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Bio Technology : October 2009
50 Australasian BioTechnology Volume 19 • Number 3 • October 2009 AusBioTALK Improving health technology assessment AusBiotech welcomes the government’s Health Technology Assessment (HTA) Review and now represents biotechnology on its Steering Commit- tee. The Review aims to “support innovation without compromising consumer safety” and make it easier for new devices and services to be adopted. A report expected later this year on the HTA Review will recommend how to improve health technology assessment in Australia. The outcome has potential to change important aspects of the way medicines, devices and diagnostics are assessed for market access and reimbursement in the future. Nicola Roxon, Minister for Health and Ageing, and Lindsay Tanner, Minister for Finance and Deregulation, have under- taken the HTA Review as a joint portfolio exercise. It is currently looking at the operations of key committees associated with the regulation and reimbursement of medical devices, diagnostics and combination device/drug therapies. The process was initiated via a discussion paper issued in March, framing the problems the Review is trying to address. The Review will consult with an 18-member stakeholder reference group which includes AusBiotech, Medicines Australia, the Medical Technology Association of Australia, a number of government departments and doctor groups and is chaired by Deputy Secretary of the Department of Health and Ageing, David Learmonth. It is due to report in December. The Review's terms of reference reflect an understanding that the current system is excessively fragmented, uncoordi- nated, lacks transparency and, in particular, fails to recog- nise the increasingly common convergence of therapeutic technologies characterised by targeted therapies for diseases such a cancer. The AusBiotech-initiated Medical Device Industry Action Agenda called for a review of the Health Technology Assess- ment process as it was seen as too lengthy, complex and non-transparent. The review process is moving quite quickly and the issues AusBiotech has raised include: the paramount need for efficiency of process; • it is essential to have post-market surveillance; • the position of small indigenous companies to pay • for charge (cost shifting to industry); the need to separate listing from reimbursement; • transparency and fairness (due process) in assessment • decision making and fee structures; questioning the need for PDC as a stand-alone • committee and the undue influence of insurers/payers; proposal that following the demonstration of claims via • clerical evidence, that a premium be paid to innovation companies; politicians not to form part of the process until decision • at end. A key issue is whether there should be a single entry point for applications for market registration and funding to replace the multiple entry points. Another key matter for AusBiotech members is the areas of 'co-dependent' and 'hybrid' technologies where drugs and diagnostics or drugs and devices must converge to obtain a desired healthcare outcome. The HTA Review has also been charged with strengthening transparency and procedural fairness in assessment, deci- sion making and fee negotiation.