Czech Republic to Revamp Reimbursements, Launch EU Regulations Panel

The Czech Republic is revamping its medical device reimbursement system and preparing for implementation of the new European device regulations.

The country’s system for reimbursing for the use of medical devices is failing in that it is based on codes provided by health insurance companies, the Ministry of Health said in a Jan. 22 announcement. It intends to introduce a new reimbursement system this year through an amendment to its Public Health Insurance Act of 1997, and have it come into full force by Jan. 1, 2019.

There will be a risk of the medical device reimbursement system collapsing, and a significant increase in the cost of the public health insurance system, if legislative action is not taken, the Ministry of Health said.

Securing reimbursement from public and private health insurers has been a longstanding industry struggle, and this will be tackled by a newly established standing committee for categorization and reimbursement of medical devices.

The new committee is comprised of the Ministry of Health, the State Institute for Drug Control, patient groups, and industry associations, among several others. It held its first hearing last December and scheduled another for this month, with the goal of accelerating the amendment’s preparation.

Meanwhile, the European Commission is introducing new regulations on medical devices and in vitro diagnostics (IVDs) , and the overhaul has prompted regulatory bodies across the EU to craft their own, unique strategies to implement the regulations properly and on time.

For example, the UK’s Medicines & Healthcare products Regulatory Agency recently launched an online service for medical device and IVD submissions to provide greater transparency throughout the process, allowing submission of multiple products in bulk with a single fee, among other benefits, to facilitate the new regulations. It remains to be seen how Brexit will impact the implementation of the EU regulations (IDDM, Jan. 22).

The Czech Republic’s Ministry of Health is taking a different approach. It will to set up a Working Group on the Preparation of the EU Regulation on Medical Devices and IVD, consisting of notified bodies, the Ministry of Industry and Trade, the Ministry of Health, and the State Institute for Drug Control, among others. — Ana Mulero