The Access to Medicines Working Group (AMWG) met for a fourth time on 18 April 2008.
Since its last meeting in December, the AMWG has fruitfully advanced a number of key areas under its terms of reference. Among these are the possible impacts on the listing process of statutory price reductions for medicines on the F2 formulary, and managing uncertainty of evidence provided to the Pharmaceutical Benefits Advisory Committee (PBAC). Work on these issues is progressing well, and papers exploring these areas are well advanced.
The AMWG continues to work closely with the Therapeutic Goods Administration (TGA) and the PBAC on the capacity to further streamline and coordinate processes to reduce the time it takes to list new medicines on the PBS. In considering this term of reference, the AMWG has consulted with the TGA and has learned about separate processes being undertaken to make the registration process more efficient while maintaining regulatory rigour. The AMWG is working cooperatively with the TGA on these issues, and a working group consisting of the AMWG, the TGA and PBAC will be convened in the near future to discuss them further.
The AMWG also noted that Medicines Australia and the Department have agreed on a process to publicly release the agenda for each regular PBAC meeting, subject to some discussion on final details.
The AMWG is continuing to prepare an interim report on these issues for the Government, which is due by 30 June 2008.
Department of Health and Ageing