Joe Ludwig (Queensland, Australian Labor Party, Minister for Agriculture, Fisheries and Forestry) Share this | Hansard source

The Minister for Health has provided the following answer to the honourable senator's question:

(1) This was previously responded to at the Senate Estimates Hearing on 20 October 2011. Available at the following link:

http://www.aph.gov.au/Parliamentary_Business/Committees/Senate_Committees?url=@Hansard/s391.pdf

(2) No.

(3) As per standard practice for all externally released documents, the National Health and Medical Research Council (NHMRC) informed the Minister of its intention to publish the Literature Review of Naltrexone Implants on the NHMRC website.

(4) No.

(5) (a) The objective of the literature review was to assess the evidence relating to the use of naltrexone implants for opioid dependence in clinical practice. As such expertise was sought in the areas of clinical practice, evidence based medicine, addiction, pain management and pharmacological regulation.

  (b) The Joint NHMRC/AVCC Statement and Guidelines on Research Practice (1997) was rescinded in 2007 and replaced with the Australian Code for the Responsible Conduct of Research (2007) which is explicitly applicable to research, not the development of health care advice, such as literature reviews by officials.

(6) The Chief Executive Officer of NHMRC authorised the placement of the literature review under the main Guidelines tab. It is current practice that all NHMRC publications are listed under the main Guidelines tab on NHMRC Home Page which, when accessed, provides a very clear explanation that the material on the website includes publications as well as guidelines.

(7) (a) This question has already been answered. Please refer to a previous response provided by the then Minister for Health and Ageing, the Hon Nicola Roxon MP, Senate Question Number S11000910 published on 19 September, 2011.

  (b) NHMRC advises that the 'Naltrexone implant treatment for opioid dependence–Literature Review' (Literature Review) was drafted by staff of the Office of NHMRC. The Executive Director representing this work is Professor John McCallum.

  (c) The NHMRC is an independent, expert scientific body which is well placed to advise government and the community on health issues.

(8) During the budget estimates hearing of the Community Affairs Committee on 22 October 2008, Ms Halton informed the committee that the Therapeutic Goods Administration (TGA) and Dr O'Neil had engaged in a 'very long conversation about the need to ensure that, if he is manufacturing, he meets good manufacturing practice.'

On 4 May 2011, the TGA imposed conditions on the manufacturing licence for Dr O'Neil's company 'Go Medical' which prevent further manufacturing at his Selby Street site as a result of safety and quality concerns.

(9) The objective of the literature review was to assess the evidence relating to the use of naltrexone implants for opioid dependence in clinical practice. As such, expertise was sought in the areas of clinical practice, evidence based medicine, addiction, pain management and pharmacological regulation.

(10) (a) No. For your information, please refer to a previous answer provided by the then Minister for Health and Ageing, the Hon Nicola Roxon MP, to Parliamentary Question on Notice R09000613 published on 12 May 2009."

  (b) No.

  (c) Yes.

(11) The NHMRC is an independent, expert scientific body which is well placed to advise government and the community on health issues.

(12) Yes.

(13) No. The NHMRC is an independent, expert scientific body which is well placed to advise government and the community on health issues.

(14) The Minister has confidence in NHMRC as an independent, expert scientific body which is well placed to advise government and the community on health issues.