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. • There is a difference between the standards by which the AAT judges the safety and efficacy of medicines and the standards used for registering therapeutic goods by regulatory agencies worldwide. • This raises the question as to whether the appeal process against TGA decisions appropriately serves the Australian public interest.

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. RESULTS: Data collection was completed with a response rate of 59.0%. Participants who had received and filled at least one prescription medicine in the previous 3 months, and eligible for analysis (n=952), were asked to self-report the level of financial burden from obtaining these medicines. Extreme and heavy financial burdens were reported by 2.1% and 6.8% of participants, respectively. A moderate level of burden was experienced by a further 19.5%. Low burden was recorded for participants who said that their prescription medicines presented either a slight burden (29.0%) or were no burden at all (42.6%). CONCLUSION: A substantial minority of participants who had obtained prescription medicines in the 3 months prior to survey experienced a level of financial burden from the cost of these medicines that was reported as being moderate to extreme.

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. In the US, qui tam provisions - the component of anti-fraud or anti-false claims laws involving payments to whistleblowers - have been particularly successful in providing critical evidence allowing public prosecutors to recover damages for fraud and false claims made by corporations in relation to federal and state health care programs. The US continues to strengthen such anti-fraud measures and to successfully apply them to a widening range of areas involving large public investment. Australia still suffers from the absence of any comprehensive scheme that not only allows treble damages recovery for fraud on the public purse, but crucially supports such actions by providing financial encouragement for whistleblowing corporate insiders to expose evidence of fraud. Potential areas of application could include direct and indirect government expenditure on health care service provision, pharmaceuticals, medical devices, defence, carbon emissions compensation and tobacco-related illness. The creation in Australia of an equivalent to US anti-false claims legislation should be a policy priority, particularly in a period of financial stringency.

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. US-based multinational pharmaceutical companies are lobbying for TPPA provisions like those in the Australia-US Free Trade Agreement, which reduce government cost-effectiveness regulatory control of pharmaceuticals, threatening equitable access to medicines. They also advocate increased TPPA intellectual monopoly privilege protection, which will further limit the development of Australian generic medicine enterprises and restrict patient access to cheap, bioequivalent prescription drugs. Of particular concern is that proposed TPPA multilateral investor-state dispute settlement procedures would allow US corporations (as well as those of other TPPA nations) to obtain damages against Australian governments through international arbitral proceedings if their investments are impeded by Australian public health and environment protection legislation.

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. The current thinking of government safety and cost-effectiveness regulators appears to be that these products give rise to few if any nano-specific issues. This article challenges that proposition and seeks to explore what features of nanomedicines may create unique or heightened policy challenges for government systems of cost-effectiveness regulation. The Australian Pharmaceutical Benefits Scheme (PBS) is a key exemplar of the latter type of regulation in that it links expert scientific evaluation of cost-effectiveness with the pricing of PBS-listed drugs. In the current global financial crisis such systems are likely to become increasingly attractive and how they handle the demands made upon them by nanomedicines (including by application of a variation of the precautionary principle) is likely to be of considerable interest to policy makers worldwide.

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. The four NMP principles of industry, standards, access and use are applicable to all phases of the medical device life-cycle and align with existing medical devices policy. This article proposes that Australia's approach to medical devices stands to benefit from an equivalent whole-of-government policy.

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. Such in vitro studies do reveal concerns--for example, related to oxidative stress and granuloma formation--but their uncertain clinical ramifications may require more integration in preclinical drug discovery of research characterizing structure-toxicity relationships and limiting safety liabilities. Regulatory considerations for medically related nanoproducts should also involve improving cost-effectiveness systems and ensuring that industry involvement in standard-setting does not become a means of reducing competition. It is also important that nanotechnology policy and regulation encourages new models of safe drug discovery and development that are more systematically targeted at the global burden of disease.

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.

'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. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines.

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. There also appears to have been little attention paid in this context to policies fostering industry sustainability and public affordability (as encouraged by the National Medicines Policy). One notable example includes that failure to consider facilitating mutual exchanges on regulatory assessment of health technology safety and cost-effectiveness (including reference pricing) in the context of ongoing free trade negotiations between Australia and China (the latter soon to possess the world's largest generic pharmaceutical manufacturing capacity). The importance of a thriving Australian domestic generic pharmaceutical and bio/nano tech industry in terms of biosecurity, similarly appears to have been given insufficient policy attention.Reasons for such policy oversights may relate to increasing interrelationships between generic and 'brand-name' manufacturers and the scale of investment required for the Australian generics and bio/nano technology sector to be a significant driver of local production. It might also result from singularly effective lobbying pressure exerted by Medicines Australia, the 'brand-name' pharmaceutical industry association, utilising controversial interpretations of reward of pharmaceutical 'innovation' provisions in the Australia-US Free Trade Agreement (AUSFTA) through the policy-development mechanisms of the AUSFTA Medicines Working Group and most recently an Innovative Medicines Working Group with the Department of Health and Ageing. This paper critically analyses such arguments in the context of emerging challenges for sustainable industrial renewal in Australia's bio/nanopharma sector.

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. A recent senate inquiry recommended the establishment of a working party, including representatives of the Therapeutic Goods Administration, to consider whether bulk materials classified as safe should be routinely reassessed for use at the nanoscale level by a permanent, distinct nanotechnology regulator. Safety regulation of nanotherapeutics may present unique risk assessment challenges, given the novelty and variety of products, high mobility and reactivity of engineered nanoparticles, and blurring of the diagnostic and therapeutic classifications of "medicines" and "medical devices". Nanotherapeutics is likely to make increasing claims on a particular area of Australian health care regulatory strength: scientific cost-effectiveness assessment of innovation in medical products. Any review of Australian regulation of nanotechnology should include a critical analysis of both safety issues and cost-effectiveness assessment systems for nanotherapeutics.

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. Overseas tenders for off-shore fractionation services are likely to be highly competitive due to their low manufacturing costs and accumulated expertise. Off-shore fractionation could compromise the safety of Australia's blood supply through delays in processing and transportation, issues related to quality control, and even the siphoning of stock to overseas markets. This could compromise the long-term care of Australian patients and create a serious national security risk in the event of a terrorist attack or natural disaster. Australia's AUSFTA obligation to recommend changes does not equate to an obligation to actually proceed. The states and territories should carefully consider whether such changes would be in our national interest. The long-term security of the Australian people in the current security environment is dependent on continuance of an on-shore fractionation plant and appropriate back-up facilities.

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. This paper examines whether these recommendations and their implementation may provide a unique opportunity not only to modernize relevant monitoring standards and processes, but related compensation systems for disease associated with workplace-related exposure to toxic dusts. It critically analyzes the likely role of the new Australian Safety and Compensation Council (ASCC) in this area. It also considers whether recommendations related to potential workplace related harm from exposure to nanoparticles could commence a major shift in Australian healthcare regulation.

Flexner's ethical oversight reprised? Contemporary medical education and the health impacts of corporate globalisation.

BACKGROUND: Abraham Flexner's famous reports of 1910 and 1912, Medical Education in the United States and Canada and Medical Education in Europe, were written to assist the development of a positive response in university curricula to a revolution in understanding about the scientific foundations of clinical medicine. Flexner pointed out many deficiencies in medical education that retain contemporary resonance. Generally underemphasised in Flexner's reports, however, were recommendations promoting a firm understanding of and commitment to medical ethics as a basis of medical professionalism. Indeed, Flexner's praise for the scholastic basic of German medical education appeared somewhat ironic when the ethical inadequacies of prominent Nazi doctors were revealed at the Nuremberg Trials. CORPORATE GLOBALISATION AND ITS IMPACT ON MEDICAL PROFESSIONALISM: This article suggests that contemporary medical educators, like Flexner, may be at risk of inadequately addressing a major challenge to evolving medical professionalism. Medical ethics, health law and even the international right to health are now increasingly emphasised in medical curricula. The same cannot be said, however, of lobbying principles arising from the structures of corporate globalisation, although these are rapidly becoming an even more dominant force in shaping medical practice around the globe. Conclusion Today it is the normative tension between medical ethics, health law and international human rights on the one hand and the lobbying principles and strategies of corporate globalisation that must urgently become the focus of major recommendations for reshaping the teaching of medical professionalism. Suggestions are made as to how this might practically be achieved.