Written Answers Nos. 348-355
348. Deputy Bernard J. Durkan asked the Minister for Health if he remains satisfied that reimbursement in respect of new and orphan drugs and other emergency drugs is sufficiently speedy and capable of meeting the demand; if he has identified any shortcomings in relation to same; when these will be addressed; and if he will make a statement on the matter. [61612/22]
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 fifty-two new medicines. This included twenty-seven oncology medicines and nineteen medicines for the treatment of rare diseases.
Budget 2022 has allocated a further €30 million for the reimbursement of new medicines and as of 7 November the HSE has approved reimbursement for 47 new drugs, nine of which were orphan drugs. Further dedicated funding has also been announced for new drugs in Budget 2023.
349. Deputy Bernard J. Durkan asked the Minister for Health if he is satisfied that the health services can be co-ordinated in such a way as to ensure a modern response to patients' needs in all areas throughout the country; and if he will make a statement on the matter. [61613/22]
Amharc ar fhreagraThe Government and the Health Minister remain fully committed to delivering further progress on the Sláintecare reform. Work is focused on increasing capacity, developing better patient-centred primary and community care models, implementing innovation in new technology and better ways of working.
Significant progress was made this year to date in key areas of Sláintecare implementation, including but not limited to:
- Approval by Government of the the public-only Consultant Contract, to ensure that care will be provided to patients when they need it most;
- Approval by Government of the next phase of the Enhanced Provision of Elective Care Programme and progression of the development of new Elective Hospitals in Cork and Galway to change the way in which day case, scheduled procedures, surgeries, scans and outpatient services can be better arranged across the country, ensuring greater capacity in the future and help to address waiting lists;
- Approval by Government of a Business Plan for Regional Health Areas and ongoing work on the development of an implementation plan and development of a population-based approach to service planning and resource allocation;
- In the Enhanced Community Care (ECC) there has also been great progress. There are 152 Primary Care Centres (PCCs) in operation, with 19 more scheduled by year end. The GP Access to Diagnostics, the Chronic Disease Management and the Home Support Programmes are ongoing. Over 2,158 staff were recruited, and many specialist teams were established, such as 91 Community Healthcare Networks (CHNs) and 18 Community Specialist Teams (CSTs). 30 Integrated Care Programmes for Older Persons (ICPOPs) will be operational by year end.
- Publication of the Sláintecare Integration Fund End of Programme Report, which demonstrated wonderful examples of innovation and change and examples of how innovative thinking can bring about meaningful and long-lasting change to health and social care in Ireland.
I look forward to reporting Sláintecare progress in detail in our end of year progress report.
350. Deputy Bernard J. Durkan asked the Minister for Health the steps that are being taken to augment child and adult mental health services in CHO 7; if the precise measures deemed to be necessary are being taken forthwith; and if he will make a statement on the matter. [61614/22]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
351. Deputy Bernard J. Durkan asked the Minister for Health the number of applicants for medical cards granted in the past 12months to date; the number who were refused or who are under investigation in the same period; and if he will make a statement on the matter. [61615/22]
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.
354. Deputy Bernard J. Durkan asked the Minister for Health the extent to which hospital building programmes and extensions are sufficiently in hand to meet the urgent demand such as at Naas hospital, County Kildare and other hospitals throughout the country; and if he will make a statement on the matter. [61618/22]
Amharc ar fhreagraAs the Health Service Executive is responsible for the delivery of public healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.
355. Deputy Bernard J. Durkan asked the Minister for Health the programme for the provision of primary care centres throughout County Kildare having regard to those already in operation, those planned and approved or those pending; and if he will make a statement on the matter. [61619/22]
Amharc ar fhreagraAs the Health Service Executive (HSE) holds responsibility for the provision, along with the maintenance and operation of Primary Care Centres, I have asked the HSE to respond directly to the Deputy as soon as possible.
