Serbia

Serbia is the biggest non-EU member state in Central Eastern Europe and has been an EU candidate state since 2012. Since 2014 the country has been engaged in accession negotiations to join the EU. The economy of Serbia is a service-based upper middle-income economy with the tertiary sector accounting for two-thirds of total GDP and functions on the principles of the free market. The average growth of Serbia's GDP in the last five years was 4% per year. Serbia is a unitary parliamentary constitutional republic with a proportional electoral system. Legislative power is vested in the unicameral National Assembly, which also wields constitutional authority in the republic. The official language is Serbian, but in total there are also 15 minority languages spoken.---

Healthcare budget

$4.2 billion

Inhabitants

7 million

GDP per capita

$8.633

Currency

RSD (1 RSD = 0,0085 euro)

World Ranking

GDP 80th

Statistics as April 21st 2021

Serbian healthcare

The healthcare system of Serbia is governed by the Ministry of Health and is managed by the National Health Insurance Fund (RFZO), which covers all citizens and permanent residents. Private health insurance exists in supplementary form to cover faster access to medical services and to enhance choice.

The quality of services is ranked 19th in the Euro Health Consumer Index (2018), with challenges in the form of low HCP income, poorer quality of facilities and services outside the biggest centers (teaching hospitals and medical institutes) and longer waiting times for certain non-urgent procedures.

Healthcare spending in Serbia is slightly above EU average, it allocates 10.4% of GDP for health spending (vs. EU avg. 9.8%), the most recent data (2017 v 2018) shows an increase of 19.6 %.The Health Insurance Fund (RFZO) is the major financing source of public health and accounts for 65% of total expenditures for health.

Serbian pharmaceutical environment

Serbia is a significant pharmaceutical market in Central Eastern Europe, the biggest among non-EU member states in the region, steadily growing over recent years.

In 2020 it was worth 1.2 billion EUR, with Rx products contributing 85% and OTC products 15%.

The Serbian drug reimbursement system is based on reference pricing requiring the lowest price from the reference basket consisting of Croatia, Slovenia, and Italy.

The implementation of centralized procurement was introduced in 2013, resulting in some forced price reductions, particularly in the case of high-volume products and generics. Access to innovative medicines and orphan drugs is facing funding challenges but is showing constant improvement over the last decade.

Todays challenges

The expected life at birth is 76 years (2019), a 2-year increase since 2009, but still 5 years below the EU-27 average (81 years).

The healthcare budget is under pressure due to the ageing population an increased use of medicines and the introduction of new medicines. Further factors are due to the economic challenges which include a relatively high unemployment rate of 13.5% (2020).

Obesity is present in 24% of adults (vs. 12% world avg.), smoking is one of nation’s main healthcare hazards, with 34% of adults being smokers’ that results in almost one fourth of all deaths.

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Market Access

Achieving reimbursement and getting the right price are the 2 most important drivers for a successful launch of an innovative pharmaceuticals in our part of Europe. Health Authorities in any European country decide individually based on their local regulations, policies, framework, social values and available health care budget.

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Market Authorisation

Unlike other regions, in the EU a number of options is available to obtain a marketing authorisation. Centralised at the European Medicines Agency in Amsterdam or decentralised with the individual competent authorities of the member states, each marketing authorisation application procedure has its pros and cons.

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Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

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