Zmeny v zákone o osobitnom odvode od 1. januára 2025: Na čo by sa mali farmaceutické spoločnosti (výrobcovia a veľkodistribútori liekov) pripraviť?

The Amendment to the Act on Special Levy on Business in Regulated Industries will expand the number of pharmaceutical companies – especially manufacturers and wholesale distributors of medicines – which will be subject to reporting and levy obligations. Companies with pre-tax profits exceeding EUR 3 million should pay close attention to these changes.

In connection with the recently approved consolidation package, we would like to draw attention to the less widely discussed changes to the Act on Special Levy on Business in Regulated Industries (“the Special Levy Act”) which will affect pharmaceutical companies, particularly manufacturers and wholesale distributors of medicines.

Status prior to the Amendment of the Special Levy Act

Prior to the Amendment, there was some uncertainty regarding whether an entity with an exclusive license from the State Institute for Drug Control (SUKL) falls under the definition of a regulated person, and therefore whether the obligation to pay the levy applies to it.

This uncertainty in the legislation began on 15 June 2018, when the responsibility for issuing licenses for activities in the sector of pharmacy was shifted from the Ministry of Health of the Slovak Republic (MoH SR) to the SUKL through an amendment to the Act on Medicines and Medical Devices.

Status following the Amendment of the Special Levy Act

The approved Amendment to the Special Levy Act now explicitly covers entities licensed by the SUKL, in addition to those with licenses from the MoH SR.

Consequently, from 1 January 2025 license holders in the pharmaceutical sector will be required to fulfill reporting and levy obligations:

·       If their pre-tax profit exceeds EUR million

·       Regardless of which license they hold to carry out activities in the sector of pharmacy

It should be noted that when assessing whether the EUR 3 million threshold has been exceeded, all a company’s profitable activities are considered, regardless of whether these are regulated or unregulated. It is only subsequently, when calculating the levy, that the profit is allocated to regulated activities based on the ratio of revenues from regulated activities to total revenues.

For illustration, a wholesale distributor with a profit of EUR 4 million, deriving 90% of its revenues from regulated activities, will pay a levy for 2025 of approximately EUR 160,000.

In connection with the levy, we have encountered several practical problems:

We have experience that companies frequently find it challenging to distinguish clearly between revenues derived from regulated activities and those from unregulated ones, or their accounting methods do not facilitate this separation. Before the beginning of next year, it is therefore advisable to ensure that this distinction can be made easily.

It should also be noted that the legally required method for calculating the levy does not reflect a company’s actual business situation, since most profits often come from selling unregulated products, yet the levy is calculated based on the proportion of total revenues. Therefore, it may be beneficial to consider dividing regulated and unregulated activities into separate companies.

Regulated entities must comply with numerous reporting requirements, which can often be confusing. Moreover, the data reported, which serves as the basis for calculating the regulated levy, may vary (in a way that may seem illogical) depending on whether the entity, when accounting under IFRS, uses the so-called bridge method for determining the tax base or maintains parallel accounting according to Slovak accounting procedures.

If you would like to learn more about this topic or are interested in our assistance, please do not hesitate to reach out to the author of this article or directly contact your manager at EY in Slovakia.