Labor continues to ask questions about intellectual property provisions relating to biologics in the Trans Pacific Partnership Agreement (TPP).
Former trade minister Andrew Robb recently signed the 12-country agreement before announcing his retirement from politics.
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 TPP' 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".
Andrew Robb has 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'.
In contrast, the US says the TPP 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.
In a speech to the House of Representatives, NSW Labor MP Pat Conroy desribed the outcome as a "worry".
"There is still considerable uncertainty around biologics. We were promised that there would only be a five-year protection for biologics, but in the text it states that it is either eight years or five years plus an equivalent of a further three years, which seems very wishy-washy to me," he said.
"It is either five years or eight years. It cannot be both at the same time. But United States negotiators are saying it is eight. The member for Goldstein, the previous trade minister, is saying it is five. If it is eight, that is of great concern."
Mr Conroy said Labor would continue to subject the agreement text to significant scrutiny.