Time to increase patent terms for new medicines, says Medicines Australia

10 February 2013

Patent terms for innovative medicines should be extended to compensate for increasing delays in regulatory approval, pharma trade group Medicines Australia chief executive Brendan Shaw will tell the federal government review of Australia’s patent system at a public hearing today (February 11).

Pharmaceutical patents are currently granted up to five years’ extension to account for regulatory delays. Dr Shaw said there was a strong argument to be made for increasing patent term extensions given that Therapeutic Goods Administration approval processes had lengthened significantly since 1998, when patent term extensions were introduced, and delays in listing on the Pharmaceutical Benefits Scheme had almost doubled.

AusBiotech, representing the nation’s biotechnology firms, last month also called for longer patent terms, noting that the erosion of incentives to develop and patent innovative medicines in Australia is caused by a raft of forces, including the trend towards medicines that target smaller patient groups (markets), increasing regulatory and reimbursement time, costs, complexity and uncertainty, increased cost and risks of clinical trials (The Pharma Letter January 24).

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