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...
Pharmeca a.s. provides services in the areas defined by this
legislative framework:
Act No. 48/1997 Coll.,on Public Health Insurance and on Amendments to Some Related Acts, as amended.
Implementing legislations:
Decree
No. 376/2011 Coll., which implements certain provisions of the Public Health
Insurance Act, as amended,
Decree No 384/2007 Coll., on the list of reference groups, as amended,
Decree No 385/2007 Coll., on the list of active substances for adjunct or add-on therapy;
Decree
No. 63/2007 Coll., on reimbursement of medicines and foodstuffs for special
medical purposes, as amended,
Decree
No. 618/2006 Coll., which issues framework agreements, as amended,
Decree
No. 134/1998 Coll., which issues a list of medical services with point values,
as amended,
Decree
on the determination of point values, the amount of payments for paid services
and regulatory restrictions - always issued for the current year.
Act No. 551/1991 Coll., on the General Health Insurance
Company of the Czech Republic, as amended.
Act No. 280/1992 Coll., on departmental, branch, corporate
and other insurance companies, as amended.
Act No. 592/1992 Coll., on public health insurance premiums,
as amended.
Act No. 378/2007 Coll., on Pharmaceuticals, as amended.
Implementing legislations:
Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 54/2008 Coll., on the method of prescribing medicinal products, particulars to appear on medical prescriptions, and rules governing the use of medical prescriptions, as amended,
Decree No. 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended,
Decree No. 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended,
Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended,
Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended,
Decree
No. 236/2015 Coll., on the determination of conditions for prescription,
preparation, distribution, dispense and use of individually prepared medicinal
products containing cannabis for medical use, as amended,
Decree
No. 415/2017 Coll., on the implementation of certain provisions of the Act on
Medicinal Products relating to electronic prescriptions, as amended,
Decree No. 329/2019 Coll., on prescribing medicinal products in the provision
of health services, as amended.
Act No 167/1998Coll, on addictive substances and amending certain other acts, as amended
Implementing legislations:
Decree No. 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended,
Decree No. 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them, as amended,
Government
Regulation No. 463/2013 Coll., on lists of addictive substances, as amended.
Act No. 268/2014 Coll., on medical devices and amending Act
No. 634/2004 Coll., on administrative fees, as amended,
Implementing legislations:
Decree No. 62/2015 Coll., on the implementation of certain
provisions of the Medical Devices Act, as amended,
Government Regulation No. 56/2015 Coll., on technical
requirements for in vitro diagnostic medical devices,
Government Regulation No. 55/2015 Coll., on technical
requirements for active implantable medical devices,
Government Regulation No. 54/2015 Coll., on technical
requirements for medical devices.
Act No. 22/1997 Coll., on Technical Requirements for Products and amendments to some related acts, as amended.
Act No. 90/2016 Coll., on the assessment of the conformity
of specified products when they are placed on the market, as amended.
Act No. 372/2011 Coll., on health services and conditions for their provision (the Health Services Act), as amended.
Decree
No. 373/2016 Coll., on the transfer of data to the National Health Information System,
as amended.
Act No. 500/2004 Coll., Administrative Code, as amended.