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 Header Item Written Answers Nos. 1-15
 Header Item Medicinal Products Licensing
 Header Item Medical Card Eligibility
 Header Item Health Services Reform
 Header Item Home Help Service Provision
 Header Item HSE Expenditure

Wednesday, 19 December 2012

Dáil Éireann Debate
Vol. 787 No. 4

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Written Answers Nos. 1-15

The following are questions tabled by Members for written response and the ministerial replies as received on the day from the Departments [unrevised].

  Questions Nos. 1 to 9, inclusive, answered orally.

Medicinal Products Licensing

 10. Deputy Niall Collins Information on Niall Collins Zoom on Niall Collins asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the actions taken to date and his future plans to tackle counterfeit medicine; and if he will make a statement on the matter. [54535/12]

 17. Deputy Niall Collins Information on Niall Collins Zoom on Niall Collins asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the actions taken to date and the future plans the Gardaí have developed to tackle counterfeit medicine; and if he will make a statement on the matter. [55493/12]

Minister of State at the Department of Health (Deputy Alex White): Information on Alex White Zoom on Alex White I propose to take Questions Nos. 10 and 17 together.

The Irish Medicines Board (IMB) is responsible for the regulation of medicines in Ireland. It works with all stakeholders, including the industry and law enforcement agencies, to ensure as far as possible that counterfeit or falsified medicines do not reach the public.

IMB enforcement officers work in cooperation with An Garda Síochána and the Revenue Customs Service throughout the year to detect counterfeit and illegal medicines coming into the State and to investigate instances of illegal supply of medicines over the Internet from retail outlets not authorised to supply medicines, or illegal supply of medicines on the illicit market. Prosecutions have been brought by the IMB and by the DPP against persons breaching regulations under the Irish Medicines Board Acts 1995-2006 relating to the unauthorised manufacture, importation and supply of medicines, to protect public health and protect against the health risks associated with counterfeit medicines.

Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level. The IMB is part of a global rapid alert system on medicines in the authorised supply chain, which monitors and acts on reports of counterfeit medicines that are detected in the supply chain from the manufacturer through to the patient. The IMB participates in two further rapid alert systems, one EU and one global, which deal with counterfeit medicines in illegal markets and pharmaceutical crimes.

For the last five years the IMB, Revenue Customs Service and An Garda Síochána have participated in a unified interagency operational approach in Ireland called Operation PANGEA. This is an international initiative coordinated by Interpol, to tackle the internet supply of counterfeit and illegal medicines. The principal focus of Operation PANGEA is the protection of public health. The IMB is represented on the global organising committee for this operation. The activity conducted during this operation is ongoing throughout the year in Ireland with the Revenue Customs Service detecting illegal supplies of medicines at ports and airports and working with Gardaí in investigations to identify criminal activity and prevent harmful internet-supplied medicines getting to unsuspecting members of the public purchasing online.

Memoranda of Understanding exist between State agencies to support this collaborative approach to combating counterfeit medicines, such as that between the IMB and Revenue Customs Service. The Irish Medicines Board (Miscellaneous Provisions) Act, 2006, provides that Revenue Customs Service officers have enforcement powers under the Act to enable them to adequately respond to instances of illegal importation of medicines, medical devices and other healthcare products. This has proven to be a very positive approach and is evidenced by the amounts of illegal medicines detained annually at the entry points to the State. Further, the Gardaí continually work to identify supply lines of controlled drugs in order to prevent them getting into the drug abuse market.

To date, no counterfeit medicines have been detected in the legitimate medicines supply chain in Ireland. However several instances of counterfeit medicines have been found in the UK and other EU countries over the last ten years even though these countries have been active in taking significant steps to deter this activity.

At an EU level, it is recognised that, as falsifications become more sophisticated, the risk to EU patients increases every year. The new Falsified Medicines Directive, Directive 2011/62/EU, will come into effect from the 2nd January 2013. The transposition of the Directive into Irish law is in progress. This new legislation will further tighten the regulatory regime to prevent the possibility of infiltration of counterfeit medicines into medicines wholesalers and pharmacies and is intended to further protect patients. It introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. These new measures include:

-An obligatory authenticity feature on the outer packaging of key medicines;

-A common, EU-wide logo to identify legal online pharmacies and make it easier to distinguish between legal and illegal online pharmacies throughout the European Union;

-Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and

-Strengthened record-keeping requirements for wholesale distributors.

These new measures will be progressively introduced over the next few years.

The public can be assured that the area of counterfeit medicines is constantly under review. The different State agencies, in particular the IMB, An Garda Síochána and Revenue Customs Service, are working in a cooperative manner to deter, detect and investigate instances of illegality regarding medicines and will continue to do so.

Medical Card Eligibility

 11. Deputy John Browne Information on John Browne Zoom on John Browne asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the reason he narrowed eligibility for the over 70 years medical card; and if he will make a statement on the matter. [57058/12]

Minister of State at the Department of Health (Deputy Alex White): Information on Alex White Zoom on Alex White Due to the current financial climate, it is necessary to identify measures to mitigate the escalating costs of the medical card scheme for both the over 70's cohort and the under 70's cohort.

The changes to income limits for the over 70's, which were announced in Budget 2013, will affect about 5% of the entire over 70's population, which is in the region of 20,000 of the 360,000 over-70's medical card holders. Under the new arrangements, it is envisaged that 92% of the over 70's will retain their medical cards.

At present, people over 70 are entitled to a medical card if their income is less than €700 per week for a single person or €1,400 for a couple. In line with measures announced in Budget 2013, the income limits are being reduced to €600 a week for an individual and €1,200 a week for a couple. This will mean that a single person with an income under €600 per week or a couple with an income under €1,200 per week, will still qualify for a medical card. If a single person has an income of between €600 and €700 per week, or a couple has an income of between €1,200 and €1,400 per week, they will qualify for a GP visit card instead of a medical card. People who lose the medical card will be entitled to make use of the Drugs Payment Scheme (DPS) which reimburses the cost of medication that exceeds a monthly threshold.

  Question No. 12 answered with Question No. 7.

Health Services Reform

 13. Deputy Timmy Dooley Information on Timmy Dooley Zoom on Timmy Dooley asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the key priorities in his new health framework document; and if he will make a statement on the matter. [57063/12]

Minister for Health (Deputy James Reilly): Information on Dr. James Reilly Zoom on Dr. James Reilly On 15 November last, I, together with my colleagues Minister Kathleen Lynch and Minister Alex White launched Future Health: A Strategic Framework for Reform of the Health Service 2012-2015. The core of the Government’s health reform programme is a single-tier health service, supported by Universal Health Insurance and designed in accordance with the principles of social solidarity. Future Health sets out the building blocks towards the introduction of UHI and maps out 48 time defined actions that will be taken to achieve the Government’s objectives.   

Future Health   is founded on:

- A new focus on health and wellbeing, moving away from simply treating ill people to a new concentration on keeping people healthy;

- Reforming our primary, hospital and social care services so we deliver care at the lowest level of complexity;

- Reforming our structures so we deliver services effectively and efficiently; and

- Reforming our financial systems so we can enhance financial control and create the incentive to deliver cost effective care.

I am determined to maintain access and quality during the reform process. We must address huge financial challenges while keeping services safe and of high quality. For this reason, Future Health   proposes that change be implemented in a step by step manner on the basis of good evidence.

I recognise that effective consultation and collaboration with stakeholders will be crucial for the successful implementation of the reform programme. In the two weeks following the launch of Future Health,   I met with some 1,500 local clinical and administrative staff and management as well as regional health forums at fifteen different events across the four HSE regions. I was accompanied by my Department and by the HSE Director General designate of the HSE.   This proved to be a very valuable and worthwhile exercise as it allowed me to outline my plans directly to frontline staff and management, and to engage in productive discussion and debate on health service reform.

The actions in Future Health are already being implemented as a matter of priority and I will ensure that this progress continues next year.    I am confident that with the involvement and support of all of the main stakeholders in the health system, we can deliver on our objectives in the best interest of patients.

Home Help Service Provision

 14. Deputy Mary Lou McDonald Information on Mary Lou McDonald Zoom on Mary Lou McDonald asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly if he will set out in precise terms how he will honour the commitment given (details supplied) in the wake of the budget to restore the core community services of home help hours and home care packages; and if he will make a statement on the matter.  [57006/12]

Minister of State at the Department of Health (Deputy Kathleen Lynch): Information on Kathleen Lynch Zoom on Kathleen Lynch The Government remains firmly committed to supporting vulnerable older people to live in dignity and independence in their own homes and communities for as long as possible. Mainstream Home Help and enhanced Home Care Package services are core to not only supporting vulnerable older people's preferred wishes, but also to reducing pressures elsewhere in the wider care system. The demand for these services, and for additional community based supports such as Meals-on-Wheels and Day or Respite Care, will continue as the demographics, and complex needs, of older people change.

The capacity of the Health Service Executive to provide approved levels of home support services is continually reviewed in the context of overall resources available at particular times. Notwithstanding the recent reduction in HSE home support provision towards the end of this year, to address overall urgent funding pressures, investment in these services will still be significant. All measures are taken by the HSE to ensure that as many people as possible receive a prioritised service, in line with assessed individual needs.

The matters raised by the Deputy are being considered at present in the context of finalising the HSE Service Plan for next year. This is due be published in the near future, in line with agreed procedures and time frames. However, as clearly indicated recently in relation to Social Care services under Budget 2013, the Government will next year restore to 2012 levels core provision of home help, home care packages and personal assistant hours. As is the case with all aspects of HSE Service Plans, these services will be reviewed on a regular basis, in the context of achieving agreed targets or taking account of evolving circumstances over the course of 2013. The Local Health Offices will continue to allocate and monitor services as normal. This includes, at individual recipient level, regular assessment and reviews, to ensure that prioritised resources are directed towards the most vulnerable.

HSE Expenditure

 15. Deputy Bernard J. Durkan Information on Bernard Durkan Zoom on Bernard Durkan asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the degree to which he is satisfied that frontline and or essential services can be retained within the context of the budget for his Department for the year ending 31 December 2013, with particular reference to the extent it has been found possible to identify the precise areas of the service incurring the most cost overruns in each of the past four years to date; if any particular steps have been taken to monitor expenditure on a half yearly, monthly, weekly or daily basis in such a way as to ensure that no shortfall occurs at the end of the year and that areas within the services showing a tendency to overrun budget are identified regularly and early in order to facilitate any remedial action required; and if he will make a statement on the matter. [56973/12]

 192. Deputy Bernard J. Durkan Information on Bernard Durkan Zoom on Bernard Durkan asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly if he is satisfied regarding the adequacy of the budget for his Department to meet in full the projected requirements in the coming year; the extent, if any, to which any unforeseen expenditure can be provided for; and if he will make a statement on the matter. [57322/12]

 196. Deputy Bernard J. Durkan Information on Bernard Durkan Zoom on Bernard Durkan asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the extent to which he has put in place procedures to monitor day to day costs in the health service with a view to prevention of budgetary overruns at year's end; and if he will make a statement on the matter.  [57326/12]

Minister for Health (Deputy James Reilly): Information on Dr. James Reilly Zoom on Dr. James Reilly I propose to take Questions Nos. 15, 192 and 196 together.

As we are all aware, the country still faces serious challenges in respect of the public finances, and the need to meet the targets agreed with the Troika, as part of the Memorandum of Understanding between the Government and the Troika. Notwithstanding these challenges, the Government agreed to provide the Health Group of Votes with an additional €150m over and above the expenditure ceiling set last year.

In respect of next year, Gross Expenditure under the Health Group of Votes will be €14,024 million in 2013. This will consist of €13,627 million in current expenditure and €397 million in capital expenditure. The level of health services to be delivered within the available funding will be set out in the HSE National Service Plan. The Plan will also set out the measures required to fund unavoidable pressures and commitments made under the Programme for Government. In line with the Programme for Government funding will be allocated to further develop mental health services and provide free GP care for persons with certain conditions.

As I have outlined in this House on previous occasions, I have instructed the HSE that efficiencies must be achieved in the first instance before patient services are affected, and in this regard patient safety must be paramount. During 2012 my Department undertook a number of initiatives to address concerns around financial control in the Health Service Executive. These included engaging an expert from the UK NHS to examine the financial management of the HSE and make recommendations regarding strengthening and improving the management of its finances. An assessment of this report and an action plan for the implementation of its recommendations, was also undertaken by PA Consulting. Both reports will be published shortly.

As regards regular monitoring of expenditure, there is intensive engagement between officials from my Department and the HSE each month. My Department provides detailed analysis each month on expenditure trends to the Department of Public Expenditure and Reform, and there is regular engagement between officials from that Department, my own Department and the HSE. The Executive is managed by each Regional Director, both financially and service delivery wise, within a national framework, with the information collated by the Corporate Planning & Performance Directorate of the HSE. This consolidated information forms the basis of its Performance Report, which the Deputy will be aware, is published every month. The Report provides an overall analysis of key performance data from Finance, HR, Hospital and Primary & Community Services. The activity data reported is based on Performance Activity and Key Performance Indicators outlined in the HSE National Service Plan. A Supplementary Report is also produced each month which provides more detailed data on the metrics covered in the Performance Report. The October Performance Report is due to be published this week, and will be available on the HSEs website -

My Department and the HSE is working collaboratively with PA Consulting on a Financial Improvement Programme with a view to strengthening the Executive's financial and performance management and reporting systems during 2013.

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