Drug Policy in Romania.

Objectives: The objectives of this article were to describe the characteristics of the drug policy in Romania in the last 10 years and to present the consequences in terms of patient accessibility to drugs.

Methods: The Romanian health care system with pricing and reimbursement legislation was studied while considering the evolution of pricing and reimbursement processes, the key stakeholders, and the reasons behind changes. A critical appraisal was done covering published materials on the effects of pricing and reimbursement decisions.

Results: Romania uses an external reference pricing model considering the lowest price from 12 European Union countries. The result is the visible list price, which is used by the payer as the basis for the reimbursement prices. The reimbursed price depends on the type of drug and the therapeutic area. The claw-back taxation reduces the reimbursement prices by another 12% to 75%, depending on the type of reimbursement for each drug: unconditional (more than 4000 drugs) or conditional (19 drugs) reimbursement. As a consequence, the Romanian prices are one of the cheapest in the European Union, some drugs are leaving the country subject to intracommunity trade and more than 2000 drugs have disappeared from the market in the last 5 years.

Conclusions: The drug policy in Romania is centered on price reduction using different techniques and no value-based criteria are used. The pricing is not included in the health technology assessment system, managed entry agreements are not used, and the main effect visible at the patient level is the lack of drugs for some therapeutic areas.