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Slovakia
transparency obligations overview

Latest update: 14 September 2018 | Important Notes
PHARMACUETICAL

Report Due Date

Law: Annually, by 31 January and 31 July
Code: Disclosures shall be made on an annual basis, and each reporting period shall cover a full calendar year. The first reporting period shall be the calendar year 2015. Each member company shall make disclosures within six months after the end of the relevant reporting period.

Authority

Law: Law 362/2011; Slovakian Ministry of Health. Reports are submitted to NCZI (National Health Information Center)
Code: AIPM

Who Must Report

Law: Pharmaceutical companies that hold a marketing authorization as well as the healthcare professionals and wholesalers
Code: AIPM members

Covered Recipients

Law: Healthcare professionals (HCPs)
Code: HCPs, pharmacists and healthcare organizations (HCOs)
MEDICAL DEVICE

Report Due Date

By the end of February of the following year

Authority

SK-MED

Who Must Report

Members of MedTech and/or SK-MED

Covered Recipients

Healthcare organisations (HCOs)

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 expenditure
  • Clinical trials, non-interventional studies and post-marketing safety studies
  • Market research
  • Lectures and consultancy
  • Registration fees, travel, accommodation and meals
  • Gifts and donations

Disclosures must be made at the individual level and include:

  1. Name and address of the recipient
  2. Value of the expenditure/benefit

Code: Transfers of value related to:

  • Donations and grants
  • Contribution to costs related to professional events
    • Registration fees
    • Sponsorship agreements with healthcare organisations or third parties appointed by HCOs to manage a professional event
    • Travel and accommodation
  • Fees for services and consultancy

Member companies shall disclose research-and-development transfers of value in each reporting period on an aggregate basis.

How to Report

Law: Disclosures are submitted to NCZI (National Health Information Center) in one of two ways:

  1. Through the web-application Health Information Indicators System (ISZI)
  2. By filling in the form for advertising, marketing and money and non-cash payments in Excel and sending via email

The report must state the value of advertising and marketing expenses and non-financial, in-kind benefits given to HCPs either directly or indirectly. The report must include the name and address of the recipients and the value of the expenditure or benefits.

Code: Individual disclosure, unless not possible, then aggregate disclosure. Each Member shall publish a note summarising the methodologies used by it in preparing the disclosures and identifying transfers of value for each category described in Section 14.4.1 of the Code. The Code: “For consistency purposes, disclosures will be made using a structure set forth in Section 0 hereof.”

Disclosures can be made in either of the following ways, provided that they are unrestricted and publicly available:

  1. On the Member’s relevant website
  2. On a central platform, such as one provided by the relevant government, regulatory or professional authority or body or an association, provided that disclosures made on a central platform shall be made, so far as possible, using a structure set forth in Section 14.7 of the Code.

Disclosures shall be made in the Slovak language. Members are also encouraged to make disclosures in English language in addition.

Medical Device Companies

What is reported:

Aggregate spend regarding educational grants, including donor name, device name and total amount for the past calendar year

How to Report

An example of the template can be found in annex II of the following source: MedTechEurope Code_of_Ethics.pdf
Disclosures shall be made on the EthicalMedTech website (ethicalmedtech.org).

Note

Furthermore, according to the law (362/2011):

  • HCPs have to declare the income received from financial and non-financial interactions with both pharmaceutical and medical device companies to the state authority.
  • This requirement also covers the non-financial benefits received in relation to sponsorships to educational conferences.
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 reflects that 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 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 such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • 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)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

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