Romania - Country Commercial Guide
Healthcare
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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 USD2,385 per person and 5.69 percent of GDP, one of the EU’s lowest per capita. Government healthcare spending, which made up 78.3 percent of this total, is greater than in other Eastern European markets like Bulgaria or Greece, and slightly lower than in countries like Hungary. The current healthcare spending in Romania was forecast to continuously increase between 2024 and 2028 by in total 7.5 billion U.S. dollars (+37.68 percent). After the eight consecutive increasing year, the spending is estimated to reach 27.3 billion U.S. dollars and therefore a new peak in 2028. 

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 operate 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. 

The regulatory system has been lacking stability and predictability 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 publishing of the list of compensated medicines is not predictable at all because of budgetary limits, some drugs wait for almost 2 years to be included. 

The government 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, to improve drug access (USD54,600). The demand for medicine will also rise because of proposed changes to medical coverage through the creation of an optional health insurance scheme. Despite these ambitious expenditure intentions, the 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 research financing, Romania’s biotechnology industry 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. Romania’s health sector labor force is highly educated in biology, pharmacy, and biochemistry. 

The leading private healthcare company in Romania in 2022 was Medlife, with the highest revenue of 1.8 billion Romanian lei, followed by Regina Maria, with 1.6 billion Romanian lei. The highest net profit also was recorded by Regina Maria - 47.9 million Romanian lei, while Teo Healthcare suffered a 10.9 million net loss. 

Leading Subsectors  

Medical Devices 

Table: Total Market Size for Medical Devices
 2019 2020 2021 
Total Local Production 275.84 274.33 287.15 
Total Exports 165 179 168 
Total Imports 373 358 427 
Imports from the US 13.8 9.71 12.8 
Total Market Size 483.84 453,33 455.15 
Exchange Rates 1USD = 4.23 RON 1 USD = 4.24 RON 1 USD = 4.16 RON 

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

In 2021, Romania imported $427M in Medical Instruments, becoming the 47th largest importer of Medical Instruments in the world. Germany ($121M), the Netherlands ($74.3), China ($32M), Italy ($25.1M) and Austria ($20.9M) are the main countries from which Romania imports medical equipment. United States imports represent 3% of the total imports, with an estimated value of $12.8M.  

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), the second one after Poland. Romania is expected to grow and offer major business prospects; however, difficult pricing and reimbursement rules are still impeding market expansion and corporate engagement. The value of the drug market in Romania increased by 21% in the 12-month period between October 2021 and September 2022 compared to the previous 12-month period, to a total of RON 24 bln (EUR 5 bln). The sales of prescription drugs through pharmacies rose by 18% Year-Over-Year (YoY) to RON 14.4 bln, while the sales of over the counter (OTC) products through pharmacies advanced by 25% YoY to RON 6.6 bln and the hospital segment posted the steepest advance (+29% YoY) to RON 3.74 bln. 

In the first quarter of 2023, Sun Pharma emerged as the top company in the pharmaceutical industry in Romania with a revenue of 328 million Romanian lei. It’s worth noting that in 2022, they were ranked third with a revenue of 1.11 billion Romanian lei. Following closely behind were Novartis and Sanofi. 

The number of pharmacies in Romania has slightly variated in recent years, peaking at 8,181 units in 2021, then slightly dropping to 8,135 units by 2022. The biggest pharmacy chains have expanded considerably, while smaller pharmacies were disadvantaged. By the end of 2022, Catena had the highest number of pharmacies in the country, followed by Dr. Max, with 769 drugstores. Consequently, Catena remained the most important company in the pharmaceutical retail sector, totaling a revenue worth 6.3 billion Romanian lei. Romania ranked among the top five European countries with the highest rate of pharmacies per capita, recording a rate of 6.1 pharmacies per 10,000 inhabitants in urban areas. 

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 inspection of 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, the 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 

Revenue in the Romanian health IT market is expected to reach US$388.40m in 2023. The talent pool is also outstanding - entrepreneurs and young start-uppers are now looking very eagerly to create solutions for the healthcare sector. The largest market is expected to be Digital Fitness & Well-Being with a total revenue value of US$228.60m in 2023.  

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:  Achiziții - Ministerul Sănătății (ms.ro) 

Resources 

Contact Information  

Monica Bogodai, Commercial Specialist 

monica.bogodai@trade.gov