Fergus O'Dowd (Louth, Fine Gael)
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201. To ask the Minister for Health his views on a request from the Irish Pharmacy Union (details supplied); and if he will make a statement on the matter. [36248/14]

Kathleen Lynch (Cork North Central, Labour)
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The Health Products Regulatory Authority (HPRA), is the competent authority for the regulation of medicines in Ireland. The HPRA is responsible for determining the method of sale and supply of a medicine and also determining whether it should be available on prescription, or not.

The HPRA is committed to the current Irish health care policy which aims, where appropriate, to provide patients with increased access to safe medicines, at the lowest level of complexity and cost. In July 2014, the HPRA published a list of 12 active substances contained in medicines currently classified as prescription-only medicines (POM), which could be safely reclassified to be available for sale “over the counter” (OTC) in pharmacies. This list includes products for the treatment of migraine, acid-reflux symptoms, hay fever, cold sores, muscle pain and inflammation, fungal skin and nail infections and other inflammatory skin conditions.

This was a significant development. It represented the outcome of measures which have been undertaken by the HPRA to explore unmet needs in the availability of non-prescription medicines in Ireland. It also follows recommendations made by an independent consultative panel established by the HPRA to specifically assist its review of this area.

Arising from the publication of the above mentioned list, expressions of interest in reclassification of certain medicines have been received from the marketing authorisation holders (MAHs). The HPRA is now working with manufacturers and MAHs to progress.

In reclassifying a medicine there are number of factors that need to be considered. These include the safety profile of the product, the proposed condition for treatment, the expected duration of use, the suitability of a condition for self diagnosis with or without the intervention of a pharmacist, the potential for interactions with other medicines and the possibility of misuse. In the relation to the medicines highlighted by the Irish Pharmacy Union (IPU) (fluconazole, chlorampenicol and aspirin), the decision on reclassification is more complex due to additional safety concerns relating to the use of these medicines. The HPRA is continuing to review these concerns.

HPRA will continue to consider medicines which may be suitable for reclassification.