Louise O'Reilly (Dublin Fingal, Sinn Fein)
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962. To ask the Minister for Health the status of the ongoing demonstration project on pre-exposure prophylaxis; the stage in this project the HSE is currently at; if PrEP should be found feasible for HSE availability, if funding will be available to facilitate access to this drug, should that be found feasible; and if he will make a statement on the matter. [35887/17]

Catherine Byrne (Dublin South Central, Fine Gael)
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One of the priority actions identified under the Sexual Health Strategy 2015-2020 was to 'prioritise, develop and implement guidance to support clinical decision making for STI testing, screening and treatment and on the appropriate use of antiretroviral therapy in HIV prevention’.

As part of this action, a multisectoral PrEP (HIV pre-exposure prophylaxis) working group, with a wide range of professional and community representation, was established by the HSE Sexual Health and Crisis Pregnancy Programme in 2016. The terms of reference of this multisectoral group includes the development of clinical guidance documents and recommendations in relation to the use of HIV PrEP in Ireland.

A report on population estimates of MSM (men who have sex with men) eligible and likely to avail of PrEP in Ireland, using data from the Men who have Sex with Men Internet Survey Ireland (MISI) 2015 survey, was developed in collaboration with the Health Protection Surveillance Centre (HPSC).

The working group is exploring questions in relation to the feasibility, acceptability and uptake of HIV PrEP in Ireland and work has commenced on identifying how these priority questions can be answered through a project within existing clinical infrastructures.

In addition, the working group had explored the possibility of running a ‘demonstration project’ in Ireland with the support of a manufacturer of a relevant authorised product, however, I understand that the demonstration project is not being pursued at this juncture as the window of opportunity has now closed.

The working group has also progressed work on the development of standards for PrEP service provision and other issues relevant to any future ‘model of care’ and implementation of a PrEP clinical service within a HIV prevention programme to people who would meet determined eligibility criteria and in services meeting agreed standards.

A pharmaceutical manufacturer has submitted a rapid review dossier to the HSE and a rapid review has been formally commissioned from the NCPE (National Centre for Pharmacoeconomics). This is in line with the standard process under the Health (Pricing and Supply of Medical Goods) Act 2013. Given the likely scale of investment that would be required to support the introduction of PrEP, it may also require a full Health Technology Assessment. The timeline to complete this process would be in the order of at least 6 to 12 months.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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963. To ask the Minister for Health his views on the ongoing injunction action (details supplied) regarding the availability of generic pre-exposure prophylaxis; if such an action will have an effect on the potential availability of PrEP with the HSE; and if he will make a statement on the matter. [35888/17]

Catherine Byrne (Dublin South Central, Fine Gael)
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As the Deputy will appreciate, I cannot comment on matters that are before the courts.