Legislative frameworks to combat illicit trade in medical products in Slovakia

  1. What legislative framework is there to combat illicit trading and other illegal activities in counterfeited/falsified/diverted medicines in your jurisdiction?
  2. What other products apart from medicines are covered by the above legislative framework in your jurisdiction (i.e. medical devices, veterinary medicines, cosmetics)?
  3. Are illicit trading, counterfeiting/falsification and other illegal activities involving medicines regarded as a separate group of crimes in your jurisdiction, or are they prosecuted as crimes in more general categories, such as intellectual property or fraud?
  4. Has the Medicrime convention been ratified in your jurisdiction? If so, how is it implemented?
  5. What types of liability exist in your jurisdiction for counterfeiting/falsification of medicines (and other products, if applicable)? Is separate liability provided for falsification/counterfeiting of biologics (e.g. vaccines)?
  6. Which state bodies/agencies are involved in anti-counterfeiting activities regarding medicines (and other products, if applicable) in your jurisdiction, and what are their roles? What is the role of the Pharmaceutical inspectorate in anti-counterfeiting activities in your country?
  7. How can the manufacturers, MAHs or IP rights holders for affected products be engaged in investigations regarding illicit trade/counterfeiting/falsification, and what rights do they have during such investigations?
  8.  Is it possible to recover damages caused by the counterfeiting/falsification of a medicine (or other products, if applicable)?
  9. Is it possible to sell medicines, medical devices and veterinary medicines online in your jurisdiction? If so, what are the specific rules and restrictions around these activities?
  10.  What protective measures and safety features (e.g. 2D verification, anti-tampering devices or other labelling requirements) are required in your jurisdiction to combat illicit trading and counterfeited/falsified medicines?
  11.  Are there any legislative developments in your jurisdictions in the sphere of combating illicit trading and other illegal activities involving counterfeited/falsified medicines (and other products, if applicable)?

1. What legislative framework is there to combat illicit trading and other illegal activities in counterfeited/falsified/diverted medicines in your jurisdiction?

The Slovak legislative frameworks to combat illicit trading and other illegal activities in counterfeited/falsified/diverted medicines and medical devices consist, in general, of:

  1. criminal law dealing with specifically recognised crimes related to illegal activities with medicines and medical devices;
  2. administrative law (regulatory) on the basis of a breach of the rules set down primarily by the laws related to pharmaceuticals and other laws covering regulations of certain products can occur; and
  3. civil law based on a breach of rules primarily regulating unfair competition and protection of intellectual property.

2. What other products apart from medicines are covered by the above legislative framework in your jurisdiction (i.e. medical devices, veterinary medicines, cosmetics)?

The above legislative framework applies in general, thus counterfeited or falsified or diverted products can be challenged under all the above measures, in some cases simultaneously.

3. Are illicit trading, counterfeiting/falsification and other illegal activities involving medicines regarded as a separate group of crimes in your jurisdiction, or are they prosecuted as crimes in more general categories, such as intellectual property or fraud?

The Criminal Code of the Slovak Republic recognise some categories of crimes directly related to: (i) illicit trading; (ii) the counterfeiting and falsification of medicines and medical devices. However, some actions by perpetrators can be also prosecuted as crimes in general categories.

4. Has the Medicrime convention been ratified in your jurisdiction? If so, how is it implemented?

No.

5. What types of liability exist in your jurisdiction for counterfeiting/falsification of medicines (and other products, if applicable)? Is separate liability provided for falsification/counterfeiting of biologics (e.g. vaccines)?

Depending on the severity and the nature of the illegal activity, there could be:

  1. Criminal law liability: liability for most severe breach of a legal obligation provided by private or public laws. In such case, the respective criminal authority must commence criminal proceedings (either ex officio or on the basis of a complaint filed by a third party), and establish the liability of the perpetrator. In the Slovak Republic, both individual persons and legal entities are subject to criminal liability, however not each crime can be perpetrated by a legal entity.
  2. Administrative law liability: liability for a breach of legal obligation provided by either public or private laws. In such case, the respective regulatory authority must commence administrative offence proceedings (either ex officio or on the basis of a complaint filed by a third party) and establish the liability of the offender.
  3. Civil law liability: in the Slovak Republic, this arises from the breach of a legal obligation provided by private laws or contracts. Non-contractual liability must be in most cases assessed by civil courts in a judicial dispute because infringers do not usually accept their liability.

We also note that civil law liability and administrative or criminal law liability can usually be applied simultaneously and the remedies requested separately.

There is no specific liability for the falsification/counterfeiting of biologics (e.g. vaccines), so the above specified liabilities apply mutatis mutandis.

6. Which state bodies/agencies are involved in anti-counterfeiting activities regarding medicines (and other products, if applicable) in your jurisdiction, and what are their roles? What is the role of the Pharmaceutical inspectorate in anti-counterfeiting activities in your country?

The State Institute for Drug Control (the “SIDC”) is the primary regulatory authority for the quality and safety control of medicinal products and medical devices. The SIDC issues decisions to register medicines for human use, to issue licences for activities with specified substances, and to supervise pharmacy and control the manufacture and wholesale distribution of medicinal products and medical devices.

The Institute for the State Control of Veterinary Biologicals and Medicaments is the primary regulatory authority regarding veterinary medicines.

The Ministry of Health of the Slovak Republic is the primary regulatory authority regarding cosmetics. Control of cosmetics is supervised by the Public Health Authority of the Slovak Republic.

Other state bodies might be involved in anti-counterfeiting activities, depending on the nature of the activities and products. Those bodies would be, e.g. courts, customs and financial authorities, trade licensing authorities, Slovak trade inspection, regional veterinary authorities, and the police.

7. How can the manufacturers, MAHs or IP rights holders for affected products be engaged in investigations regarding illicit trade/counterfeiting/falsification, and what rights do they have during such investigations?

Manufacturers, MAHs and IP rights holders are usually the damaged parties in the civil, administrative and criminal proceedings, because their rights have been negatively affected by the offenders and in most cases the offenders either caused damage to the right holders or obtained unjust enrichment.

Under Slovak law, damaged parties have mainly the right to request the respective authority to oblige the offender to compensate the damage and repay the unjust enrichment. Damaged parties are entitled to file a complaint with the administrative or criminal authorities regarding a breach of laws. Damaged parties may in criminal proceedings file a motion for damages. Damaged parties also have the right to review the administrative/criminal files, be present at investigative acts and at oral hearings, propose evidence to be supplemented and submit statements in the matter.

8. Is it possible to recover damages caused by the counterfeiting/falsification of a medicine (or other products, if applicable)?

Manufacturers, MAHs and IP rights holders can request, in all civil law, administrative law and criminal law proceedings, that the offender (infringer) compensates the damage and repays the unjust enrichment by the counterfeiting and falsification of the products.

In civil law proceedings, the Manufacturers, MAHs and IP rights holders can also (and primarily) request the infringer to cease and desist the infringing activity, remedy the unlawful state, and compensate the immaterial harm (either by non-monetary satisfaction, e.g. by apology, or by monetary satisfaction).

In cases where IP rights are infringed, they may also request the infringer to disclose the information on the origin and distribution networks of the goods or services which infringe the intellectual property rights and the court can order, at their request and at the infringer’s expense, the decision is published in full or in part.

Under Slovak law, it is also possible to request interim measures, e.g. interim cease and desist and the production of evidence.

9. Is it possible to sell medicines, medical devices and veterinary medicines online in your jurisdiction? If so, what are the specific rules and restrictions around these activities?

Yes, in general it is possible to sell medicines, medical devices and veterinary medicines online; however, selling prescription drugs and certain medical devices via the internet is prohibited.

For the online sale of pharmaceuticals, the following elementary requirements must be met:

  • only a pharmacy (holder of legally required licence) can sell online;
  • a pharmacy needs to notify the SIDC certain data and the date of the start of online sales;
  • internet pages need to meet certain requirements and include certain information.

Similar rules apply also to the online sale of veterinary medicines.

10. What protective measures and safety features (e.g. 2D verification, anti-tampering devices or other labelling requirements) are required in your jurisdiction to combat illicit trading and counterfeited/falsified medicines?

Under EU Directive 2011/62/EU, the Falsified Medicines Directive (the “FMD”), the non-profit organisation SOOL was founded in July 2017 to ensure the development and management of the National Medicines Verification System. Marketing authorisation holders and parallel distributors that market products in Slovakia must ensure that prescription-only medicine packs released into the Slovak market carry unique identifiers and anti-tamper devices according to the FMD, and that the data for the products are uploaded to the system.

In addition, manufacturers and distributors are required to follow the rules on the Good Manufacturing and Distribution Principles.

11. Are there any legislative developments in your jurisdictions in the sphere of combating illicit trading and other illegal activities involving counterfeited/falsified medicines (and other products, if applicable)?

Currently there are no new legislative developments relating specifically to combating illicit trading and other illegal activities involving counterfeited/falsified medicines.

Petra Čorba Stark
Portrait ofMartin Baláž
Martin Baláž
Associate
Bratislava