Data exclusivity could go to 12 yrs
Pharma in Focus | 8 November 2016
Data exclusivity could go to 12 yrs
by Nick Lush
Despite the Australian government’s position that the current five year limit will remain, doubt has already been sown because of the TPP’s reference to achieving a "market outcome" of eight years by administrative means.
Now US publication World Trade Online has reported that the leading Republican supporter of 12 years’ exclusivity, Senate Finance Committee Chairman Orrin Hatch, may have succeeded in persuading non-US signatories such as Australia and NZ who have been holding out for shorter periods to de facto adopt the 12 year limit.
’Multiple sources characterised the work as a ’clarification’ of how individual countries will implement the TPP biologics provision, including their regulatory landscape on the ground - which countries like New Zealand and Australia have claimed already amounts to a market exclusivity period for biologics drugs of more than 12 years - and how TPP will affect their market exclusivity for biologics in the future," the publication says.
Such a ’clarification’ would not require any re-negotiation of the deal but could be enough to persuade sufficient members of the Republican dominated Congress to ratify it during the ’lame duck’ period following this week’s presidential election.
The TPP faces almost certain death if either presidential candidate, Clinton or Trump, is elected and supporters have a very narrow window in which to have it ratified by a Congress in which opposition is still strong.
In reaction to the latest development, Patricia Ranald, convener of the Australian Fair Trade and Investment Network has challenged the government to recommit to its promise not to extend exclusivity in Australia beyond the current five years.
"The Australian government should reject the push from US Republican Congress members to increase biologic medicine monopolies by seven years, even more than the extra three years which has already been agreed in the TPP text," Dr Ranald said.
"The extra three years of monopoly in the current TPP text is already unacceptable. It is outrageous that the US is demanding an even greater increase, a total of seven years of extra monopoly. This would be a time bomb for PBS cost blowouts, leading to pressure for price rises at the chemist. We call on the Australian and other governments to reject this proposal," Dr Ranald said.
