❓ Question regarding funding provided to the Fresh Start Recovery Program and the progress of their naltrexone implant registration with the TGA. The answer reveals funding amounts, their purpose, and that no application has been made to the TGA.
AnsweredQoN 4320Legislative Assembly
QuestionView source ↗
The Education and Health Standing Committee is currently undertaking an
Inquiry into the Adequacy and Appropriateness of Prevention and Treatment Services for Alcohol and Illicit Drug Problems in Western Australia
. As part of this inquiry, the Committee heard from Dr George O’Neil on 16 June 2010 about the progress of the Fresh Start Recovery Program in applying to the Therapeutic Goods Administration (TGA) for the full registration of its naltrexone implants. Can the Minister please confirm:
(a) all funds provided to the Fresh Start Recovery Program by the Western Australian Government between 2008–2009 and 2009–2010; and
(i) the purpose for which these funds were provided; and
(ii) any requirements placed on the Fresh Start Recovery Program in regard to the provision of these funds;
(b) the current stage of TGA’s assessment of the application from the Fresh Start Recovery Program for the full registration of its naltrexone implants; and
(i) what remains to be assessed by the TGA;
(ii) how much longer the approval process might take; and
(iii) whether there are any impediments to the TGA assessing the data provided by the Fresh Start Recovery Program?
Inquiry into the Adequacy and Appropriateness of Prevention and Treatment Services for Alcohol and Illicit Drug Problems in Western Australia
. As part of this inquiry, the Committee heard from Dr George O’Neil on 16 June 2010 about the progress of the Fresh Start Recovery Program in applying to the Therapeutic Goods Administration (TGA) for the full registration of its naltrexone implants. Can the Minister please confirm:
(a) all funds provided to the Fresh Start Recovery Program by the Western Australian Government between 2008–2009 and 2009–2010; and
(i) the purpose for which these funds were provided; and
(ii) any requirements placed on the Fresh Start Recovery Program in regard to the provision of these funds;
(b) the current stage of TGA’s assessment of the application from the Fresh Start Recovery Program for the full registration of its naltrexone implants; and
(i) what remains to be assessed by the TGA;
(ii) how much longer the approval process might take; and
(iii) whether there are any impediments to the TGA assessing the data provided by the Fresh Start Recovery Program?
AnswerView source ↗
Answered
31 January 2011
Responded by
Minister for Mental Health
Response time
76 days
(a)
2008/09 = $1,201,306 (GST exclusive)
2009/10 = $1,727,168 (GST exclusive)
(i) The funding to the Fresh Start Recovery Program (operated by Australian Medical Procedures Research Foundation (AMPRF)) is for assessment, counselling and patient support services.
(ii) With the majority of the funds the normal requirements of a Service Agreement apply, such as provision of the service in line with contracted outputs, and provision of regular financial and activity reports. The funds provided to the Fresh Start Recovery Program in the 2009/2010 year included $500,000 provided via a separate Grant Agreement, which was also conditional on agreement to proceed with three reviews:
1. Data and research review to assess and validate current data held by AMPRF and advise on the suitability and rigour of the data to support an application to the Therapeutic Goods Administration (TGA) for registration of the naltrexone implants.
2. Financial audit of AMPRF to assess the essential income and expenditure of the Fresh Start Recovery Program associated with the treatment of Western Australians with opiate and alcohol problems.
3. Clinical and service reviews of Fresh Start's treatment services to assess the quality of the services provided, and determine those aspects that are necessary to the work to achieve TGA registration.
(b) I have been advised that no application has yet been made to the TGA for the naltrexone implants to be evaluated for registration.
(i - iii) Not applicable
Notice: This document is created or edited using unregistered or evaluation copy of rtLib valid for testing or development purposes only. To use it for productive or any other purposes please register it. You may purchase the license on
http://www.rtlib.com
2008/09 = $1,201,306 (GST exclusive)
2009/10 = $1,727,168 (GST exclusive)
(i) The funding to the Fresh Start Recovery Program (operated by Australian Medical Procedures Research Foundation (AMPRF)) is for assessment, counselling and patient support services.
(ii) With the majority of the funds the normal requirements of a Service Agreement apply, such as provision of the service in line with contracted outputs, and provision of regular financial and activity reports. The funds provided to the Fresh Start Recovery Program in the 2009/2010 year included $500,000 provided via a separate Grant Agreement, which was also conditional on agreement to proceed with three reviews:
1. Data and research review to assess and validate current data held by AMPRF and advise on the suitability and rigour of the data to support an application to the Therapeutic Goods Administration (TGA) for registration of the naltrexone implants.
2. Financial audit of AMPRF to assess the essential income and expenditure of the Fresh Start Recovery Program associated with the treatment of Western Australians with opiate and alcohol problems.
3. Clinical and service reviews of Fresh Start's treatment services to assess the quality of the services provided, and determine those aspects that are necessary to the work to achieve TGA registration.
(b) I have been advised that no application has yet been made to the TGA for the naltrexone implants to be evaluated for registration.
(i - iii) Not applicable
Notice: This document is created or edited using unregistered or evaluation copy of rtLib valid for testing or development purposes only. To use it for productive or any other purposes please register it. You may purchase the license on
http://www.rtlib.com
Explore WA Government Data
Search the full archive in the free dashboard, or query programmatically via API.
Explore more
Government Gazette
Appointments, regulatory notices, planning changes.
Hansard
Debates, questions, speeches and sentiment.
Tabled Papers
Reports and documents tabled in Parliament.
Committees
Committee profiles and recent reports.
Regulations
Subsidiary legislation with filters and summaries.
Bills
Proposed laws and parliamentary progress.
Acts
Current WA legislation and summaries.
Explanatory Memoranda
Bills with EMs (text/PDF) available.
Members
MP profiles, party breakdown and rankings.
Pollie Rankings
Data-driven rankings across 19 categories.
Amendment Chains
Track how schemes and regulations evolve over time.