(The full document is located online at http://www.aph.gov.au/hansard/senate/commttee/S7062.pdf)

The following exchange is between Senator Conroy, the Opposition Spokesman for Trade; and Mr. Deady, the Chief Australian Negotiator, US-Australia FTA

Page 104

Senator CONROY-Representatives from the Australian (generic) pharmaceuticals industry have expressed to me concerns that intellectual property issues as they specifically affect pharmaceuticals will not be excluded from the negotiations. The industry is concerned that the US negotiators have flagged the possibility of Australia introducing a paragraph 4 process similar to the current US process linking intellectual property with the regulatory approval process…

Senator CONROY-Has the US raised the possibility of a paragraph 4 or something similar?

Mr Deady-Again, I really do not want to get into the detail of the negotiations here. I can say that there are a number of issues in the IP chapter that we are still negotiating hard with the Americans. This is another chapter where they do have some ambitions. They are the demanders in this chapter. We are working to achieve an outcome that meets our needs as well as listening to what the Americans are putting to us. There are some issues in relation to the arrangements as they apply to the marketing approvals for pharmaceuticals prior to the end of the patent terms. There are a couple of articles that they are talking about there. The UnitedStates are not asking us to replicate their legal system and their processes in relation to those things, but there are some issues concerning the marketing approvals in advance of the patent terms that are being talked about in that chapter.

Senator CONROY-Are they seeking a paragraph 4 style arrangement?

Mr Deady-They are not seeking the replication of their arrangements.

Senator CONROY-I did not say 'replication'; I said 'a similar thing'.

Mr Deady-Paragraph 4, as I understand it, is an automatic 30-month extension of patent terms. They are not seeking that.

Senator CONROY-And less than 30 months?

Mr Deady-All I will say is that we are talking to them. They are raising some issues in relation to the arrangements for approvals prior to the marketing of the drugs whilst they are still under patent but coming up to the patent ending. There are some issues there that they have raised with us that we are looking at and talking to them about but nothing as specific as the paragraph 4 you mentioned.

Senator CONROY-I understand from industry sources the US has also raised the possibility of extending the five-year data exclusivity for chemical entity, which would inhibit further growth of the generic drug market in Australia. Is that correct?

Mr Deady-All I can say is this falls into this basket of issues in relation to patents where the Americans are raising issues in relation to the way this treatment goes prior to the ending of the patents…