DoHA opened the meeting and confirmed attendance and apologies.
|Department of Health and Ageing (DoHA)||Medicines Australia (MA)||Apologies|
|David Learmonth||Brendan Shaw||Adriana Platona|
|Felicity McNeill||Andrew Bruce||Paul Creech|
|Tracey Duffy||Mendel Grobler||Jim Crompton|
|Nick Henderson||David Grainger||Ian Noble|
|Sharon Wadey||Amish Chaturvedi|
Minutes from the 25 August 2011 were accepted.
|DoHA / MA||Comparator formulary data
DoHA tabled a paper on comparator formulary data from the 2011 PBAC meetings (March and July).
Noted that November data is not yet publicly available. The number of applications where the comparator is an F2 drug is very small. The vast majority of submissions chose, and PBAC accepted, an F1 comparator.
MA to provide qualitative analysis and identify any gaps prior to next AMWG meeting (proposed for July 2012).
|DoHA / MA||Parallel processing
DoHA to revise guidelines via the PBAC Guidelines Working Group (PGWG) – last meeting was Oct 2010. MA requested this to be revised for currency to include parallel processing and managed entry scheme.
DoHA to revise PBAC guidelines via the PGWG to include parallel processing and managed entry scheme.
|MA’s HEWG/ DUSC||Transparency
DoHA and MA to develop a template for reporting – predicted versus actuals.
DoHA to provide feedback on framework to MA.
|MA||Joint Medicines Policy Conference (JMPC)
MA to provide outcomes from the Joint Medicines Policy Conference to the AMWG.
MA to upload outcomes from the August 2011 JMPC meeting on its website.
MA to develop paper on current activities that could progress issues raised at the JMPC, including identifying gaps and recommendations on how to address these gaps, for consideration at next AMWG meeting (proposed for July 2012).
Note: all parties have resourcing limitations so focus is on priority areas and what is already covered by existing work.
|DoHA / MA||Data Working Group (DWG) report
The DWG has almost completed drafting of the second PBS expenditure and growth monitoring report. Progress on this report has been slower than anticipated due to heavy workloads and resource constraints. This second report builds on the first report tabled to AMWG in August 2011.
DoHA to seek Ministerial approval to table report at next Pharmaceutical Industry Working Group (PIWG) meeting.
MA to respond to letter from DoHA outlining source of unpublished PBS data reported in Medicines Australia's 2012 Factbook.
MA to correct referencing on its website in relation to “unpublished PBS data from the Department of Health and Ageing”.
DoHA and MA to discuss the work of the Horizon Scanning Working Group on: a) the direction and structure of the paper; b) any particular case studies for the next report; and c) any suggestions of other ways of looking at the data.
DoHA requested the 3 – 5 year projection to continue. In relation to longer term horizon scanning, DoHA suggested a focus on areas such as fiscal impacts or where current policy or systems could create methodological challenges.
MA to provide list of potential areas of horizon scanning for the long term at next AMWG meeting (proposed for July 2012).
|DoHA||Post-PBAC listing timeframes (clause 28 and 29 of the MoU)
DoHA and MA to update the PBS listing timeframes, noting they are currently being met.
(Paper was provided at May 2011 AMWG meeting).
|DoHA / MA||AMWG Annual Report
The Annual Report has been drafted collaboratively and is being progressed to the Minister for tabling.
The AMWG report is one of four reports required to be tabled in Parliament.
DoHA to provide final changes to MA shortly, before provision to the Minister for publication and tabling, if agreed.
- Frequency of AMWG meetings and subgroup meetings is to be reduced in 2012. The focus will be on progressing reports and commitments under the MoU.
- Noted DoHA preference for policy work to be progressed out of session where possible, and linked to priority areas of existing work.
- MA to host and provide the secretariat role for next meeting.
- Proposed meeting for 24 July 2012 will remain until further notice.
To be removed for next meeting (proposed for 24 July 2012)
DoHA and MA to provide update on MoU implementation at the next meeting, including EAPD.
Noted letter from DoHA to MA acknowledging support and outcomes of EAPD.
Noted some administrative burden by industry and DoHA in establishment of EAPD systems.
Noted legislative amendments scheduled for 1 October 2012.
|M12||DoHA||Post market surveillance
Post market surveillance – the Department to provide regular updates to the AMWG in relation to the implementation of this measure.
Noted statins and anticoagulant reviews underway.
Noted NPS Medicare Insight program.
|M13||DoHA||AMWG action item list
The AMWG Secretariat to prioritise the production and distribution of AMWG meeting action items.