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Slovakia
transparency obligations overview
PHARMACUETICAL
MEDICAL DEVICE
Pharmaceutical Companies
What is reported:
Law: The value of advertising and marketing expenses and non-monetary benefits provided directly or indirectly to HCPs in the following categories:
- Marketing and drug promotion
- Clinical trials
- Non-interventional studies and post-marketing safety studies
- Market research
- Lectures and consultancy
- Registration fees
- Travel and accommodation
- Hospitality and meals
- Gifts and donations
Note:
The Act No. 595/2003 Coll. on Income Tax, as amended (the “Income Tax Act”) creates additional reporting obligations. Marketing authorization holder, manufacturing authorization holder, pharmaceutical company, wholesale authorization holder, pharmacy or a third party intermediary shall report to the Tax Authority no later than 31 January following the calendar year in which the benefit was provided the amount of each benefit in cash or in kind provided to HCP (natural persons), including the date when the benefit was provided, recipient’s details (name, surname, address of the medical facility where the recipient works, date of birth, tax ID).
The providers of the benefits shall also report the amount of benefits in cash or in kind to the recipient not later that by the end of the respective calendar year.
Code: Transfers of value related to:
- Donations and grants
- Contribution to costs related to professional events
- Fees for services and consultancy
- Research and development
Medical Device Companies
SK-MED adopted the MedTech Europe Code. The SKMED Code has been binding on its members as of the 1st of February 2018.
What is reported:
Member Companies shall publish information relating to grants provided to support third party organized educational conferences via the European platform (MedTech Transparency), and this in aggregate form (donor name, name of organization and total amount for the past calendar year) at the latest by the end of February of the following year.
Important notes:
- This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
- Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information provided reflects the most recent changes and is still applicable.
- Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding – in most cases – suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. In case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
- Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
- Reporting date normally means the date the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
- The information does not take into consideration (unless explicitly mentioned):
- Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
- Transparency related to patient organizations (unless the patient organization is considered an HCO)
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