Written Answers Nos. 315-328
315. Deputy Neasa Hourigan asked the Minister for Health his plans to update and modernise CORU’s assessment of recognition process, given that it remains a paper-based and lengthy process; if he is aware whether the process acts as a deterrent to health and social care professionals looking to work in Ireland; and if he will make a statement on the matter. [12022/23]
Amharc ar fhreagraThe process for the recognition of international qualifications operated by CORU, the Health and Social Care Professionals Council, has been fully digital, using an application portal and back-end system which supports processing, validation, assessment and reporting activities, since September 2021. A pilot for two high-volume professions ran from March to September of that year. Following a period of transition when applications were accepted in the old format (paperless but email based) and via the new application portal, all applications (with the exception of those requiring additional supports) have been made through an application portal on the CORU website at: Apply for Recognition - Coru since January 2022.
In 2022, CORU’s Registration Boards made 48% more decisions on applications for recognition of International Qualifications than they had in 2021. Despite this rapid rise in applications and decisions the average time required to deliver a recognition decision dropped to 69 days in Q3 and Q4 of 2022. This was a significant reduction on the 2021 average of 87 days and the 2020 average of 75 days (the 2018 and 2019 averages were 72 and 75 days respectively).
Delivering a recognition decision includes validation and checking of all evidence supplied such as degree certificates and transcripts, a portfolio style assessment of all relevant qualifications held and additional work-based learning where relevant, formulation of a recommendation by a team of experts, and consideration of that recommendation and final decision by the Registration Board. In some cases, this involves a request for, and analysis of, additional information.
This was achieved through completion of the transition into a fully digital system alongside a number of other changes, made with the support of my Department, to reduce the time required to assess international qualifications while maintaining the necessarily robust assessment system in the interests of public protection. These other initiatives included: transition to a Voice over IP telephone system to ensure effective and efficient phone support to applicants to reduce email traffic which is slower; transition to a new VPN system to improve connectivity; changes in procedures; changes in staffing and organisation; and increased frequency of decision-making meetings of the registration boards.
CORU is in the process of procuring a system which will integrate the processes of recognition of international qualifications and registration for all applicants which will further reduce administrative requirements and timeframes for applicants.
316. Deputy Pádraig O'Sullivan asked the Minister for Health the average length of time it takes to approve an EMA-approved orphan medicine in Ireland, from receipt of application for reimbursement to actual approval; how this compares with EU counterparts; and if he will make a statement on the matter. [12031/23]
Amharc ar fhreagraThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
317. Deputy Pádraig O'Sullivan asked the Minister for Health the average length of time it takes to approve an EMA-approved medicine for reimbursement in Ireland, from receipt of application for reimbursement to actual approval; how this compares with EU counterparts; and if he will make a statement on the matter. [12032/23]
Amharc ar fhreagraThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
318. Deputy Pádraig O'Sullivan asked the Minister for Health the average length of time it takes to approve an EMA-approved cancer drug in Ireland, from receipt of application for reimbursement to actual approval; how this compares with EU counterparts; and if he will make a statement on the matter. [12033/23]
Amharc ar fhreagraThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
319. Deputy Pádraig O'Sullivan asked the Minister for Health if he will outline the research that has been done internally in his Department to analyse or compare how Ireland ranks with EU counterparts for the approval of EMA-approved orphan medicines; and if he will make a statement on the matter. [12034/23]
Amharc ar fhreagraThe Health (Pricing and Supply of Medical Goods) Act 2013 provides a rigorous process for the assessment of new medicines for reimbursement. This allows taxpayers to be confident both that the right medicines are chosen, and that those medicines are approved at a price that can sustainably be afforded in a budget-limited health service. Economic assessment is valuable to stretch the funds granted to the HSE as far as possible, allowing them to provide a range of services as well as innovative medicines for all citizens.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority. In line with the 2013 Act, and the national framework agreed with industry, a company must first submit an application to the HSE to have a new medicine added to the reimbursement list.
The timing of company applications for reimbursement in different countries can vary for a number of reasons, not least the available market share in each country. Once a company responsible for the commercialisation of a new medicine receives market authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. Describing timelines for reimbursement from EMA approval to HSE reimbursement approval does not consider this important factor and misrepresents the process, as statutorily the HSE would not be able to approve or assess a drug until an application for reimbursement was received.
When an application is made to have a product added to the reimbursement list in Ireland, the HSE is required, under the 2013 Act, to decide within 180 days of receiving the application, to either add the medicine to the reimbursement list or refuse to reimburse the medicine. In assessing the application, the HSE is required to consider a range of criteria including the magnitude of the clinical effect, cost effectiveness, budget impact, opportunity cost and unmet need.
The principal factors in determining the speed of reimbursement are the price at which a manufacturer applies for the reimbursement of a product and the outcome of the HSE’s rigorous assessment process as to its clinical and cost-effectiveness.
In terms of the time taken from application to a decision on reimbursement, the HSE advise that the biggest impediments to achieving the 180-day timeline is often the failure of companies to provide sufficient evidence to support the efficacy of some medicines, and the need for the HSE to get involved in protracted negotiations in seeking to achieve better prices for the State.
The State is committed to providing timely access to new and innovative medicines to all patients. Budget 2021 allocated €50 million for the reimbursement of new drugs, enabling the HSE to approve 52 new medicines. 18 of these medicines had orphan designation.
Budget 2022 allocated a further €30 million for the reimbursement of new medicines allowing the HSE to approve 60 new drugs, 16 of which had orphan designation. Further dedicated funding of €18 million was allocated in Budget 2023.
The pricing and reimbursement of medicines is a national competence. Different pharmaceutical reimbursement systems are currently in place across the EU. As Member States operate different systems, a direct comparison of the reimbursement of products is not possible.
320. Deputy Pádraig O'Sullivan asked the Minister for Health the number of EMA-approved orphan drugs that were approved for reimbursement in each of the years 2016 to 2022; the date these drugs were applied for initially, in tabular form; and if he will make a statement on the matter. [12035/23]
Amharc ar fhreagraThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
321. Deputy Pádraig O'Sullivan asked the Minister for Health the number of staff allocated to the National Rare Disease Office; the qualifications of the staff working there; if additional resources will be allocated; and if he will make a statement on the matter. [12036/23]
Amharc ar fhreagraA breakdown of the staff employed as whole-time equivalents (WTE) in the National Rare Diseases and their qualifications is set out in tabular form below as of 7 March 2023. Any additional funding requests for the National Rare Diseases Office will be considered as part of the Annual Estimates process.
|
Position |
WTE |
Qualifications |
|
Clinical Lead |
0.3 |
MD, FRCPI, FRCPC, FCCMG (Clinical Genetics) Clinical Professor of Medicine of Rare Disorders, TCD; Full Clinical Professor, UCD |
|
Deputy/Asst. Clinical Lead |
0.4 |
Currently vacant – plan to recruit in 2023 |
|
Business Manager |
1.0 |
BA HRM; Project Management |
|
Information Scientist |
0.9 |
MSc Genetic Counselling |
|
Information Scientist |
0.6 |
PHD Medical Genetics; MSc Genetic Counselling |
|
Information Scientist |
0.4 |
MSc in Clinical Neuroscience |
|
Information Scientist |
0.2 |
MSc in Clinical Neuroscience |
|
Administrator |
1.0 |
Currently vacant – soon to be filled |
|
Total WTE in post |
3.4 |
|
|
Total WTE allocated |
4.8 |
322. Deputy Pádraig O'Sullivan asked the Minister for Health the number of genetic consultants employed in Ireland; the plans, if any, to recruit additional consultants specialising in genetics; and if he will make a statement on the matter. [12037/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
323. Deputy Pádraig O'Sullivan asked the Minister for Health the average time expended during the orphan drugs reimbursement process waiting for industry or pharmaceutical companies to revert with additional information that has been requested of them; his views on whether this is a significant factor in the delay of the process; how this can be improved; and if he will make a statement on the matter. [12038/23]
Amharc ar fhreagraThe HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
324. Deputy Pádraig O'Sullivan asked the Minister for Health if he has met with a group (details supplied); if the group would qualify for any funding; and if he will make a statement on the matter. [12039/23]
Amharc ar fhreagraI am advised by my Office that there is no record of any such meeting request; and nor has my Department received any request for funding.
325. Deputy Michael Lowry asked the Minister for Health if he will clarify his and the HSE's position on Special Leave with Pay for HSE personnel suffering from long-term Covid illness and unable to work; if the present Special Leave with Pay scheme will be extended for eligible staff beyond 30 June 2023; and if he will make a statement on the matter. [12041/23]
Amharc ar fhreagraThe Department of Public Expenditure and Reform have provided for Special Leave with Pay (SLWP) for the recommended isolation period (currently 7 days), for civil and public servants nationally who contract Covid.
For certain employees who remain unfit to attend the workplace and are suffering from long-Covid, a temporary Scheme, specific to the public health service was introduced to provide for Paid Leave for Public Health Service Employees unfit for work post Covid infection.Employees who met the eligibility criteria for the Scheme will have transferred to the Scheme retrospectively from 1st July 2022.For those who do not meet the criteria for the temporary Scheme but remain unwell, the provisions of the Public Service Sick Leave Scheme may be utilised. It is my understanding that an epidemiological survey is planned by the HSE which will provide insight into the prevalence of long-Covid in the Irish population including risk factors for developing long Covid. The HSE has also commissioned a review by the Health Information and Quality Authority to assess the latest international evidence on long Covid.I am acutely aware of the issues experienced by public health employees in relation to long Covid and am committed to providing support. I have asked staff in my Department to look at available options.
326. Deputy Catherine Connolly asked the Minister for Health his plans to expand public healthcare services for children with disabilities, with a view to decreasing the use of private providers in this area; and if he will make a statement on the matter. [12050/23]
Amharc ar fhreagraAs this question refers to service matters, I have asked the Health Service Executive (HSE) to respond to the Deputy directly, as soon as possible.
327. Deputy Marian Harkin asked the Minister for Health the number of emergency call outs to all ambulance stations in counties Sligo, Leitrim, Donegal and Roscommon in 2021 and 2022 on a monthly basis, in tabular form; and if he will make a statement on the matter. [12055/23]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
328. Deputy Marc MacSharry asked the Minister for Health given the expiry of the National Cardiovascular Health Strategy; ‘Changing Cardiovascular Health Policy’ four years ago, when is it proposed that the Government will publish a new National Cardiovascular Strategy. [12057/23]
Amharc ar fhreagraIreland has a strong track record in leading Europe and the world with policies to tackle cardiovascular disease (CVD). There is evidence that our strategies are working. We are achieving a reduction in hospital admissions for heart attack as well as a reduction in stroke mortality in Ireland. The recently published Irish National Audit of Stroke (INAS) on 31st January 2023 indicates that the mortality rate for ischaemic stroke had decreased by 29% during the period reviewed 2013 to 2022. The Sláintecare Programme is driving new investments in CVD prevention and management for people who have suffered a heart attack or stroke.
The HSE National Stroke Strategy 2022-2027 represents the single greatest investment in stroke services since the launch of the National Clinical Programme for Stroke in 2010. This strategy will assist in addressing the challenge faced in Ireland with the predicted increase in the total number of strokes in Europe, an ageing demography and the rapidly changing milieu of acute stroke treatment.
Recognising National CVD strategies were in place from 1999 to 2019 a National Review of Cardiac Services was undertaken.
The National Review of Specialist Cardiac Services commenced in January 2018 under the Chairmanship of Professor Phillip Nolan and a Steering Group formed from nominations of interested stakeholders representing medical, professional/technical staff, nursing and patient representatives.
The aim of the Cardiac Services Review is to recommend configuration for a national adult cardiac service to achieve optimal patient outcomes at population level with particular emphasis on the safety, quality and sustainability of the services that patients receive. This aligns with the Sláintecare reform Programme. In terms of scope, the National Review covers scheduled and unscheduled hospital-based services for the diagnosis and treatment of cardiac disease in adults and considers CVD preventive strategies.
Substantial progress has been made on the National Review of Specialist Cardiac Services and it recently held the final NRCS Steering Group meeting IN Q4 2022. The NRCS Report is finalised and due to be presented to the Minister in Q1, 2023.
