protein corona: a new focus for safe, sustainable and equitable development of nanomedicines.

Much contemporary nanotoxicology, nanotherapeutic and nanoregulatory research has been characterized by a focus on investigating how delivery of engineered nanoparticles (ENPs) to cells is dictated primarily by components of the ENP surface. An alternative model, some implications of which are discussed here, begins with fundamental physicochemical research into the interaction of a dynamic nanoparticle-protein corona (NPC) with biological systems. The proposed new model also requires, however, that any such fresh NPC physicochemical research approach should involve integration and targeted collaboration from the earliest stages with nanotoxicology, nanotherapeutics and nanoregulatory expertise.

Toxicological and public good considerations for the regulation of nanomaterial-containing medical products.

Increasing research interest in the new and unusual properties of nanotechnology-related pharmaceuticals and medical devices has led to international and national reviews of safety regulation. Significant considerations emerging here are the relative paucity of metrological and toxicological data, as well as the absence of adequate funding and standardized approaches for its acquisition. Some areas are better researched, such as the toxicity of carbon nanotubes and use of engineered nanoparticle titanium and zinc oxides as broad-spectrum ultraviolet-blocking agents.

Nanotechnology in global medicine and human biosecurity: private interests, policy dilemmas, and the calibration of public health law.

This paper considers how best to approach dilemmas posed to global health and biosecurity policy by increasing advances in practical applications of nanotechnology. The type of nano-technology policy dilemmas discussed include: (1) expenditure of public funds, (2) public-funded research priorities, (3) public confidence in government and science and, finally, (4) public safety. The article examines the value in this context of a legal obligation that the development of relevant public health law be calibrated against less corporate-influenced norms issuing from bioethics and international human rights.

Whistleblowing and scientific misconduct: renewing legal and virtue ethics foundations.

Whistleblowing in relation to scientific research misconduct, despite the benefits of increased transparency and accountability it often has brought to society and the discipline of science itself, remains generally regarded as a pariah activity by many of the most influential relevant organizations. The motivations of whistleblowers and those supporting them continued to be questioned and their actions criticised by colleagues and management, despite statutory protections for reasonable disclosures appropriately made in good faith and for the public interest. One reason for this paradoxical position, explored here, is that whistle blowing concerning scientific misconduct lacks the policy support customarily derived from firm bioethical and jurisprudential foundations.

Challenges for Australia's Bio/Nanopharma Policies: trade deals, public goods and reference pricing in sustainable industrial renewal.

Industrial renewal in the bio/nanopharma sector is important for the long term strength of the Australian economy and for the health of its citizens. A variety of factors, however, may have caused inadequate attention to focus on systematically promoting domestic generic and small biotechnology manufacturers in Australian health policy. Despite recent clarifications of 'springboarding' capacity in intellectual property legislation, federal government requirements for specific generic price reductions on market entry and the potential erosion of reference pricing through new F1 and F2 categories for the purposes of Pharmaceutical Benefits Scheme (PBS) assessments, do not appear to be coherently designed to sustainably position this industry sector in 'biologics,' nanotherapeutics and pharmacogenetics.

'Linkage' pharmaceutical evergreening in Canada and Australia.

'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases.

Nanotherapeutics: new challenges for safety and cost-effectiveness regulation in Australia.

Nanotechnology is a revolutionary field of micro-manufacturing involving manipulation, by chemical or physical processes, of individual atoms and molecules. Pharmaceutical and medical device manufacturers, both in Australia and internationally, have significant investments in nanotechnology research and development. It is important that safety regulation of nanotherapeutics keep pace with this growing level of industry interest.

Potential impact of AUSFTA on Australia's blood supply.

Australia is largely self-sufficient in its supply of safe, fresh blood products because of the goodwill of non-remunerated, volunteer donors, plus rigorous testing and processing standards. CSL Limited is the sole provider of plasma fractionation services in Australia, enjoying exclusive rights under the Plasma Fractionation Agreement with the Australian Government. In the Australia-United States Free Trade Agreement (AUSFTA), Australia agreed to review its current contract with CSL Limited, and to recommend to the states and territories that the process be opened up to overseas tender.

Policy challenges from the "White" Senate inquiry into workplace-related health impacts of toxic dusts and nanoparticles.

On 22 June 2005 the Senate of the Commonwealth of Australia voted to establish an inquiry into workplace harm related to toxic dust and emerging technologies (including nanoparticles). The inquiry became known as the "White" Inquiry after Mr Richard White, a financially uncompensated sufferer of industrial sandblasting-induced lung disease who was instrumental in its establishment. The "White" Inquiry delivered its final report and recommendations on 31 May 2006.

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good.

Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins.