Country in Focus: Serbia

The Republic of Serbia is located at the crossroads of the Central and South Eastern Europe in the southern Pannonian Plain and the central Balkans. The capital of Serbia is Belgrade (Beograd) which ranks among the largest and oldest cities in the South Eastern Europe.

Serbia has a parliamentary democracy with the currency Serbian Dinar. Since 1993, the dinar has depreciated remarkably, which is why many investors still do not see Serbia as a great place to invest. Serbia is currently a candidate country for the accession to the European Union and is estimated to join the Union by 2026. 

Serbian Pharmaceutical Market

The total value of the pharmaceutical market in Serbia is € 833 million and it is estimated that it will grow by 6.7% from 2019 to 2021. The majority of the market is dominated by Rx medicines with a value of € 719 million, while the OTC market value is € 114 million.

Biosimilars and original biologics represent 24% of the total market share value of the Rx segment. Biosimilars have grown by 49%. Key growth drivers are antineoplastics, medicines used in diabetes, antithrombotic agents, and anti-asthma & COPD.

Medis on the Serbian Pharma Market

Medis, a partner of choice for medical marketing in the CEE, with the HQ based in Ljubljana, Slovenia, has been present in Serbia for almost 20 years. The subsidiary in Belgrade employs more than 30 people, majority of them with natural science education.

As far as the Serbian pharmaceutical market is concerned, Medis is the fastest growing pharmaceutical company with the highest sales contribution in 2020 (IQVIA May 2020).

In the Rx segment, the therapeutic focus is on rare diseases, neurology, and pulmonology/allergology. Ophthalmology is also well-developed and evolving strongly. In the hospital sector, Medis holds a strong position in plasma derivatives. Consumer healthcare focuses on the immune system and infant nutrition.

Commercialisation activities in Serbia are coordinated and supported by the Medis HQ in Ljubljana. Local marketing, sales, medical and regulatory teams successfully apply global strategies to the Serbian market.

Health Insurance System

After the split of former Yugoslavia, the Republic of Serbia, as well as other ex-Yugoslavian countries, inherited the Bismarck healthcare system model. Healthcare system in Serbia is based on universal health coverage. The public healthcare network is organised and governed by three main institutions:

• The Ministry of Health – in charge of policymaking, standards’ adoption and quality control;
• The Institute for Public Health – tasked with the collection and analysis of public health data and the proposal of relevant measures; 
• The National Health Insurance Fund (NHIF) – competent for healthcare financing at every level.

Private health insurance exists in supplementary form (covers faster access and enhanced consumer choice).

The health system itself has faced several obstacles in the past due to the constant change of government. Nevertheless, a real change in government attitudes has been observed in recent years. The National Health Insurance Fund and the Ministry of Health have improved and facilitated the value and access to innovative medicines and modern therapies.

Some positive results can already be visible. It is expected that health care funding will increase in the coming years. Moreover, a better regulatory landscape and the EU accession have already had positive effects, for example: health care is accessible regardless of the social status. Furthermore, the medical staff in Serbia is well-trained and welcoming.

The Reimbursement Procedures and Timelines

The competent body for reimbursement decision-making is the National Health Insurance Fund. 

The prices of medicines are calculated on the basis of the prices set in the three main reference countries – Croatia, Italy and Slovenia – and are recalculated annually. The reimbursable price is set and financed by the National Health Insurance Fund and cannot exceed the maximum allowed price. 

Medicines with a marketing authorisation in Serbia and dietary products can be listed on the Positive List (List A, B, C). Exceptionally, medicines without a marketing authorisation may also be included, but only if there is no medicine with the same INN on the market and the medicine is urgently needed for diagnostics or therapy (List D).

Only registered medicines may apply for reimbursement. Official timeline for registration is 9 months (7 months for the CP medicines). Average timeline for registration in practice is 2 years (1 year for the CP medicines). The National Health Insurance Fund reimbursement decision must according the rule book be made within 6 months after documentation submission. The average timeline for reimbursement is much longer than 12 months.

The reimbursement of innovative medicines is delayed in comparison to other EU countries mostly due to budget restrictions and the time required to register a medicine. Prescription medicines are purchased through public procurement.

Medis’ Recent Market Access Achievements

Medis has a proven track record of finding innovative market access solutions in Serbia.

Recent reimbursement success stories include:

• Named Patient Sales Program (NPP) for spinal muscular atrophy was approved by the MoH. We are very proud that we have succeeded in drawing the attention of the MoH to this debilitating disease and in organizing its immediate availability for the patients in need.
• The reimbursement of innovative medicines indicated for multiple sclerosis supports the multiple choices in the treatment of this devastating disease. We have managed to access the second line and oral first line MS therapy.
• Access to innovative medicine for management of severe pain was secured. Patients suffering from pain have the medicine available which simultaneously modifies pain and prevents constipation.
• Innovative medicine for pulmonary hypertension was among the first five products to be reimbursed outside metabolic rare diseases after a long period with no reimbursement update.