Written Answers Nos. 416-434
416. Deputy Dara Calleary asked the Minister for Health when the HSE will make a decision on the reimbursement for a second line lung cancer drug (details supplied); his views on the delays in the drug reimbursement process and the stress this places on persons with serious illnesses; and if he will make a statement on the matter. [17895/18]
View answerThe 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 pursuant to the community drugs scheme, the company must first submit an application to the HSE to have the new medicine added to the reimbursement list.
As outlined in the Framework Agreement with industry, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).
The NCPE conducts health technology assessments (HTAs) for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.
The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process.
I have been informed by the HSE that they are currently assessing the following indication for reimbursement:
- KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
The NCPE is currently conducting a HTA on this indication. Once completed, the HSE will evaluate this application for reimbursement in line with the criteria laid out within the 2013 Act.
417. Deputy Mary Lou McDonald asked the Minister for Health the form, date and amount of all invoices issued to his Department by a company (details supplied) in each of the years 2007 to 2017, in tabular form. [17908/18]
View answerMy Department has not received any invoices from the company in question between 2007 and 2017.
418. Deputy Michael Healy-Rae asked the Minister for Health if the case of a person (details supplied) regarding the cross border initiative will be examined; and if he will make a statement on the matter. [17915/18]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly.
419. Deputy Peter Burke asked the Minister for Health if an appointment for a person (details supplied) will be expedited; and if he will make a statement on the matter. [17916/18]
View answerUnder 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 National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.
420. Deputy Paul Kehoe asked the Minister for Health if he will address matters (details supplied) regarding vaccine safety; and if he will make a statement on the matter. [17920/18]
View answerThiomersal is a mercury-containing compound that has been used since the 1930s to prevent contamination in some vaccines. Thiomersal is NOT the same as methyl mercury, which can accumulate in the body and become toxic. A European review of the available evidence concluded that there is no evidence of harm from thiomersal in vaccines other than hypersensitivity reactions. The World Health Organization has concluded that there is no evidence of mercury toxicity in infants, children, or adults exposed to thiomersal in vaccines.
The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland. I am informed by the HPRA that there is no thiomersal in any of the vaccines used in the childhood immunisation programme in Ireland.
Aluminium has been used in vaccines for many decades to improve the body's response to vaccination. It is a component of the HPV vaccine Gardasil and several other vaccines. The World Health Organization's (WHO) Global Advisory Committee on Vaccine safety (an expert clinical and scientific advisory body) has concluded that there is no evidence of a health risk from aluminium-containing vaccines.
The safety of the aluminium adjuvant used in Gardasil has been established in clinical studies and the level of aluminium present is tightly controlled as part of the quality control testing of the vaccine. Gardasil which contains amorphous aluminium hydroxyphosphate sulphate adjuvant was tested in non-clinical safety assessment studies where daily monitoring for physical signs did not reveal any notable effects on any physiological function. In addition, the safety of Gardasil was tested in human clinical studies and no signs of concern were identified. Apart from the expected immune response and local injection site reactions, there was no evidence of systemic effects (such as effects on CNS, respiratory, cardiovascular, and renal systems) caused by HPV L1 VLP vaccines such as Gardasil from study data and there is no data to suggest that Gardasil crosses the blood brain barrier. The pharmacological evaluation of Gardasil focused on the evaluation of primary pharmacodynamics (i.e. immunogenicity) as the vaccine did not show any effects apart from the expected immune response.
The contract for the supply of pandemic influenza vaccine during the 2009 pandemic included clauses concerning indemnification of the manufacturers. As all of the vaccines used in the State's immunisation programmes have been approved for use in the European Union by the European Medicines Agency there is no requirement for indemnity.
421. Deputy Tom Neville asked the Minister for Health his views on a matter raised in correspondence relating to a person (details supplied); and if he will make a statement on the matter. [17926/18]
View answerUnder 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.
422. Deputy Mary Butler asked the Minister for Health the status of an operation for a person (details supplied) at UHW; and if he will make a statement on the matter. [17927/18]
View answerUnder 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 National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.
423. Deputy Fergus O'Dowd asked the Minister for Health his views on increasing the means allowance for a single person and a couple over 70 years of age for medical cards; his plans to increase the limits to the 2009 or 2013 limits; and if he will make a statement on the matter. [17928/18]
View answerUnder the Health (Alteration of Criteria for Eligibility) (No. 2) Act 2013, when a person attains the age of 70, the medical card income limits are €500 gross income per week for a single person and €900 gross income per week for a couple.
Persons aged 70 or older, who are assessed as ineligible under the gross income thresholds, may also have their eligibility assessed under the means-tested medical card scheme if they so wish, for example in the event that they face particularly high expenses, e.g. nursing home or medication costs. This scheme is open to all persons, irrespective of their age and assessment is based on net income and assessable outgoing expenses. The general scheme, although having lower income thresholds, provides for income disregards and relevant outgoings to be taken into account in the assessment process.
Furthermore, persons, including those aged over 70 years, may be deemed eligible for a medical card on a discretionary basis, if they are judged to face undue hardship in arranging GP services as a result of medical or social circumstances. In addition, from August 2015, all persons aged 70 or older qualify for a GP Visit Card, regardless of income.
There are no proposals at present to amend the legislation for the granting of eligibility for medical cards for persons aged 70 and over. However, it should be noted that the gross income limits are reviewed annually and considered in the context of the budget.
424. Deputy Mary Butler asked the Minister for Health if a person (details supplied) will be allocated electronic braces for lower limbs; and if he will make a statement on the matter. [17929/18]
View answerAs this is a service matter it has been referred to the HSE for direct reply to the Deputy.
425. Deputy Éamon Ó Cuív asked the Minister for Health if adequate funding will be provided to an organisation (details supplied) in 2018; and if he will make a statement on the matter. [17980/18]
View answerAs this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
426. Deputy Niamh Smyth asked the Minister for Health if an appointment for a child (details supplied) will be expedited with an organisation; and if he will make a statement on the matter. [17982/18]
View answerThe Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.
As 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.
427. Deputy Niall Collins asked the Minister for Health if under the lobbyist register it is expected that calls from lobbyists are recorded; if this is the practice in his Department; and if he will make a statement on the matter. [17989/18]
View answerIt is not the practice in my Department to record phone calls from any source.
As provided for under the Lobbying Act 2015, the Standards in Public Office Commission established and maintains the on-line register of lobbying and oversees compliance with the legislative provision. The purpose of the register is to make information available to the public on the identity of those communicating with Designated Public Officials. Persons lobbying have to register with the Standards Commission and are required to submit returns on their lobbying activities.
As a Designated Public Official, all representations, including requests for meetings received by me are recorded on this register.
428. Deputy Clare Daly asked the Minister for Health if the sum of €6,600 paid to a person (details supplied) in respect of the Symphysiotomy and Pubiotomy Review - An Imaging Perspective, which was published as Appendix 1 to the Clark report, was additional to the sum of €58,950 which was paid to the person from 2014 to 2016 under the heading of clinical advice to the symphysiotomy payment scheme. [18000/18]
View answerThe Surgical Symphysiotomy Ex-gratia Payment Scheme, which was approved by Government, concluded with the publication of the Report of its independent Assessor, Judge Maureen Harding Clark, on 22 November 2016.
Records of payments made relating to the Scheme show that, following instructions from Judge Clark, my Department arranged for total payments of €58,950, less statutory deductions, to be made to the person in question. This amount included the €6,600 referred to by the Deputy. That sum was for reading and commenting on one of the draft chapters in the Judge's report and preparing and furnishing the review for the Judge, which formed Appendix 1 of the Report, and for attending 12 meetings with her. The balance of the payments to the person were for the preparation of radiological reports for the Judge relating to individual applicants to the Scheme.
429. Deputy Bernard J. Durkan asked the Minister for Agriculture, Food and the Marine when a payment will issue to a person (details supplied) under the knowledge transfer scheme. [17397/18]
View answerKnowledge Transfer (KT) is one of a suite of measures included under the Rural Development Programme 2014-2020 and involves the formation of knowledge transfer groups across the beef, dairy, equine, sheep, tillage and poultry sectors.
Farmer participants attend group meetings and produce a Farm Improvement Plan in consultation with their KT Facilitator. For each year of the three-year programme participants receive a reimbursement in the amount of €750 for a primary sector and €375 for a secondary sector where all requirements of the programme have been met.
The person named is a primary participant in the Knowledge Transfer Sheep Programme. He has met all requirements of the scheme and has now been cleared for payment. It is expected that payment will issue to the person named shortly.
430. Deputy Pat Breen asked the Minister for Agriculture, Food and the Marine the status of an application by persons (details supplied); and if he will make a statement on the matter. [17406/18]
View answerThe persons named were approved into GLAS 1 with a contract commencement date of 1 October 2015 and have received payments in respect of the 2015 scheme year as well as the 2016 advance payment.
An inspection was carried out in relation to the GLAS participation of the above mentioned. Once the issues relating to the inspection have been finalised the case will move forward for payment.
The persons named have also been advised that, if they are dissatisfied with the outcome of the inspection, they have the option to appeal this decision to the Agriculture Appeals Office.
431. Deputy Pearse Doherty asked the Minister for Agriculture, Food and the Marine if his attention has been drawn to the concern in the communities of Burt, Bridgend, Burnfoot and Inch Island in the Inishowen Peninsula, County Donegal, at the widespread removal of landscape features such as trees and hedges across an estate (details supplied); and if these works are in compliance with all relevant domestic legislation and European directives. [17412/18]
View answerAn application under the Environmental Impact Assessment (Agriculture) Regulations 2011 was received by the Department of Agriculture, Food and the Marine in September 2017 regarding land located within Lough Swilly Special Protection Area (Site Code: 004075), involving an area of just over 6 hectares. The application was then referred to the National Parks and Wildlife Service as is normally the case involving SAC/SPA. The proposed works involved 'land drainage works on land used for agriculture' including ancillary scrub removal. An approval for these works was subsequently granted following this consultation.
It is important to identify that works outside of an SAC/SPA site, such as trimming of hedges (within the prescribed 'open' period for such works) or cleaning of existing drains are not subject to, and therefore do not breach the European Communities [(Environmental Impact Assessment) (Agriculture) Regulations 2011 (as amended 2017)].
In the event of potential breaches to the management requirements of an SAC/SPA, this should be brought to the attention of the National Parks and Wildlife service locally.
432. Deputy Michael Healy-Rae asked the Minister for Agriculture, Food and the Marine the reason for bringing in new operators (details supplied) in Kilmakilloge Harbour; and if he will make a statement on the matter. [17414/18]
View answerApplications for aquaculture licences are considered by my Department in accordance with the provisions of the 1997 Fisheries (Amendment) Act, the 1933 Foreshore Act and applicable EU legislation. The licensing process includes a period of Statutory and general public consultation in respect of applications, and licensing decisions are made following the fullest consideration of all aspects of each application including environmental, technical and public interest aspects.
The licensing process also provides for an appeals mechanism in respect of Ministerial decisions via the Aquaculture Licences Appeals Board which is an independent body established by Statute for the specific purpose of considering such appeals.
In order to facilitate the aquaculture licensing process in Kilmakilloge Harbour my Department requested BIM to conduct a Carrying Capacity Study of the area. BIM has recently submitted to my Department a ‘Working Draft’ of the study report. This is not BIM’s final draft of the study report and it is expected that, in the normal way, further drafts will be generated in the course of ongoing communications and discussions with my Department.
In the meantime, as licence applications, including renewals, are under formal consideration by my Department as part of a Statutory process it would not be appropriate for me to comment further at this time.
433. Deputy Robert Troy asked the Minister for Agriculture, Food and the Marine if a TAMS 2 payment will be awarded to a person (details supplied) following a review of the application; and if he will make a statement on the matter. [17422/18]
View answerThe applicant in question applied for sheep fencing under the Animal Welfare, Safety and Nutrient Storage Scheme of TAMS II.
This application was the subject of an on-farm inspection. It is a requirement that the payments claimed be verified as part of such an inspection. In this case an issue arose in relation to the dates of the payments made. The over-claim calculated resulted in a nil payment.
The applicant was advised of the position in a letter from the Department dated 10 April 2018. A written request for a review of this decision was received from the applicant on 20 April 2018. The case will now be reviewed by the Department and the applicant will be advised in writing of the outcome. Should the applicant remain dissatisfied with the outcome of this review it will remain open to them to submit an appeal to the Agriculture Appeals Office.
434. Deputy John Deasy asked the Minister for Agriculture, Food and the Marine the reason for the delay in issuing 2017 GLAS and organic payments to a person (details supplied); and when payment will issue. [17457/18]
View answerThe person named was approved into GLAS 1 with a contract commencement date of 1 October 2015 and has received all payments in respect of 2015 and 2016.
Each GLAS claim must clear all validation checks before the 2017 advance payment can be made. My Department is continuing to work to complete the checks required in this case. Once this case clears the validations, the 2017 advance payment will be made. GLAS payments are issuing on a weekly basis.
The Organic Farming Scheme payment will be processed following successful processing of GLAS payment.
