Access to Medicines Working Group (AMWG) - 2 December 2016

Page last updated: 15 March 2017

AMWG Meeting:

The second and final meeting of the AMWG for 2016 occurred on 2 December. The AMWG is scheduled to meet twice yearly with work to be progressed out of session by the respective subgroups. The co-Chairs will seek a meeting with the Minister for Health to brief on the progress of the AMWG in the first quarter of 2017.


Attendees included co-Chairs: Mr Andrew Stuart (Deputy Secretary of Department of Health) and Mr Wes Cook (Chairman of Medicines Australia); representatives from Medicines Australia and the Pharmaceutical Benefits Division of the Department of Health (the Department).


To reconvene and update the AMWG on progress against the three current work‑streams:

  1. Managed Access Program (formerly Managed Entry Scheme)
  2. Section 99ACB of the National Health Act 1953
  3. Transparency of PBS processes


Verbal reports to the AMWG on the progress and achievements to date were made.

Managed Access Program

Significant progress had been made towards the development of the MAP. The Department provided both the Draft Suitability Criteria and the Draft Work Plan to Medicines Australia, with feedback to be provided in early 2017.


There remain points of disagreement on the interpretation of section 99ACB of the National Health Act 1953. The co-chairs have agreed to meet in February 2017 to discuss further.


Medicines Australia and the Department noted the ongoing work of the Transparency sub-group to improve the efficiency of the PBAC process. Both parties also discussed the role and purpose of the Public Summary Documents, in the broader context of addressing consumer needs, including the work being undertaken by international regulators.

Other business:

Medicines Australia reiterated its desire for selection of comparators to be the next topic for discussion on the AMWG agenda, noting that AMWG had originally had four policy priorities, with work on Post-Market Reviews having been concluded. Both parties acknowledged that the introduction or cessation of policy topics for the AMWG will need to be endorsed by the Minister.


The AMWG is expected to reconvene in 2017, with dates to be confirmed and with the respective subgroups to progress work in the meantime.