AMWG Interim Report to Government - Attachment F

PDF printable version of Access to Medicines Working Group – Terms of Reference - (PDF 19 KB)

Access to Medicines Working Group – Terms of Reference

1. Providing strategic oversight of joint activities undertaken by the Department and Medicines Australia to enhance the Pharmaceutical Benefits Scheme (PBS) processes; and
2. As a result of reforms to the PBS announced in 2006, considering issues relating to timely and appropriate access to effective new medicines on the PBS, including:

• the capacity to further streamline and coordinate processes to reduce the time it takes to list a medicine on the PBS;
• possible impacts on the listing process of mandatory price reductions from 1 August 2008 for medicines on the new F2 formulary;
• the potential for improving clinical trial, economic and financial data to inform Pharmaceutical Benefits Advisory Committee (PBAC) and Pharmaceutical Benefits Pricing Authority (PBPA) decision making processes;
• in collaboration with the PBAC, developing and articulating a set of principles for assessing evidence and information relating to new medicines and for improving the transparency of the decision making process;
• the practical limitations to the evidence available to the PBAC to facilitate decision making around access to new medicines and the development of options to manage uncertainty in such situations;
• opportunities for informing and learning from the broader international debate about evidentiary requirements and trends in drug development to support the economic evaluation of new medicines.