Between 2010 and 2012 just one of the 139 new medicines to receive market authorisations globally was approved for reimbursement in Serbia, compared with 44 in Bulgaria and 27 in Croatia; meaning a severe lack of patient access to much-needed treatments as well as an extremely challenging environment for innovative life science companies operating in Serbia.

The small wheels have started to turn, and the big wheel will turn very soon

Bojan Trkulja, INOVIA

However, attitudes appear to be shifting and the Serbian healthcare and life sciences sphere stands on the brink of significant change. Bojan Trkulja, managing director of INOVIA, Serbia’s innovative pharmaceutical manufacturers’ association feels that “the mindset of the government is changing, and the industry is expecting increased funding, starting in 2018, as the government is setting up a National Strategy on Medicines, a strategic plan outlining the changes to be implemented in Summer 2018. The small wheels have started to turn, and the big wheel will turn very soon.”

In concrete terms, managed entry agreements (MEAs) – introduced after almost three years of negotiation between the industry, the health fund and the World Bank – have been key in initiating an improved market access situation in Serbia. MEAs – contractual agreements between companies and healthcare payers introduced when decisive conclusions on price and reimbursement cannot be made due to uncertainties about the clinical evidence and/or financial impact of the drug – help share the cost of uncertainty between the payer and the company. Two models of MEAs are now being utilized in Serbia, as Trkulja explains: “First was the cross-product model where the company has to achieve savings for the Health Fund on the medicine that is already reimbursed, so that for the amount of saving they could get another product on the reimbursement list. The second model related to rebates, where the company would give a certain percentage of the yearly amount of the product for free as a rebate. Currently we are working on the third model: the ‘hidden price’ model. The main characteristics of this model is that you are obliged to offer the medicines at a lower price than listed on the reimbursement list. This is hugely important as in Serbia prices of medicines are not freely formed. Here, the government sets the prices, and the process is very lengthy and complex.”

Mylan’s country manager for Serbia, Slovenia, Montenegro and Macedonia, Milos Davidovic, now sees a “willingness of the Ministry, of the national agency as well as of the healthcare fund, to listen to what the industry needs and has to offer and to find better solutions for the country” while MSD’s Skuljec describes how “In 2016, our relationships with healthcare authorities drastically improved, to such an extent that they now recognize patients’ needs and openly discuss with pharmaceutical companies on our shared goals.” While Serbia still has a long way to travel on this front, AstraZeneca’s country director, Ksenija Purkovic considers MEAs to be “a light at the end of the tunnel … Some of the Big Pharma companies in Serbia have managed to sign MEAs and have shown the necessary flexibility and pricing strategies to introduce new molecules into the market. For example, 23 molecules were reimbursed this year, this was the first reimbursement update in the last five years.”

Writer: Patrick Burton