Pharmaceutical Industry Australia

In terms of the influence exerted by the public and the private sectors on dmg regulation, these 10 countries can be placed along a continuum, as depicted in Figure 3.3 below. Cuba, where the Government has exclusive power over regulatory decisions, is at one extreme, and Australia, where consumers and the pharmaceutical industry have official representation and make recommendations to the TGA, at the other. 

Membership of committees Australia is the only country in the group with a system for including pharmaceutical industry representatives on committees which have the power to consider applications. 

In terms of qualifications, Australia appears to have the most demanding recruitment requirements for GMP inspectors. The TGA s GMP auditors need to have worked in industry before their appointment and undergo 6-12 months formal training after appointment. Similarly, GMP inspectors in the Netherlands must have acquired experience in the pharmaceutical industry. 

In order to promote a uniform approach to offering compensation to subjects and indemnity to investigators and institutions conducting clinical trials, Medicines Australia has published a Form of Indemnity for Clinical Trials and Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Chnical Trial. These documents are based on those published by the Association of the British Pharmaceutical Industry and are available from www.medicinesaustralia.com.au (the Medicines Australia website). 

We live in an era in which the value of medicines can no longer be assumed and the phrase evidence based is no longer restricted to the realm of academics. The increasing financial burden on our healthcare systems has prompted decision-makers around the world to demand that the pharmaceutical industry provide proof of the value of new drugs being introduced into the market. Decision-makers in certain countries (e.g. Australia and Canada) have taken this requirement a step further by linking reimbursement approval to the provision... 

Komesaroff, P. A. and I. H. Kerridge. 2002. Ethical Issues Concerning the Relationships between Medical Practitioners and the Pharmaceutical Industry. The Medical Journal of Australia 176 118-121. 

Nevertheless, it appears that pharmaceutical industry lobbyists in Australia may already be using ambit claims about the impact of the AUSFTA PBS-related provisions on "innovation" to push for favorable governmental and bureaucratic decisions. Claims related to cost-effectiveness may include that the PBAC process should be more willing to break the therapeutic groupings of reference pricing for new products on pharmacologic, rather than health outcome data. 

The Industry Commission report on the Pharmaceutical Industry (Owens 1996) encapsulates the future direction of drug regulation in Australia in one of its recommendations, namely ... 

Conduct, established by the pharmaceutical industry. Prosecutions for breaches of the TG Act are extremely rare. Complaints about advertising through the CRP or through the industry body Medicines Australia are common and often initiated by competitors. Although the sanctions available to these bodies are not, strictly speaking, enforceable in law, the risk of TGA scrutiny is usually enough to ensure that advertisers comply with their rulings. 

In summary, the ADRAC committee performs a unique and important public health role in Australia. The work of the committee and the secretariat provides vital support for Australian health care workers seeking information about the adverse effects of drugs. In return, ADRAC enjoys strong support from doctors, pharmacists, and the pharmaceutical industry in the form of voluntary, spontaneous reports of ADRs. In this way, ADRAC works with other stakeholders to make a positive contribution to the quality use of medicines in Australia. 

OTA reviewed recent trends in payment methods for prescription drugs in five countries Australia, Canada, France, Japan, and the United Kingdom. To a greater or lesser extent in each of these countries, drug payment policy is governed by two potentially conflicting objectives to minimize health insurance prescription drug costs and to help the country s domestic pharmaceutical industry. Payment policies represent a blend between these objectives. 

Australia s domestic pharmaceutical industry is very small, and the country represents a small proportion of the world market for prescription drugs.31 Consequently, Australia has not had a major economic stake in promoting pharmaceutical R D. Instead, the main objective of Australia s pharmaceutical payment policies has been to minimize the cost of drugs, both to the government and to its citizens. Recently, though, the government has made efforts to promote the... 

Australia Dept, of Health and Ageing, Guidelines for the pharmaceutical industry on preparation of submissions to the Pharmaceutical Benefits Advisory Committee including major submissions involving economic analyses, http //www. health.gov.au/pbs/pubs/pharmpac/gusubpac.htm, accessed March 11, 2002. 

Paul F Long is a molecular microbiologist whose research sits at the interface of chemistry, biology and clinical pharmaceutics. He has worked in natural product drug discovery in both the health service and pharmaceutical industry, as well as more recently in academia with international collaborations spanning Europe, Japan, the USA and Australia. His interests extend to applying pharmacogenomics to problems in paediatric clinical pharmacy from the use of natural product-derived therapeutics. 

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