Counterfeiting and modifying prescriptions for medicinal products and medical devices is to become a separate offence after a new one. The aim is to better protect patients and keep the medicines available in Slovakia. The change is proposed by the Ministry of Justice of the Slovak Republic in cooperation with the Ministry of Health of the Slovak Republic in the amendment of the Criminal Law approved today by the government. Forgery of medical documentation and medical devices should also be punishable.
We have been able to push for an important change that will significantly strengthen the protection of patients and the entire system of prescription and dispensing of medicines. Counterfeiting recipes will be a new crime. This means more certainty that the medicines the patient needs will remain available in Slovakia, said Minister of Health Kamil Šaško.
The amendment introduces the specific facts of the offence of forgery, modification or execution of a false prescription, prescription or medical certificate. Such conduct will be punishable by up to 3 years imprisonment. Stricter penalties are to be applied in more serious cases, for example if such action is committed by a healthcare professional or if there is more damage or benefit.
The strictest consideration should be given to the misuse of counterfeit or false prescription when ordering medicinal products through an information system for the special ordering of medicinal products, which serves the pharmacies to secure the medicinal product for a particular patient in case the pharmacy does not have it in stock. In such a case, the proposal provides for a penalty rate of between 3 and 8 years.
Counterfeiting of drug dossiers will also be punishable
The amendment also responds to the need to more clearly address the deliberate counterfeiting or modification of medicinal products and medical devices, as well as the documentation accompanying their manufacture, supply and use. These include, for example, medicinal product handling authorisations, good manufacturing or wholesale practice documents, analytical certificates or documentation on the receipt, delivery, transport, import and export of medicinal products. For medical devices, the modification applies, for example, to the EU declaration of conformity, certificate of conformity, instructions for use or free sales certificate.
The proposal will now be discussed by the Slovak National Council. Once the legislative process has been completed, the new legislation is foreseen to have effect from 1 January 2027.