The profile committee of the State Duma approved the expansion of the powers of Roszdravnadzor to confiscate medical products
The State Duma Committee on Health Protection at a meeting on March 24 recommended that the deputies adopt in the first reading a bill on amendments to 323-FZ “On the basics of protecting the health of citizens in the Russian Federation.” The proposed draft amendments regulate the right of Roszdravnadzor to make decisions on the seizure of falsified, low-quality medical devices and their destruction, as well as to file lawsuits for enforcement of such decisions.
The bill, developed by the Ministry of Health of the Russian Federation, was submitted to the State Duma on February 2, 2021. At the end of January, the expansion of these powers of Roszdravnadzor was approved by the Government of the Russian Federation.
The document proposes to amend Art. 38 and 86 323-FZ, concerning the circulation of medical products and the powers of Roszdravnadzor. In particular, the law will stipulate the obligation of the owners of counterfeit, substandard or counterfeit medical products to pay the costs of removing substandard products from circulation, and not just their destruction.
At the same time, Roszdravnadzor will have the right to go to court with claims for the enforcement of decisions on the seizure of falsified, low-quality medical products and their destruction. If the amendments are adopted, the Government of the Russian Federation will approve the procedure for the seizure by Roszdravnadzor of substandard medical products that do not pass as material evidence in criminal or administrative cases.
Profile amendments to 323-FZ were developed by the Ministry of Health of the Russian Federation back in March 2019 on behalf of Deputy Prime Minister Tatyana Golikova. Then it was assumed that Roszdravnadzor will receive the authority to collect through the court compensation for the costs of seizing and storing substandard or falsified medical devices.
In July 2020, the Ministry of Health also presented the Procedure for the destruction of falsified, substandard and counterfeit medical products seized in the course of detecting violations during their circulation. In accordance with the document, such medical devices will be subject to destruction by a court decision or by a decision of Roszdravnadzor or its territorial bodies.
The current legislation assumes that counterfeit and substandard medical devices are subject to seizure and subsequent destruction or export from the territory of Russia, and counterfeit ones – to confiscation and destruction. Removal of medical devices from the country must be carried out by the company that imported them, and the owner of the medical devices must compensate for the costs of destruction.