A leaked copy of the TPP's intellectual property chapter confirms the 'ambiguity' of the outcome in relation to data exclusivity for biologics with the requirement for countries to adopt an additional 'market protection' period.
Prime Minister Malcolm Turnbull and Trade Minister Andrew Robb have repeatedly said the agreement does not require Australia to go beyond its current legislated five-year data exclusivity period for biologics.
Yet they have not publicly acknowledged the agreement's inclusion of a 'market protection' period for biologics.
The leaked chapter published by Wikileaks is dated Monday 5 October, the final day of negotiations. It reveals the outcome on data exclusivity for biologics is complex, nuanced and ambiguous.
However, it is clear that, while the agreement allows countries to stick with a legislated 5 year data exclusivity period for biologics, it requires them to deliver a 'market protection' period "comparable" to 8 years.
The leaked chapter confirms that, as previously reported by BiotechDispatch, the 12 signatory countries must adopt one of two options in relation to biologics.
They can either grant: 8 years of legislated data exclusivity; or, "deliver a comparable outcome in the market" based on 5 years data exclusivity and "other measures...recognizing that market circumstances also contribute to effective market protection."
Trade Minister Andrew Robb argued during the negotiations that Australia's current five year data exclusivity period for all pharmaceuticals is effectively longer because of regulatory and reimbursement processes.
This is unlikely to satisfy the US.
A US-based industry source told BiotechDispatch the US is certain to demand clarity and evidence of these "other measures" and "market circumstances" adding up to 8 years or the "comparable outcome" during its certification process for the TPPA.
The agreement also provides for a review of the provisions in relation to biologics after 10 years, "with a view to providing effective incentives for the development of new pharmaceutical products that are or contain a biologic, as well as with a view to facilitating the timely availability of follow-on biosimilars, and to ensuring that the scope of application remains consistent with international developments regarding approval of additional categories of new pharmaceutical products that are or contain a biologic."