Michael Healy-Rae (Kerry South, Independent)
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549. To ask the Minister for Health the reason a company (details supplied) initially developed the drug Isotretinoin; and if he will make a statement on the matter. [23069/15]

Michael Healy-Rae (Kerry South, Independent)
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550. To ask the Minister for Health the precise date Roaccutane was first marketed here; the authorisation agreement in place and name and those involved; and if he will make a statement on the matter. [23070/15]

Michael Healy-Rae (Kerry South, Independent)
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551. To ask the Minister for Health the total number of prescriptions written for Roaccutane each year; and if he will make a statement on the matter. [23074/15]

Michael Healy-Rae (Kerry South, Independent)
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552. To ask the Minister for Health the reason Roaccutane was newly authorised, in view of reports of adverse drug reactions; and if he will make a statement on the matter. [23077/15]

Michael Healy-Rae (Kerry South, Independent)
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553. To ask the Minister for Health the date of the first adverse drug reaction report in connection with Roaccutane reported to the Health Products Regulatory Authority; if he will supply this report by age, gender and year; and if he will make a statement on the matter. [23078/15]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 549 to 553, inclusive, together.

No information is available on the reasons the company initially developed the drug Isotretinion.

Roaccutane was first authorised for use in Ireland on 19 April 1983. The date of first marketing of the product is unknown as companies are not obliged to supply that information.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE) has statutory responsibility for the administration of the GMS and Community Drugs Schemes. Only data on the number of prescriptions written for Roaccutane under the GMS and Community Drugs Schemes can be provided by the HSE. This matter has been referred to the HSE for attention and direct reply to you. If you have not received a reply from the HSE within 15 working days, please contact my Private Office and they will follow up the matter with them.

Renewal of authorised medicines including Roaccutane are based on the benefit/risk profile at the time of authorisation, updated with new information from use of the product (including reported adverse reactions) since the original authorisation date. Renewal of the authorisation is granted if the benefits are still considered to outweigh its risks when the product is used in accordance with the approved product information, including any risk mitigation measures. The authorisation for Roaccutane was last renewed on 10 July 2009 for an unlimited period, in accordance with EU legislation. As with all other medicines, it remains subject to ongoing review of the benefit/risk profile as new information from national, European and global experience is received.

The first adverse drug reaction report in connection with Roaccutane was reported to the Health Products Regulatory Authority (HPRA) on 31 March 1986 by a male patient whose age is unknown. It should be noted that this patient was also taking vitamin B complex. Detailed information relating to this and all other adverse reactions reported to the HPRA was forwarded to the Deputy on 26 May 2015.