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Greens may delay new TGA pathway
Posted 5 February 2018
Objections by the Greens to proposed changes to complementary medicine rules could slow down the provisional approval pathway for promising new medicines contained in the same bill - if it gets support from Labor and crossbenchers for amendments to the legislation.
The legislation is due to be debated in the Senate today and a Greens spokesperson told Pharma in Focus the party would be seeking to amend the bill and remove the measures to deregulate complementary medicine advertising and claims without testing for effectiveness.
The spokesperson called on Labor and the crossbench to join the Greens in supporting their amendments.
The Community Affairs Legislation Committee prepared a report over the summer on the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 [Provisions] and the Therapeutic Goods (Charges) Amendment Bill 2017, prior to them going before the Senate today. That report was tabled on Friday.
The first bill contains nine different schedules, each dealing with a different reform element ranging from the fast tracking of pharmaceuticals through to more contentious issues such as the deregulation of advertising of complementary medicine, complementary industry self-regulation and much more.
The Greens spokesperson said the party supported significant elements of the bill "including the fast track registration for pharmaceuticals".
However, he said, "the Liberal government has packaged up these much needed changes to our pharmaceutical system with other potentially harmful measures that would deregulate the advertisement and claims of complementary medicines that have not been tested for effectiveness".
It was unclear whether Labor would support the Greens move though Labor Senators on the committee had added a number of additional footnote comments on matters which they believed "should receive further consideration by the government and parliament".
These included the advertising and complaints-handling reforms, the permitted indications list and consumer protections for complementaries.
The Greens three-page "dissenting report" in the same document noted many submitters considered consultation had "not been adequately represented in the drafting of the bill" while also calling for elements of the legislation to be amended.
The committee's 48-page report noted there were few dissenting voices on the provisional approval pathway for promising new medicines as "much of the evidence provided to this committee expressed support" and called for bill to be passed.
Until this point the pathway had theoretically been on track for implementation in the second half of this year - though some industry observers considered the timeline overly optimistic. An amendment process would likely put that timing in doubt.
David Rowley
Posted 5 February 2018
Objections by the Greens to proposed changes to complementary medicine rules could slow down the provisional approval pathway for promising new medicines contained in the same bill - if it gets support from Labor and crossbenchers for amendments to the legislation.
The legislation is due to be debated in the Senate today and a Greens spokesperson told Pharma in Focus the party would be seeking to amend the bill and remove the measures to deregulate complementary medicine advertising and claims without testing for effectiveness.
The spokesperson called on Labor and the crossbench to join the Greens in supporting their amendments.
The Community Affairs Legislation Committee prepared a report over the summer on the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 [Provisions] and the Therapeutic Goods (Charges) Amendment Bill 2017, prior to them going before the Senate today. That report was tabled on Friday.
The first bill contains nine different schedules, each dealing with a different reform element ranging from the fast tracking of pharmaceuticals through to more contentious issues such as the deregulation of advertising of complementary medicine, complementary industry self-regulation and much more.
The Greens spokesperson said the party supported significant elements of the bill "including the fast track registration for pharmaceuticals".
However, he said, "the Liberal government has packaged up these much needed changes to our pharmaceutical system with other potentially harmful measures that would deregulate the advertisement and claims of complementary medicines that have not been tested for effectiveness".
It was unclear whether Labor would support the Greens move though Labor Senators on the committee had added a number of additional footnote comments on matters which they believed "should receive further consideration by the government and parliament".
These included the advertising and complaints-handling reforms, the permitted indications list and consumer protections for complementaries.
The Greens three-page "dissenting report" in the same document noted many submitters considered consultation had "not been adequately represented in the drafting of the bill" while also calling for elements of the legislation to be amended.
The committee's 48-page report noted there were few dissenting voices on the provisional approval pathway for promising new medicines as "much of the evidence provided to this committee expressed support" and called for bill to be passed.
Until this point the pathway had theoretically been on track for implementation in the second half of this year - though some industry observers considered the timeline overly optimistic. An amendment process would likely put that timing in doubt.
David Rowley
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