Access to Medicines Working Group (AMWG) Communique –14 April 2016
Page last updated: 8 September 2016
The first meeting of the AMWG for 2016 occurred on 14 April. The AMWG is scheduled to meet twice yearly with work to be progressed out of session by the respective subgroup.
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 (DoH).
To reconvene and update the AMWG on progress against the three current work‑streams:
- Managed Access Programme (formerly Managed Entry Scheme)
- Section 99ACB of the National Health Act 1953
- Transparency of PBS processes
Verbal reports to the AMWG on the progress and achievements to date were made.
Managed Access Programme
Significant progress had been made on developing a framework for a Managed Access Programme (MAP). It was noted that a framework had been endorsed by the Pharmaceutical Benefits Advisory Committee (PBAC), with work underway to establish processes to support its implementation.
There remain fundamental points of disagreement on the interpretation of section 99ACB of the National Health Act 1953. Both parties have exchanged proposed frameworks, however at the time of the meeting there remain points of difference that may not be able to be resolved. Both parties agreed to progress with planned discussions to seek a pathway forward.
Medicines Australia and DoH noted that the subgroup was identifying and pursuing initiatives to support greater transparency of processes for the community, and greater efficiency for DoH and industry, including identifying efficiencies to free up capacity for more complex initiatives such as MAP.
Medicines Australia and DoH discussed the implementation of the policy for removing the originator from price disclosure calculations, part of the PBS Access and Sustainability package. Both parties acknowledged their desire to ensure the policy is administered in a manner that maintains supply of important medicines. Both parties discussed activities that may assist DoH and the industry in the lead up to the October 1 Price Disclosure reductions, such as additional education and information sharing.
Medicines Australia also reiterated its desire for selection of comparators to be the next topic for discussion on the AMWG agenda, when other work streams are completed.
The AMWG is expected to reconvene in around October 2016 with the respective subgroups to progress work in the meantime.