Romania to Set Drug Prices Against Average of Lowest 3 EU Countries

Date: July 14, 2021 | Region: EUROPE | Type: Editor’s ChoiceRegulation | Keywords: #maximum 
#order #policy #price #regulation #romania #setting

PRICENTRIC BRIEF:

  • Romanian Health Minister Ioana Mihăilă has signed an order amending regulations for the calculation of maximum prices of medicines in Romania
  • The move will help to ensure market availability of some essential medicines for patients in the country, by introducing a new category of pharmaceuticals dubbed “essential medicines,” for which the maximum approved price will be the average of the lowest three prices in the European countries in Romania’s reference basket
  • Mihăilă explained: “For medicines for which there is a marketing authorization in Romania, the danger of withdrawal from the country decreases considerably and, at the same time, the Romanian market becomes attractive for essential medicines that do not have a marketing authorization at this time, the aim being to ensure adequate and continuous stocks of medicines in pharmacies and hospitals”

THE DETAILS

BUCHAREST, Romania – Romanian Health Minister Ioana Mihăilă has signed an order amending regulations for the calculation of maximum prices of medicines in Romania.

The move will help to ensure market availability of some essential medicines for patients in the country, by introducing a new category of pharmaceuticals dubbed “essential medicines,” for which the maximum approved price will be the average of the lowest three prices in the European countries in Romania’s reference basket.

Under the new policy, the Minister of Health will approve a new list of essential medicines within 30 days of the entry into force of the changes

According to a press release from the Ministry, for a drug to be considered essential, it must meet two conditions:

  • Be on the latest list of essential drugs recommended by the World Health Organization
  • Be on the list of drugs reimbursed 100% by the National Health Insurance House

As it stands, Romania just references the lowest country price in its group of European Union (EU) countries, but the changes will “ensure the availability of essential medicines for patients in Romania,” according to Mihăilă.

She added, “For medicines for which there is a marketing authorization in Romania, the danger of withdrawal from the country decreases considerably and, at the same time, the Romanian market becomes attractive for essential medicines that do not have a marketing authorization at this time, the aim being to ensure adequate and continuous stocks of medicines in pharmacies and hospitals.”

The measure is meant to reduce bureaucracy in the price setting process at the level of the Ministry of Health, to ensure a “greater accuracy of the data and to reduce the processing times of the price correction.”

In addition to the changes, a new digital submission system will be introduced for drugmakers to submit their pricing data from the catalogs of the comparison countries, instead of sending the photocopies of the respective catalogs.

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