Labor accuses Government of TPPA backdown on biologics

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Labor has accused the Turnbull Government of backtracking on its commitment not to extend the data exclusivity period for biologics in the Trans Pacific Partnership Agreement (TPPA).

The agreement that covers 40 per cent of the world’s economy includes extensive provisions relating to intellectual property, including in relation to pharmaceuticals. The most relevant for Australia is a provision relating to data exclusivity periods for biologics.

The US pushed hard for the adoption of a 12-year data exclusivity period for biologics but encountered significant opposition, notably from Australia, which maintains a legislated 5-year period for all pharmaceuticals, including biologics.

The final wording of the TPPA has provided some public ambiguity in relation to the issue. It says countries can provide a legislated 8-year period, or a ‘market protection’ period that delivers a “comparable outcome” of 8 years comprised of a legislated 5 year period plus “other measures”.

Former trade minister Andrew Robb avoided discussing the specifics of the wording, preferring to focus on the ability for Australia to avoid legislating an 8-year period and using language such as the ‘Australian way’.

However, the US has consistently said, including publicly, that the TPPA requires countries to guarantee a minimum 8-year period, through either a single legislated period or in combination with an additional ‘market protection’ period.

Mr Robb is understood to have argued during the negotiations that Australia’s regulatory and reimbursement processes provide an ‘effective’ data exclusivity period in addition to the legislated 5-year period. The US is known to be seeking guarantees on these matters given, in their absence, Congress is unlikely to back the TPPA.

Labor has jumped on comments by Trade Minister Steve Ciobo at a conference in Melbourne.

“Whoever wins the forthcoming Australian election will need to play a key role in terms of what can be done around biologics which seems to be the main sticking point … with respect to the debate that is happening in the US,” he said.

Whilst not an explicit concession on the issue, Mr Ciobo's comments indicate the Government does understand the the importance of this matter to the US.

"Labor calls on the Coalition to come clean on its plans to erode the PBS," said shadow trade minister Penny Wong and shadow health minister Catherine King in a joint statement.

"A Shorten Labor Government will not accept any provisions or changes to the TPP which will increase the cost or restrict the availability of medicines for Australians."