389. Deputy Gino Kenny asked the Minister for Health if his Department will consider replicating the FDA black box warning regarding cautionary use by persons under 18 years of age on antidepressants such as Prozac in the USA on the packaging of similar drugs here (details supplied); and if he will make a statement on the matter. (Question 17660/18 asked on 24 Apr 2018 - Medicinal Products Regulation)

Minister for Health (Deputy Simon Harris): The legal framework for provision of detailed warnings for medicines across the EU is through the product information, which specifically provides for the format and content of these documents. The summary of product characteristics (SmPC) for the healthcare professional and the package leaflet (PL) for patients are reviewed and approved as an intrinsic part of the licensing of a medicine, and continuously updated to reflect the current state of kno...

62. Deputy Gino Kenny asked the Minister for Health when parent representatives will be included in the primary care steering group in view of a motion agreed by Seanad Éireann; his views on whether parents of sick children should be represented on the steering group in view of the fact that the policies being discussed and decided will directly affect their children and that they have a unique insight and experience being full-time carers; and if he will make a statement on the matter. (Question 16895/18 asked on 19 Apr 2018 - Primary Care Services Provision)

Minister for Health (Deputy Simon Harris): As this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply.
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91. Deputy Gino Kenny asked the Minister for Health his plans to use a drug approval and reimbursement system for MS drugs similar to that in Germany (details supplied); and if he will make a statement on the matter. (Question 16408/18 asked on 19 Apr 2018 - Medicinal Products Reimbursement)

Minister for Health (Deputy Simon Harris): The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. The Act specifies the criteria for decisions on the reimbursement of medicines.
In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pur...

225. Deputy Gino Kenny asked the Minister for Health if his attention has been drawn to the distress that delaying Parts 2 and 3 of the Children and Family Relationships Act 2015 has had on families in view of assurances that they would be commenced in the last quarter of 2017; if Parts 2 and 3 will be commenced as a matter of urgency; and if he will make a statement on the matter. (Question 8828/18 asked on 19 Apr 2018 - Commencement of Legislation)

Minister for Health (Deputy Simon Harris): A number of technical drafting issues have come to light in relation to Parts 2 & 3 of the Children and Family Relationships Act 2015. The implications of these issues are being explored by officials in my Department and the Office of the Attorney General and clarification on whether primary legislation is required to resolve these issues is being sought. In the event that primary legislation is required I would seek to deal with it as a matter of urg...

135. Deputy Gino Kenny asked the Minister for Health the rights a person has when a general practitioner patient dispute occurs; if there are procedures in place to resolve these disputes; and if he will make a statement on the matter. (Question 16833/18 asked on 18 Apr 2018 - General Practitioner Services)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 135 to 139, inclusive, together.
As these questions relate to operational matters, I have arranged for the questions to be referred to the Health Service Executive for direct reply to the Deputy.
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136. Deputy Gino Kenny asked the Minister for Health if a general practitioner can unilaterally decide to remove medical card patients that they deem difficult without a patient’s ability to challenge this decision or have access to a process that will adjudicate the matter; and if he will make a statement on the matter. (Question 16834/18 asked on 18 Apr 2018 - General Practitioner Services)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 135 to 139, inclusive, together.
As these questions relate to operational matters, I have arranged for the questions to be referred to the Health Service Executive for direct reply to the Deputy.
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137. Deputy Gino Kenny asked the Minister for Health if the process of general practitioner removal of medical card patients from their list will be examined; if there are policies, structures and patient representation in place in this regard; and if he will make a statement on the matter. (Question 16835/18 asked on 18 Apr 2018 - General Practitioner Services)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 135 to 139, inclusive, together.
As these questions relate to operational matters, I have arranged for the questions to be referred to the Health Service Executive for direct reply to the Deputy.
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138. Deputy Gino Kenny asked the Minister for Health if there are statistics available regarding the number of medical card and private patients removed from general practitioner lists and the reasons for removal; and if he will make a statement on the matter. (Question 16836/18 asked on 18 Apr 2018 - General Practitioner Services)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 135 to 139, inclusive, together.
As these questions relate to operational matters, I have arranged for the questions to be referred to the Health Service Executive for direct reply to the Deputy.
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139. Deputy Gino Kenny asked the Minister for Health his plans to ensure that general practitioner patients have full rights and protection in patient general practitioner disputes including a right to challenge a general practitioner decision and to protect their good name, especially in relation to sourcing another general practitioner; and if he will make a statement on the matter. (Question 16837/18 asked on 18 Apr 2018 - General Practitioner Services)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 135 to 139, inclusive, together.
As these questions relate to operational matters, I have arranged for the questions to be referred to the Health Service Executive for direct reply to the Deputy.
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157. Deputy Gino Kenny asked the Minister for Health if the abolition of the loco parentis clause in paediatric homecare packages will be reconsidered (details supplied); and if he will make a statement on the matter. (Question 16922/18 asked on 18 Apr 2018 - Home Care Packages Administration)

Minister for Health (Deputy Simon Harris): As this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply.
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378. Deputy Gino Kenny asked the Minister for Health when the result of the assessment of the PKU treatment drug Kuvan will be made available; and if he will make a statement on the matter. (Question 13807/18 asked on 27 Mar 2018 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.
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418. Deputy Gino Kenny asked the Minister for Health the amount of State funding provided to a charity (details supplied) since 2002; and if he will make a statement on the matter. (Question 9500/18 asked on 27 Feb 2018 - Departmental Funding)

Minister of State at the Department of Health (Deputy Jim Daly) (Deputy Jim Daly): The Department of Health can detail the amount of money granted through the Department of Health National Lottery Discretionary Fund, and will also request the HSE to provide details of all funding provided to Console. 
However, the Deputy should note that Console may have received additional State funding from other bodies and Departments, which will not be contained within this answer. 
Console was funded a tota...

481. Deputy Gino Kenny asked the Minister for Health the difficulties in relation to importing a product (details supplied) which has been prescribed for a person under special licence and for which the parent needs to travel regularly to the Netherlands to collect; the HSE’s plans to reimburse the medication costs through the long-term illness or alternative scheme; and if he will make a statement on the matter. (Question 9928/18 asked on 27 Feb 2018 - Cannabis for Medicinal Use)

Minister for Health (Deputy Simon Harris): As Minister for Health, I have issued 5 licences for cannabis-based products for medical use by named patients. This allows for the importation of these products from other countries, including The Netherlands. There are no difficulties in importing such products on foot of a valid Ministerial licence.
However, there may be issues in some countries with the exporting of cannabis-based products. This is a matter for the authorities of the exporting co...

137. Deputy Gino Kenny asked the Minister for Health if sativex is available or being prescribed by general practitioners here; and if he will make a statement on the matter. (Question 8889/18 asked on 21 Feb 2018 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
On 11 July 2014, the Misuse of Drugs Regulations 1988 were amended to allow for certain cannabis-based medicinal products to be used in Ireland. The Health Products Regulatory Authority subsequently granted a marketing authorisation for the cannabis-b...

69. Deputy Gino Kenny asked the Minister for Health the guidelines on the proposed cannabis access programme; when he envisages the programme being fully operational; and if he will make a statement on the matter. (Question 6095/18 asked on 08 Feb 2018 - Cannabis for Medicinal Use)

Minister for Health (Deputy Simon Harris): On foot of the 2017 HPRA report ‘Cannabis for Medical Use – A Scientific Review’ I announced the establishment of a cannabis for medical use access programme for patients under the care of a consultant and suffering from certain medical conditions which have failed to respond to all other previous treatments.
The Programme is intended to facilitate access to cannabis-based products that are not authorised as medicines but are of a standardised quality a...

76. Deputy Gino Kenny asked the Minister for Health if a decision has been made by the HSE on the drug, Kuvan, for those that are living with PKU; and if he will make a statement on the matter. (Question 6094/18 asked on 08 Feb 2018 - Medicinal Products Licensing)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 76 and 186 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, under the Health (Pricing and Supply of Medical Goods) Act 2013.
In reaching a decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which it may have sought, includin...

206. Deputy Gino Kenny asked the Minister for Health his plans to extend the recent HSE decision to reimburse the Freestyle Libre system for children and young adults to adults that have type 1 diabetes; and if he will make a statement on the matter. (Question 6245/18 asked on 07 Feb 2018 - Long-Term Illness Scheme Coverage)

Minister for Health (Deputy Simon Harris): Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
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850. Deputy Gino Kenny asked the Minister for Health if he has given consideration to reimbursing the €80 charge that persons with haemochromatosis must pay if they do not hold a medical card for venesection procedures; if the petition from persons who are anxious for the charge to be removed will be responded to; if further consideration will be given to adding haemochromatosis to the long-term illness scheme; and if he will make a statement on the matter. (Question 55038/17 asked on 16 Jan 2018 - Hospital Services)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 736, 749, 751, 850, 864 and 968 together.
The Health Act 1970 (as amended) provides that all people ordinarily resident in the country are entitled, subject to certain charges, to public in-patient hospital services, including consultant services, and to public out-patient hospital services. Under the Health (In-Patients Charges) (Amendment) Regulations 2008, a person who has been referred to a hospital for an in-patien...

255. Deputy Gino Kenny asked the Minister for Health if a decision has been made in relation to the libre continuous glucose monitoring system being made widely available to persons with type 1 diabetes here; and if he will make a statement on the matter. (Question 52637/17 asked on 12 Dec 2017 - Medicinal Products Availability)

Minister for Health (Deputy Simon Harris): Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
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371. Deputy Gino Kenny asked the Minister for Health the steps he will take to facilitate a person’s (details supplied) need to travel to the UK; and if he will make a statement on the matter. (Question 50100/17 asked on 28 Nov 2017 - Treatment Abroad Scheme)

Minister for Health (Deputy Simon Harris): Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
The HSE operates the Treatment Abroad Scheme (TAS) for persons entitled to treat...

40. Deputy Gino Kenny asked the Minister for Health if his attention has been drawn to the fact that returning nurses that have trained elsewhere must complete an adaption course to become fully registered to work here but that the number of hospitals offering the course has reduced leading to some nurses having to pay approximately €2,800 to do it privately; the way in which this impacts on their job choices to work in the private sector to try to recoup this expense; the implications for staffing of public hospitals; and if he will make a statement on the matter. (Question 48175/17 asked on 15 Nov 2017 - Nursing and Midwifery Board of Ireland)

Minister for Health (Deputy Simon Harris): The Nursing and Midwifery Board of Ireland (NMBI) has advised that all applications for registration on a division or divisions of the register of nurses and midwives are individually assessed. If the applicant has obtained his or her nurse or midwife qualification in an EU/EEA country, they are entitled to have their qualifications assessed pursuant to the Recognition of Professional Qualifications Directive 2005/36/EC. If their qualifications fall u...

51. Deputy Gino Kenny asked the Minister for Health the likely timescale of the conclusion of HSE negotiations with the manufacturer of the drug Kuvan; his views on the urgency of it being made available for persons with PKU here; and if he will make a statement on the matter. (Question 48174/17 asked on 15 Nov 2017 - Medicinal Products Reimbursement)

Minister for Health (Deputy Simon Harris): I propose to take Questions Nos. 49 and 51 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In reaching a decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which may have been so...

406. Deputy Gino Kenny asked the Minister for Health his plans to make the FreeStyle Libre flash glucose monitoring system available to persons with type 1 diabetes in view of the fact it is now available to UK NHS patients; and if he will make a statement on the matter. (Question 41617/17 asked on 03 Oct 2017 - Medical Aids and Appliances Provision)

Minister for Health (Deputy Simon Harris): Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
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59. Deputy Gino Kenny asked the Minister for Health the circumstances in which the drug, Vimizin, a treatment for those that suffer from the rare disease Morquio, has been refused funding by the HSE; and if he will make a statement on the matter. (Question 40922/17 asked on 28 Sep 2017 - Medicinal Products Reimbursement)

Minister for Health (Deputy Simon Harris): The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE issued a Notice of Proposal not to support reimbursement of Elosulfase alfa (Vimizim) to the manufacturer BioMarin in June 2017.
The Health (Pricing and Supply of Medical Goods) Act 2013 allows suppliers at least 28 days in wh...

810. Deputy Gino Kenny asked the Minister for Health the estimated yearly cost of providing free sanitary products (details supplied) to women with medical cards; and if he will make a statement on the matter. (Question 36989/17 asked on 11 Sep 2017 - Medical Card Data)

Minister for Health (Deputy Simon Harris): As this is a service matter, it has been referred to the Health Service Executive for direct reply to the Deputy. 
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