Romania

In early 2020, the value of Romania’s pharmaceutical market rose to EUR 4.46 billion, which accounts for prescription medicines (EUR 3.35 billion) and drugs sold over the counter (EUR 1.1 billion).

In Romania, private and public medical service providers operate in tandem. Although Romania has a universal health coverage system, not all health care services are covered and additional out of pocket costs are required for certain treatments and prescriptions.

Insured patients can seek medical care in public or private healthcare units, which have reimbursement agreements with either Romania’s National Health Insurance House or one of its district health insurance houses. Further, patients insured through Romania’s National Health Insurance system can access medicines and certain medical devices from pharmacies that have reimbursement agreements with health insurance houses, either free-of-charge or by making a co-payment.

Romania’s Payer Stakeholders 

Romania has a highly centralized Social Health Insurance (SHI) system. The Ministry of Health (MOH) is primarily responsible for healthcare governance, while the National Health Insurance House (NHIH) regulates the system. Both the Ministry of Health and NHIH have local level representation, through district health insurance houses (DHIHs) and district public health authorities (DPHAs).

Health care services are delivered in 42 districts. DHIHs purchase services from physicians, specialty care practices, hospitals, labs, and other providers at the local level. Furthermore, healthcare providers might be paid by the Ministry of Health under national health programs.

Under the SHI scheme, Romanian citizens who contribute to health insurance are covered, along with their children. Pensioners also have access to a comprehensive benefit package, while those who are uninsured (approximately 10 percent of the population) are only eligible for minimal healthcare services, such as emergency medical care.

Important Points to Keep in Mind

No medicinal product may be placed on the market unless a marketing authorization has been issued by The National Agency for Medicines and Medical Devices (NAMMD), which was organized in 2010. After a new medicine obtains market authorization from the NAMMD, the marketing authorization holder (MAH) applies to the Ministry of Health to set a price. Prices for OTC drugs are not regulated; however, the MAH is required to notify the MOH of said price within 30 days after the drug has been on the market.

The price of a prescription medicine can be reimbursed at a level of 100 percent, 90 percent, 50 percent, or 20 percent, and is largely dependent on the reimbursement list where the medicine is included. The list of the international non-proprietary names (“INNs”) reimbursed in Romania is approved by the Government. Based on the INN Reimbursement List, the NHIH and the MOH distribute the lists providing the trade names and reimbursement values applicable for medicinal products in the social health insurance system and the national health programs.

The price of medical devices is not regulated; however, in the case of reimbursed medical devices, their reimbursement value is approved by the MOH and/or the NHIH. If a medicine is reimbursed in the national health insurance system, its reimbursement price shall be approved according to certain specific rules applicable to each reimbursement list. 

As a rule, insured patients obtain the reimbursed medicines free-of-charge or with a price reduction from a pharmacy that has previously concluded a supply (reimbursement) agreement with the NHIH or with the local health insurance house. Pharmacies submit reimbursement data for each month to the relevant health insurance house. The health insurance house should pay the pharmacies the reimbursement amounts within 120 days of submitting the relevant documentation.

In 2009, Romania introduced a claw-back tax, which requires drug manufacturers to pay a quarterly contribution for reimbursed medicines, based on consumption reported by the NHIH. This system has received criticism throughout the years because it does not consider the differences in sales between manufacturers, and generic drug producers were hit the hardest. During the first half of 2020, the tax was reduced to: 15 percent for domestic drug manufacturers (for both generic and innovate medicines), 25 percent for foreign innovative drug manufacturers and 20 percent for foreign generic drug manufacturers.

 

Implications for Industry

One priority for the Romanian health system is bringing new medications to market that are more effective or present fewer side effects than other existing medications for treating certain diseases. In this regard, streamlining the cost of medicines for which there are generic equivalents could allow new medications with therapeutic benefits to be included in the reimbursement circuit as soon as possible after their registration on the market. The Competition Council of Romania therefore recommended including a drug product on the reimbursement list as soon as it has obtained marketing authorization and a price has been set, according to the provisions of Order 861/2014.

With strong regional and local expertise in Romania, GLOBALHealthPR offers invaluable insight to achieve market access, reimbursement and marketing success.

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