AMWG Interim Report to Government - Attachment E

Page last updated: 18 November 2008

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Future Work of the Access to Medicines Working Group

The Access to Medicines Working Group has highlighted the following areas in which the future work of the group may be directed, once the projects currently underway are complete.

Whilst subjects listed below are areas where work may be carried out, the group has given priority to streamlining the registration of new medicines and managing uncertainty in PBAC submissions. These projects will continue to be the focus of the group’s endeavours in the immediate future.

Two identified areas of future work are:

Understanding the Pharmaceutical Benefits Advisory Committee decision making process

Notwithstanding the extensively documented processes and criteria described in a set of guidelines issued by the PBAC, sponsors advise that the factors influencing decision making in the medicines evaluation process are not always well understood.

This work will therefore examine how to achieve a better understanding to assist companies preparing submissions, and potentially reduce the number of resubmissions required. Better prepared submissions are also less burdensome on the PBAC and facilitate more informed decision making.

Understanding innovation in the drug development process

Innovation is considered to be essential to the business of the pharmaceutical industry.

This work would be to develop a shared understanding of the nature and dimensions of innovation that underpin the drug development process. This would include examining how the PBS listing process shapes incentives towards innovation.