Time: 16:15

Nine submissions done and two due by month end…

Industry advocacy at AusBiotech is in ‘top gear’ with nine submissions completed on behalf of members in the past 12 weeks and two due by the end of the month.

AusBiotech’s appearance today at the Senate Inquiry hearing into the ‘Price regulation associated with the Prostheses List Framework’ joins numerous submissions made over the past few months, on issues ranging from regulation of medical technologies to intellectual property provisions for pharmaceuticals and gene technology.

AusBiotech is currently inviting members’ comments on the TGA’s consultation paper regarding changes to accessing unapproved therapeutic goods and the Senate Inquiry into funding for research for cancers with low survival rates.

Unapproved therapeutic goods

The call for comment from the TGA is amongst a raft of consultations stemming from the recommendations of the Medicines and Medical Devices Review (MMDR). Comments are sought on changes proposed to the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme. The proposed changes would introduce a notification system for access to certain unapproved therapeutic goods for patients with non-life threatening conditions. Under the proposal, the existing SAS A notification and SAS B application access pathways would remain in place.

The MMDR Review also recommended improving the TGA processes for unapproved therapeutic goods by establishing an integrated, online system to manage notifications, approvals and reporting requirements.  The TGA is seeking general feedback about the idea of moving to an online system, but targeted consultation with regular users of the current paper-based system will occur once the design of the system is further developed.

The closing date for submissions is 29 March 2017 and more information is available online.

Funding for Research into Cancers with Low Survival Rates

The Senate has established a Select Committee into Funding for Research into Cancers with Low Survival Rates to inquire and report on the impact of health research funding models on the availability of funding for research into cancers with low survival rates.

The Inquiry will looks at the impact of health research funding models on the availability of funding for research into cancers with low survival rates. The terms of reference include:

  • The current National Health and Medical Research Council funding model, which favours funding for types of cancer that attract more non-government funding, and the need to ensure the funding model enables the provision of funding research into brain cancers and other low survival rate cancers; and
  • The obstacles to running clinical trials for brain cancers and other cancers with relatively lower rates of incidence, with regard to funding models that could better support much-needed clinical trials and funding support for campaigns designed to raise awareness of the need for further research.

The closing date for submissions is 31 March 2017 and more information is available online.

All submissions to Government can be found at the AusBiotech website.

Members wishing to contribute comment in regard to the above-named consultations, should contact AusBiotech’s Deputy CEO, Lorraine Chiroiu (lchiroiu@ausbioetch.org / 03 9828 1400).