A mass of documents, opinions and approvals for free medications
Serbia is significantly lagging behind the countries in the region and Europe regarding the efficiency in expanding the list of medications the citizens may obtain at the expense of healthcare, or with minimal participation in the costs. One of the greatest obstacles is the complicated procedure of getting registered in the National Health Insurance Fund’s List of Medications, which requires filing even 14 mandatory and two optional documents and going through nine steps of verification, obtaining opinions and validations by line institutions.
Along with the pharma-therapeutic opinion and a study providing assessment about the quality of medication, companies need to submit numerous copies of various documentation, a confirmation that they would ensure continuous supply of medication for at least 12 months, a certificate of registration in the Business Registries Agency, the proposed wholesale price of medication, and even a document listing all papers that are being submitted.
Before the application is even taken into consideration by line institutions, the company needs to pay a fee of 74,500 or 144,000 RSD depending on the type of medicine. The documentation should be submitted to the National Health Insurance Fund in both paper and electronic form, of which two copies in paper, four on CDs and one through web application. However, this does not guarantee a quick procedure because a medication can wait for an approval for years, and during that time, it can even lose the epithet of an innovative medication.
- NALED’s analysis implemented within the project “Supporting public administration reform in Serbia”, realized in partnership with German Development Cooperation (GIZ), has shown that this procedure could be much easier if performed entirely electronically. The proposed simplification proposes an obligation of submitting only two documents electronically – pharma-therapeutic opinion and the study, while the data from other documents would be directly entered in the application. Further one, the fee would be paid immediately, but the company could receive a reimbursement if the medicine loses the status of innovative in the meantime. The National Healthcare Insurance Fund received our recommendations with open hands and we are working on their implementation together - says Una Ljubičić, Vice President of NALED’s Healthcare Alliance and Business Unit Lead for Serbia, Central Balkans countries, Bulgaria and Moldavia in Pfizer.
Global experiences show that electronic procedures are up to 3.5 times less expensive for the sate compared to those performed at counters, and within the project, NALED therefore plans to propose concrete steps for optimization and digitalization of 28 administrative procedures in the field of healthcare and agriculture, starting from the procedure of forming the price of medication and its placement in the List of Medications, to registration of agricultural households and the entry to the Registry of entities handling food.
A part of procedures encompassed in the project “Supporting the public administration reform in Serbia”, with a proposal of their digitalization, is included in the 11th edition of NALED’s Grey Book which was presented in January 2019, as well as the first Grey Book of Healthcare prepared by companies and local governments within NALED’s Healthcare Alliance.
The graphic overview of the current procedure for placing new medicines on the List of Medications, as well as the proposal for simplification, can be viewed on the link.