site.btaGovernment Details Reimbursed Medicines Price Setting Procedure

Sofia, December 20 (BTA) - The Government approved changes in the Ordinance on the conditions, rules and procedure for regulation and registration of prices of medicinal products, theCabinet's press service said on Wednesday.

The changes rendered the existing procedure for price formation of medicinal products paid by public funds more precise by clearly determining the way of using the sources of the lowest producer prices. This will guarantee full objectivity of the regulated prices compared to the benchmark ones.

It is proposed to impose a ban on the inclusion of combined medicinal products in which at least one of the components is sold over-the-counter in the Positive Drug List. This means that when such a product is sold, the law-maker's will to reimburse only therapies prescribed by a physician is circumvented.

Under the new requirements, the National Council on Reimbursement of Medicinal Products will give an opinion on the inclusion, change or exclusion of medicinal products of the Positive Drug List. This will apply to medicines paid during in-patient care outside the value of the medical services provided. These are mostly medicines for targeted therapy of malignant growths which account for a considerable part of the budget of the National Health Insurance Fund.

The ban on market authorization holders or their authorized representatives to increase registered prices of medicinal products sold over the counter by a percentage higher than the statistically reported inflation is extended by two years.

The prices of drugs sold over the counter are not subject to regulation because there is a registration regime applicable to them. This leads to a markup of prices and has an adverse effect on the population's ability to buy them, respectively, restricts the patients' access to these products.

Representatives of patient organizations met with Prime Minister Boyko Borissov and Health Minister Kiril Ananiev on Wednesday.

Speaking to journalists, Stanimir Hazurdzhiev of the National Patient Organization voiced satsifaction with the decision to reverse the moratorium on new drugs.

He said that the sides discussed both short-term and long-term measures to improve the healthcare system, and hospital and medicine policies. An agreement was reached that expensive medicines will be prescribed according to European rules.

Bulgaria has 400 hospitals and according to a World Bank analysis it needs only 150.
That's why Bulgaria needs a national health map, which will reflect on the state of hospital care, said Plamen Taushanov, of the Bulgarian Association for Patients' Defence. He also urged for a change in the health insurance model.