Tuesday, 7 Nov 2017

Written Answers Nos. 668 - 690

Assisted Human Reproduction

Ceisteanna (668)

Mattie McGrath

Ceist:

668. Deputy Mattie McGrath asked the Minister for Health the status of legislation governing assisted human reproduction; and if he will make a statement on the matter. [45896/17]

Freagraí scríofa

Minister for Health

As the Deputy will be aware, on Tuesday 3 October 2017 the Government approved the drafting of a Bill on assisted human reproduction (AHR) and associated areas of research. Officials in my Department are engaging with the Office of the Attorney General in relation to the process of drafting this Bill. The General Scheme is published on the Department's website and has been submitted to the Joint Oireachtas Committee on Health for review.

The introduction of legislation in relation to AHR and associated research is a priority for me, however, it is not possible at this time to give a definitive timeline for the completion of the Bill and its subsequent passage through the Houses of the Oireachtas.

Question No. 669 answered with Question No. 662.

Hospital Appointments Status

Ceisteanna (670)

John McGuinness

Ceist:

670. Deputy John McGuinness asked the Minister for Health if an early appointment will be arranged for a person (details supplied) [45905/17]

Freagraí scríofa

Minister for Health

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 scheduling of appointments for patients is a matter for the hospital to which the patient has been referred. Should a patient's general practitioner consider that the patient's condition warrants an earlier appointment, he or she should take the matter up with the consultant and the hospital involved. In relation to the specific case raised, I have asked the HSE to respond to you directly.

Health Services Provision

Ceisteanna (671)

John McGuinness

Ceist:

671. Deputy John McGuinness asked the Minister for Health if the funding for the care of a person (details supplied) will be made available; the options of care being considered; and the timeframe for a final long-term decision in the matter. [45906/17]

Freagraí scríofa

Minister of State at the Department of Health

As this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Health Services Provision

Ceisteanna (672)

John McGuinness

Ceist:

672. Deputy John McGuinness asked the Minister for Health if HIQA, the Medical Council, the Nursing and Midwifery Board, the Pharmaceutical Society and the Quality Assurance and Verification Division have responded to the request from his Department to examine documents provided by a person (details supplied); if the organisations have responded to the Secretary General as requested; if the HSE and QAVD have made contact directly with the person as requested by the Secretary General; and if he will make a statement on the matter. [45908/17]

Freagraí scríofa

Minister for Health

As the Deputy is aware there are a number of serious care and patient safety issues raised across a number of services in relation to this case.

Because of the complexity and range of matters raised, the HSE's Quality Assurance and Verification Division has been asked by the Director of the National Patient Safety Office in my Department to follow up regarding actions required and communicating with the family. I am advised by the HSE that this process is ongoing.

My Department has also referred the correspondence in question to the relevant regulatory bodies for their consideration and action as appropriate.

Regulatory bodies have in place processes to manage information referred to them in line with their statutory functions. It would not be appropriate for my Department to provide further comment in this regard.

Rare Diseases Strategy Implementation

Ceisteanna (673)

Billy Kelleher

Ceist:

673. Deputy Billy Kelleher asked the Minister for Health the action taken to implement recommendations 30 to 39 of the national rare disease plan on access to medicines and technologies, in tabular form [45915/17]

Freagraí scríofa

Minister for Health

A National Rare Disease Plan for Ireland was launched by the Minister in July 2014. This is a generic policy framework for rare diseases. The scope of the plan is broad given that there are 8,000 rare diseases approximately affecting millions of EU citizens; and consequently, there can be a dearth of expertise and knowledge about some rare diseases, simply because they are so rare. Earlier this year, the Department published a Progress Report on the Rare Disease Plan.

The Steering Group Recommendations on access to medicines and technologies for people with rare disease in the Republic of Ireland and the actions taken to date are outlined as follows:

Recommendation	Action
30. The HSE develop a Working Group to bring forward appropriate decision criteria for the reimbursement of orphan medicines and technologies. The approach should include an assessment system similar to that for cancer therapies established under the National Cancer Control Programme and link with the CAVOMP at European level.	The terms of reference have been developed for a Rare diseases technology review committee and this will largely follow the approach in place for technology review of cancer treatments. Michael Barry has been appointed Chair of this committee.
31. The HSE undertake a preliminary economic evaluation of current activity and costs for orphan medicine and technologies for rare disease patients across all hospitals settings.	The Acute Hospital Drugs Management Programme is undertaking a project to understand the patient numbers on enzyme replacement treatment, the cost of this treatment and the place of treatment.
32. Applications for the use of orphan medicines and technologies in hospitals be dealt with in the context of a national budget, rather than through individual hospital budgets, and that the HSE take account of this.	The Acute hospitals drugs management programme is examining how approved enzyme replacement treatment might be funded via a centralised mechanism in a similar way to multiple sclerosis.
33. The HSE develop a publicly available annual report documenting the use of both existing and new-to-market orphan medicines and technologies in Ireland and a summary of applications received and decisions relating to those applications.	Not commenced
34. The existing horizon scanning between pharmaceutical companies and the HSE, including clinical value assessment authorities, continue and be enhanced so as to improve information available regarding orphan medicines in the pipeline and the future needs for these medicines.	There is a formal horizon scanning process in place via the corporate pharmaceutical unit in the HSE.
35. The capacity to prescribe all orphan medicines and technologies for ultrarare conditions be limited to specialist teams designated through the Centres of Expertise.	Enzyme replacement treatment this is in place.
36. The HSE apply a set of guidelines on the prescribing of orphan medicines and technologies in Ireland. The HSE should evaluate clinical outcomes regarding use of orphan medicines.	This is a function of the Rare Diseases Technology Review committee.
37. Clinicians should provide data necessary to the monitoring of prescription patterns and pharmacovigilance, so as to ensure patient safety and high-quality healthcare.	This is already in place for some orphan conditions and clinicians are obliged to report any adverse events for drugs which they prescribe.
38. Early dialogue between the HSE and companies who are running clinical trials in Ireland with Irish patients where license approval is imminent.	Not commenced
39. Sponsors could be offered an incentive to run trials in Ireland increasing access to innovation for Irish patient	Not commenced

The National Centre for Pharmacoeconomics (NCPE) conducts the economic evaluation of new and existing technologies (e.g. pharmaceuticals, vaccines, diagnostics) to determine their cost effectiveness or value for money.

A new Committee called the “Rare Diseases Medicinal Products/Technology Review Committee” was established in June 2017 by the NCPE. The terms of reference for the Committee have been finalised and the responsibilities of the Committee include the review of proposals for funding of new products for rare diseases or expanded indications for existing products for rare diseases.

The Committee will also contribute to the development of clinical guidelines for relevant Orphan Medicinal Products and support the implementation of same.

Dr. Michael Barry is the Chair of the Committee since 13 September 2017. It is expected that Committee will begin its work in early 2018 after appointment of the necessary support staff.

Long-Term Illness Scheme

Ceisteanna (674)

Catherine Murphy

Ceist:

674. Deputy Catherine Murphy asked the Minister for Health further to Parliamentary Question No. 1031 of 2 May 2017, if he will provide a historical list of the products added to and removed from the long term illness scheme since its introduction; and if he will make a statement on the matter. [45920/17]

Freagraí scríofa

Minister for Health

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.

Drugs Payment Scheme Coverage

Ceisteanna (675)

Billy Kelleher

Ceist:

675. Deputy Billy Kelleher asked the Minister for Health the orphan drugs considered for reimbursement by the National Centre for Pharmacoeconomics in each of the years from 2011 to 2016 and to date in 2017, by the year of final recommendation, in tabular form; and if each drug was recommended for reimbursement [45921/17]

Freagraí scríofa

Minister for Health

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.

Health Services

Ceisteanna (676, 838)

Mary Butler

Ceist:

676. Deputy Mary Butler asked the Minister for Health if he will provide a progress report on the national review of cardiac services in Ireland; when this review will commence; if he has identified a cardiologist that will lead this review; and if he will make a statement on the matter. [45922/17]

David Cullinane

Ceist:

838. Deputy David Cullinane asked the Minister for Health when the planned national review into cardiac care will commence; if it will be independent; the role the HSE and the ACS programme will play in the review; if it will be overseen by an international expert; if its conclusions will replace the Herity report for the south east; if it will examine the range of travel time for PPCI for those living in regions without 24-7 PPCI; if it will take into account activity generated from a mobile cath lab deployed at UHW; and if he will make a statement on the matter. [46914/17]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 676 and 838 together.

As you know I wrote to you on this matter yesterday. My Department has been working on a proposal for a national review of cardiology services which is now at an advanced stage and which I plan to commence shortly.

Rare Diseases

Ceisteanna (677)

Billy Kelleher

Ceist:

677. Deputy Billy Kelleher asked the Minister for Health if he will report on the work of the technical review committee for orphan drugs; the date of the committee's establishment; the membership of same; the chairperson of the committee; the date of their appointment; the number of meetings that have taken place; the recommendations that have been made by the committee; the action taken to implement recommendations; and if he will make a statement on the matter. [45927/17]

Freagraí scríofa

Minister for Health

The National Centre for Pharmacoeconomics (NCPE) conducts the economic evaluation of new and existing technologies (e.g. pharmaceuticals, vaccines, diagnostics) to determine their cost effectiveness or value for money.

A new Committee called the “Rare Diseases Medicinal Products/Technology Review Committee” was established in June 2017 by the NCPE. The terms of reference for the Committee have been finalised and the responsibilities of the Committee include the review of proposals for funding of new products for rare diseases or expanded indications for existing products for rare diseases.

The Committee will also contribute to the development of clinical guidelines for relevant Orphan Medicinal Products and support the implementation of same.

Dr. Michael Barry is the Chair of the Committee since 13 September 2017. It is expected that Committee will begin its work in early 2018 after appointment of the necessary support staff.

Long-Term Illness Scheme

Ceisteanna (678)

Catherine Murphy

Ceist:

678. Deputy Catherine Murphy asked the Minister for Health if he will re-establish the entitlement to free testing strips under the long-term illness scheme for persons diagnosed with gestational diabetes during pregnancy; the rationale for the cessation of the scheme; the amount saved on a monthly basis since the entitlement ceased; and if he will make a statement on the matter. [45936/17]

Freagraí scríofa

Minister for Health

As this is a service matter, it has been referred to the Health Service Executive for direct reply to the Deputy.

Hospital Appointments Status

Ceisteanna (679)

Mary Lou McDonald

Ceist:

679. Deputy Mary Lou McDonald asked the Minister for Health the status of a hip replacement operation in respect of a person (details supplied); and if he will make a statement on the matter. [45938/17]

Freagraí scríofa

Minister for Health

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 scheduling of appointments for patients is a matter for the hospital to which the patient has been referred. Should a patient's general practitioner consider that the patient's condition warrants an earlier appointment, he or she should take the matter up with the consultant and the hospital involved. In relation to the specific case raised, I have asked the HSE to respond to you directly.

Medical Card Applications Data

Ceisteanna (680)

Tom Neville

Ceist:

680. Deputy Tom Neville asked the Minister for Health the status of a medical card application by a person (details supplied). [45942/17]

Freagraí scríofa

Minister for Health

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.

National Treatment Purchase Fund

Ceisteanna (681)

Peter Burke

Ceist:

681. Deputy Peter Burke asked the Minister for Health if a person can access the National Treatment Purchase Fund for an operation they have been waiting on for 18 months (details supplied); and if he will make a statement on the matter. [45943/17]

Freagraí scríofa

Minister for Health

I acknowledge that waiting times are often unacceptably long and I am conscious of the burden that this places on patients and their families.

Reducing waiting times for the longest waiting patients is one of this Government's key priorities. Consequently, Budget 2017 allocated €20 million to the NTPF, rising to €55 million in 2018. Budget 2018 allocated additional funding in the region of €10m for the remainder of 2017 to fund patient treatment across a range of key specialties and procedures.

Under waiting list initiatives run by the NTPF, the NTPF liaises directly with hospitals to identify patients to be treated. The patients are then contacted to arrange the details of treatment.

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.

In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to you directly.

Health Care Infrastructure Provision

Ceisteanna (682)

Billy Kelleher

Ceist:

682. Deputy Billy Kelleher asked the Minister for Health the number of purchase orders processed by purchase officers in County Mayo since January 2017 in logistics and inventory management in respect of health business services; the number of persons that worked on theses purchase orders; the number at grade 4 and over; the combined salary of these persons; and if he will make a statement on the matter. [45951/17]

Freagraí scríofa

Minister for Health

Your question has been referred to the Health Service Executive for direct reply as the HSE is responsible for the delivery of health care infrastructure projects.

Health Services Provision

Ceisteanna (683)

Billy Kelleher

Ceist:

683. Deputy Billy Kelleher asked the Minister for Health if a case review will be carried out for a person (details supplied); and if he will make a statement on the matter. [45956/17]

Freagraí scríofa

Minister of State at the Department of Health

As this is a service matter I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Medicinal Products Reimbursement

Ceisteanna (684, 685)

Billy Kelleher

Ceist:

684. Deputy Billy Kelleher asked the Minister for Health the steps he will take regarding the unprecedented High Court appeal brought by a company (details supplied) against the HSE decision not to reimburse for Translarna for the treatment of Duchenne muscular dystrophy for two children; and if he will make a statement on the matter. [45957/17]

Billy Kelleher

Ceist:

685. Deputy Billy Kelleher asked the Minister for Health if his Department or the HSE will work towards an interim arrangement to treat children with Translarna; and if he will make a statement on the matter. [45958/17]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 684 and 685 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 HSE informed my Department of its decision not to reimburse Ataluren (Translarna) in July 2017. The HSE, in deciding not to reimburse Translarna, cited uncertainty around clinical evidence but advised the applicant that it would be open to reviewing any additional clinical evidence if any should become available. The HSE informed the applicant of this decision, in keeping with the requirements of the 2013 Act. The applicant has appealed the HSE’s decision to the High Court, which is part of the statutory process under Section 27 of the 2013 Act.

As proceedings have now issued against the HSE, this is now subject to the Courts process.

It would be inappropriate for me to comment on a matter currently before the Courts.

Hospital Appointments Delays

Ceisteanna (686)

Lisa Chambers

Ceist:

686. Deputy Lisa Chambers asked the Minister for Health the reason for the delay in scheduling a date for a person (details supplied) to have a surgical procedure that was recommended by a consultant over two years ago; the timeframe for this procedure in this case; and if he will make a statement on the matter. [45959/17]

Freagraí scríofa

Minister for Health

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 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 you directly.

Question No. 687 answered with Question No. 620.

Medical Aids and Appliances Provision

Ceisteanna (688)

James Browne

Ceist:

688. Deputy James Browne asked the Minister for Health the estimated cost of the provision of a defibrillator in each public building owned by his department and agency under the aegis of his Department; and if he will make a statement on the matter. [45974/17]

Freagraí scríofa

Minister for Health

The Department of Health does not own any buildings. However, in relation to Hawkins House, where the Department is currently situated, a defibrillator was purchased for €2,359.50 in July 2005. I have asked the HSE to reply directly to the Deputy regarding the cost of defibrillators within its organisation. Details for other bodies under the aegis of the Department are operational matters for the bodies concerned and the Deputy should contact the relevant Director/CEO/Registrar directly.

Medical Card Applications

Ceisteanna (689)

Niamh Smyth

Ceist:

689. Deputy Niamh Smyth asked the Minister for Health further to parliamentary question number 392 of 17 October 2017, if an application for a medical card by a person (details supplied) will be expedited in view of the fact that information provided in the previous application was omitted during processing; the timeframe for a decision to issue; and if he will make a statement on the matter. [45983/17]

Freagraí scríofa

Minister for Health

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.

Strategic Communications Unit

Ceisteanna (690)

Niall Collins

Ceist:

690. Deputy Niall Collins asked the Minister for Health the meetings of the strategic communications unit he or his Department officials attended; the date and location of each such meeting; and if he will make a statement on the matter. [45994/17]

Freagraí scríofa

Minister for Health

The Strategic Communications Unit of the Department of the Taoiseach will proactively identify, develop and deliver identified major cross-Government, citizen-centred communications campaigns.

I, and officials from my Department, met with officials from the Strategic Communications Unit in Leinster House on 25 October 2017.