The Access to Medicines Working Group (AMWG) met for a fifth time on 13 August 2008.
Since its last meeting in April, the AMWG has completed and submitted to the Government its Interim Report, which is currently under consideration. The AMWG considers that as a consequence of completing the Interim Report it is now opportune to undertake a new round of stakeholder consultations. Meetings will therefore be arranged in the coming weeks between stakeholders and the co-chairs.
The AMWG continues to work closely with the Therapeutic Goods Administration (TGA) and the Pharmaceutical Benefits Advisory Committee (PBAC) on the capacity to further streamline and coordinate processes to reduce the time it takes to list new medicines on the PBS. The TGA has set in train a series of initiatives that will lead to the registration process being more efficient while maintaining regulatory rigour. The AMWG agreed to hold a workshop with key internal stakeholders to further explore efficiencies in the time following a PBAC recommendation to listing a medicine on the PBS.
The AMWG noted that the process agreed between Medicines Australia and the Department to improve the capacity for individuals and other stakeholders to provide input to the PBAC would be implemented through the public release of the agenda for each regular PBAC meeting. This will be in place later in 2008, prior to the November PBAC meeting, subject to some discussion on final details.
The AMWG also noted that the Department will be directing some effort toward expanding the use of post market data and that Medicines Australia would be undertaking some background work on understanding innovation in the drug development process.
Department of Health and Ageing