Exactly one year ago, the Ministry of Health of the Slovak
Republic submitted for public consultation a draft decree intended to
significantly change the rules for determining reimbursement of medicines from
public health insurance. Although the document is technical in nature, it has
attracted considerable attention. A total of 333 comments have been
submitted and published within the consultation process, including 16
classified as substantial comments.
The main purpose of the proposed decree is to define the
detailed methodology for calculating the multiplier of gross domestic product
(GDP) per capita, which is used to determine the so-called threshold value of
an assessed medicinal product. This value is a key factor in deciding whether a
medicinal product will be reimbursed from public health insurance based on its
cost-effectiveness.
The original expectation was that the decree would enter
into force on 1 June 2025. However, the timeline has been delayed, as by
15 May 2026 the Ministry had only announced the start of the comment
evaluation process.
Another draft proposal, concerning the pharmacoeconomic
evaluation of medicinal products, has already completed the public consultation
phase and is currently awaiting the Ministry’s assessment of the submitted
comments.
The purpose of this proposal is to reduce the discount rate
used in pharmacoeconomic evaluations from 5% to 3.7% per annum,
following the proposed modification of the methodology for determining the
cost-effectiveness threshold.
Here as well, 16 comments were submitted during the
consultation process, including 5 substantial comments. The comments
addressed not only the proposed level of the discount rate itself, but also the
possibility of applying lower discount rates for technologies with long-term
benefits.
Comments were also submitted by the Slovak Ministry of
Finance, which fundamentally disagrees with the method used to assess the
financial burden. According to the Ministry, the expected positive budget
impact is not sufficiently transparent, and it is unclear to what extent this
impact results specifically from the proposed change in the discount rate as
opposed to other measures, such as the above-mentioned proposal concerning
changes to medicinal product threshold values. The interconnection between both draft proposals has also
been highlighted by the Slovak Antimonopoly Office, which recommended
withdrawing the proposal from the legislative process until broader
professional consensus is reached within the wider framework of medicinal
product categorisation.
We will continue monitoring the outcome of the consultation
process and keep you informed.
The article is based on publicly available information relating to Slovak legislation.
Current developments surrounding draft decrees of the Ministry of Health of the Slovak Republic concern both the calculation of the GDP multiplier used to determine the threshold value of assessed...
From January 1, 2025, Slovakia will include medicines
and medical devices in the reduced VAT rate of 5%. This move is part of a
broader tax reform aimed at improving access to essential goods for the
population while reducing the financial burden on patients. The changes are
likely a response to the European Commission’s assessment of public finances
and an effort to reduce the budget deficit.
This change contrasts with developments in the Czech
Republic, where, as of January 1, 2024, the VAT rate on medicines increased
from the original 10% to 12%, as we mentioned in our previous article Changes
in VAT Rate for Pharmaceuticals.
What Impact Will the Reduced VAT Rate Have in
Slovakia?
The lower VAT rate is expected to significantly reduce
costs for patients in Slovakia for medical devices and medicines, both in
outpatient and hospital care. The direct financial impact on individuals will
depend on specific measures and pricing policies. For comparison, Slovakia’s
VAT on medicines has dropped from 10% to 5%, which could lead to a more
noticeable impact on final prices than in the Czech Republic, where the rate
was increased.
Impact on External Price Referencing for Medicines
The reduced VAT rate in Slovakia, however, will not
affect the external price referencing (EPR) of medicines, used by some
countries to set maximum prices and reimbursement levels in their markets. The
VAT change does not reflect in EPR because the reference price is almost
universally based on the manufacturer’s price.
At the same time, this change offers an opportunity to
compare tax policies across the EU, where VAT rates on medicines and medical
devices vary significantly. For example, according to data
from EFPIA (European Federation of Pharmaceutical Industries and
Associations) as of January 1, 2024, Spain applies a 4% VAT rate on medicines,
while Denmark has a standard rate of 25%.
Stay tuned to our website for more updates on
legislative changes and their impact on healthcare in the EU.
From January 1, 2025, Slovakia will introduce a significant change in its tax policy. This step is part of a broader tax reform aimed at improving access to essential goods for the population while...