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Challenges for Australia's bio/nanopharma policies: trade deals, public goods and reference pricing in sustainable industrial renewal

Faunce, Thomas

Description

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...[Show more]

dc.contributor.authorFaunce, Thomas
dc.date.accessioned2009-04-14T00:22:05Z
dc.date.accessioned2010-12-20T06:05:10Z
dc.date.available2009-04-14T00:22:05Z
dc.date.available2010-12-20T06:05:10Z
dc.identifier.issn1743-8462
dc.identifier.urihttp://hdl.handle.net/10440/19
dc.description.abstractIndustrial 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.
dc.format16 pages
dc.publisherBioMed Central
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
dc.sourceAustralia and New Zealand Health Policy
dc.source.urihttp://www.anzhealthpolicy.com/content/4/1/9
dc.subjectKeywords: amoxicillin; atorvastatin; BRCA1 protein; clopidogrel; cytochrome P450; felodipine; generic drug; hepatitis B vaccine; human growth hormone; lopinavir plus ritonavir; macrogol; novel erythropoiesis stimulating protein; omeprazole; peginterferon; ranitidin
dc.titleChallenges for Australia's bio/nanopharma policies: trade deals, public goods and reference pricing in sustainable industrial renewal
dc.typeJournal article
local.identifier.citationvolume4
dcterms.dateAccepted2007-06-01
dc.date.issued2007-06-01
local.identifier.absfor180102
local.identifier.ariespublicationu9507981xPUB268
local.type.statusPublished Version
local.contributor.affiliationFaunce, Thomas, ANU Medical School
local.bibliographicCitation.issue9
local.bibliographicCitation.startpage1
local.bibliographicCitation.lastpage16
local.identifier.doi10.1186/1743-8462-4-9
dc.date.updated2015-12-09T09:19:10Z
local.identifier.scopusID2-s2.0-34347407380
CollectionsANU Research Publications

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