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Ministry of Health opens a discussion platform to address issues 
in the field of medical devices

Updated: Dec 4, 2023

In recent months, several significant issues have accumulated in the medical devices agenda that require swift solutions. Rising inflation and an unprecedented increase in the cost of supplying medical devices to the market in the Czech Republic are creating pressure for alleviation of price regulation as well as for an increase in reimbursement from health insurance. At the same time, the situation within the process of inclusion of separately charged material (”ZUM”) in the codes of health insurance companies is escalating. The Ministry of Health is fully aware of the seriousness of the situation and has set up a discussion platform for associations of medical device suppliers, health insurers, professional societies, SÚKL and ÚZIS, and other stakeholders in order to quickly identify acute problems as well as to find possible solutions that are acceptable to all parties.

On 22 April 2022, the first meeting was held where individual stakeholders presented their current concerns in the field of medical device regulation. The aim of this meeting was thus not to find an immediate consensus on an adequate solution to the problems, but to divide the partial topics into meaningful units and to set a timetable for further discussions. It was also decided that the spheres of outpatient and inpatient care should be addressed relatively separately.

This was followed by the first substantive meeting of the entire platform on 6 May 2022, which was devoted to the issue of price regulation. A consensus was found relatively quickly that it was necessary to proceed to partial price deregulation of reimbursed medical devices, based on the rule that a priori those reimbursement groups that include at least four medical devices from four different manufacturers should be deregulated. Some exceptions may be made in the case of heterogeneous reimbursement groups where, although the above condition is fulfilled, such groups contain completely non-interchangeable medical devices whose suppliers have a monopoly or oligopoly position. The market share of the manufacturers concerned within a particular reimbursement group will also be examined to avoid that there are products from four manufacturers in a group but one of them has a market share of over 70 %, etc.

The health insurers are to carry out an analysis and should prepare a proposal for price deregulation. The next meeting will take place on 3 June 2022 and will focus on the area of separately billed materials.

Author: Jakub Král


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