Compassionate supply response
11 December 2019
24 October 2019
[name and contact details redacted]
Dear [name redacted]
REQUEST FOR INFORMATION
Thank you for your request dated 3 September 2019 under the Official Information Act 1982 (OIA) for information relating to communications with Sanofi around compassionate supply.
You asked for:
Any and all communication regarding compassionate supply, between Pharmac and anyone representing the pharmaceutical company Sanofi, during 2018 and 2019.
The only communications we identified to be in scope of your request was communications between PHARMAC and Sanofi related to a funding application for Myozyme for Pompe Disease.
In my letter to you on 27 September 2019, I advised you that we needed to consult before providing the information. PHARMAC has now consulted with Sanofi. We did this to clarify with Sanofi what information in their Myozyme funding application we could release, as this information is commercially sensitive.
Based on Sanofi’s feedback, we have determined that releasing the whole funding application would likely prejudice Sanofi’s commercial position. However, we have provided you the extract below from the application:
“Of the 9 current LOPD patients, 4 are receiving free of charge compassionate supply MYOZYME from Sanofi Genzyme and 3 patients are receiving treatment as part of a clinical trial.”
We have also provided you a letter from PHARMAC to Sanofi dated 31 January 2019 in respect of the application [PDF, 437 KB]. The content of this letter is largely publicly available as part of the clinical advice record for the Rare Disorders Subcommittee of PTAC.
Please note that PHARMAC approaches its assessment of requests for information under the OIA on the basis that, once released, the information becomes publicly available - in other words 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 redacted information from the documentation, as it is either out of scope, or because 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));
- enable PHARMAC to carry on, without prejudice or disadvantage, negotiations, including commercial negotiations (section 9(2)(j)); and
- 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.
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 trust that this information answers your queries. We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.
Director, Engagement and Implementation
Last updated: 11 December 2019