Written Answers Nos. 127 - 137
127. Deputy Mary Lou McDonald asked the Minister for Health if the Health Service Executive will provide funding for persons diagnosed with scoliosis to attend clinics overseas to receive treatments, such as the ScolioGold treatment, which is currently not available; and if he will make a statement on the matter. [9443/15]
Amharc ar fhreagraThe HSE operates a Treatment Abroad Scheme (TAS), for persons entitled to treatment in another EU/EEA member state or Switzerland under EU Regulation 1408/71, as per the procedures set out in EU Regulations 574/72, and in accordance with Department of Health Guidelines. Patients, in conjunction with their Irish based public referring hospital consultant, have the ability to apply to the HSE TAS seeking access to public healthcare outside the state through model form E112. The treatment must not be available within the State or not available within a time normally necessary for obtaining it. Applications to TAS are processed and a determination given in accordance with the statutory framework prior to a patient travelling to avail of treatment.
The TAS allows for an Irish based medical consultant to refer a patient that is normally resident in Ireland for treatment, in a public hospital, in another EU/EEA member state or Switzerland, where the treatment in question meets the following criteria:
(a) The application to refer a patient abroad has been assessed and a determination given before that patient goes abroad.
(b) Following clinical assessment, the referring Consultant certifies the following:
- They recommend the patient be treated in another EU/EEA country or Switzerland;
- The treatment is medically necessary and will meet the patient’s needs;
- The treatment is a proven form of medical treatment and is not experimental or test treatment;
- The treatment is in a recognised hospital or other institution and is under the control of a registered medical practitioner;
- The hospital outside the state will accept EU/EEA form E112 (IE).
Each application to TAS is processed and given a formal written decision. If that decision is one of decline, the reason for that decision is clearly outlined and the option of an appeal is afforded.
128. Deputy Brendan Smith asked the Minister for Health if he will ensure that adequate funding is provided for the residential centres of the Camphill Community of Ireland to ensure the continuation of services at those centres throughout the country; and if he will make a statement on the matter. [9445/15]
Amharc ar fhreagraAs the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy. If the Deputy has not received a reply from the HSE within 15 working days, he can contact my Private Office and they will follow the matter up with the HSE.
129. Deputy Jack Wall asked the Minister for Health the position regarding an application for the fair deal nursing home package in respect of a person (details supplied) in County Kildare; and if he will make a statement on the matter. [9446/15]
Amharc ar fhreagraAs this is a service matter it has been referred to the Health Service Executive for direct reply. 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.
130. Deputy Patrick O'Donovan asked the Minister for Health if he will provide details of all properties rented by his Department; the annual cost of the leases; the duration of the leases; and the capacity and occupancy of each premises as of 31 January 2015. [9460/15]
Amharc ar fhreagraThe only lease currently held by my Department is Block D, Irish Life Mall, Dublin 1. The annual cost of this lease is €98,500. The time remaining on this lease is 8 years and 9 months.
These premises were originally the head office of the Women's Health Council which has since been subsumed into my Department. We have had the premises sublet to other parties over the interim period and is now occupied on a temporary arrangement by the National Lottery Regulator. The capacity/occupancy of these premises is a matter for the Lottery Regulator. My Department is in negotiations with the Lottery Regulator regarding the transfer of the lease to them.
131. Deputy Dominic Hannigan asked the Minister for Health if he will maintain the level of funding that is provided to a service (details supplied) in view of the great impact it has on the lives of the persons who attend; and if he will make a statement on the matter. [9468/15]
Amharc ar fhreagraAs the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy. If the Deputy has not received a reply from the HSE within 15 working days, he can contact my Private Office and they will follow the matter up with the HSE.
132. Deputy Martin Ferris asked the Minister for Health the position regarding an application for a medical card in respect of a person (details supplied) in County Kerry and when they will receive a reply. [9469/15]
Amharc ar fhreagraThe Health Service Executive has been asked to examine this matter and to reply to the Deputy as soon as possible.
The Health Service Executive operates the General Medical Services scheme, which includes medical cards and GP visit cards, under the Health Act 1970, as amended. It has established a dedicated contact service for members of the Oireachtas specifically for queries relating to medical cards and GP visit cards, which the Deputy may wish to use for an earlier response. Contact information has issued to Oireachtas members.
If the Deputy has not received a reply from the HSE within 15 working days, please contact my Private Office who will follow up the matter with them.
133. Deputy Brendan Griffin asked the Minister for Health the dental treatments available to a person (details supplied) in County Kerry; and if he will make a statement on the matter. [9470/15]
Amharc ar fhreagraAs this is a service matter, I have asked the HSE to respond to you directly. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.
134. Deputy Michael Healy-Rae asked 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 Roaccutane since its introduction in 1983; and if he will make a statement on the matter. [9474/15]
Amharc ar fhreagra135. Deputy Michael Healy-Rae asked the Minister for Health if the Health Products Regulatory Authority or its officers have ever received reports of side effects of Roaccutane; and if he will make a statement on the matter. [9475/15]
Amharc ar fhreagra136. Deputy Michael Healy-Rae asked 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]
Amharc ar fhreagra137. Deputy Michael Healy-Rae asked the Minister for Health his plans to change the patient information leaflet to state Roaccutane is a chemotherapy drug; and if he will make a statement on the matter. [9477/15]
Amharc ar fhreagraI 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.
