Labor Senators agree that many of the reforms in this legislation – such
as the provisional approval pathway for promising new medicines – are positive
and should be implemented.
Labor Senators, however, share several concerns about the legislation
which were raised in submissions.
Advertising and complaints handling reforms
Labor Senators believe that a higher level of caution is warranted
regarding the removal of the pre-approval system for advertisements.
It is not yet clear if the improved post-market surveillance, stronger
penalties for regulatory violations and new complaints handling system will be
sufficient to render the pre-approvals system unnecessary.
Permitted indications list
Labor Senators note the divergent views of stakeholders in relation to
the permitted indications list for complementary medicines.
The reforms, including removal of the use of 'free text' indications, on
balance, appear to strengthen consumer protections. There were many stakeholders
who nonetheless felt the reforms should go further.
Further concerns were raised that the TGA Bill is inconsistent with
Australian Consumer Law and needs to be changed to provide for meaningful
consumer remedies, in particular scope for class action by consumers who have
Labor Senators believe these matters should receive further
consideration by the Government and Parliament.
Senator Murray Watt
Hon Lisa Singh
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