Overview

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. The cost of healthcare in Romania in 2021 was USD16.7 billion, or USD872.3 per person and 5.9 percent of GDP, one of the EU’s lowest per capita. Government healthcare spending, which made up 78.5 percent of this total, is greater than in other Eastern European markets like Russia, Moldova, and Ukraine, but slightly lower than in countries like Croatia. Despite attempts to promote primary care, the amount of health spending dedicated to primary and ambulatory care (18.6%) is the second lowest in the EU (behind Bulgaria). In 2018-19, Romania established new screening programs, yet per capita spending on prevention is the second lowest in the EU.

Almost all significant global corporations operate in Romania, despite challenges with reimbursement, harsh claw-back taxes, and payment delays. Due to the nation’s accessible position to Western Europe and affordable labor force, multinationals have also established industrial operations there. Numerous generic drug manufacturers also have operations in Romania, but in recent years, problems like the claw-back tax and pricing concessions required by the National Health Insurance House (CNAS) have compelled numerous businesses to remove their goods from the Romanian market, lay-off employees, or scale back their operations in the nation. Because of this, Romanian producers of generic medications have concentrated on designating the nation as a manufacturing base from which to export their products to more profitable markets.

In March 2020, Romania chose centralized administration of the COVID-19 pandemic, with district-level decision makers enforcing local actions. The prime minister oversaw emergency response and created crisis management organizations. The National Committee for Special Emergency Situations created a technical and scientific pandemic reaction group and emergency action plan in January 2020. The Romanian Ministry of Health paid for COVID-19-related drugs, equipment, and consumables in 2020. It covered isolating COVID-19 patients in specific facilities. The government presented a legislative budget adjustment to assure finances for COVID-19 services, including bonuses for health staff treating cases and salary increases for those working on prevention and control. Along with reallocations from the national budget, the European Commission provided extra funding from 2019 (approximately EUR 483 million) and 2020 European Structural and Investment Funds (around EUR 637 million). These money were used for Personal Protective Equipment (PPE), testing and medical equipment, home medical and social assistance for elderly persons, hygiene goods for vulnerable populations, and health professional bonuses. Donations and charity provided more finances and goods.

The regulatory system has been generally considered stable and predictable over the past one to three years. Government decisions are issued and amended each year for the approval of the framework agreement regarding conditions for providing medical assistance in the social health insurance system, and for approval of national health programs, and enactments. Ministry of Health’s Order No. 269/2017 lays out obligations to ensure adequate and continuous stocks of medicines.

The government coalition proposes to use RON25.7 billion (USD5.9 billion) acquired from the National Recovery and Resilience Plan and the Health Operational Program to limit healthcare privatization and raise public health spending by at least 0.5 percent of GDP per year. This will go toward enhancing primary care, healthcare infrastructure, and the purchase of prescription medications. The overall yearly budget of the National Health Insurance Fund will be increased by at least 0.5 percent, or RON240,000, in order to improve drug access (USD54,600). The demand for medicine will also rise as a result of proposed changes to medical coverage through the creation of an optional health insurance scheme. Despite these ambitious expenditure intentions, the coalition’s opposing parties’ divergent ideologies will impede the advancement of reforms.

In terms of Romania’s innovation centers, the city of Iasi, which is also the second-largest city in terms of the number of universities, is quite significant. The sole medical imaging cluster in Romania and the EU is in Iasi. The cluster helps innovators and connects private organizations like hospitals with businesses in the IT and software sectors.

Due to a lack of financing for research, the biotechnology industry in Romania has developed slowly. Only two of the eight enterprises engaged in biotechnology research and development create products for human medicinal use. Iași’s Tehnopolis Technological Park offers biotechnology labs, but it primarily draws businesses from other industries, like IT. The health sector labor force here and throughout Romania is educated and has background in biology, pharmacy, and biochemistry.

Leading Subsectors

*Total market size = (total local production + imports) - exports) / Units: $ millions
Source: OEC Trade Data

Romania became the 48th largest medical instrument importer in the world in 2020 by importing $358M in medical equipment. Medical instruments were Romania’s 52nd most imported good that year. Germany ($104M), the Netherlands ($58.9M), China ($37.5M), Austria ($16.5M), and Italy ($16.3M) are the main countries from which Romania imports medical equipment. United States imports represent 2.71% of the total imports, with an estimated value of $9.71M.  Between 2019 and 2020, Romania’s imports of medical instruments from China ($10.3M), the Netherlands ($9.18M), and Austria ($5.78M) grew at the fastest rates.

The agency that regulates access of pharmaceuticals and medical devices in Romania is The National Agency for Medicines and Medical Devices (ANMDM), a public institution that reports to the Ministry of Health. On market placement, class I medical devices, including sterile and/or measuring devices; custom-made medical devices and custom-made active implantable medical devices; systems and procedure packages referred to in Article 29 of Government Decision no. 54/2009; and in-vitro diagnostic medical devices all require a mandatory NAMMD registration of manufacturers, or their authorized representatives established in Romania. NAMMD notification by manufacturers, their authorized representative, importers or distributors established in Romania/other Member State on putting into service in Romania of the following types of medical devices is mandatory:

(a) Classes IIa, IIb and III medical devices

(b) In-vitro diagnostic medical devices covered by Annex no. 2 to Government Decision no. 798/2003

(c) In-vitro diagnostic medical devices for self-testing

(d) active implantable medical devices.

Pharmaceuticals

Romania is one of the biggest markets for pharmaceuticals in Central and Eastern Europe (CEE). Moreover, the fact that it spends less on medication per person than more notable Central European nations like Poland, the Czech Republic, and Hungary illustrates how underdeveloped it is. Romania is expected to grow and offer major business prospects; however, difficult pricing and reimbursement rules are still impeding market expansion and corporate engagement. Romanian pharmaceutical sales in 2021 totaled USD4.4 billion, or USD232.6 per person, or 1.6% of GDP and 26.7% of health spending. In the same year, spending on prescription drugs made up 75.1% of all medication expenditures, with patented drugs accounting for 31.5% of that total (43.5 percent). OTC medicine sales totaled USD1.1 billion in the same year, accounting for the remaining 25.0 percent of the market. The persistent underfunding of the healthcare sector is highlighted by Romania’s disproportionate spending on medicines as a percentage of healthcare costs. Although Romania’s per capita drug spending is lower than that of more developed markets, it is nevertheless greater than that of its Balkan neighbors and comparable to Bulgaria.

Reimbursement

Government Decision No. 720/2008 approves the List made up of international non-proprietary names corresponding to medicines of which insured persons benefit, with or without personal contribution, based on medical prescription, in the social health insurance system. Decision also addresses international non-proprietary names corresponding to medicinal products granted under national health programs, i.e., international non-proprietary name (INN) reimbursement list, as subsequently amended and supplemented.

The process for adding a drug to the national reimbursement system so pharmacists can give it free or at a discounted price to insured patients is as follows:

• Obtain a marketing authorization from the EMA or NAMMD under the national evaluation procedure or EU decentralized mutual recognition procedures
• Confirm national pricing approval from the Health Ministry
• Secure NAMMD health technology review to establish if the INN may be included
• Apply for government decision to include the drug’s INN on the national reimbursement list
• Receive Ministry of Health and/or NHIH order to include international trade name in national list of reimbursed drugs.
• Establish Distribution channels for the drug to pharmacies, who will sell it to patients at a discount or for free, depending on the reimbursement level.

The Romanian government and central authorities (NAMMD, Ministry of Health, NHIH) decide if a pharmaceutical product is covered by the national health insurance system. Pharmaceutical businesses must follow certain protocols for drug reimbursement. Stages include:

• Application for a NAMMD examination of the premises and specific corporate and technical papers and information about the manufacturer/distributor and the relevant premises
• Await NAMMD review of application dossier and inspects the factory or warehouse. If the NAMMD produces a favorable inspection report, the production license/wholesale authorization will be awarded within 90 days.

Health IT

The health system in Romania has undergone multiple changes in digital information systems in the last 30 years. Healthcare units are equipped with a range of IT solutions and the necessary communication and information technologies, but despite this, there is an insufficient share of information on patient status and treatment history, caused by lack of standardization and interoperability. Sharing of information between providers is limited and, in many cases does not take place at all or only for a totally insufficient purpose. Therefore, the issue of managing and exchanging medical information and documents is an important topic for Romania’s future eHealth strategy.

Even if there are several developed solutions on the market, for an exchange of medical information systems and regional data exchange, the possibility of interconnecting these systems is limited, and there is no state-guaranteed alternative to ensure an accessible, safe and secure environment for the exchange of medical information.

In November 2020, Ministry of Health announced the development of a proposed eHealth Strategy, yet to be approved and implemented. Strategic objectives of the eHealth Strategy were tracked through a few indicators:

1. Establishment of Digital Health Agency
2. Number of IT devices at medical service providers in Romania
3. Number of medical service providers connected to interoperability network of Digital Health Agency
4. Number of partnerships with international authorities with roles in developing the field of eHealth

The Romanian IT market is expected to reach a volume of EUR 7.3 billion by 2022. The talent pool is also outstanding: in 2019 Romania held the 8th position within the EU27’s “Employed ICT specialists by educational attainment level – Tertiary education” ranking 2nd. Entrepreneurs and young start-uppers are now looking very eagerly to create solutions for the healthcare sector.

Cluj-Napoca has distinguished itself over the years as one of the most important innovation hubs in Romania, and is one of the regions supported within the EIT Health Regional Innovation Scheme. Together with 13 other moderate regions in Central, Eastern, and Southern Europe are being equipped with education, acceleration, and innovation opportunities.

Opportunities

NRRP- National Recovery and Resilience Plan

In the context of the COVID-19 crisis, the European Commission established a Recovery and Resilience Mechanism to give effective and meaningful financial help to Member States to accelerate the implementation of sustainable reforms and related public investment. Regulation (EU) 2021/241 of the European Parliament and the Council of 12 February 2021 approved the mechanism. Investment and reform measures submitted by Romania under the NRRP include:

• Digitalization of health: developing an integrated e-Health system, connecting over 25,000 healthcare providers and telemedicine systems. €470 million
• Strengthened resilience of the health system: investing in modern hospital infrastructure to ensure patient safety and reduce the risk of healthcare-associated infections in hospital settings. €2 billion

Ministry of Health Tenders

The Project Management Unit under the Ministry of Health manages a budget of €1 billion to support a comprehensive reform program focusing on three main components: (1) streamlining the hospital network, (2) strengthening outpatient care, and (3) governance in the health sector and improving administration:  https://www.ms.ro/programe/banca-internationala-pentru-reconstructie-si-dezvoltare-nr-8362-ro/#tab-id-3 

Resources

• National Agency for Medicines and Medical Devices in Romania (NAMMDR)
• National Recovery and Resilience Plan (NRRP): Part II, Section 12: Health
• Ministry of Health
• Romanian Hospital Convention (ROHO) - 28 – 30 September 2022: Bucharest, Romania
• Building Health Bucharest International Forum- 30th of September 2022: Bucharest, Romania
• International Conference on Medical & Health Science- 23-24 October 2022: Bucharest Romania
• IEEE International Conference on e-Health and Bioengineering- 17-18 November 2022: Bucharest, Romania

Contact information 

Monica Bogodai

monica.bogodai@trade.gov