New regulation on cost-volume and cost-volume-result agreements to grant the patients more access to innovative therapeutic options

On the 26th of April 2018 the Romanian Official Gazette no. 365, published the Government Emergency Ordinance No. 32/2018 dated 24th of April 2018, (“GEO 32/2018”) amending and supplementing the Government Emergency Ordinance No. 77/2011 relating the contributions to finance expenditures in the Romanian health sector (“GEO 77/2011”). The GEO 32/2018 became effective on the date of publication.

The most important amendments are:

  • The establishment of distinct mechanisms concerning the conclusion of cost-volume and cost-volume-result agreements for medicines that involve conditional inclusion in the list of medicines issued by the National Agency for Medicines and Medical Devices (“NAMMD”). Under GEO No. 32/2018, patients will have access to all medicines based on the therapeutic indication, stage of the disease, and other associated diseases.
  • The fixed-rate scales for cost-volume contracts to be applied progressively to the quarterly consumption of medications based on the ratio between the number of patients actually treated in a year quarter and of eligible patients under that agreement.

The fixed rate scales used are the following:

  1. Single medicine with conditional inclusion

2. Two or more medicines with conditional inclusion

  • Cost-volume-result agreements will have an effective cost per patient. This effective cost will be applicable both for the situation in which there is only a single medicine or if there are two or more substitutable medicines with the same therapeutic indication.
  • Patients that currently benefit from cost-volume or cost-volume-result agreements, transitional rules are established.
    The cost-volume agreements and cost-volume-result agreements in execution on the effective date of the amendments (26 April 2018) will remain subject to the law in effect on the date they were concluded.

If these agreements are due to expire in the first two months of the last calendar quarter of validity, they will be extended, upon the agreement of the parties, until the end of that quarter.

Please do not hesitate to contact us if you need any additional information, clarifications, or details about these changes.

Stratulat Albulescu - Attorneys at law