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 Header Item Written Answers Nos. 270-281
 Header Item Health Services Issues
 Header Item Animal Testing
 Header Item Substance Misuse
 Header Item Departmental Funding
 Header Item Medicinal Products Expenditure
 Header Item Medicinal Products Supply
 Header Item Medicinal Products Supply
 Header Item Medicinal Products Prices
 Header Item Home Help Service Provision

Thursday, 27 June 2013

Dáil Éireann Debate
Vol. 808 No. 3

First Page Previous Page Page of 79 Next Page Last Page

Written Answers Nos. 270-281

Health Services Issues

 270. Deputy Joe McHugh Information on Joe McHugh Zoom on Joe McHugh asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the position regarding the State's services for sufferers of vasculitis; if his Department acknowledges potential improvements in pertinent medical research and medical resources; and if he will make a statement on the matter. [31407/13]

 273. Deputy Joe McHugh Information on Joe McHugh Zoom on Joe McHugh asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly if he will consider establishing a registry of vasculitis sufferers in this State or alternatively a North-South registry that would facilitate development of relevant non-statutory support groups and would enable sufferers to work together to establish commonly beneficial resources; if he will raise this matter at an upcoming meeting of the North-South Ministerial Council; and if he will make a statement on the matter. [31410/13]

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. 270 and 273 together.

  There is no set treatment regime for vasculitis. Treatment depends on the type of vasculitis that a person has, the organs affected and the severity or otherwise of the condition. Treatment may involve taking over the counter medication and/or prescription medication or, in certain cases, surgery. A patient's General Practitioner or Consultant is in the best position to advise on the particular treatment options in each individual case.

  There are no plans to establish a national registry of sufferers or to raise this matter at the North South Ministerial Council.

Animal Testing

 271. Deputy Joanna Tuffy Information on Joanna Tuffy Zoom on Joanna Tuffy asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly when Regulation 1223/2009 dated 11 March 2013 in relation to the ban on animal-tested cosmetics will be fully implemented and if the submission of the Irish anti-Vivisection Society (details supplied) will be taken into account; and if he will make a statement on the matter. [31408/13]

Minister of State at the Department of Health (Deputy Alex White): Information on Alex White Zoom on Alex White Regulation 9 of S.I. No. 870 of 2004 which prohibits the marketing of cosmetic products and ingredients that have been tested in animals has been in force since 11 March 2009, except for a derogation relating to three toxicity checks. On 11 March 2013, this derogation ended, and no further testing on animals of cosmetics or ingredients can take place.

It has been the policy of the Department of Health not to licence the use of live animals for testing of cosmetics in Ireland and this is confirmed by the statistical information provided by the Department to the European Commission under Article 13 of Directive 86/609/EEC, as amended. Furthermore, there have been no incidences of breaches of this ban detected in ongoing European cosmetic surveillance programmes brought to the attention of the Irish Medicines Board (IMB) or my Department to date.

The relevant Regulations require the manufacturer of the product, the manufacturer's agent, the person to whose order the cosmetic product is manufactured for, or the person who first supplies the cosmetic product in the European Union, to ensure that cosmetics imported, distributed or retailed in Ireland or the EU comply with the legislation. Enforcement of the legislation is provided for in Regulation 12 of S.I. No. 870 of 2004 and the IMB is the Competent Authority responsible for ensuring that the legislation is complied with.

On 11 March 2013 the EU Commission published a Communication on the animal testing ban. This Communication concluded that the marketing ban should enter into force, be coherently implemented throughout the EU and that the research and development of alternative testing methods for toxicity of cosmetics should be prioritised as part of the EU's trade and international cooperation agenda.

All comments received will be taken into account and modifications made to the guidance document as deemed appropriate.

Substance Misuse

 272. Deputy Caoimhghín Ó Caoláin Information on Caoimhghín Ó Caoláin Zoom on Caoimhghín Ó Caoláin asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly if the position of chief executive officer of the Addiction Counsellors of Ireland is funded by his Department; and if he will make a statement on the matter.  [31409/13]

Minister for Health (Deputy James Reilly): Information on Dr. James Reilly Zoom on Dr. James Reilly The position of Chief Executive Officer of the Addiction Counsellors of Ireland is not funded by my Department.

 Question No. 273 answered with Question No. 270.

Departmental Funding

 274. Deputy Billy Kelleher Information on Billy Kelleher Zoom on Billy Kelleher asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the reason only €300,000 of €3 million funding that he announced in January 2013 has been spent to date; and if he will make a statement on the matter. [31422/13]

 275. Deputy Billy Kelleher Information on Billy Kelleher Zoom on Billy Kelleher asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the catchment areas that will benefit from the staff recruited at the Health Service Executive therapeutic unit for children with autism at (details supplied) in Dublin 9 following his allocation of €300,000 for north Dublin; and if he will make a statement on the matter. [31423/13]

 276. Deputy Billy Kelleher Information on Billy Kelleher Zoom on Billy Kelleher asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the reason 30% of the €1 million funds spent on autism in 2013 went to north Dublin; and if he will make a statement on the matter. [31424/13]

Minister for Health (Deputy James Reilly): Information on Dr. James Reilly Zoom on Dr. James Reilly I propose to take Questions Nos. 274 to 276, inclusive, together.

The HSE National Review of Autism Services: Past, Present and Way Forward Report (2012) and the Progressing Disabilities Services for Children and Young People (0-18s) Programme set out the policy context for the provision of autism services to children and young people.

The objective of the Progressing Disabilities Programme is to achieve a national, unified approach to delivering disability health services so that there is a clear pathway to the services for all children, regardless of where they live, what school they go to or the nature of their disability. This Programme aims to remedy the variations in service provision around the country. To assist in addressing some of these variations, I announced the allocation of €1m in funding for autism and early intervention services in 2012.

Beechpark is a regional, community-based HSE service which provides specialised clinical supports for children with a specific diagnosis of autistic spectrum disorder up to 18 years of age, who attend designated special schools, outreach preschools and outreach classes in Dublin, Kildare and Wicklow. I approved €300,000 of this funding, which equates to five therapists posts, for Beechpark services in Dublin, north of the Liffey, based on the options contained in a report prepared by the HSE. This was to address the pressing needs of its catchment area, with a particular emphasis on reducing waiting times. The report also proposed an allocation for Beechpark in the Dublin Mid-Leinster region which was to be rolled out in year two.

Following ongoing discussions on the best way forward in relation to Beechpark Autism Services, the HSE has confirmed that the funding approved will be allocated to HSE Dublin North East in 2013 for Beechpark in order to address the waiting list for services in Dublin North East. This will provide, in the first instance, for the recruitment of the necessary five therapy staff. The catchment areas that will benefit are the Local Health Office areas of Dublin North, Dublin North Central and Dublin North West.

I also established an Independent Review Group in 2012, to look at the Beechpark model of services and how resources could be used in the best and most effective way, in light of the HSE Review of Autism Services and the re-organisation of services underway in line with the 0-18s Programme. Further funding in relation to Beechpark and other regions of the country, was put on hold, pending the outcome of this Review. I understand that this Review is expected to be concluded shortly.

The HSE has confirmed that the €300,000 is just a first step in 2013. The balance of funding for autism and early intervention services nationally will be made available. The issue of the allocation of these further resources will be required to be looked at, in light of the findings of the Independent Review.

Medicinal Products Expenditure

 277. Deputy Caoimhghín Ó Caoláin Information on Caoimhghín Ó Caoláin Zoom on Caoimhghín Ó Caoláin asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly if he will provide in tabular form the total drugs bill for the State in the years 2011, 2012 and to date in 2013; if he will provide a breakdown of same by on-patent, off-patent branded and generic; and if he will make a statement on the matter. [31426/13]

Minister of State at the Department of Health (Deputy Alex White): Information on Alex White Zoom on Alex White The cost to the HSE of drugs and medicines supplied under the GMS, Drug Payment and Long Term Illness schemes was €1.53 billion in 2012 and €1.47 billion in 2011. Figures for 2013 to date are not yet available.

  I have asked the HSE to provide a breakdown of this expenditure by on-patent, off-patent branded and generic to the Deputy.

Medicinal Products Supply

 278. Deputy Caoimhghín Ó Caoláin Information on Caoimhghín Ó Caoláin Zoom on Caoimhghín Ó Caoláin asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly if he will detail the most recent Irish Pharmaceutical Healthcare Association and Association of Pharmaceutical Manufacturers in Ireland agreements in relation to the supply of drugs to the State; the savings expected from these deals in 2013 and subsequent years; and if he will make a statement on the matter. [31427/13]

Minister of State at the Department of Health (Deputy Alex White): Information on Alex White Zoom on Alex White Following intensive negotiations involving the Irish Pharmaceutical Healthcare Association (IPHA), the HSE and the Department of Health, a major new deal on the cost of drugs in the State was concluded in October last. It will deliver a number of important benefits, including:

- significant reductions for patients in the cost of drugs;

- a lowering of the drugs bill to the State;

- timely access for patients to new cutting-edge drugs for certain conditions; and

- reducing the cost base of the health system into the future.

  The IPHA agreement provides that prices are referenced to the currency adjusted average price to wholesaler in the nominated EU member states in which the medicine is then available. The prices of a range of medicines were reduced on 1 November and further price reductions were implemented on 1 January 2013 in accordance with the agreement.

  The gross savings arising from this deal will be in excess of €400m over 3 years. €210 million from the gross savings will make available new drugs to patients over 3 years. Thus, the deal will result in a net reduction in the HSE expenditure on drugs of about €190m.

  The Department of Health and the HSE also successfully finalised discussions with the Association of Pharmaceutical Manufacturers in Ireland (APMI), which represents the generic industry, on a new agreement to deliver further savings in the cost of generic drugs. Under this Agreement, since 1 November 2012, the HSE only reimburses generic products which have been priced at 50% or less of the initial price of an originator medicine. In the event that an originator medicine is priced at less than 50% of its initial price the HSE requires a generic medicine to be priced below the originator price. This represents a significant structural change in generic drug pricing and should lead to an increase in the generic prescribing rate.

  It is estimated that the combined gross savings from the IPHA and APMI deals will be in excess of €120 million in 2013.

Medicinal Products Supply

 279. Deputy Caoimhghín Ó Caoláin Information on Caoimhghín Ó Caoláin Zoom on Caoimhghín Ó Caoláin asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly if he will provide an update in the work undertaken by the national task force on prescribing and dispensing; the savings expected to be delivered by this approach; and if he will make a statement on the matter. [31428/13]

Minister of State at the Department of Health (Deputy Alex White): Information on Alex White Zoom on Alex White The HSE has been working with GPs over many years to encourage better quality prescribing of drugs in Ireland. In 2012, the HSE's Medicines Management Programme was established and one of its key tasks is to communicate with prescribers regarding best practice.

The Programme has identified 'preferred drugs' for prescribers when prescribing Proton Pump Inhibitors (PPIs) or statin medication for patients. This is the first time that the State has introduced a preferred drug initiative. PPIs are prescribed for patients with peptic ulcer disease and/or reflux and statin medication is for high cholesterol. The preferred PPI is Lansoprazole and the preferred statin is Simvastatin. The HSE is asking doctors to prescribe these preferred drugs in order to save money, both for patients who pay for their medication and to deliver savings of an estimated €15million for the taxpayer.

A further initiative underway to assist with GP prescribing is the launch of the HSE's Prescribing Guidance System (PGS). This system supports prescribers with integrated 'point of prescribing' information making it easier for GPs to make decisions in line with MMP prescribing guidance. In turn, the system also gives assurance regarding the effectiveness of prescribing guidance interventions.

It is anticipated that this prescribing guidance system will be a critical assistance to the GP community and significantly important to the wider health system.

Medicinal Products Prices

 280. Deputy Caoimhghín Ó Caoláin Information on Caoimhghín Ó Caoláin Zoom on Caoimhghín Ó Caoláin asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly if he will provide an update on the Health (Pricing and Supply of Medical Goods) Bill 2012; if the Bill has been enacted; the impact it has had or is expected to have on prescribing practices; the cost savings expected from same; and if he will make a statement on the matter.  [31429/13]

 288. Deputy Caoimhghín Ó Caoláin Information on Caoimhghín Ó Caoláin Zoom on Caoimhghín Ó Caoláin asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly if there are plans to introduce competitive tendering for high volume off-patent drugs; the savings such a move would deliver; and if he will make a statement on the matter. [31437/13]

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. 280 and 288 together.

The Health (Pricing and Supply of Medical Goods) Act 2013 was commenced on Monday, 24 June 2013. This Act provides for the introduction of a system of generic substitution and reference pricing. It also sets out statutory procedures governing the supply, reimbursement and pricing of medicines and other items to patients under the GMS and community drug schemes.

  The commencement of this Act provides the Irish Medicines Board (IMB) and the HSE with a robust statutory framework for the introduction of generic substitution and reference pricing on a phased basis, with priority given to those medicines which will achieve the greatest savings for patients and the State.

  Previously, when a specific brand of medicine was prescribed for a patient, a pharmacist could only supply that particular brand, even when less expensive generic versions of the same medicine were available. The Act now permits pharmacists to substitute medicines prescribed, provided that they have been designated as safely interchangeable by the IMB.

  The IMB will review an initial 20 active substances, which equates to approximately 1,500 individual medicines. It is expected that the first List of Interchangeable Medicines, containing groups of atorvastatin products, will be published in mid-August. The IMB will publish subsequent lists for other groups of medicines on an ongoing basis. From the end of the year onwards, hundreds of thousands of prescriptions will be subject to generic substitution, which will offer choice and reduced prices to patients.

  The legislation provides that the HSE may set a reference price for each group of interchangeable products published on the List of Interchangeable Products. Reference pricing involves the setting of a common reimbursement price, or reference price, for a group of interchangeable medicines. It means that one reference price is set for each group or list of interchangeable medicines, and this is the price that the HSE will reimburse to pharmacies for all medicines in the group, regardless of the individual medicine's prices. The first reference price is expected to be implemented by November.

  Under the latest agreement negotiated with the Association of Pharmaceutical Manufacturers of Ireland which came into effect on 1st November 2012, the price of generic medicines published on the List of Interchangeable Medicines by the IMB will be immediately reduced from not more than 50% to not more than 40% of the pre-patent expiry prices of the equivalent branded original medicines, i.e. a reduction of 20% on the current price of generic products. This price reduction will take effect in advance of the setting of a reference price.

  Eligible patients using State drug schemes like the Medical Card or Drugs Payment Scheme will not face any additional costs for products priced at or below the reference price. If a patient would like to receive a particular brand that costs more than the reference price then the patient will have to pay the additional cost of that product. In cases where substitution is prohibited for clinical reasons, patients will not face any additional costs if the prescribed product costs more than the reference price.   

  The Act also provides that the HSE may use a competitive process to determine the relevant price of medicines reimbursed under the community drugs schemes. While there are no plans at present to introduce competitive tendering, in the case of high volume, off-patent medicines, it is expected that the HSE will set reference prices where appropriate. Reference prices will be set in accordance with the criteria set out in the legislation, in particular, securing value for money for the taxpayer.

  This legislation will promote price competition, a greater use of generics and deliver lower medicine prices for the taxpayer and for patients. It is not possible, at this juncture, to provide accurate figures regarding potential savings resulting from the introduction of generic substitution and reference pricing, as these depend on various factors including prevailing prices, number of competitors, availability of substitute products, and market dynamics.

Home Help Service Provision

 281. Deputy Caoimhghín Ó Caoláin Information on Caoimhghín Ó Caoláin Zoom on Caoimhghín Ó Caoláin asked the Minister for Health Information on Dr. James Reilly Zoom on Dr. James Reilly the total number of home help hours and home care packages delivered in each of the years 2011, 2012 and to date in 2013 and the cost of same; the expected total for same for the full year of 2013; and if he will make a statement on the matter. [31430/13]

Minister of State at the Department of Health (Deputy Kathleen Lynch): Information on Kathleen Lynch Zoom on Kathleen Lynch As this is a service matter it has been referred to the Health Service Executive for direct reply.


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