Written Answers Nos. 500-519
502. Deputy Colm Burke asked the Minister for Health his views on whether medicines pricing and intellectual property rights are unrelated, with pricing determined by national governments through industry negotiations and intellectual property rights set through international trade agreements as incentives for innovation; and if he will make a statement on the matter. [38284/22]
View answerWhile the pricing of medicines is not considered to be fully unrelated to intellectual property rights, particularly in the context of monopoly suppliers, pricing determination remains a national competency. The European Commission has developed an intellectual property rights framework to encourage and sustain innovation by the pharmaceutical industry in developing new medicinal products. For the case of medicines, Supplementary Protection Certificates are available to extend patent protection for medicinal products whereby several years have passed while clinical trials were underway and in advance of receipt of a marketing authorisation. The framework ensures that a return on investment is achievable if a product makes it to market and ensures the continued investment by the pharmaceutical industry in the development of new and innovative medicinal products.
Specific to the setting of prices in Ireland, the Health (Pricing and Supply of Medical Goods) Act 2013 is the primary legislation that governs medicine pricing and reimbursement procedures and policies. Under the 2013 Act, the Health Service Executive (HSE) has the power to set the relevant reimbursement prices for certain medicinal goods. Section 21(2) of the 2013 Act sets out the factors that the HSE must take into account when setting the relevant reimbursement prices proposed by the supplier of a medicine, which are as follows:
(a) the equivalent relevant prices (if practically available) of each item in all other Member States where the item is marketed, (b) the relevant prices of therapeutically similar listed items, (c) the potential therapeutic benefits in each case, (d) the budget impact of each item, (e) the ability of suppliers to meet demand, (f) the resources available to the Executive, and, (g) any agreement on pricing in place with industry
The HSE has also agreed and set out standard processes with industry in relation to the assessment of pricing and reimbursement applications for medicines. In that context, the 2021-2025 multiannual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in reducing the cost of medicines and improving access to innovative new medicines for patients.
Although the use of the Health Act 2013 remains a viable option for the State in managing drug expenditure, it is accepted that there are wider benefits to maintaining a collaborative and cooperative approach with industry to the supply and pricing of medicines while the terms of such framework agreements continue to deliver for all stakeholders.
The new deals will deliver improved access for patients to new and innovative medicines, reductions in the cost of existing medicines and an easing of financial pressure on the health services into the future. It is estimated that this will result in the state paying between €600 million and €700 million less for medicines than it would otherwise.
As part of a pricing and reimbursement application for a new chemical entity, the manufacturer submits a price application form (PAF) for a medicine it wishes the HSE to include on its reimbursement list / for hospital pricing approval. Under the IPHA agreement, the price included in the PAF must be no more than the average price based on 14 nominated states. The states include Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom (UK). This is referred to as external reference pricing (ERP) whereby the price in a ‘basket’ of reference countries is used to derive an acceptable price.
For generic and biosimilars, reimbursement is automatically approved, provided the pricing is in line with the generic and biosimilar (and hybrid) pricing framework/agreement. The pricing of such medicines is linked to the price of the originator or patented medicine.
HSE decisions on which medicines are reimbursed are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.
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 purpose of challenging the pharmaceutical company pricing is to arrive at a position of value for money. In doing so, resources are used as effectively as possible to reimburse a wide range of medicines.
504. Deputy Colm Burke asked the Minister for Health his views on whether a proposal by an organisation (details supplied) on equity-based tiered pricing would help to broaden access to new medicines for all Europe’s citizens; and if he will make a statement on the matter. [38286/22]
View answerThe HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for reply to the Deputy.
506. Deputy Colm Burke asked the Minister for Health if he intends to increase his Department’s representation in Brussels to ensure Ireland’s position is adequately represented in European Council negotiations; and if he will make a statement on the matter. [38288/22]
View answerMy Department has significant engagement at EU level, which is supported and serviced by the Permanent Representation of Ireland to the European Union in Brussels. The resourcing of this work is kept under review to ensure Ireland’s health interests are adequately promoted and represented within the EU and its institutions. Accordingly, with the agreement of the Department of Foreign Affairs, the staffing complement seconded from the Department of Health to the Permanent Representation in Brussels has increased at times of particular demand, such as during Ireland’s Presidency of the Council of the European Union and also in response to increased workloads associated with the management of the COVID-19 pandemic. Undoubtedly the health area has assumed a greater profile internationally since the experience of COVID-19 and officials in my Department will, in consultation with the Department of Foreign Affairs as appropriate, give due consideration to any associated resourcing needs going forward.
507. Deputy Michael Creed asked the Minister for Health if he will consider the reimbursement of international normalized ratio test strips and machines for warfarin patients. [38289/22]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.
The HSE have advised that International Normalised Ratio (INR) self-testing strips such as CoaguChek® are not reimbursable under the General Medical Services (GMS) and Community Drug Schemes. Equipment such as machines are also not reimbursed by the HSE Primary Care Reimbursement Service (PCRS) under Community Drug Schemes.
Whilst a range of diagnostics are available on the Reimbursement List for use in Diabetes, a change in HSE policy would be required to expand this to other therapeutic areas such as INR testing ancillaries.
On very rare occasions, CoaguChek® strips were approved for reimbursement in the most exceptional circumstances under Discretionary Hardship Arrangements where it was clear that there was no other option for the patient i.e. the person was bed bound or could not travel to the INR clinic.
508. Deputy Michael Ring asked the Minister for Health the salary of four roles within his Department (details supplied); and if he will make a statement on the matter. [38298/22]
View answerThe Secretary General of my Department has a current annual salary of €297,869 since 1 February 2022.
The requested salary information paid to Ministers and/or Ministers of State in my Department is available on the Department of Public Expenditure and Reform (DPER) website at the following link: assets.gov.ie/216182/3ab494d7-88f3-4138-83f3-4d307f81c6e8.pdf.
Circular 04 of 2022 sets out the pay scales as of 1 February 2022 for general service grade civil servants working in my Department and is available on the Department of Public Expenditure and Reform’s website at www.gov.ie/en/circular/ef515-application-of-1st-february-2022-pay-adjustments/ and Circular 15-2022 sets out the pay scales as of 1 July 2022 for certain Civil Service Grades working in my Department and is available on the Department of Public Expenditure and Reform’s website at www.gov.ie/en/circular/f45ad-circular-15-2022-fempi-pay-restoration-1-july-2022/.
509. Deputy Duncan Smith asked the Minister for Health the projected cost of providing additional funding to section 39 organisations to provide pay increases in line with the public service pay deal; the breakdown by each organisation; and if he will make a statement on the matter. [38331/22]
View answerFirstly, I would like to acknowledge the important role played by those working in Section 39 organisations around the country.
Under Section 39 of the Health Act 2004, the HSE provides financial assistance to organisations to provide services similar or supplementary to a service that the HSE may provide. However, Section 39 organisations are privately owned and run, and staff in these organisations are not public servants. Their terms and conditions of employment, once in line with employment legislation, are strictly between the employer and the employee.
Certain Section 39 organisations have achieved pay restoration in recent years. An agreement was reached at the WRC in October 2018, in relation to a process of pay restoration for staff employed by 50 agencies only. Pay restoration commenced in April 2019 with an annual pay increase of up to €1,000. Any outstanding balance was paid in 2020 and 2021. A further WRC engagement followed in December 2020 in relation to a final phase of 250 organisations who were identified as part of the earlier agreement. A payment arrangement consisting of three phases was agreed with the first two payments to be made in 2021, and the third and final payment due to be made in 2023.
I am unable to advise you of projected costs for providing additional funding to Section 39 organisations. The previous pay restoration is absolutely limited and only applicable to those included in the initial WRC agreement. There is no scope to revisit the eligibility criteria for the process and that process has reached a final resolution.
510. Deputy Duncan Smith asked the Minister for Health the amount spent on agency staff in 2021 and to date in 2022 across the health service broken down by staffing type and to whom the payments were made; the breakdown of the amount spent on nursing agency staff to date in 2022; his plans to address same; and if he will make a statement on the matter. [38332/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy, as soon as possible.
511. Deputy Duncan Smith asked the Minister for Health the estimated cost of reducing the drugs payment scheme threshold to €50; the estimated full-year cost of a reduction in same from €100 to €80; and if he will make a statement on the matter. [38333/22]
View answerThe Drug Payment Scheme (DPS) provides for the refund of the amount by which expenditure on approved prescribed medicines or medical and surgical appliances exceeds a named threshold in any calendar month. The DPS is not means tested and is available to anyone normally resident in Ireland.
On 1 January 2022, the DPS threshold was reduced to €100 per month. On 1 March 2022, the DPS threshold was further reduced the DPS threshold to €80. The DPS significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.
The €14 reduction to €100 has cost an additional €5m and the €20 reduction to €80 has cost a further €3.4m. There have been almost 38,000 additional claimants on December 2021 levels.
Preliminary data further suggests the full year budget impact of the threshold change from €100 to €80, which came into effect on 1 March 2022, may be around €20m.
Based on this first month of data, the full year estimated minimum cost of reducing the DPS threshold from the current threshold of €80 per month to €50 per month is €39m*.
*This data is subject to the following caveats:
- The source data used is the claiming month March 2022, the first claiming month for the new DPS threshold of €80 per month.
-The source data is annualized to determine cost (i.e., multiplied by 12).
-The costings exclude the cost for any individuals who are below the current threshold level of €80 per month.
-The costings exclude any impact resulting from an aging demographic.
512. Deputy Duncan Smith asked the Minister for Health the projected full-year costs of the free contraception scheme for women aged 17 to 25 years in 2023; if funding is already in place for 2023; the estimated amount that it would cost to extend the scheme up to women aged 45 years; and if he will make a statement on the matter. [38334/22]
View answerThe Programme for Government, 2020 commits to providing free contraception for women, starting with the 17-25 age cohort. My Department's Contraception Implementation Group, convened in July, 2021, has been working with partners, including the HSE, towards ensuring that the scheme will commence in late August, or early September 2022. Funding of approximately €9m has been allocated for this in Budget 2022.The scheme will be open to all 17-25 year-old women ordinarily resident in Ireland and will provide for:
The cost of prescription contraception;
The cost of necessary consultations with medical professionals to discuss suitable contraception options with individual patients and to enable prescription of same;
The cost of fitting and/or removal of various types of long-acting reversible contraception (LARCs) plus any necessary checks, by medical professionals certified to fit/remove same;
The cost of training and certifying additional medical professionals to fit and remove LARCs;
The cost of providing the wide range of contraceptive options currently available to GMS (medical) card holders, which will also be available through this scheme, including contraceptive injections, implants, IUS and IUDs (coils), the contraceptive patch and ring, and various forms of oral contraceptive pill, including emergency contraception.
Full year costings for 17-25 year-olds will be considered in the context of Estimates 2023 and are estimated at €26m. However, no costings have been finalised to date and no funding allocations for future years agreed at this stage. Estimated costings for wider age ranges have been included in the Report of the Working Group on Contraception, which is available on the Department’s website.
The design of citizen engagement information and publicity campaigns to support and promote the roll out of the scheme will be finalised in the coming weeks by officials in the Department’s Press and Communications Team, the HSE’s Communications team and relevant subject matter experts.
Formal consultations with medical representative bodies with regard to service provision under the scheme have commenced and are ongoing. The legal framework for the scheme will be provided by the Health (Miscellaneous Provisions) (No. 2) Bill, 2022. The Bill has now passed all stages in the Oireachtas .
513. Deputy Duncan Smith asked the Minister for Health the estimated cost in 2023 of reducing prescription charges to €1 per item with a cap of €10 for all or to 50 cent per item with a cap of €5 for all; the overall cost of abolishing the charges; and if he will make a statement on the matter. [38335/22]
View answerThe Health Services (Prescription Charges) Regulations 2020 (S.I. No. 464/2020) reduced prescription charges to €1.50 per item for all eligible persons with a cap of €15 per person or family per month.
The Health Services (Prescription Charges) (Over 70s) Regulations 2020 (S.I. No. 465/2020) reduced prescription charges for medical card holders over 70 to €1.00 per item, with a cap of €10 per person or family per month.
Both reductions were effective from 1 November 2020.
The cost of the proposed reductions for those aged over 70:
The full year minimum cost of reducing the prescription charge to €0.50c for eligible persons over 70 and reducing the monthly cap to €5.00 per person or family, is €12.9m.
The full year minimum cost of abolishing prescription charges for eligible persons over 70 is €25.9m.
The cost of the proposed reductions for those under 70:
The full year minimum cost of reducing the prescription charge to €1 for eligible persons under 70and reducing the monthly cap to €10.00 per person or family, is €8.4m
The full year minimum cost of reducing the prescription charge to €0.50c for eligible persons under 70 and reducing the monthly cap to €5.00 per person or family, is €16.8m.The full year minimum cost of abolishing prescription charges for eligible persons under 70 is €37.7m.
Therefore, the minimum cost of abolishing prescription charges for all eligible persons would be approximately €63.6m.
All of these costings are subject to the following caveats:
The forecasted cost is based on persons with claims submitted in the period to the end of April 2022 and is annualised for a 12-month period to give the annual impact.
The reported cost does not reflect the impact of the increase in eligibility numbers experienced in April 2022 onwards resulting from the Ukrainian Support Programme.
Any reduction in or the removal of prescription charges may result in a change in client behaviour.
514. Deputy Duncan Smith asked the Minister for Health the estimated cost of providing in 2023 medical cards to all those diagnosed with cancer; and if he will make a statement on the matter. [38336/22]
View answerUnder the Health Act 1970, eligibility for a medical card is based primarily on means. The Act obliges the HSE to assess whether a person is unable, without undue hardship, to arrange general practitioner services for himself or herself and his or her family, having regard to his or her overall financial position and reasonable expenditure.
The issue of granting medical or GP visit cards based on having a particular disease or illness was previously examined in 2014 by the HSE Expert Panel on Medical Need and Medical Card Eligibility. The Group concluded that it was not feasible, desirable, nor ethically justifiable to list medical conditions in priority order for medical card eligibility. In following the Expert Group’s advice, a person’s means remains the main qualifier for a medical card.
However, every effort is made by the HSE, within the framework of the legislation, to support applicants in applying for a medical card and, in particular, to take full account of the difficult circumstances in the case of applicants who may be in excess of the income guidelines. The HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income threshold where they face difficult financial circumstances, such as extra costs arising from an illness. Social and medical issues are also considered when determining whether undue hardship exists for an individual accessing general practitioner or other medical services.
Furthermore, the HSE also has a system in place for the efficient provision of medical cards in response to emergency situations i.e., in circumstances where persons are in need of urgent ongoing medical care or are receiving end of life care. In these cases, a medical card is issued within 24 hours of receipt of the required patient details and completed medical report by a healthcare professional. Additionally, patients who have been certified by their treating Consultant as having a prognosis of 24 months or less are also now eligible for a medical card without a means assessment.
Finally, it should be noted that since 2015 medical cards are awarded without the need of a financial assessment to all children under 18 years of age with a diagnosis of cancer, for a period of five years.
With regard to the estimated cost of providing a medical card in the manner sought, this information is not readily available and it is, therefore, not possible to provide an estimate of the cost of the proposal.
515. Deputy Duncan Smith asked the Minister for Health the estimated cost of increasing medical card income limits by 5%, 10% or 20%; the projected additional number of cards that would be issued in each case; and if he will make a statement on the matter. [38337/22]
View answerEligibility for a Medical Card is primarily based on a financial assessment which is conducted by the HSE in accordance with the Health Act 1970 (as amended). The HSE assesses each medical card application on a qualifying financial threshold. This is the amount of money that an individual can earn a week and still qualify for a card. It is specific to the individual’s own financial circumstances.Persons aged 69 and under are assessed under the general means tested medical card thresholds which are based on an applicant’s household income after tax and the deduction of PRSI and the Universal Social Charge. Certain expenses are also taken into account, i.e. mortgage payments, which help to increase the amount a person can earn and still qualify for a medical card.Persons aged 70 or older are assessed under the over 70s medical card income thresholds which are based on gross income. It should be noted that in November 2020, the weekly gross medical card income thresholds for those aged 70 and over were increased to €550 per week for a single person and €1,050 for a couple. This increase ensures that a greater proportion of those aged 70 and over now qualify for a medical card.With regard to the estimated cost of the deputy's proposals, the data required to model these are not readily available and it is therefore not possible to provide an estimate of the associated cost or number of cards.
However, I wish to assure the Deputy that, to ensure the medical card system is responsive and sensitive to people's needs, my Department keeps medical card issues, including the current medical card income thresholds under review and any changes are considered in the context of Government policy, the annual budgetary estimates process and other issues which may be relevant.
516. Deputy Duncan Smith asked the Minister for Health the funding provided for the home support service in 2022, the number of homecare packages funded; the projected additional cost of providing a homecare package to each identified case in 2023; and if he will make a statement on the matter. [38338/22]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
517. Deputy Duncan Smith asked the Minister for Health the number of homecare and home help hours that were funded in 2021 and 2022; respectively; and the amount that was not utilised due to staffing shortages; and if he will make a statement on the matter. [38339/22]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
.
518. Deputy Duncan Smith asked the Minister for Health the number of personal assistant hours that were funded in 2022; the number of persons who are currently supported; the number who have applied but not yet been granted support; and if he will make a statement on the matter. [38340/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
519. Deputy Duncan Smith asked the Minister for Health the cost of the flu vaccine programme in 2021 and 2022 respectively; the number of doses that are expected to be provided in 2022; the number of doses ordered by the State; the estimated cost to provide the flu vaccine free to all; and if he will make a statement on the matter. [38341/22]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
