New Regulations on Pricing and Reimbursement of Medicinal Products in Croatia
Lawyer Ira Perić Ostojić outlines two major new regulatory updates regarding pricing and reimbursement for drugs in Croatia.
- Bylaw regulating the maximum permitted wholesale price of the prescription medicinal products
The bylaw regulates the detailed criteria for determining the maximum permitted wholesale price of prescription medicinal products in Croatia and the calculation of such prices by the Croatian Agency for Medicinal Products and Medical Devices (HALMED).
Generally, the calculation by HALMED is mandatory and is carried out: (i) when the products are being first placed on the Croatian market; and (ii) on an annual basis, once a year, starting on the first working Monday in February.
With the annual calculation, HALMED is obliged to publish on its website the list of new maximum permitted wholesale prices in Croatia within 100 days from the beginning of the annual calculation, whereas the new maximum prices (will) start to apply 60 days from the date of such publication.
The wholesale prices of the products that are above the new maximum prices calculated by HALMED (will) need to be reduced to the new prices determined by HALMED, while the prices that are below the new prices calculated by HALMED (will) remain the same.
The bylaw also provides for the possibility, in specific cases and under specific conditions, to request from HALMED permission to have/set the prices of the products higher than the new maximum permitted wholesale prices.
The beginning of the annual calculation of prices for 2019 based on the new bylaw is set for 15 April 2019.
- Bylaw regulating listing of the products on the Croatian Health Insurance Fund’s (HZZO) reimbursement lists and determination of prices covered by the HZZO
The new bylaw sets out:
a) detailed criteria for listing of the medicinal products on the HZZO reimbursement lists;
b) a comprehensive list of reasons and requirements in connection to the requests for listing the medicinal products, supplementing the reimbursement lists and amending the information contained on the lists as well as documents that need to accompany such requests;
c) HZZO’s decision making process;
d) possibility to enter into financing agreements regarding the listed medicinal products;
e) deletion of medicinal products from the list;
f) measures and methods for determining the price of the listed medicinal products that will be covered by HZZO; and
g) alignment of the prices of the listed medicinal products (i.e. after the annual calculation of the maximum permitted wholesale prices by HALMED, in case of medicinal products intended for hospital use and alignment through reference products’ groups and subgroups).