Kosovo has recently adopted a new law to regulate the pricing of medicinal products (Law on Pricing of Medicinal Products). This marks the first time that Kosovo has taken steps to regulate the pricing of medicinal products, and it is a significant milestone in an upcoming major reform within the healthcare and pharmaceutical sector. The reform also includes new laws on medicinal products and medical devices, health insurance, and related areas.
The Law on Pricing of Medicinal Products is designed with a simple and straightforward regulatory regime, with the expectation that it will help reduce the prices of medicinal products. Furthermore, it aims to promote transparency, foster healthy competition, increase the availability of medicines, and enhance the role of pharmacists within pharmacies.
According to the provisions of the Law on Medicinal Products, all Marketing Authorization Holders in Kosovo (MA Holders) are required to submit and recommend the prices of their medicinal products to the newly established Commission for Medicinal Products Pricing (Commission).
The Commission will subsequently compare the recommended prices submitted by the MA Holders with a basket of countries used for reference prices. This basket includes Albania, North Macedonia, Montenegro, Croatia, and the country of origin of the product. Based on this comparison, the Commission will calculate the average wholesale price using the two lowest prices from the reference countries.
The expectation is that, due to the simple and straightforward regulatory and compliance requirements, the recommended prices by MA Holders will be lower in Kosovo compared to those in the basket of the reference countries. In such cases, the lower price recommended by the MA Holder will prevail.
Additionally, an interesting rule within the law stipulates that the price of a generic product must not exceed 70% of the value of the original product that holds Marketing Authorization in the Republic of Kosovo. Furthermore, the price declaration provided by the MA Holders will be valid for a maximum of one (1) calendar year.
The information in this document does not constitute legal advice on any particular matter and is provided for general informational purposes only.
By Visar Ramaj, Partner, RPHS Law