Cannabidiol with tetrahydrocannabinol (Sativex) clinical advice paper for PTAC

21 December 2020 

Dear [name and contact details withheld]

REQUEST FOR INFORMATION

Thank you for your request dated 23 November 2020 under the Official Information Act 1982 (OIA) for information relating to Sativex.

Following our OIA response issued 20 November 2020, you requested a copy of the clinical advice paper for cannabidiol with tetrahydrocannabinol (Sativex) for Multiple Sclerosis (MS) spasticity, epilepsy, and pain, including pain associated with spasticity which was prepared for review by the Pharmacology and Therapeutics Advisory Committee (PTAC) at their August 2015 meeting.

Please find the Sativex paper, including appendices, attached with this response.

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 a small amount of information from the documents as we consider this is necessary to protect the privacy of natural persons (section 9(2)(a)) and/or;

• protect information where the making available of the information would be likely to unreasonably prejudice the commercial position of the person who supplied or who is the subject of the information (section 9(2)(b)(ii)); and/or
• protect information which is subject to an obligation of confidence 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))

Additionally, we have withheld copies of abstracts and/or research papers included in the appendices of the Sativex paper as these may be subject to Copyright laws and on the grounds that the information requested is already publicly available (section 18(d) of the OIA) from the publisher or information providers. Details of the papers referenced can be found within the document provided with this response.

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.

Yours sincerely

Rachel Read 
Manager, Policy and Government Services