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Thursday, 25 August 2011
Page: 5642

Naltrexone

(Question No. 835)


Senator Ludlam asked the Minister representing the Minister for Health and Ageing, upon notice, on 13 July 2011:

In regard to the ‘Naltrexone implant treatment for opioid dependence-Literature Review’ on the National Health and Medical Research Council (NHMRC) website:

(1) Apart from the reference group, can the writers and advisers of this report be named.

(2) Who were the independent peer reviewers who were consulted before the report was published, and what was the review process.

(3) Is there an opportunity for other professionals in the field to critique and review this document:

(a) if so, what is the process and could professionals (international or Australian) in the current naltrexone medicine field be asked to review the document; and

(b) if not, why not.

(4) Why is there a gap between the end of the literature review period in July 2009 and the publication of this report in March 2011 and why has there not been an inclusion or review of any publications within this time period.

(5) Will this review prevent current implant treatment in Australia under the special access scheme.

(6) Given the current practice of treating patients under the special access scheme, managed by the Therapeutic Goods Administration under the Therapeutic Goods Act 1989, is the NHMRC operating outside its jurisdiction by making recommendations counter to current practice and approval by the TGA.


Senator Ludwig: The Minister for Health and Ageing has provided the following answer to the honourable senator’s question:

(1) NHMRC advises that the ‘Naltrexone implant treatment for opioid dependence-Literature Review’ (Literature Review) was drafted by staff within the office of NHMRC. NHMRC would prefer not to disclose the name of the author(s) of the Literature Review or the five peer reviewers who provided feedback on the document during its development. The Group Head overseeing this work is Professor John McCallum.

The NHMRC respects the privacy of the experts that agreed to participate in the peer review process and the author and NHMRC would need to liaise with them to seek their permission.

The Council of NHMRC also provided advice in relation to the Literature Review. The Council includes the chief medical and health officers of each state and territory as well as the chairs of NHMRC’s Principal Committees. The full membership can be found on the NHMRC website.

(2) The NHMRC Reference Group suggested suitable peer reviewers to provide the NHMRC with feedback on the draft Literature Review.

Fifteen independent peer reviewers were invited to participate in the peer review process. Seven of those invited agreed to participate and were sent a copy of the draft document to consider, however only five submitted comments to NHMRC.

The peer reviewers provided extensive comments which were taken into account before finalising the document through the Council of NHMRC.

NHMRC respects the privacy of the experts that agreed to participate in the peer review process. The NHMRC would need to liaise with these peer reviewers and seek their permission.

(3) As NHMRC has released the Literature Review, no further consultation on the document is scheduled. However, to ensure that members of the public have access to information that is based on the most recent scientific evidence, NHMRC can review the document should new evidence be published in a reputable peer reviewed journal in relation to naltrexone implants.

The office of NHMRC maintains a watching brief on a range of issues and will search the literature periodically to determine whether new literature relating to this issue surfaces. The public is welcome to write to NHMRC to bring their attention to any literature. Generally, significant new evidence would be required for NHMRC to update documents such as literature reviews.

(4) The initial search of the literature was conducted in June 2009. Subsequent to this search, NHMRC became aware of two additional papers that were in the process of being published. NHMRC agreed to include both papers in the review. Therefore, the Literature Review includes literature published up to October 2009.

After assessing the literature, the office of NHMRC developed the first draft of the Literature Review. NHMRC convened an Expert Reference Group (Group) to discuss the draft Literature Review in February 2010.

Following the meeting of the Group, the office of the NHMRC undertook various actions to ensure the quality of the final product.

The Council of NHMRC, with its membership comprising chief medical and health officers of each state and territory as well as the chairs of NHMRC’s

Principal Committees, considered the draft Literature Review and advised of its release. The Minister for Health and Ageing, the Hon Nicola Roxon MP, and the Minister for Mental Health and Ageing, the Hon Mark Butler MP, were advised of the imminent publishing of the Literature Review via NHMRC’s website. On receipt of their acknowledgment, the Literature Review was placed on the website. This occurred on 30 May 2011.

(5) No. Naltrexone implants are not registered (approved) therapeutic goods. Sections 18 and 19 of the Therapeutic Goods Act 1989 set out the circumstances in which medicines that are not approved for use in Australia can be imported and supplied.

NHMRC’s Literature Review has no bearing on the way in which naltrexone implants are currently regulated via the Therapeutic Goods Administration’s regulatory framework.

(6) No. In publishing the Literature Review, NHMRC is translating the evidence into advice for the Australian community. NHMRC’s Literature Review has no bearing on the way in which naltrexone implants are currently regulated via the Therapeutic Goods Administration’s regulatory framework.