Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

134. To ask the Minister for Health if the Health Products Regulatory Authority had any correspondence with a pharmaceutical company (details supplied) regarding the safety or otherwise of Ro/Accutane since its introduction in 1983; and if he will make a statement on the matter. [9474/15]

Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

135. To ask the Minister for Health if the Health Products Regulatory Authority or its officers have ever received reports of side effects of Ro/Accutane; and if he will make a statement on the matter. [9475/15]

Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

136. To ask the Minister for Health if the Health Products Regulatory Authority or its officers have ever received money or gifts from a pharmaceutical company (details supplied); and if he will make a statement on the matter. [9476/15]

Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

137. To ask the Minister for Health his plans to change the patient information leaflet to state Ro/Accutnae is a chemotherapy drug; and if he will make a statement on the matter. [9477/15]

Kathleen Lynch (Cork North Central, Labour)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 134 to 137, inclusive, together.

Roaccutane (isotretinoin) capsules are authorised in Ireland for the treatment of severe forms of acne which are resistant to adequate courses of standard therapy with systematic antibacterials and topical therapy. Roaccutane is not authorised in Ireland for the treatment of cancer and therefore this is not reflected in the product information.

The Health Products Regulatory Authority (HPRA) has confirmed that a total of 289 reports of suspected adverse reactions associated with the use of Roaccutane were notified to the HPRA from 1983 up to the end of February 2015. The majority of the reports received have been consistent with the expected pattern of adverse effects for Roaccutane, as described in the product information. Skin reactions such as dry skin, dry lips and inflammation of the lips were commonly reported as were mood swings, depression and anxiety. Other frequently reported symptoms included headache, nose bleeds, muscle and joint pain and eye disorders such as dry eyes and conjunctivitis.

It is standard practice that there is regulatory correspondence with the pharmaceutical company and the HPRA in the context of post-marketing safety monitoring (which includes review and evaluation of suspected adverse reaction reports, published literature and post-marketing safety studies). Companies have an obligation to report suspected adverse reactions associated with the use of their products to the competent authority, i.e. the HPRA, as a condition of their authorisation.

Roaccutane was first authorised in 1983 and the company has been obliged to submit a renewal application every five years. It is also obliged to submit "periodic safety update reports" to the HPRA at regular intervals, for assessment of safety data post-authorisation.

Roaccutane has been closely monitored at a national and European level since it was first authorised and its benefits and risks were last reviewed at EU level in 2011. The benefits of treatment are considered to outweigh the risks, when the product is used in accordance with the product information.

The HPRA has stated that members of the Authority, its advisory committees and staff are bound by the requirements of section 24 of the Irish Medicines Board Acts 1995 and 2006, the Ethics in Public Office Act and the HPRA's Code of Conduct and Conflict of Interest Policy, both of which are available on the HPRA website. It is a policy of the HPRA that members of the Authority, its advisory committees and staff must not receive benefits of any kind from a third party which might reasonably be seen to compromise their personal judgement or integrity.

The HPRA prohibits the acceptance of money as cash, cash vouchers or cash equivalents from any industry or sector regulated by the HPRA. Gifts may not be solicited, directly or indirectly. Only gifts of very modest value are acceptable in limited circumstances or where it is the custom in the country concerned to give such gifts and where to decline may cause offence. At all times the actions of those employed or engaged in the activities of the HPRA must be above suspicion and not give rise to any conflict of interest, and their dealings with commercial and other interests should bear the closest possible scrutiny. The Conflict of Interest Policy on the HPRA website provides detailed guidance and requirements.