The 12-country Trans Pacific Partnership Agreement (TPPA) covering 40 per cent of the world's economy has been finalised in the US overnight.
While the agreement text has not been released, it appears the US has fallen short in its push to secure a formal increase in data exclusivity periods for biologics, although the wording is understood to introduce the concept of 'effective protection'.
On data exclusivity for biologics, the USTR simply said the intellectual property chapter includes commitments relating to the protection of undisclosed test and other data submitted to obtain marketing approval of a new pharmaceutical or agricultural chemicals product.
At the press conference announcing the agreement, USTR Michael Froman said it includes at least five years of data exclusivity for biologics, complemented by "other mechanisms" the 12 countries have in place in order to encourage innovation in the sector.
BiotechDispatch understands the final agreement provides two options on data exclusivity.
The first is that countries will adopt at least eight-years of data exclusivity for biologics. The second is that countries will 'provide effective protection', including a minimum five-year data exclusivity period plus 'other measures' and 'circumstances in the marketplace' that 'deliver a comparable outcome' to the eight-year period.
The second option appears to reflect a combination of the five plus three option floated last week and Trade Minister Andrew Robb's argument that Australia's formal five year data exclusivity period is effectively longer because of regulatory and reimbursement timelines.
The US and industry are expected to use the agreement to push for the eight years, while the Australian Government will argue current laws meet the requirement.
Disagreement over data exclusivity for biologics was one of the final issues resolved in the agreement that has taken over five years to negotiate.
The agreement does include other changes to intellectual property and transparency provisions relating to pharmaceutical reimbursement systems.
These changes, which are understood to broadly reflect the wording of the bilateral US-Australia Free Trade Agreement, will probably mean no real change in Australia.
In contrast, the requirement for patent term extensions and transparency and clarity around process in government pharmaceutical reimbursement systems will mean reform of New Zealand's PHARMAC.
In a statement, the New Zealand Government said, "As a result of TPP, PHARMAC will make some administrative changes to increase transparency. These include setting a timeframe for considering funding applications. This timeframe is up to New Zealand to determine, and can be extended. New Zealand will also establish a specific review process for funding applications that PHARMAC has declined."
The USTR confirmed provisions relating to transparency and procedural fairness with respect to listing and reimbursement for pharmaceutical products or medical devices are included in an annex to the 'Transparency and Anti-Corruption' chapter.
The agreement was cautiously welcomed by the global generics sector but the research-based and biotechnology industries expressed disappointment.