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Executive Summary
Ireland has a dual healthcare system that consists of both private and public healthcare options. The public healthcare system is regulated by the Irish government’s Health Service Executive (HSE). The overall non-capital allocation to the HSE for 2019 is just over €16 billion; this is 19% greater than the expenditure in 2013 of €13.6 billion. The Irish healthcare market maintains a strong affinity with the United States (U.S.), as many of its doctors and consultant specialists are trained at leading U.S. healthcare facilities. Strong relationships also exist between American and Irish universities and hospitals. In 2017 there were 10,665 inpatient beds and 2,170 outpatient or ‘day’ beds distributed across 48 public hospitals. Private hospitals operate almost one-third of the acute hospitals in Ireland, with 1,796 inpatient beds in 2017.
There are about 2,500 General Practitioners (MDs) in Ireland working in group practices, primary care centers, single practices, and health centers around the country.
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Market Entry
Ireland is open to Foreign Direct Investment and a strong, export-driven economy. As the only English-speaking member of the Euro-zone, the country serves as a natural test market and location from which to begin distribution throughout the European Union (EU), potentially reaching 742 million people. U.S. medical device products are well regarded in Ireland and the market is highly receptive to new and innovative American medical equipment and technologies.
U.S. companies exporting to Ireland should obtain local representation through one of the 100 qualified agents or distributors in the market. CE marking is a legal requirement. Irish labeling requirements are like those elsewhere in the EU, except Irish authorities require the name and the EU address of the manufacturer, distributor, or packer to also appear on the label. Ireland applies EU tariffs (TARIC) which are based on the international Harmonized System (HS) of product classification. Duty rates on manufactured goods from the U.S. generally range from 5-8% and are usually based on the cost, insurance and freight value of the goods at the port of entry. Additionally, free trade is permitted between the 28 EU member states and the four members of the European Free Trade Association (EFTA): Iceland, Liechtenstein, Norway, and Switzerland.
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Current Market Trends
Over the past ten years, population health at the national level presents decreasing mortality rates and increasing life expectancy. In March 2019, the Minister for Health published Sláintecare Action Plan 2019, a ten-year plan for health reform. Sláintecare (Healthcare in the Irish language) is a vision for a new health service in Ireland which provides a high-level policy roadmap to deliver whole-system reform and universal healthcare.
The plan is developed in five key components: population health, entitlements, integrated care, funding, and implementation.
The Irish Government is an advocate of preventative medicine, focusing on breast, cervical, bowel, and diabetic retina screening/checks. Opportunities exist for equipment that saves time and resources and produces cost savings; however, quality is a key driver when winning contracts. In 2017, almost all hospitals reported being over budget with an average overrun of 7%. This indicates a need for new tools and initiatives to drive productivity and efficiency within the sector.
A recent report, commissioned by the Irish Medical and Surgical Trade Association, on the state of medical equipment management throughout the Irish health service shows that a significant public health risk exists from continuing to utilize aging and obsolete medical equipment.
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Market Size
Healthcare Spending (Including Investment)
| …as percent of GDP |
7% (2018) |
| … of which spent on inpatient services (including long-term care) |
N/A |
| … of which spent on pharmaceuticals/consumables |
N/A |
| … of which spent on investments |
N/A |
| … of which spent on outpatient services |
N/A |
Hospitals, Procedures, Healthcare Professionals
| Number of Hospitals |
66 |
| … Public |
49 |
| … Private |
18 |
| Number of Hospital Beds |
13.8 (2016) |
| … available beds per 1000 |
3 |
| … of which in general hospitals |
N/A |
| … of which in specialized clinics and rehab centers |
N/A |
| Number of Surgical Procedures |
11,608 (2017) |
| Physicians |
15,382 (2018) |
Demographics (Source: Albanian Institute of Statistics)
| Population |
4,853,506 (2017) |
| Life expectancy men/women |
82 (2017) |
| Infant mortality |
3.1 deaths per 1,000 live births (CSO 2018) |
| Percent of population older than 65 |
14% (2017) |
| …projection, 2030 |
20.8 - 21.7 (projection 2030) |
| Annual Deaths |
30,484 (2017) |
| …caused by [highest disease burden] |
Malignant neoplasms (2017) |
| …caused by [second highest] |
Diseases of the circulatory system |
| Prevalence of [fastest growing disease burden] |
N/A |
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Current Demand
According to the Economic and Social Research Institute (ESRI), Ireland’s rapidly growing and aging population will create an exponential demand for increased healthcare services by 2030. Current challenges include budgetary pressures, the development of a more hospital-centric model of care, long waiting lists, and a rise in the incidence of chronic illness. This results in an increased demand for health services with a focus on acute hospitals, primary care, and services for older persons.
The Irish Government has published The National Development Plan 2018-2027 which sets out almost €116 billion of significant investment over the next ten years. In particular, the Government has allocated €10.9 billion of funding for healthcare between now and 2027 to the building of new hospitals and additional capacity in existing facilities in different areas (maternity, acute care, trauma, oncology, eHealth systems, mental health, disability, residential care, etc.).
In December 2013, the Government launched the eHealth strategy with the purpose of outlining the importance of recognizing Digital Health as a national infra-structural investment for Ireland. eHealth Ireland is the HSE’s office of the Chief Information Officer which has been tasked with delivering Ireland’s eHealth strategy.
The National Service Plan 2019 sets out the type and volume of health and social care services to be provided by the HSE in 2019 with regard to the resources and funding available, priorities across all services, healthcare needs and predictable increases in demand.
Across the public sector opportunities are identified on Medical Care Pharma, Laboratory Equipment & Diagnostics, Health Technology and Medical Professional Services, Surgical and Interventional Devices & Consumables.
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Registration Process
The EU requires that those ‘placing devices on the market must register their contact details and details of their device(s) with the competent authority in the member state where they have their registered place of business’. The competent authority for the Republic of Ireland is the Health Products Regulatory Authority (HPRA) which monitors medical devices for safety and quality concerns once placed on the market. The organization also regulates medical device manufacturing, wholesale and distribution companies, and medical device notified bodies. These notified bodies, or standards bodies, are separate organizations that initially assess and approve new medical devices. The official standards body in Ireland is the National Standards Authority of Ireland (NSAI). Medical devices that have been approved have to bear a CE mark – this indicates it meets the basic requirements for safety and effectiveness under European law.
The HPRA provides guidance documents and information leaflets on the regulatory and registration process of medical devices on the Irish market. On 26th May 2017, Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) entered into force. These two new EU Regulations will replace the current Directives which have been in place for over 25 years. The MDR will become fully applicable from 26th May 2020 while the IVDR will be fully applicable from 26th May 2022. The new Regulations define obligations for all economic operators (manufacturers, importers, distributors and authorized representatives). To ensure a smooth transition, we highly recommend registering medical devices to be compliant with the new regulations.
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Reimbursement
The Primary Care Reimbursement Service (PCRS) is part of the Health Service Executive (HSE) and is responsible for processing and making payments on a national basis to healthcare professionals like MDs, dentists, and pharmacists for the provision of health services to members of the public. Ireland has a comprehensive, government funded public healthcare system. Over 30% of people in Ireland have medical cards. Medical cards allow people to get a wide range of health services and medicines free of charge. Charges apply for visits to a local doctor except for approved medical card holders, which includes all children under six years. As of the end of December 2017, approximately 45% of the Irish population has private health coverage in Ireland; the health insurance market in Ireland is estimated to be worth over €2 billion in premiums each year.
Products classified as non-drug (medical devices) can be submitted for reimbursement. Queries can be emailed to reimbursement.applications@hse.ie. More information is available at https://www.hse.ie/eng/about/who/cpu/non-drug-reimbursement-applications/.
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Barriers
There are no specific barriers to market entry for American medical devices.
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Procurement & Tenders
All public sector contracting authorities advertise procurement opportunities and award notices on the eTenders Procurement website, the Irish Government’s electronic tendering platform. The Office of Government Procurement centralizes procurement and assumes responsibility for Sourcing and Contracting for the common expenditure categories. US exporters should register as a Supplier Companies.
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U.S. Commercial Service Contact Information
Name: Anthea Zanella
Position: Commercial Assistant
Email: anthea.zanella@trade.gov
Phone: +353 1 237 5862
