In 2020, we were hit by the first wave of the COVID-19 pandemic, and at the same time the Medical Devices Act (current Act No. 89/2021 Coll.) was being debated in the Chamber of Deputies. It was a very strange time when patients were afraid to visit their doctors' surgeries, and doctors were equally worried about potential infection from their patients. Both sides were thus keen to minimise personal encounters. This was countered by the Ministry of Health, as well as by health insurers, through the promotion of telemedicine procedures. As far as prescribing medicines was concerned, the situation was relatively simple thanks to the eRecept system. This allowed doctors to issue prescriptions remotely without any problems.
In the case of medical devices, however, the situation is worse, as it is not yet possible to electronic prescribing. Following an initiative by patient organisations, members the House Health Committee adopted an amendment that introduced the possibility of issuing electronic vouchers. In order to give the State Institute for Drug Control peace of mind and enough time to prepare the ePoukaz system, a so-called floating efficiency was established. This means that the live operation of the system will start in the second calendar month following the month in which the Ministry of Health issues a declaration in the Collection of Laws that the ePoukaz is ready and fully operational.
In summer 2021, a test run for suppliers of prescribing and dispensing IT systems was launched. Initial plans called for the launch of the live version of the system from early 2022, but it subsequently became clear that somewhat more time would be needed for the Ministry to issue the necessary implementing decree containing the ePoukaz requirements. In November 2021, the Ministry of Health officially promised the public a date for the launch of the electronic prescription of medical devices from 1. 3. 2022. However, in the meantime, it has not held comment procedures on the aforementioned decree. It is still pending and since we are already in February, it is obvious that the ePoukaz system will not be launched from March. There are now two possible options. Either the ministry will assess that electronic prescribing of medical devices is a priority in times of a pandemic, then a minor delay of about one to two months can be expected, or it will continue as before and then we’ll be waiting for the new act on medical devices and IVDs to come into force, which is also very late. We do not expect it until this autumn.
Author: Jakub Král
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