Submission to the 2013 Review of Medicines and Poisons Scheduling Arrangements - CSL Behring Australia

The submission period for this review commenced on 2 April 2013.

Page last updated: 14 May 2013

Summary

Thank you for the opportunity to input to the current scheduling review.

CSL Behring has had limited experience in recent years with the scheduling process, however I would like to make the following comments;
  1. In general the changes have been positive, with greater transparency and clarity around roles and responsibilities, and decision making.
  2. We support the introduction of a mechanism for review of Scheduling decisions.

The background document reports that introducing a mechanism for reconsideration or appeal of decisions, may delay access to new drugs. However, it is generally understood that the scheduling of a new chemical entity will give rise less often to the need for appeal than other activities such as Switching or changes to the Poisons Standard Appendices etc. As with product registration, scheduling activities impact patient access, and it is felt that an opportunity for of review of these decisions is also appropriate.