Written Answers Nos. 527-544
527. Deputy Sandra McLellan asked the Minister for Health in relation to the treatment abroad scheme if it is normal procedure for funding to be pulled last minute after the person (details supplied) has landed in the country where the treatment is due to take place; and if he will make a statement on the matter. [28324/15]
View answerThe HSE operates the Treatment Abroad Scheme (TAS) for persons entitled to treatment in another EU/EEA member state or Switzerland under EU Regulation (EC) No. 883/2004, as per the procedures set out in EU Regulations (EC) No. 987/2009, and in accordance with Department of Health Guidelines. Patients have the ability to apply to the HSE TAS seeking access to public healthcare outside the state through model form E112. As part of the approval process it is required that the hospital outside the state will accept form E112 (IE). Acceptance of this form effectively means payment for the treatment will be at a state to state level following from the aim of the EU Regulation to facilitate free movement for citizens of their social security entitlements within member states.
The Deputy should be reminded that the HSE has never withdrawn approval from any patient including this child. The approval granted remains in place and is consistent with the criteria for the Scheme. The approval letter provided in this case specified that the approval granted for treatment abroad was limited to the particular treatment and to the hospital within the public system as was listed in that approval letter. The child attended a private facility which was not the hospital listed in the approval letter and which does not accept model form E112 as a method of payment. The issue of availing of private healthcare outside the terms of the Scheme and the approval given, is a matter for the parents and referring doctors and cannot be addressed by the HSE TAS. However, the HSE is cognisant of this child's situation and is currently reviewing the case. A decision on the review of the case will be issued within days. The availing of the treatment abroad in the public health sector remains an option which would be fully funded as per the approval issued.
528. Deputy Pearse Doherty asked the Minister for Health further to Parliamentary Question No. 113 of 22 April 2015, when a person (details supplied) in County Donegal will receive an appointment from Letterkenny General Hospital in County Donegal; and if he will make a statement on the matter. [28325/15]
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. In relation to your further query in this matter, I have asked the HSE to respond to you directly. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.
529. Deputy Michael Healy-Rae asked the Minister for Health if he will provide the details of what dictates or requires the product information for Roaccutane to be reviewed and updated; the number of times this has been done since its authorisation in 1983; the way the Health Products Regulatory Authority and its European Union counterparts have worked with a pharmaceutical company (details supplied) to facilitate availability of appropriate product information in association with Roaccutane since 1983; if he will provide all data, documentation and details relating to this; and if he will make a statement on the matter. [28326/15]
View answer530. Deputy Michael Healy-Rae asked the Minister for Health if he will provide details of all licence renewal applications for Roaccutane since its authorisation in 1983; and if he will make a statement on the matter. [28327/15]
View answer531. Deputy Michael Healy-Rae asked the Minister for Health if he will provide all data documents, details and standards of quality, as part of the marketing authorisation for Roaccutane submitted by a pharmaceutical company (details supplied) to the Health Products Regulatory Authority in 1983, prior and post, and in order of submission; and if he will make a statement on the matter. [28328/15]
View answer532. Deputy Michael Healy-Rae asked the Minister for Health the laws in place governing the immediate reporting by health care professionals of adverse drug reactions in regard to Roaccutane, since its authorisation in 1983; if he will make it a criminal offence if adverse drug reactions are not reported immediately; and if he will make a statement on the matter. [28329/15]
View answer533. Deputy Michael Healy-Rae asked the Minister for Health the fee, as regulated and approved by the Minister for Health, that is paid for licence renewal; to whom and by whom this fee is payable; if he will provide details of all approvals from the Minister for Health, and of a pharmaceutical company's (details supplied) involvement in regard to Roaccutane since 1983; and if he will make a statement on the matter. [28330/15]
View answer537. Deputy Michael Healy-Rae asked the Minister for Health the regulations and agreement that were made between the Minister for Health, a pharmaceutical company (details supplied) and the Health Products Regulatory Authority, in association with Roaccutane, since 1983, and prior to marketing; the reason Roaccutane received unlimited marketing authorisation on 10 July 2009; and the role and involvement the Minister for Health, the company and the Authority have. [28362/15]
View answer538. Deputy Michael Healy-Rae asked the Minister for Health the pregnancy prevention programmes that have been in place for Roaccutane since 1983; the role the Health Products Regulatory Authority and a pharmaceutical company (details supplied) have; the details of same; and if he will make a statement on the matter. [28363/15]
View answerI propose to take Questions Nos. 529 to 533, inclusive, 537 and 538 together.
Under European and Irish legislation, all medicinal products must be authorised before being marketed. They are issued with a Marketing Authorisation (MA). Roaccutane was first authorised for use in Ireland on 19 April 1983. Comprehensive standards of quality for applications for MAs are contained within EU and Irish legislation, and regulatory guidance documents. These were comprehensively referenced in my answer to PQ 26769/15. The same legislation covers all data requirements as well as pharmacovigilance requirements.
The product information requirements, including their format and content, are also detailed in these guidance documents. Both are approved as an intrinsic part of the licensing of a medicine and continuously updated to reflect the current state of knowledge of the medicine concerned and the risks associated with its use, as new data become available and is assessed by the HPRA and/or its European counterparts.
The package leaflet is subject to user-testing to ensure its ease of readability by patients. Package leaflets are available in the medicine’s packaging and on the HPRA and other websites. Any changes to the licence document or product information deemed necessary after assessment of applications are made by the company concerned. There have been numerous updates to the product information for Roaccutane; currently available records indicate at least 27 updates to these documents, with multiple changes made to them in the context of some of these updates.
There is currently no fee for the renewal of MAs. Rather, companies pay the HPRA an annual maintenance fee of €650 for the first 10 MA's they hold and €812 for additional authorisations; this is to cover all aspects of routine dossier management and maintenance, including the work associated with on-going pharmacovigilance activities. Information on the renewal of the authorisations for medicinal products was provided in my response to PQ 18776/15.
Roaccutane was last renewed on 10 July 2009 with an unlimited MA. Unlimited MAs are a requirement of the legislation as explained that same response of May 2015. An unlimited authorisation does not preclude changes to the product information for healthcare professionals and patients. Changes can be made, when required, on the basis of ongoing pharmacovigilance activities and assessments.
Part of this ongoing pharmacovigilance is the monitoring, review and evaluation of reported adverse drug reactions. Reporting of adverse events has been a function of the HPRA since its establishment as the Irish Medicines Board (IMB) in 1995, and prior to 1995 by the National Drugs Advisory Board (NDAB). Reporting of suspected adverse reactions by healthcare professionals (e.g. doctors/dentists/pharmacists/nurses) and patients/carers is undertaken on a voluntary basis, with all groups strongly encouraged to report when they consider a medicine may have contributed to the effects experienced. WHO data indicates that Ireland was ranked tenth highest reporter across 121 participating countries during 2014, reflecting the active contribution of Irish healthcare professionals to the reporting programme. Given these levels of reporting and the very positive response of healthcare professionals to requests for reports over the years, it is not considered that a mandatory based system of reporting by healthcare professionals is appropriate or necessary. The HPRA does however continue to regularly remind health care professionals about reporting adverse drug reactions via its Drugs Safety Newsletter.
Since it was first authorised for use in Ireland, Roaccutane (isotretinoin) has been contraindicated in women who are pregnant or breastfeeding. Use of isotretinoin has also been consistently contraindicated in women of childbearing potential since the product was first authorised, unless all of the conditions specified in the product information are met.
An EU wide Pregnancy Prevention Plan (PPP) was introduced in October 2003 to further reduce the potential risk of pregnancy in women by expanding the available information and highlighting the well-known and documented risks related to use in women of child-bearing potential. These measures include supplementary information distributed to prescribing doctors, pharmacists, other relevant healthcare professionals and patients, including the following:
- Physician’s guide to prescribing Roaccutane to female patients;
- Physician’s checklist for prescribing to female patients;
- Patient information brochure;
- Important information for patients prescribed Roaccutane on contraception; and
- Pharmacist’s guide to dispensing Roaccutane.
The PPP applies across all EU member states and is monitored and reviewed at EU level. The company submits the information gathered through the PPP on a yearly basis to the competent authority for each EU member state (i.e. HPRA in Ireland). The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC), (at which Ireland is represented by the HPRA) assesses the data provided to consider any need to strengthen/amend the PPP as part of the regular review of the effectiveness of these risk minimisation measures.
Licence applications and licence renewal applications contain commercially sensitive information. The HPRA has a duty to protect confidential information submitted by companies, healthcare professionals and patients and cannot release the information requested without third-party consent.
534. Deputy Thomas P. Broughan asked the Minister for Health if he will report on his recent estimations of the amount of funding that is required to fix our failing healthcare systems, including funding for acute hospitals, emergency rooms, community care, nursing home care, residential care for those with disabilities, and residential detoxification services, per heading; and if he will make a statement on the matter. [28353/15]
View answerHealth care infrastructure projects support service delivery and are determined by the demands and pressures of the service to be delivered. There will always be more infrastructure projects than can be funded by the Exchequer and future developments must be prioritised for consideration within the context of the overall capital envelope available to the health service. A focused review of priorities and the current and emerging health care pressures and demands has been completed in the context of the review by the Department of Public Expenditure of the State's public capital investment needs for the five year period 2016-2020. The outcome will be set out in that Department's Medium Term Capital Investment Framework Report and will outline the capital envelope decided upon by the Government for the period to 2020 identifying priority areas for investment, including health care investment. The report will be published when the Government has considered and made its decisions on future capital investment. Therefore it would not be timely to comment on the process at this stage.
535. Deputy Thomas P. Broughan asked the Minister for Health if he will report on whether he is making a Supplementary Estimate for 2015; and if he will make a statement on the matter. [28354/15]
View answerThe Exchequer funding provided in 2015 provided a more realistic funding level for the health services and was very welcome as part of a two year programme to put the health services on a more sustainable financial footing.
However, pressures are arising in a number of areas, particularly in relation to expenditure on acute hospital services, demand led schemes and legal settlements. In addition, the Government committed additional funding of €74m earlier this year to address the issue of delayed discharges and ED pressures, which of itself would require a Supplementary Estimate.
Whilst it is clear that a Supplementary Estimate will be required, given the uncertainty around certain expenditure areas, it is too early to quantify this requirement.
My Department continues to work closely with the HSE to ensure that the greatest degree of budgetary control is exercised.
536. Deputy Thomas P. Broughan asked the Minister for Health if he has considered the possibility of introducing a sugar tax on food stuffs with a high-sugar content; the potential health benefits to persons by reducing their intake of refined sugar; and the potential revenue to the Exchequer by introducing such a tax; and if he will make a statement on the matter. [28355/15]
View answerConsideration has in the past been given to the introduction of a levy on Sugar Sweetened Drinks. In 2012 the Department commissioned a Health Impact Assessment of a sugar sweetened drinks levy, which concluded that, "price increases tend to decrease demand but the degree to which this happens is variable because consumer behaviour and industry response to tax is difficult to predict". Subsequent to this the European Region of the World Health Organisation (WHO), has recently published a document on the experience of other European countries and showed a mixed picture. In some countries this is viewed as income generation and has no impact on consumption but in others the early indications suggest a reduction in consumption of sugar sweetened drinks. This matter is being kept under review. An Obesity Policy and Action Plan is currently under development and will address a broad range of measures to reduce the level of overweight and obesity in Ireland.
539. Deputy Michelle Mulherin asked the Minister for Health the reason it will take a minimum of six months before an additional rheumatologist post will be filled, given that the post was approved at the last medical-human resources forum of the Health Service Executive west; and if he will make a statement on the matter. [28422/15]
View answerAs this is a service matter, I have asked the HSE to respond to you directly. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.
540. Deputy Bobby Aylward asked the Minister for Health if he will prioritise a medical operation for a person (details supplied), as a matter of urgency; and if he will make a statement on the matter. [28431/15]
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. In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to you directly. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.
541. Deputy Tom Fleming asked the Minister for Health his views on a recent study revealing that a far higher proportion of Ireland's elderly population live in long-term nursing homes than the European average; his plans to liaise with other Departments to examine the economics of the provision of services and financial support for those elderly persons who are well enough to stay at home; and if he will make a statement on the matter. [28442/15]
View answerGovernment policy is and will continue to be to prioritise facilitating older people to remain in their own homes and communities for as long as possible, and ensuring that appropriate residential care is available when it is needed.
The HSE provides a range of community-based services aimed at ensuring older people receive safe, timely and appropriate care and treatment at the lowest level of complexity, and as close to home as possible.
In its National Service Plan (NSP) for 2015 the HSE stated that it will continue to progress the strategic realignment of services to provide home care and community support services in order to maximise the potential of older people in their own homes and communities. The levels of home supports planned for in the NSP are:
- 10.3 million hours of home help service supporting 50,000 people - this is same level of service as 2014.
- 13,800 people in receipt of a home care packages at any one time - this includes an additional 600 people supported under the delayed discharges initiative.
- 190 people in receipt of an intensive home care package at any one time - these packages were introduced for the first time in 2014 for people with more complex care needs.
It would be of great concern to me if we were placing more people in residential care than happens in other comparable countries, but I do not think that this is in fact the case. The proportion of older people in residential care is a constantly changing one, and international comparison can be quite problematic because of differences in models of care and in definition of what constitutes long term residential care etc. However, in Ireland we generally have somewhere between 4% to 4.5% of those aged over 65 in residential care, and this is about average for other countries in the OECD.
Notwithstanding this, I would hope to reduce this number further. The Review of the Nursing Homes Support Scheme, as well as considering the historical and future operation of the Scheme itself, will consider how community and other services should be developed in order to facilitate more older people to stay at home for longer, and towards this end it identifies the services that should be prioritised into the future as resources allow. These include home care, better linkages between acute and community services, short stay beds, the use of assistive technology and consideration of new residential models on a collaborative basis by the Departments of Health and Environment and Local Government. The Review is almost complete and will be published as soon as possible.
542. Deputy Dan Neville asked the Minister for Health the position regarding the provision of a wheelchair to a person (details supplied) in County Limerick; and if he will make a statement on the matter. [28449/15]
View answerAs the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy. If the Deputy has not received a reply from the HSE within 15 working days, he can contact my Private Office and they will follow the matter up with the HSE.
543. Deputy Caoimhghín Ó Caoláin asked the Minister for Health when a decision will be made on an application to the Health Service Executive by a company (details supplied) to have funding for the drug Fampyra reinstated. [28452/15]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to reimbursing any medicine, the HSE considers a range of statutory criteria including clinical need, cost-effectiveness and the resources available to the HSE.
The decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. They are not political or ministerial decisions.
In May 2013, the HSE decided that it could not approve the reimbursement of Fampridine under the GMS or other schemes, as the manufacturer (Biogen Idec) had failed to demonstrate or provide any formal justification for the prices proposed. The HSE decision was in line with many other European countries who have also, to date, not provided for the drug under their public health systems.
The HSE re-engaged with the company in July 2014 (and again in October 2014) seeking improved commercial offerings. The outputs of those commercial engagements were re-considered by the HSE Drugs Committee at its November 2014 meeting.
The Committee decided to seek additional detailed information from clinical experts as to how a responder-only reimbursement scheme (i.e. patients confirmed as positive responders to the medication) would operate for this product. The feasibility of this option is currently under consideration.
544. Deputy Robert Troy asked the Minister for Health if he will expedite an appointment for surgery for a person (details supplied) at the Midland Regional Hospital in Tullamore in County Offaly. [28454/15]
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 Health Service Executive, 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. If you have not received a reply from the HSE within 15 working days please contact my Private Office and my officials will follow the matter up.
