19 November 2015 Via email: matt@matthewtaylor.co.nz Dear Matt REQUEST FOR INFORMATION I am writing further to your request dated 23 September 2015 under the Official Information Act 1982 (OIA) for information relating to HPV and Hepatitis A vaccines. You also made a similar request to the Ministry of Health, which was transferred to us. This response addresses both requests. You asked for copies of any information held in relation to funding the HPV and Hepatitis A vaccines for males who have sex with males. 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). Please find the requested information attached. A number of documents included within the scope of your request are publicly available online (note that some of these are subject to copyright). Your request, to the extent it includes these documents, is therefore refused in reliance on section 18(d) of the OIA on the basis that they are publicly available. For your convenience, links to these documents are provided below. These are: 1. 2012 Antigen Review: Human Papillomavirus (http://www.immune.org.nz/sites/default/files/research_articles/Ebook%20HPV% 20v2.pdf) 2. PTAC Immunisation Subcommittee Minutes (March 2013) (http://www.pharmac.health.nz/assets/ptac-immunisation-subcommittee-minutes2013-03-06.pdf) 3. PTAC Minutes (August 2013) (http://www.pharmac.health.nz/assets/ptac-minutes-2013-08.pdf) 4. Gardasil Data Sheet (found online at Medsafe) (http://medsafe.govt.nz/profs/datasheet/g/Gardasilinj.pdf) 5. BMJ Research Document (http://www.bmj.com/content/339/bmj.b3884.long) A108045 qA37311 6. Public Summary Document PBAC (http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/201111/pbac-psd-quadrivalent-nov11) 7. The New England Journal of Medicine: “HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia” (http://www.nejm.org/doi/full/10.1056/NEJMoa1010971) 8. The New England Medical Journal article: “Impact of the Human Papillomavirus (HPV) Vaccine on Genital Wart Diagnoses at Auckland Sexual Health Services” (http://www.nzma.org.nz/journal/read-the-journal/all-issues/2010-2019/2011/vol124-no-1339/article-oliphant) 9. Economic Evaluation of Human Papillomavirus Vaccination in Developed Countries (http://www.ncbi.nlm.nih.gov/pubmed/19684446) 10. The New England Journal of Medicine: “Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Diseases in Males” (http://www.nejm.org/doi/full/10.1056/NEJMoa0909537?query=featured_home) Additionally, two documents were withheld entirely because we consider this is necessary to:     (under 9(2)(b)(ii)): ”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” (under 9(2)(ba)(i)): “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” (under section 9(2)(i)): “enable PHARMAC to carry out without prejudice or disadvantage, commercial activities” (under section 9(2)(j)): “enable PHARMAC to carry on, without prejudice or disadvantage, negotiations, including commercial negotiations” The documents withheld in full are: 1. CSL Biotherapies (NZ) Ltd: funding application to PHARMAC for Quadrivalent Human Papillomavirus (14 December 2012) 2. CSL Biotherapies (NZ) Ltd: synopsis funding application to PHARMAC for Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine (December 2012) Some portions of the documents we are releasing to you have also been withheld (these are clearly marked in black) and are withheld in reliance on the same sections set out above. You have asked specifically for the grounds in support of withholding under section 17(2)(b) of the OIA. I can advise as follows: A108045 qA37311   The information withheld includes pricing offers and other material relating to a commercial proposal that has been made to PHARMAC by a supplier. PHARMAC is only able to secure the best achievable pricing if suppliers can be assured, where applicable, that their pricing offers will remain confidential (in some cases confidentiality is maintained indefinitely even if a product is listed on the pharmaceutical schedule via a confidential rebate or other mechanism). Suppliers who offer confidential pricing to PHARMAC would suffer commercial prejudice if their pricing offers to PHARMAC were revealed to other buyers in the global pharmaceutical market. As the proposal remains open at the present time, public disclosure would prejudice the current commercial activities and negotiations of both parties. 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. In your request you referred to complaints made to the Human Rights Commission and the refusal to agree to mediation in relation to those complaints. For completeness I note that PHARMAC has had no involvement in any complaints to the Human Rights Commission relating to the funding of HPV or Hepatitis A for males who have sex with males, and we hold no information on any such complaints. 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 the provision of these documents answers your queries, if you have any further questions please feel free to contact us again. Yours sincerely Jude Urlich Director, Engagement and Implementation A108045 qA37311