Pharmaceutical Industry In Australia Research Articles

Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia

National Regulatory Authorities (NRAs) globally are facing the challenge of evaluating pharmaceutical products in a speedy manner, whilst simultaneously ensuring adequate efficacy, safety and quality of approved products. Additionally, common expectations include that the evaluation process is competent, flexible, commensurate with risk, efficient and rapid. In 2014, the Australian regulatory system was out of step with global regulatory developments which led to a comprehensive regulatory review and reform process. As part of the reforms, two Facilitated Regulatory Pathways (FRP) were developed for prescription medicines: Priority Review (PR) and Provisional Approval (PA). Furthermore, regulatory reliance and recognition arrangements have been expanded with the Therapeutic Goods Administration (TGA) making increased use of evaluation reports by trusted NRAs. The new pathways have been utilised by the pharmaceutical industry in Australia since 2017, with the number of medicines going through these pathways gradually increasing. Additional facilitated pathways have been developed following the review, providing alternatives to the standard pathway for registration of prescription medicines in Australia. The reform is timely, helping to position Australia well in the current global regulatory climate.

How do health consumer organisations in Australia manage pharmaceutical industry sponsorship? A cross-sectional study.

Objective The aim of this study was to investigate how health consumer organisations manage their relationships with the pharmaceutical industry in Australia. Methods We identified 230 health consumer organisations that received pharmaceutical industry support from 2013 to 2016 according to reports published by Medicines Australia, the industry trade association. A random sample of 133 organisations was selected and their websites assessed for financial transparency, policies governing corporate sponsorship and evidence of potential industry influence. Results In all, 130 of the 133 organisations evaluated received industry funding. Of these 130, 68 (52.3%; 95% confidence interval (CI) 43.4-61.1%) disclosed this funding. Nearly all (67; 98.5%) reported the identity of their industry donors, followed by uses (52.9%), amount (13.2%) and proportion of income from industry (4.4%). Less than one-fifth (24/133; 18.0%; 95% CI 11.9-25.6%) had publicly available policies on corporate sponsorship. Six organisations (7.2%; 95% CI 2.7-15.1%) had board members that were currently or previously employed by pharmaceutical companies, and 49 (36.8%; 95% CI 28.6-45.6%) had company logos, web links or advertisements on their websites. Conclusion Industry-funded health consumer organisations in Australia have low transparency when reporting industry funding and few have policies governing corporate sponsorship. Relationships between health consumer organisations and the industry require effective actions to minimise the risks of undue influence. What is known about this topic? Pharmaceutical industry funding of health consumer organisations is common in the US and Europe, yet only a minority of such organisations publicly disclose this funding and have policies regulating their relationships with industry. What does this paper add? Industry-funded health consumer organisations in Australia have inadequate financial transparency and rarely have policies addressing corporate funding. Organisations that have received more industry funding are more likely to report it publicly. What are the implications for practitioners? Robust policies addressing corporate sponsorship and increased transparency are needed to maintain the independence of health consumer organisations. Governments may also consider regulating non-profit organisations to ensure public reporting of funding sources.

Deterrents to knowledge-sharing in the pharmaceutical industry: a case study

Purpose– This study aims to explore deterrents to knowledge-sharing in pharmaceutical manufacturing. Effective knowledge-sharing is fundamental to stimulation of the process of knowledge absorption. The limited proximal communication between the employees in the pharmaceutical industry stifles their knowledge-sharing behaviour significantly.Design/methodology/approach– A cross-sectional case study, consisting of semi-structured interviews with managers and scientists, was conducted in a multinational pharmaceutical company in Australia. Respondents were asked to answer questions regarding their current knowledge-sharing practices and to identify organisational deterrents to knowledge-sharing. The data were condensed into themes according to the thematic analysis method.Findings– The pharmaceutical industry is extensively regulated and its excessive competitiveness is cultivating organisational reticence towards the development of a knowledge-sharing culture. Nine categories of deterrents to intra- (within) and inter-organisational (between organisations) knowledge-sharing have been identified. These categories include high cost of sharing knowledge, information technology limitations, knowledge-hiding, lack of socialisation, lack of trust culture, non-educational mindset, organisational politics, poor leadership and time pressure.Research limitations/implications– The population of this study consists of managers and practitioners working for a pharmaceutical company. Hence, the generalisability of the findings to other health-care settings is unknown.Practical implications– The findings have implications for leaders and managers who should be aware of these professional diversities, instigators as well as the ripple effects of limited knowledge-sharing to guide the organisation towards developing an optimal knowledge-sharing culture.Originality/value– A focussed investigation of knowledge-sharing behaviour within the pharmaceutical industry in Australia, considering the pressure applied to this industry over the past decade. This case study specifically focusses on the diversity of deterrents to knowledge-sharing in the pharmaceutical manufacturing industry.

The vexed issue of therapeutic combinations and contributory patent infringement in Australia

The Australian Patents Act includes a provision which deems the supplier of a product to a person who will use that product in a manner which infringes a patent to infringe that patent as a contributory infringer. The concept of contributory patent infringement is one known to the patent laws of many countries, but in many respects the way in which Australian Courts have approached contributory patent infringement gives far greater scope to a patentee than in many of those jurisdictions. The consequence for the generic pharmaceutical industry in Australia is potentially far-reaching. This article looks at the practical consequences of some recent Australian Federal Court decisions which have been decided in the area and which create practical hurdles that any generic entrant into the Australian marketplace will need to navigate.

The Trans-Pacific Partnership Agreement: a threat to affordable medicines and public health

The Trans-Pacific Partnership Agreement: a threat to affordable medicines and public health

Comment: Interactions Between the Medical Profession and the Pharmaceutical Industry in Australia

Comment: Interactions Between the Medical Profession and the Pharmaceutical Industry in Australia

Gifts, Drug Samples, and other Items Given to Medical Specialists by Pharmaceutical Companies

Aim To ascertain the quantity and nature of gifts and items provided by the pharmaceutical industry in Australia to medical specialists and to consider whether these are appropriate in terms of justifiable ethical standards, empirical research and views expressed in the literature.

Empirical uncertainty and moral contest: A qualitative analysis of the relationship between medical specialists and the pharmaceutical industry in Australia

Alliances between the medical profession and the pharmaceutical industry have become increasingly widespread in recent years. While there are clearly benefits for doctors and their patients derived from the medical profession working with industry, concern has arisen that the commercial imperative of industry may conflict with physicians’ independence and professional integrity. This paper reports the findings of an in-depth interview study with 50 Australian medical specialists undertaken to explore how and why they interact with the pharmaceutical industry and to gain insight into specialists’ moral evaluation of the relationship and its consequences. Analysis of the qualitative data led to the categorizing medical specialists into three types—Confident Engagers, Ambivalent Engagers and Avoiders—based on their descriptions and evaluations of their relationship. The majority of interviewees believed that some relationship with the pharmaceutical industry was inevitable, that there were both risks and benefits associated with the relationship and that as individuals they were competent in minimizing the risks and maximizing the benefits. However, their views diverged on the extent and magnitude of the risks and benefits. The data suggested that there is considerable variance in specialists’ judgments of what constituted appropriate industry largesse. Specialists’ relationship with the pharmaceutical industry has inherent tensions that are managed by different doctors in different ways. Moral evaluation of the relationship and its consequences varies and the ethical concerns surrounding the relationship appeared as an area of contest. The findings suggest that in developing normative guidelines for academic and professional practice, policy makers should recognise and account for the complexity of the relationship and for the variation in medical specialists’ views and feelings.

Medical specialists and pharmaceutical industry‐sponsored research: a survey of the Australian experience

To characterise research relationships between medical specialists and the pharmaceutical industry in Australia. Questionnaire survey of medical specialists listed in the Medical Directory of Australia and believed to be in active practice, conducted in 2002 and 2003. Details of medical specialists' involvement in pharmaceutical industry-sponsored research, and reports of potentially undesirable research outcomes. Of 2120 specialists approached, 823 (39%) responded. Participation in pharmaceutical industry-sponsored research was more commonly reported by those in salaried practice (49%) than those in private practice (33%); P < 0.001. 216 reported that industry had made initial contact, compared with 117 who had initiated contact with industry. 14.0% of respondents reported premature termination of industry-sponsored trials, which they considered appropriate when in response to concerns about adverse drug effects. 12.3% of respondents reported that industry staff had written first drafts of reports, which they viewed as an acceptable practice for "internal" documents only. Of greatest concern to respondents were instances of delayed publication or non-publication of key negative findings (reported by 6.7% and 5.1% of respondents, respectively), and concealment of results (2.2%). Overall, 71 respondents (8.6%) had experienced at least one event that could represent breaches of research integrity. These data indicate a high level of engagement in research between the pharmaceutical industry and medical specialists, including those in private practice. Examples of possibly serious research misconduct were reported by 8.6% of respondents, equivalent to 21% of those with an active research relationship with industry.

State Supremacy in Decline

This paper discusses the dynamics of the international pharmaceutical industry, and how these are creating problems for the Australian government in its efforts to manage change within the regulated domestic industry. The paper argues that regulatory reform and industry development policy have eroded the capacity of the federal government to maintain the pricing regime associated with the Pharmaceutical Benefits Scheme (PBS) since 1950. The bargaining strength of the transnational firms which dominate the pharmaceutical industry in Australia is increasing; current global rationalisation of manufacturing and of R&D make threats to relocate more credible than in the past.

Industry comment on the 1995 revised Australian pharmacoeconomic guidelines.

This article is a critique of the 1995 revised Australian guidelines (the revised guidelines)lll for the pharmaceutical industry on preparation of submissions to the Phannaceutical Benefits Advisory Committee (PBAC). PBAC is the body responsible in Australia for recommending the approval of drugs for reimbursement on the Phannaceutical Benefits Scheme (PBS). The guidelines were first released to the pharmaceutical industry in Australia in August 1990, were revised in August 1992 and became mandatory in January 1993. The intention for the current revision of the guidelines was signalled in the preface to the 1992 guidelines,l21 The opinions expressed in this article are an interpretation of the collective opinion of the Health Economics Subcommittee of the Australian Pharmaceutical Manufacturers Association (APMA), of which the authors are members. The revised guidelines appear to primarily reflect a clinical preference in evaluation methodology. They fail to encourage the application of true economic theory to the evaluation of pharmaceuticals, and will therefore fail to foster the growth of sound health economic analysis. There has been a shift from encouraging the use of estimated final health outcomes in the former guidelines to specifying the selection of outcomes on scientific rather than economic criteria in the 1995 revised guidelines. This approach values the certainty of a measured outcome in a controlled experimental environment more highly than the relevance of the outcome in the estimation of actual benefit of a product in community use. Thus, the revised guidelines focus on the assessment and grading of the quality of the presented data, with little regard to the contribution these data will make in the final assessment of the true economic and clinical value of the product.

Government initiatives in the development of a pharmaceutical industry in Australia.

Government policy recognizes that the purchasing power of the government, through the Pharmaceutical Benefits Scheme, has suppressed prices and returns to the pharmaceutical industry in Australia, and that research, development and export activities have been low. The factor (f) scheme is designed to provide some pricing relief to those companies willing and able to undertake particular industry development activities. This scheme, together with the other changes implemented by the government, will result in the restructuring and development of the pharmaceutical industry in Australia.