Romania approves changes to healthcare claw-back tax

Romania

On 18 May 2020, Law 53/2020 for financing certain expenses in the healthcare sector entered into force, which included reducing the "claw-back tax" to 15% for domestic drug manufacturers (both generic and innovative), based on consumption reported by the National Health Insurance House (as previously reported here).

In addition, Law 53/2020 also provides the following reduced but differentiated claw-back taxes: 25% for foreign innovative drug manufacturers and 20% for foreign generic drug manufacturers. In each case, the percentage will be applied to the total consumption communicated by the National Health Insurance House.

It should also be noted that the Government Emergency Ordinance no. 31/2020 of 27 March 2020 capped the percentage of the claw-back tax for the first quarter of 2020 at 27.65%: the same level of the fourth quarter of 2019.

Law 52/2020, passed on 15 May 2020, approved and amended Government Emergency Ordinance no. 85/2019, which amended Government Emergency Ordinance no. 77/2011.

For more information on Romania's pharmaceutical and medical supply markets, contact your regular CMS advisor or local CMS experts Valentina Parvu and Cosmin Cretu.