Written Answers Nos. 1585-1598
1588. Deputy Michael Ring asked the Minister for Health when payment will issue from the HSE to a person's former employer (details supplied) considering that they were fully eligible to receive the pandemic social recognition payment; and if he will make a statement on the matter. [57080/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy.
1589. Deputy Anne Rabbitte asked the Minister for Health the stage of approval the drug tabrecta is at; the timeline for approval; and if he will make a statement on the matter. [57081/23]
View answerThe HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.
The HSE considers the following criteria prior to making any decision on pricing / reimbursement in line with the Health (Pricing and Supply of Medical Goods) Act 2013:
(1) The health needs of the public,
(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,
(3) The availability and suitability of items for supply or reimbursement,
(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,
(5) The potential or actual budget impact of the item or listed item,
(6) The clinical need for the item or listed item,
(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,
(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and
(9) The resources available to the HSE
In terms of the specific details of the application for pricing and reimbursement of Capmatinib (Tabrecta®):
The HSE received an application for pricing and reimbursement on the 8th July 2022 from Novartis (the applicant) for Capmatinib (Tabrecta®) for advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 11th July 2022.
• The NCPE Rapid Review assessment report was received by the HSE on the 10th August 2022. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of Capmatinib compared with the current standard of care.
• The HSE commissioned a full Health Technology Assessment (HTA) on the 1st September 2022 as per agreed processes.
• The NCPE publishes details of medicines where the HSE has commissioned a Rapid Review assessment and/or a full health technology assessment on their website. The website is updated at regular intervals and includes assessment outcomes and updates on reimbursement for each individual medicine and indication listed. Details of the assessment(s) of Capmatinib (Tabrecta®) are available at www.ncpe.ie/capmatinib-tabrecta-hta-id-22049/
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
• The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. The pharmacoeconomic report will be reviewed by the HSE Drugs Group along with the outputs of any commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Executive Management Team.
• The decision making authority in the HSE is the HSE Executive Management Team. The HSE Executive Management Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
• To date a HTA submission has not been received by the NCPE.
The application remains under consideration. The HSE cannot make any comment on the possible outcomes of this application.
1590. Deputy Pádraig Mac Lochlainn asked the Minister for Health the reason for the delay for pharmacies in County Donegal not receiving ipramol at the same time as other pharmacies in the South of Ireland; and if he will make a statement on the matter. [57082/23]
View answerTeva BV, the company responsible for supplying Ipramol to patients, has not notified the Health Products Regulatory Authority (HPRA) of any shortages of Ipramol.
Additionally, the HPRA has verified with wholesalers that a significant delivery of Ipramol was received into Ireland on 19th December.
Any delays in receipt of Ipramol by pharmacies could be due to logistics delays and not from shortages of the product nationally.
1591. Deputy Paul Kehoe asked the Minister for Health the measures he is taking to control access to vaping products for children under the age of 18 years to restrict the sale of highly flavoured vapes which are marketed towards children and to control the levels of nicotine in vapes; and if he will make a statement on the matter. [57092/23]
View answerIt is an offence to sell e-cigarettes to persons under 18 since 22 December 2023 when section 28 of the Public Health (Tobacco Products and Nicotine Inhaling Products) Act 2023 was commenced. The offence carries a penalty of a fine up to €4,000 and/up to a six month term of imprisonment.
The Public Health (Tobacco Products and Nicotine Inhaling Products) Act will also introduce:
• a prohibition on the sale of nicotine inhaling products from self-service vending machines, temporary or moveable premises, and events aimed at children.
• a prohibition on the advertising of nicotine inhaling products near schools, in cinemas, or on public transport.
• My Department recently completed a public consultation to help inform future regulation of tobacco and nicotine inhaling products. This consultation looked at what further measures could be introduced to decrease the appeal of nicotine inhaling products to young people. Views were sought on the following areas:
• The display of nicotine inhaling products in shops
• Nicotine inhaling product flavours
• The appearance of nicotine inhaling products and their packaging
• Proxy sales of tobacco and nicotine inhaling products
• Smoking in outdoor dining areas
• Extending smoke free restrictions to vaping
• Increasing the age of sale for tobacco products
• Taxation of vaping liquids
• In the context of all of these considerations, options for the development of further and comprehensive legislation on nicotine inhaling products will be examined.
• The nicotine content of nicotine inhaling products is regulated by the Tobacco Products Directive (Directive 2014/40/EU). These Regulations also provide for mandatory safety and quality requirements for e-cigarettes and refill containers, including maximum volumes for cartridges, tanks and nicotine liquid containers. These Regulations were transposed into Irish law by S.I. 271 of 2016.
1592. Deputy Bríd Smith asked the Minister for Health the number of ministerial licence applications and MCAP applications have been made by clinics (details supplied); what products are available from these clinics; which products are available under MCAP and covered for reimbursement; when the MCAP review report is expected; and if he will make a statement on the matter. [57098/23]
View answerThe identity of clinicians who either apply for a Ministerial Licence or to enter the Cannabis for Medical Use Register for the purpose of treating their patients is confidential and will not be made public.
The products available to MCAP patients are defined as "specified controlled drugs" S.I. No. 262/2019 - Misuse Of Drugs (Prescription And Control Of Supply Of Cannabis For Medical Use) Regulations 2019, and are contained in Schedule 1 of the Regulations as set out below and are covered by the Long |Term Illness, GMS or Medical Card as appropriate.
|
Name of Cannabis product or preparation and brand name |
Dosage form |
Concentration of THC (percentage, weight/weight or weight/volume) |
Name of manufacturer |
|
Aurora High CBD Oil Drops |
Oral solution |
Less than 3% w/v (< 30mg/ml) This product also contains cannabidiol (CBD) 60% w/v (600mg/ml) |
Aurora Cannabis Enterprises Inc., 4439 Township Road 304, Cremona, Alberta, Canada, T0M 0R0 |
|
CannEpil ™ |
Oral solution |
0.5% w/v (5mg/ml) This product also contains cannabidiol (CBD) 10% w/v (100mg/ml) |
MGC Pharmaceuticals d.o.o., Kamniška ulica 29, 1000, Ljubljana, Slovenia |
|
Tilray Oral Solution THC10:CBD10 (25ml) |
Oral solution |
1% w/v (10mg/ml) This product also contains cannabidiol (CBD) 1% w/v (10mg/ml) |
Tilray Portugal Unipessoal Lda., Zona Industrial de Cantanhede, Lote 121, Cantanhede, 3060-197, Portugal |
|
Aurora Sedamen Softgels |
Capsules |
5mg/capsule This product also contains cannabidiol (CBD) less than 0.2mg/capsule |
Aurora Cannabis Enterprises Inc. 4250 14th Avenue, Markham, Ontario, Canada L3R 0J3 |
|
Oleo Bedrobinol |
Dried flower |
13.5% w/w (135mg/g) This product also contains cannabidiol (CBD) less than 1.0% w/w (less than 10mg/g) |
Bureau voor Medicinale Cannabis Postbus 16114 2500 BC DEN HAAG The Netherlands |
|
Oleo Bedrocan |
Dried flower |
22% w/w (220mg/g) This product also contains cannabidiol (CBD) less than 1.0% w/w (less than 10mg/g) |
Bureau voor Medicinale Cannabis Postbus 16114 2500 BC DEN HAAG The Netherlands |
|
Althea CBD12:THC10 (50ml) |
Oil |
1% w/v THC (10mg/ml) This product also contains 1.25% w/v (12.5mg/ml) cannabidiol (CBD) |
Tasmanian Alkaloids pty Ltd T/A Extractas Bioscience, Westbury, Tasmania, Australia 7303 |
|
Oleo Genetics 10:10 |
Oil (oral solution) |
1% w/v (10mg/ml) This product also contains cannabidiol (CBD) 1% w/v (10mg/ml) |
ADREX Pharma GmbH Firmungstrabe 4 56068 Koblenz Germany |
|
Oleo Genetics 25:1 |
Oil (oral solution) |
2.5% w/v (25mg/ml) This product also contains cannabidiol (CBD) <0.1% w/v (<1mg/ml) |
ADREX Pharma GmbH Firmungstrabe 4 56068 Koblenz Germany |
|
Althea THC20:CBD1 (50ml) |
Oil |
2% w/v THC (20mg/ml) This product also contains <0.1% w/v (<0.1mg/ml) cannabidiol (CBD) |
Tasmanian Alkaloids pty Ltd T/A Extractas Bioscience, Westbury, Tasmania, Australia 7303 |
The MCAP review is anticipated to be completed in 2024.
1593. Deputy Róisín Shortall asked the Minister for Health the reason letters are being sent to parents informing them that their child will be removed from primary care waiting lists unless they return a form within two weeks (details supplied); the rationale for this short timeframe of two weeks; if this practice is applied consistently across the country; if there is any recourse for parents who do not see this letter in time, for example during summer or Christmas holidays; if steps will be taken to ensure that parents with additional needs are appropriately accommodated; and if he will make a statement on the matter. [57111/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
The Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday 6th October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE.
1594. Deputy Charles Flanagan asked the Minister for Health when family members (details supplied) will get an appointment for early intervention, occupational therapy and speech and language therapy; their current place on the waiting list; and if he will make a statement on the matter. [57123/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
The Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday 6th October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE.
1595. Deputy Michael McNamara asked the Minister for Health further to Parliamentary Question No. 574 of 28 November 2023, which he claimed only part of which related to operational matters, will be answered; and if he will make a statement on the matter. [57133/23]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
As the Deputy may be aware, management and administrative grade staff in the Fórsa union in the HSE commenced industrial action on Friday 6th October. As a consequence of this industrial action, members in these grades are not engaging with political forums or processes. As a result, the question asked by the Deputy may be delayed in receiving a response directly from the HSE.
1596. Deputy Bernard J. Durkan asked the Minister for Health the reason for the shortfall in reimbursement for treatment abroad in the case of a person (details supplied); and if he will make a statement on the matter. [57149/23]
View answerAs this refers to an individual case, I have referred this matter to the HSE for their attention and direct reply to the Deputy.
1597. Deputy Carol Nolan asked the Minister for Health the total number of terminations carried out under ss. 9-12 of the Health (Regulation of Termination of Pregnancy) Act 2018, by the Ireland East Hospital Group for 2019, 2020, 2021, 2022, and to date in 2023, in tabular form; and if he will make a statement on the matter. [57164/23]
View answerUnder section 20 (1) of the Health (Regulation of Termination of Pregnancy) Act 2018:
"A notification of each termination of pregnancy carried out under the legislation must be notified to the Minister for Health within 28 days of it being carried out. Section 20, subsections (3) and (4), require the Minister to prepare a report on the notifications received in a given year not later than 30 June the following year and thereafter to lay it before the Houses of the Oireachtas and arrange for its publication."
The following information is recorded and sent to the Minister:
• Medical Council registration number of the medical practitioner who carried out the termination of pregnancy;
• The section of the Act under which the termination was carried out, i.e., section 9, 10, 11 or 12;
• Medical Council registration number(s) of the medical practitioner(s) who made the certification concerned;
• The county of residence, or place of residence (where the woman resides outside of the State) of the woman concerned;
• The date on which the termination of pregnancy was carried out.
All of the above information has been published in the Annual Reports for years the 2019-2022, which have can be found at www.gov.ie/en/collection/c26b8-annual-reports-on-notifications-in-accordance-with-the-health-regulation-of-termination-of-pregnancy-act-2018/
1598. Deputy Matt Shanahan asked the Minister for Health to review the taxation treatment of GP group practises (details supplied) with respect to the specific queries raised in correspondence; and if he will make a statement on the matter. [57169/23]
View answerWhile the collection of taxes and issues relating to the interpretation of tax law are a matter for the Revenue Commissioners, I am aware of the concerns that were raised around the tax treatment of GP's GMS income and the related guidelines issued by the Revenue Commissions.
The guidelines illustrate how GPs’ GMS income should be treated for the purposes of tax. To allow GPs and GP practices time to make any necessary adjustments to their arrangements to ensure compliance with applicable tax policy and legislation, Revenue implemented transitional arrangements up to the end of 2023.
Following engagement between my Department and the HSE with the Revenue Commissioners and the Department of Finance, the Finance (No.2) Bill 2023, now enacted, was amended so as to insert section 1008A into the Taxes Consolidation Act 1997. Section 1008A provides that where individual GPs enter into contracts with the HSE, to provide certain medical services, and provide those services in the conduct of a partnership profession with other individual GPs, the income can be treated for income tax purposes as that of the partnership, where a joint election is made. The amendment also provides that any Professional Services Withholding Tax (PSWT) credit may be claimed by the medical partnership in such circumstances. This legislation came into force on the 1st of January.
Section 1008A does not operate to treat income of an employee of a partnership as income of the partnership, nor does it apply in the case of a partnership involving any persons who are not individuals.
My Department and the HSE continue to engage with the Office of the Revenue Commissioners and the Department of Finance, as well as with the IMO, on this matter.
The current contractual arrangements for the GMS, as well as other issues, will be examined under the Strategic Review of General Practice, which will propose measures necessary to modernise the contract.
