Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Temders
Government Links
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Temders
Government Links
U.S. Commercial Service Contact Information
Executive Summary
Healthcare in Romania is dominated by the public sector, which owns most of the hospitals and provides national health insurance to almost all Romanian citizens. Healthcare expenditure was estimated at 5.8% of Gross Domestic Product (GDP) in 2018, well below the 9.6% of GDP most European Union (EU) countries average.
The public healthcare system includes national health insurance, covering almost all Romanian citizens, as well as a growing and parallel network of private healthcare. According to the new Government Program (2018-2020), the Ministry of Health is committed to the citizen (patient) and not the medical system, the end goal being that the individual does not move for a quality medical act, but the system is built as close as possible to the citizen (patient). There are additional opportunities in recent approved projects by the Government of Romania in line with the National Health Strategy 2014-2020, referring to the two important projects: construction of eight regional and one governmental hospital, as well as the overarching goal to improve quality and efficiency.
The market for medical devices, dental products, and high-technology diagnostic imaging equipment in Romania has excellent prospects for growth. The medical equipment market will continue to grow in the coming years as a result of increased demand, the development of local production, and the need to meet European quality standards.
Market Entry
Companies from the United States (U.S.) wishing to enter the Romanian market must refer to EU legislation concerning the registration, marketing, and safety standards required. It is recommended that they check for any specific national legislation that might apply to them, in addition to having a local distribution partner. The Romanian market will most likely remain heavily reliant on imports, which are expected to increase due to insufficient high-tech equipment and the acute need for renovation within hospitals.
Current Market Trends
The national allocated budget for healthcare in 2019 is $ 14.50 billion (5 % of GDP), representing an increase of 17% compared to 2018 (9% of GDP).
The main objectives are:
Allocate an additional $166 million for compensated and free medicines
Construction of regional hospitals and equipping each county hospital with a CT
Purchase of mandatory vaccines for children ($184 million)
Equip seven hospitals with linear accelerators for cancer treatment
0% income tax for physicians as of 1 January 2019
Romanian market growth was driven by macroeconomic improvement, and it is forecasted to continue its growth by a 3.4% annual rate until 2019. The Romanian healthcare industry has high growth potential and there are enough human resources providing opportunities for local or foreign investors.
The Romanian pharmaceutical market increased by 15.3% last year, to RON 16.93 billion (EUR 3.6 billion), according to data provided by market research company Cegedim. Romania’s pharmaceutical policies will continue to pose challenges to multinational pharmaceutical firms, leading to negative consequences for patient access to medicines. The revision of medicine prices, that came into force on April 1, 2017, exacerbates the withdrawal of medicines from the market. Moreover, revenues in other European markets may be impacted by the potential for pharmaceutical wholesalers exploiting parallel trade opportunities. According to BMI, Romania will remain one of the fastest growing pharmaceutical markets among EU member states; however, the risks posed by these regulatory challenges will reduce the demand and base for increased market exposure.
Best Prospects
Medical devices, dental products, and high-technology diagnostic imaging equipment have excellent prospects for growth. In addition, e-health and hospital management are two areas poised for growth as Romania pursues “e-Health” solutions to improve the standard of care, and control costs.
Medical Devices
The market for medical equipment in Romania has grown significantly in recent years, as general health spending has increased. The market will most likely remain heavily reliant on imports (around 90%), as the domestic industry mainly produces outdated equipment that can only compete with foreign products in terms of price. GE Healthcare, Varian, Siemens, and Philips hold the majority market share in the country. Import growth is expected to continue due to insufficient high-tech equipment and an acute need for renovation within hospitals.
The estimated value of Romania’s medical device market was $433 million in 2019, and it is forecasted to increase. The best prospects for suppliers are in the field of oncology, anesthesia and intensive care units, and in those medical units subordinate to both the Ministry of Health, and local authorities. The continued supply of international financing, in the form of World Bank loans, indicates that international organizations are confident that the extra capital will be of use in the development of certain areas of the healthcare sector.
Some public procurement activities are decentralized in Romania and the tenders for medical devices are organized at local county levels. High-value tenders with national utility, and those based on EU Funds or other financing are usually organized by the Ministry of Health. Hospitals and the Ministry of Health often combine multiple orders for different products and then procure them from a single supplier - an integrator. Currently, most of the large hospitals seek one supplier for medical devices, consumables, hospital furniture, laboratory equipment, and all related items. Distributors handling a wide portfolio of products can effectively address the needs of large hospitals.
There are approximately 300 medical device distributors, the most important ones representing manufacturers located in the United States, Germany, Italy, France, Japan, China, Turkey, and Switzerland. Most imports come from EU countries – from Germany, 34.7%, the Netherlands (7.8%), Belgium (7.4%) – and the United States.
e-Health
The NHIH has developed three important projects related to e-health. Two are financed with EU funds – e-Prescription (implemented in 2012) and Electronic Health Record (implemented in 2014), and one is self-funded – the e-Health Card (introduced in May 2015). The card is the only means of obtaining medical consultations and prescriptions through the national health insurance system, except for emergency medical services. All these systems are integrated into the existing centralized Sole Integrated Information System (SIUI), in use in all counties of Romania.
Romania presently has the lowest ratio of physicians per patient in the EU, and rural areas experience very limited access to health care services. This issue, combined with a lack of modern medical equipment and long travel distances to the nearest hospitals, creates a severe healthcare situation for patients living in rural areas. Considering these deficiencies, e-health and telemedicine offer a real alternative to these patients. As telecommunication networks in Romania are very well developed, the lack of traditional healthcare services can be partially addressed via telemedicine.
The Romanian government received EU funds to implement a $19 million rural telemedicine system in three counties, and the project was finalized at the end of 2015. The network currently connects nearly 200 family doctors with over 500 specialists within the counties and in main university centers.
Market Size
Healthcare spending (including investment)
US$ 14.5 billion
… as percent of GDP
5%
… of which spent on inpatient services (including long-term care)
… of which spent on pharmaceuticals/consumables
… of which spent on investments
… of which spent on outpatient services
Hospitals, Procedures, Healthcare Professionals:
Number of hospitals
515
…Public
368
…Private
147
Number of hospital beds
142,688
… available beds per capita
6.7/1000 inhabitants
…of which in general hospitals
109,307
…of which in specialized clinics and rehabilitation centers
22,842
Number of surgical procedures
Physicians
57,304
Demographics
Population
19.5 million
Life expectancy men/women
71.9 men/79 women
Infant mortality
9.4 deaths/ 1000 live births
Percent of population older than 65
16.41%
…projection, 2030
Annual deaths
256,476
…caused by diseases of the circulatory system
148,449
…caused by Neoplasm
51,754
Main Competitors
Currently, over 100 medical equipment companies are active in the Romanian market, with the most important distributors coming from the U.S., Germany, Italy, France, Japan, China, Turkey, and Switzerland. Among them are GE Healthcare, Medtronic, Philips, Varian, Johnson & Johnson, Olympus, Nihon Kohden, Greiner, Becton Dickinson, Beckman Coulter, Bioomerieux, Trinity Biotech, and Oxoid.
Current Demand
In line with the National Health Strategy (2014-2020) in Romania, the overall objective in the health sector is to facilitate access to better and safer healthcare for the general population, with emphasis on vulnerable groups. Four specific priorities and areas of intervention have been identified, namely:
Development of healthcare infrastructure
Research and development in the healthcare sector
Strengthening of public healthcare and medical assistance
Romania has one of the highest hospitalization rates in Europe and reforms aim to decrease the use of hospital services and enhance the role of alternative types of care. In addition, the Ministry of Health intends to provide funding for better medical equipment in primary care locations. The growth of the private hospital market over the next five years is also likely to boost spending, as demand for private healthcare grows with improvements in economic growth and income.
The ongoing health project will support the 2014–2020 National Health Strategy focusing on three main areas/components:
Component 1. Hospital Network Rationalization ($ 249.3 Mil) - this component would finance civil works (within the facilities’ current sites/rehabilitation), medical and other equipment, technical assistance, and training.
Component 2. Ambulatory Care Strengthening ($ 66.4 Mil) - this component would finance civil works, technical assistance, equipment, and training.
Component 3. Health Sector Governance and Stewardship Improvement ($ 13.6 Mil) - this component would finance technical assistance, equipment, communications services, and training.
First tenders for this health project were launched during spring of 2016 and the following ones are forecasted to be launched by September 2016.
Registration Process
There are no restrictions on the sales and imports of new and refurbished medical devices in Romania. The medical equipment must meet the European certification requirements and have the CE mark. Duties and taxes are applicable at the same rates to both new, and refurbished equipment. The key end-user groups for the refurbished category are private hospitals, clinics, and specialized ambulatory care segments.
Reimbursement
According to Lexology , “Only the cost of medicines included in the list of international common denominations corresponding to medicines that benefit insured persons, either with or without personal contribution, based on prescription, in the national health insurance system, as well as common international denominations corresponding to medicines granted in national health programs, may be reimbursed.”
The Ministry of Health and the National Health Insurance Authority administer the reimbursement of medicinal product costs, and reimbursement costs are covered by the National Health Insurance Fund.
The list is put together by the agency and is updated annually. It is then approved by way of a government decision.
As described in “Life sciences: product regulation and liability in Romania ,” “In order to have a medicine listed, solicitants must file a request with the agency, accompanied by the relevant documentation provided in Ministry of Health Order 861/2014, as further amended. An approval or rejection must be issued by the agency within 90 days of the application date, save for cases where the medicine’s price has yet to be approved, where the term may be extended by an additional 90 days.
Medicinal products which qualify for reimbursement may be released only by authorized pharmacies which have concluded agreements with local health insurance authorities.”
Barriers
For information on existing trade barriers, please see the National Trade Estimate Report on Foreign Trade Barriers, published by USTR and available through the following website, https://ustr.gov/sites/default/files/2019_National_Trade_Estimate_Report.pdf
Procurement & Tenders
In Romania, the organization of public auctions is governed by a package of four Laws, 98-101/2016. Most public auctions are published by the authorities on the public procurement platform: SEAP (Electronic System for Public Procurement), the rest being published on their own sites or in the press. The link for SEAP is www.e-licitatie.ro .
For procurement contracts whose estimated value exceeds a certain threshold set by the law, the contracting authority is compelled to publish a notice of intent, a participation announcement and invitation to tender.
a) $6.05 million for public procurement contracts / framework agreements for construction
b) $156,000 for public procurement contracts / framework agreements for products and services
c) $868,000 for public procurement contracts / framework agreements which have as their object services social services and other specific services
The contracting authority can purchase directly if the estimated value of procurement, excluding VAT, is less than:
a) $34,500 for products or services
b) $115,000 for construction.
U.S. Commercial Service Contact Information
Name: Monica BogodaiMonica.Bogodai@trade.gov
