Two amendments of laws relevant for pharmaceutical industry:
short summary

Two amendments relevant for the pharmaceutical industry entered into force on 21 May 2020.

Based on the latest amendment to the Reimbursement Act (Act No 363/2011), the Slovak Ministry of Health is gaining the power, during the extraordinary situation declared in relation to COVID-19, to suspend (without any specific reason) all pricing and reimbursement proceedings initiated by the Ministry of Health. After suspension, procedural periods shall not be running as well. Subsequently, after the end of the extraordinary situation, the Ministry of Health shall resume the suspended proceedings (unless the proceedings were resumed earlier). No appeal can be filed against the decision on suspension of proceedings.

Further, the Act on Art Funds is being amended by the Act amending and supplementing certain laws in the competence of Ministry of Culture relating to COVID-19. According to this amendment, the obligation to withhold and pay the levy of 2 % from gross income of recipients of author remuneration to the Literature Fund shall not apply to remuneration paid from the date of entry into force of the act (21 May 2020) until 31 December 2020. The persons paying the remuneration shall be obliged to pay the full remuneration to the authors. Recipients of the remuneration may, in their own name and on their own cost, pay the levy voluntarily. This change has an impact on the remuneration paid by pharmaceutical companies to healthcare professionals for creation of copyrighted works (e.g. scientific articles, lectures). If a remuneration has not been paid yet based on already concluded agreement, the remuneration must be paid in full to the author, including the 2 % dedicated to the levy to the Literature Fund. For the period from 21 May until 31 December 2020, new contracts with healthcare professionals or templates used should be amended to reflect that the levy to the Literature Fund shall not be withheld and paid in this period.