Due to the new Croatian Ordinance on pricing and reimbursement from this year , every MAH who wants to have its products on reimbursement list in Croatia has to sign the so called “Agreement on Ethical Advertising of Drugs”. This Agreement is between MAH and HZZO (Croatian Institute for Health Insurance). I attached Croatian version for you info.

Basically, the Agreement strictly defines ways of advertising the products which are on the reimbursement lists toward healthcare professionals and possibility of giving certain presentation gifts to them (the max. value of such present can’t be more than 150 €).

The most important article (No.5)  refers to the obligatory payment of the insurance for ethical advertising to the HZZO. The MAH is obliged to pay to the HZZO the amount of 3% of all budget reimbursed by HZZO for MAHs products on the reimbursement list. This amount makes a annual budget for promotion/presentation of medicinal products in the current year and should be paid in 4 equal parts (in Feb, May, Aug and Nov). This amount can be increased at MAHs request. The MAH is also obliged to present to the HZZO all the costs regarding promotion and presentation of medicinal products with corresponding invoices in order to receive the reimbursement of promotion/presentation costs from the HZZO. This should be done 4 times a year.

In case of breach of this Agreement by the MAH, the HZZO can erase its medicinal products from the reimbursement list. HZZO can also end the reimbursement procedure for the mentioned promotion/presentation costs.

The Agreement has been discussed and negotiates with Association of Innovative Medicines Manufacturers, Croatian Branch.