Pharmaceutical law amended to help combat counterfeit medicines


On January 1 2015 a significant addition to the Hungarian Act on Medicinal Products for Human Use (95/2005) entered into force: Paragraph 20/A, entitled “Temporary inaccessibility of electronic data”.

The amendment allows the National Institute for Quality and Organisational Development in Healthcare and Medicines to combat the sale of counterfeit drugs online faster and more effectively - namely, the institute can order the removal of online content relating to fake or prohibited medicines and require the website owner to comply with the order for up to 90 days. The website owner has to remove the content within one working day or pay a fine ranging from €315 to €3,150 (approximately $357 to $3,570). If the website owner fails to comply, the court may order that the fine be paid several times.

The authorities may report IP rights infringement at the same time, and if the court decides to make the electronic data permanently inaccessible, this decision would override that on temporary inaccessibility.

If the website owner does not challenge the institute’s decision relating to temporary inaccessibility, the name of the infringing website may be displayed on the institute’s website for up to 90 days.

Csilla Balogh, PETOŠEVIĆ, Budapest

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