Written Answers Nos. 1300-1319
1300. Deputy Billy Kelleher asked the Minister for Business, Enterprise and Innovation the details of proposals (details supplied) over the 2011 to 2018 period on an annual basis in tabular form; and if she will make a statement on the matter. [35135/18]
Amharc ar fhreagraDetails of legislation published by my Department that underwent Regulatory Impact Analysis and legislation that did not undergo Regulatory Impact Analysis in the years 2011 to 2018 are set out in the following tables.
2011
|
Regulatory Impact Analysis Undertaken |
|
Patents (Amendment) Bill 2011 |
|
Protection of Employees (Temporary Agency Work) Bill 2011 |
|
Industrial Relations (Amendment) (No. 3) Bill 2011 |
|
Competition (Amendment) Bill 2011 |
|
Bill/Act published which did not undergo Regulatory Impact Analysis |
|
Nil |
2012
|
Regulatory Impact Analysis Undertaken |
|
Credit Guarantee Act 2012 |
|
Microenterprise Loan Fund Act 2012 |
|
Workplace Relations Bill 2012 |
|
Companies Bill 2012 |
|
Bill/Act published which did not undergo Regulatory Impact Analysis |
|
Companies (Amendment) Act 2012 |
2013
|
Regulatory Impact Analysis Undertaken |
|
County Enterprise Boards (Dissolution) Bill, 2013 |
|
Employment Permits (Amendment) Bill 2014 |
|
European Union (Accession of the Republic of Croatia) (Access to the Labour Market) Bill 2013 |
|
Companies (Miscellaneous Provisions) Bill 2013 |
|
Friendly Societies and Industrial Provident Societies (Miscellaneous Provisions) Bill 2013 |
|
Industrial Development (Forfás Dissolution) Bill 2013 |
2014
|
RIA Undertaken |
|
Intellectual Property (Miscellaneous Provisions) Act 2014 |
|
Workplace Relations Bill 2014 |
|
Amendment to Workplace Relations Bill 2014 to amend the Organisation of Working Time Act 2014 |
|
Competition and Consumer Protection Bill 2014 |
|
Bill/Act published which did not undergo Regulatory Impact Analysis |
|
Nil |
2015
|
Regulatory Impact Analysis Undertaken |
|
National Minimum Wage (Low Pay Commission) Bill 2015 |
|
Industrial Relations (Amendment) Bill 2015 |
|
Bill/Act published which did not undergo Regulatory Impact Analysis |
|
Nil |
2016
|
Regulatory Impact Analysis Undertaken |
|
Knowledge Development Box (Certification of Inventions) Bill 2016 |
|
European Union (Electromagnetic Compatibility) Regulations 2016 |
|
Credit Guarantee (Amendment) Act 2016 |
|
Hallmarking (Amendment) Bill 2016 |
|
Companies (Accounting) Bill 2016 |
|
Bill/Act published which did not undergo Regulatory Impact Analysis |
|
Nil |
2017
|
Regulatory Impact Analysis Undertaken |
|
Companies (Statutory Audits) Bill 2017 |
|
Companies (Amendment) Bill 2017 |
|
Bill/Act published which did not undergo Regulatory Impact Analysis |
|
Nil |
2018
|
Regulatory Impact Analysis Undertaken |
|
Industrial Relations (Amendment) Bill 2018 – Bill published on 20th July 2018 |
|
Bill/Act published which did not undergo Regulatory Impact Analysis |
|
Nil |
1301. Deputy Maurice Quinlivan asked the Minister for Business, Enterprise and Innovation the status of the review of the Succeed in Ireland initiative; the cost of this review to date; and if she will make a statement on the matter. [35184/18]
Amharc ar fhreagraAs has been announced previously, my Department intends to commission an independent review of the Succeed-in-Ireland programme. That review will equip us with a thorough understanding of the programme’s results and its contribution to employment generation in the State. We will then be able to make a determination on its long-term future.
However, as I have made clear before, there needs to be clarity on the full and final costs of the programme before a review can be initiated. Those costs cannot be ascertained until Connect Ireland’s dispute with the IDA regarding the previous operation of the programme is resolved or otherwise concluded.
I welcome efforts that have been made to address that dispute and I understand that the two parties are currently engaged in a dispute resolution process. That process, once completed, should provide the necessary clarity on the costs of the programme to date, which will in turn allow the review to proceed.
1302. Deputy Brendan Howlin asked the Minister for Business, Enterprise and Innovation if she has requested Science Foundation Ireland to fund a public genome project and provide for the participation of Ireland in a European genome sequencing project; and if she will make a statement on the matter. [35273/18]
Amharc ar fhreagraScience Foundation Ireland does not engage in funding for any public genome project. Policy in the area of genomics is a matter for the Minister for Health and it is in that context the question of the participation of Ireland in a European genome sequencing project would be addressed.
1303. Deputy Brendan Howlin asked the Minister for Business, Enterprise and Innovation the breakdown by project for the capital allocation of €555 million in 2018 to her vote group; the breakdown by project for the proposed allocation of €620 million in 2019; and if she will make a statement on the matter. [35277/18]
Amharc ar fhreagraThe 2018 Revised Estimates Volume published by the Department of Public Expenditure and Reform provided for capital expenditure funding of €555million for use by my Department in 2018.
The breakdown of my Department's Capital allocation, by programme area, for 2018 is detailed in the following table.
|
- |
2018 |
|
Science Foundation Ireland |
€166.75m |
|
IDA Ireland |
€132m |
|
Enterprise Ireland – Subhead A7 |
€63m |
|
Enterprise Ireland – Subhead B4 (R&D) |
€122m |
|
Local Enterprise Offices |
€22.5m |
|
Memberships of International Research Organisations (eg ESA & others) |
€20.25m |
|
Programme for Research in Third Level Institutions |
€14.3m |
|
InterTrade Ireland |
€5.69m |
|
Interreg |
€3.00m |
|
Tyndall National Institute |
€4.50m |
|
National Standards Authority of Ireland |
€0.50m |
|
Credit Guarantee Scheme |
€0.50m |
|
Total |
€555m |
At this stage it is too early to state definitively the specific funding that will be provided in 2019 to support the different capital projects in my Department. The Deputy will be aware, however, that the allocations set out in the NDP are intended to enable Departments to implement the Strategic Investment Priorities to deliver on the National Strategic Outcomes identified in the National Planning Framework (NPF).
My Department’s definitive capital allocations for 2019, as referred to by the Deputy will be determined as part of the relevant annual Estimates processes.
1304. Deputy Richard Boyd Barrett asked the Minister for Business, Enterprise and Innovation the amount paid for consultancy services in each of the years 2012 to 2017; the details of these payments; the companies that received the payments; the amount received by each company; the hourly rates that applied to each company; and if she will make a statement on the matter. [35377/18]
Amharc ar fhreagraMy Department considers hiring external consultants in cases where there is not the necessary expertise to deliver the project in-house, in cases where an external assessment is deemed essential, or in cases where a project must be completed within a short time scale, and although the expertise or experience may be available in-house, performing the task would involve a prohibitive opportunity cost.
In each particular case, criteria specific to the project are used in selecting an outside agency or consultancy, including cost and value for money. Contracts are awarded based on the most economically advantageous tender (specifying, in addition to price, various other criteria including running costs, servicing costs, level of after sales service, technical assistance, technical merit, environmental characteristics).
My Department complies with the Department of Public Expenditure and Reform's guidelines for engagements of consultants by the civil service, having regard to public procurement guidelines.
Details of payments made in respect of consultancy contracts for the years 2012-2017 are provided at the following link. Contracts are not generally awarded on the basis of hourly rates.
1305. Deputy Richard Boyd Barrett asked the Minister for Business, Enterprise and Innovation the amount paid for external legal services in each of the years 2012 to 2017; the details of these payments; the companies that received the payments; the amount received by each company; the hourly rates that applied to each company; and if she will make a statement on the matter. [35391/18]
Amharc ar fhreagraDetails of the amounts paid by my Department for external legal services in each of the years from 2012 to 2017 are available at the following link. Payments are not generally made on the basis of an hourly rate.
1306. Deputy Louise O'Reilly asked the Minister for Health if his attention has been drawn to recommendation CM/Rec(2018)7 of the Committee of Ministers to Member States on guidelines to respect, protect and fulfil the rights of the child in the digital environment; the action his Department will take to meet the five recommendations contained therein; and if he will make a statement on the matter. [32482/18]
Amharc ar fhreagra1307. Deputy Louise O'Reilly asked the Minister for Health the action he will take to require business enterprises to meet their responsibility to respect the rights of the child in the digital environment as per a recommendation (details supplied); and if he will make a statement on the matter. [32483/18]
Amharc ar fhreagra1308. Deputy Louise O'Reilly asked the Minister for Health when his Department will examine the implementation of recommendation CM/Rec(2018)7 of the Committee of Ministers to Member States on guidelines to respect, protect and fulfil the rights of the child in the digital environment and the guidelines in its appendix; and if he will make a statement on the matter. [32484/18]
Amharc ar fhreagra1309. Deputy Louise O'Reilly asked the Minister for Health when his Department will review its legislation, policies and practice to ensure that they are in line with a recommendation (details supplied); and if he will make a statement on the matter. [32485/18]
Amharc ar fhreagraI propose to take Questions Nos. 1306 to 1309, inclusive, together.
The Action Plan for Online Safety was launched by An Taoiseach on 11 July last.
The Plan sets out actions across Government Departments and agencies that are being taken to protect children and adults in their online engagement in what is a particularly dynamic environment.
Six key Departments form a Sponsors’ Group. These are Education and Skills, Justice and Equality, Communications, Climate Action and Environment, Children and Youth Affairs, Health, Business, Enterprise and Innovation. The Group has a number of functions including driving implementation of the Action Plan in line with the agreed timelines: developing a framework for monitoring and reporting on implementation progress; and publishing bi-annual progress reports on Action Plan implementation on each Department’s Website.
The Department of Health leads on the development of online signposting tools for mental health supports; and implementation of Healthy Ireland. The Department, in conjunction with the HSE and its various service partners has a range of policies and initiatives to promote positive mental health and resilience, including those specifically targeted at young people. In addition, we are currently reviewing the Mental Health Act, 2001 and A Vision for Change. The issues referred to by the Deputies will be considered, as appropriate, by my Department in this wider context and as part of developing the Government's overall Action Plan.
1310. Deputy Clare Daly asked the Minister for Health if a person (details supplied) has a family relationship with another person that was involved in vaccine trials. [32538/18]
Amharc ar fhreagra1311. Deputy Clare Daly asked the Minister for Health the definition of certain vaccine damage claims referred to in point "b" of the list of broad areas to be examined by the expert group considering alternative mechanisms to the court process for resolving clinical negligence claims. [32539/18]
Amharc ar fhreagraI propose to take Questions Nos. 1310 and 1311 together.
An Expert Group chaired by the High Court Judge, Mr Justice Charles Meenan, is being established to review the law of torts and the current system for the management of clinical negligence claims.
The establishment of the Expert Group arises from a commitment made in the Programme For A Partnership Government (May 2016). This states 'We will tackle the rising cost of claims by establishing an expert group to report within 6 months on options for reforming the law of torts and the current claims process, particularly when it comes to birth injuries and catastrophic injuries, and injuries that can result from vaccination’.
Clause (b) of the Terms of Reference of the Expert Group is that the Group will:
b) consider whether there may be an alternative mechanism to the court process for resolving clinical negligence claims, or particular categories of claims, particularly from the perspective of the person who has made the claim. To do this, the Group will examine whether a mechanism could be established which would deal more sensitively and in a more timely fashion with catastrophic birth injuries, certain vaccine damage claims, or with claims where there is no dispute about liability from the outset. It will also examine whether an alternative dispute resolution mechanism or a no-fault system would be effective in some cases;
The Expert Group will meet for the first time in early September and it will decide the scope of its work within its six month timelinework on this and its other Terms of Reference.
Mr Justice Meenan has informed me that he is a nephew of the late Professor Patrick N. Meenan, who died in 2008.
1312. Deputy Robert Troy asked the Minister for Health his views on whether sleep apnoea should be included in the list of illnesses under the long-term illness scheme; and if he will make a statement on the matter. [33445/18]
Amharc ar fhreagraThe Long Term Illness (LTI) Scheme was established under section 59(3) of the Health Act 1970 (as amended). The conditions covered by the LTI are: acute leukaemia; mental handicap; cerebral palsy; mental illness (in a person under 16); cystic fibrosis; multiple sclerosis; diabetes insipidus; muscular dystrophies; diabetes mellitus; parkinsonism; epilepsy; phenylketonuria; haemophilia; spina bifida; hydrocephalus; and conditions arising from the use of Thalidomide.
Under the LTI Scheme, patients receive drugs, medicines, and medical and surgical appliances directly related to the treatment of their illness, free of charge. There are no plans to extend the list of conditions covered by the Scheme.
For people who are not eligible for the LTI scheme, there are other arrangements which protect them from excessive medicine costs.
Under the Drug Payment Scheme, no individual or family pays more than €134 a month towards the cost of approved prescribed medicines. The scheme significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.
People who cannot, without undue hardship, arrange for the provision of medical services for themselves and their dependants may be entitled to a medical card. In the assessment process, the HSE can take into account medical costs incurred by an individual or a family.
People who are not eligible for a medical card may still be able to avail of a GP visit card, which covers the cost of GP consultations.
1313. Deputy Michael McGrath asked the Minister for Health the cases the State Claims Agency is dealing with in relation to the various cancer screening programmes; the stage each case is at by programme; the notifications it has received from the HSE or the programmes themselves in relation to correspondence received from persons or their legal representatives regarding a possible claim; the approach of the agency in dealing with these cases; and if he will make a statement on the matter. [33783/18]
Amharc ar fhreagraThe State Claims Agency (SCA) has a statutory remit to manage personal injury claims, including claims in respect of clinical negligence, on behalf of Delegated State Authorities (DSA’S) to include the Health Service Executive. The SCA’s claims management objective is, while acting in the best interest of taxpayers in matters of personal injury and property damage litigation, to act fairly, ethically and compassionately in its dealings with people who have suffered injuries and/or damage and who take legal actions against the State or State bodies, and their families.
The SCA remains committed to resolving cases relating to CervicalCheck in line with the principles outlined by the Government, expediting resolution of these cases in a sensitive manner, working co-operatively with the co-defendant laboratories, utilising mediation wherever possible and placing a high priority on treating the people who have made the claims, and their families, with dignity and compassion.
The SCA has provided a report, showing all active and potential claims currently being managed by it for the National Screening Service on the National Incident Management System (NIMS)
This request for claims information is broader than cancer misdiagnosis claims which have recently been reported in previous parliamentary questions. It includes clinical and personal injury ‘general’ claims which can relate to service users, staff and members of the public, as set out in the definitions below.
This report is correct as of 23/07/2018. It is broken down into two sections.
(i) To ask the Minister for Finance the cases the State Claims Agency is dealing with in relation to the various cancer screening programmes; the stage each case is at by programme;
The SCA has 59 cases under active management (54 active claims, 5 potential claims) with respect to the national screening programmes. Of those, 10 are associated with BreastCheck, 49 are associated with CervicalCheck and 0 are associated with BowelScreen. These cases are both clinical and non-clinical (general) in nature and include cancer misdiagnosis claims.
Table 1: National Screening Service Active and Potential Claims
|
Screening Programme |
Clinical/General |
CM Status |
Grand Total |
|
Breast Check |
Clinical |
Claim under investigation |
3 |
|
Breast Check |
Clinical |
Claim Litigation |
4 |
|
Breast Check |
General |
Claim under investigation |
1 |
|
Breast Check |
General |
Claim Litigation |
2 |
|
Total |
- |
- |
10 |
|
Cervical Check |
Clinical |
Potential Claim Alerted to CM for Review |
1 |
|
Cervical Check |
Clinical |
Potential Claim under CM Review |
3 |
|
Cervical Check |
Clinical |
Claim Under Investigation |
30 |
|
Cervical Check |
Clinical |
Claim Litigation |
1 |
|
Cervical Check |
Clinical |
Trial |
2 |
|
Cervical Check |
Clinical |
Claim Conclusion Started |
6 |
|
Cervical Check |
General |
Potential Claim under CM Review |
1 |
|
Cervical Check |
General |
Claim Under Investigation |
5 |
|
Total |
- |
- |
49 |
|
Bowel Screen |
Clinical |
N/A |
0 |
|
Bowel Screen |
General |
N/A |
0 |
|
Total |
- |
- |
0 |
|
Grand Total |
- |
- |
59 |
1314. Deputy Michael Healy-Rae asked the Minister for Health if he will address a matter (details supplied) regarding personalised budgets; and if he will make a statement on the matter. [33813/18]
Amharc ar fhreagraAs the Deputy may be aware, I recently published the report of the Task Force on Personalised Budgets. The Task Force has recommended the development of a number of demonstration projects to test the operation of models of personalised budgets. The selection of a standardised assessment tool will be addressed during the development of the demonstration projects. Officials from the Department of Health, the Health Service Executive and the National Disability Authority have begun preparatory work in relation to the demonstration projects.
1315. Deputy Richard Boyd Barrett asked the Minister for Health the cost of abolishing FEMPI related cuts as they impact on general practitioners; and if he will make a statement on the matter. [35008/18]
Amharc ar fhreagraUnder the General Medical Services (GMS) contract, GPs are reimbursed for a range of services they provide to medical card and GP visit card holders. GPs are remunerated for these services primarily on a capitation basis, with a range of additional support payments and fees for specific items of service. GPs are also remunerated for services they provide on behalf of the HSE under other public health schemes, such as the Maternity and Infant Care Scheme, Primary Childhood Immunisation Scheme, etc.
The Financial Emergency Measures in the Public Interest (FEMPI) Act 2009 imposed a range of adjustments to health contractor payments. These included different levels of reductions to various GP fees and allowances and the elimination of certain payments resulting in savings of approximately €120 million per annum.
Despite reductions to the payment rates of health contractors made under FEMPI legislation, the total fees paid to GPs under the GMS scheme have increased during this period from just over €472 million in 2009 to approximately €525 million in 2017. This increase in fees is largely due to significant developments and investment in GP services introduced in recent years, with more services being made available to our citizens and additional financial support provided by the HSE.
The Public Service Pay and Pensions Act 2017 now allows the setting and varying of contractor payments on a non-emergency statutory basis.
It is my intention to put in place a new multiannual approach to fees in return for service improvements and contractual reforms based upon health policy considerations and engagement with representative bodies.
Officials from my Department and the HSE met with the Irish Medical Organisation at the beginning of May to set out the State's position in relation to reform of the GMS contract. Agreement on the delivery of service improvements and contractual reform has the potential to facilitate a substantial increase in the resourcing of general practice on a multiannual basis.
1316. Deputy Tony McLoughlin asked the Minister for Health when the HSE will make Pembrolizumab available for NSCLC patients with a low PD-L1 expression; and if he will make a statement on the matter. [32410/18]
Amharc ar fhreagraThe 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.
In Ireland the majority of patients access medicines through the publicly funded community drug schemes. In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE through the community drugs schemes, it must submit an application to have the new medicine added to the reimbursement list.
The Department has been informed by the HSE that it is currently assessing the following indication for reimbursement of pembrolizumab.
= As monotherapy 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 pembrolizumab.
The National Centre for Pharmacoeconomics (NCPE) completed a health technology assessment in May 2018 for this indication. The NCPE recommended that pembrolizumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. The HSE will now evaluate this application, in line with criteria laid out within the 2013 Act, before making a final reimbursement decision.
1317. Deputy Éamon Ó Cuív asked the Minister for Health when an operation will be provided for a person (details supplied); the reason for the delay in issuing a date for the procedure; and if he will make a statement on the matter. [32414/18]
Amharc ar fhreagraUnder 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, since 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.
1318. Deputy Eugene Murphy asked the Minister for Health the charging structure in relation to the out of hours on call doctors services by county, in tabular form; and if he will make a statement on the matter. [32417/18]
Amharc ar fhreagraThe GMS Contract requires GPs to make suitable arrangements to enable contact to be made with them, or a locum/deputy, for urgent cases outside normal practice hours. There is no provision under the GMS contract for persons who hold a medical card or GP visit card to be charged for out of hours services provided by their GP, or a locum or deputy on behalf of their own GP.
GPs receive specific payments under the GMS scheme for consultations they provide to GMS patients outside of normal surgery hours, as set out in Schedule 2 of S.I. 233/2016. The rates of payment available are summarised in the following table.
|
Payments available for Out of Hours Consultations under the GMS scheme |
|
|
Surgery consultation Monday to Friday (excluding public holidays) between the hours of 5 p.m. and 6 p.m. on the same day and 8 a.m. and 9 a.m. on the same day |
€13.88 |
|
Surgery consultation Monday to Friday between the hours of 6 p.m. and 8 a.m. the following day and any time on Saturday, Sunday and public holidays |
€41.63 |
|
Domiciliary visit out-of-hours |
€41.63 |
|
Surgery consultation or domiciliary visit out-of-hours where a general practitioner sees an additional patient under the General Medical Services Scheme during the same consultation or visit |
€13.88 |
Many GPs opt to participate in GP out of hours co-operatives as a means of meeting their contractual out of hours requirements
People who do not hold a medical or GP visit card, access GP services on a private basis. The fees charged by GPs or GP out of hours co-operatives for private out of hours consultations are a matter of private contract between patients and the GP or GP out of hours co-operative concerned.
1319. Deputy Frank O'Rourke asked the Minister for Health if consideration has been given to a drug company's submission to add the drug Translarna to the drug reimbursement scheme (details supplied); and if he will make a statement on the matter. [32420/18]
Amharc ar fhreagra1444. Deputy Brendan Smith asked the Minister for Health his plans to make the drug Translarna available through the HSE for the small number of young persons needing this particular medication in view of its availability in neighbouring jurisdictions and in 22 European countries in total; and if he will make a statement on the matter. [32933/18]
Amharc ar fhreagra1445. Deputy Jack Chambers asked the Minister for Health further to Parliamentary Question No. 125 of 13 June 2018, the status of developments in the process of negotiations for the funding of the drug Translarna; the length of time the application process will take; his views on whether a two year long application process is too long a time period for many of those that require access to this drug (details supplied); and if he will make a statement on the matter. [32934/18]
Amharc ar fhreagra1505. Deputy James Browne asked the Minister for Health if he will request the HSE to engage with a company (details supplied) regarding the drug Translarna; and if he will make a statement on the matter. [33218/18]
Amharc ar fhreagra1711. Deputy Niamh Smyth asked the Minister for Health further to Parliamentary Question No. 158 of 23 May 2018, if correspondence from a person (details supplied) in relation to same will be examined; the timeframe for the drug to be made available here; and if he will make a statement on the matter. [34349/18]
Amharc ar fhreagraI propose to take Questions Nos. 1319, 1444, 1445, 1505 and 1711 together.
The Health Service Executive 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. The 2013 Act does not give the Minister for Health any powers in this regard.
The Act specifies the criteria to be applied in reimbursement decisions, which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources available to the HSE.
Ataluren (Translarna) is a high cost medicine for the treatment of a subgroup of patients with Duchene muscular dystrophy, a rare disease. Ataluren has conditional market authorisation from the European Medicines Agency for Europe - the condition being that the company carries out further clinical trials to determine the clinical efficacy of the drug.
Applications for reimbursement of ataluren were considered by the HSE Drugs Committee and Leadership Team in 2016 and 2017. The HSE's final decision was that it was not in a position to fund the medicine on the basis of the current clinical evidence of effectiveness and the prices being sought by the applicant company.
The HSE informed the applicant of this decision, in keeping with the requirements of the 2013 Act. The applicant appealed the decision to the High Court, as part of the statutory process under Section 27 of the 2013 Act.
On 6 July 2018, my Department was informed by the HSE that a settlement of the High Court action had been reached.
The Terms of Settlement stipulate that, in the event that the applicant submits a new reimbursement application for ataluren, it would be reviewed by the HSE in a timely fashion, having regard to the relevant statutory framework.
