Important legal news impacting health care regulation in the Czech Republic
Author: Mgr. Martin Murad, Mgr. Jan Novotný
In connection with COVID-19, we have prepared a brief summary of the most important legal news impacting the health care industry and related activities in the Czech Republic.
Prohibition of distribution of medicine relating to the SARS-CoV-2 epidemic
On March 17, 2020, the Government issued a Decree No. 104/2020 Coll., on Prohibition of Distribution of Medicines. This Decree prohibits the export of all registered medicines intended for distribution in the Czech Republic, to EU Member States and to other countries. With effect from April 2, 2020, this prohibition has been limited to selected drugs listed in the Decree’s annex only. Failure to comply with the prohibition can be sanctioned with a fine of up to CZK 5,000,000.
In connection with the prohibition above, the State Institute for Drug Control (“SIDC”) issued a notice to alert distributors of medicinal products of the obligation to attach documents to all deliveries that will facilitate clear identification of whether the contents of the consignment are within the scope of specified requirements. Also, the SIDC recommends attaching an affidavit to consignments, stating which medicinal products are being delivered and attaching appropriate photo documentation of the exported medicinal products.
SIDC’s opinion on clinical trials
The SIDC has issued an opinion in which it strongly advises against the initiation of newly approved clinical trials and the inclusion of new subjects into trials with no medical benefits for enrolled subjects. However, this does not apply to clinical trials focused on COVID-19 treatment.
In relation to ongoing clinical trials, the SIDC recommends using other forms of communication with subjects of the trial, not involving “direct contact”.
Postponing the application date of Regulation 2017/745 on Medical Devices
The European Commission has adopted a proposal by which the application date of Regulation 2017/745 on Medical Devices shall be postponed by one year. This is in order to allow Member States, healthcare facilities and economic operators to give priority to measures against the COVID-19 disease.