Information about the decision to fund molnupiravir for COVID-19
15 December 2021
Dear [name and contact details withheld]
Request for information
Thank you for your request dated 12 October 2021 under the Official Information Act 1982 (OIA) for information relating to molnupiravir. You requested:
In regards to Molnupiravir…:
- All written communication between Pharmac and Merck
- All trial and study information Pharmac used to inform your decision to fund the drug
- All written communication with any people who have extensively studied the active ingredient in EIDD-2801 and believe it could be mutagenic
In our letter to you of 8 November 2021, we noted that we needed more time to consult about the release of communications and information related to questions 1 and 2 of your request. As such, we extended the time limit for your request to 8 December 2021.
On 8 December 2021, we wrote to advise that we would release the documents we hold to you but that we needed more time to finalise the documents for release.
We have now finished preparing the documents requested for release and I have included these documents with this response.
All written communication between Pharmac and Merck
Please find a copy of documents related to your request attached with this response.
Please note, to ensure we get this information to you as soon as possible, we have not released the names of some individuals from non-Pharmac parties as this would require further consultation to make a decision on release. If you do wish to request these names (and it is our assumption that you do not require these) please let us know.
All trial and study information Pharmac used to inform your decision to fund the drug
Please find a copy of documents related to, and to the date of, your request attached with this response.
As noted in our correspondence of 8 November 2021, we have not yet decided to fund molnupiravir. We have entered into an advanced purchase agreement with the supplier of molnupiravir however, our agreement is subject to molnupiravir being approved by Medsafe for use in New Zealand. This means molnupiravir will not be made available for treating mild to moderate COVID-19 symptoms until it has gained regulatory approval from Medsafe.
Documents to be released under the OIA
Please note, we approach our assessment of requests for information under the OIA on the basis that once we release the information to you it becomes available to any other party in that exact form (whether by you distributing it to others or by virtue of us receiving the same request from a different third party).
We have provided a list at the end of this letter (Appendix 1) of the publicly available clinical abstract and news articles provided to Pharmac. We have not released copies of these documents as they are already publicly available (section 18(d) of the OIA) and may be subject to copyright restrictions.
Additionally, we have redacted a small amount of information from the documents provided, or withheld documents from release, where we consider this is necessary to:
- protect the privacy of natural persons (section 9(2)(a));
- protect information where the making available of the information would be likely unreasonably to prejudice the commercial position of the person who supplied or who is the subject of the information (section 9(2)(b)(ii)); or
- protect information which is subject to an obligation of confidence or which any person has been or could be compelled to provide under the authority of any enactment, where the making available of the information would be likely to prejudice the supply of similar information, or information from the same source, and it is in the public interest that such information should continue to be supplied (section 9(2)(ba)(i).
As required under the OIA, we also considered whether, in the circumstances, the withholding of this information was outweighed by other considerations which render it desirable, in the public interest, to make this information available. In this case we did not consider that the public interest outweighed the reasons for withholding the information.
All written communication with any people who have extensively studied the active ingredient in EIDD-2801 and believe it could be mutagenic
As noted in our correspondence of 8 November 2021, we have not had any communications with any people who have extensively studied the active ingredient in EIDD-2801 and believe it could be mutagenic. Therefore, we have refused this portion of your request on the basis that the information requested is not held by Pharmac (section 18(g) of the OIA) and we have no reason to believe the information is held by, or more closely connected with the functions of, another agency.
Please note you have the right, by way of complaint under section 28(3) of the OIA to an Ombudsman, to seek an investigation and review of our decision.
We are making our information more freely available, so we now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.
Yours sincerely
Rachel Read
Manager, Policy and Government Services
Appendix 1
Armstrong, C. (2021, October 4). A treatment for Covid to be taken in a pill form will be coming to Australia. The Daily Telegraph.
Arribas, J. B. (2021). 04748 A Randomized, Controlled Phase 2 Trial of Molnupiravir for Treatment of COVID-19 in Hospitalized Adults (MOVe-IN). 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Vienna, Austria.
Burke, H. (2021, October 4). Brand new oral Covid-19 treatment bound for Australian shores. Herald Sun.
Curtis, K. (2021, October 4). Australia buys COVID treatment pills ahead of approval for new medicine. The Sydney Morning Herald.