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Reimbursement of Medical Devices

A colourful bouquet of systems in CEE countries

Many regulatory issues in the field of Medical Devices (MDs) are unified throughout the EU and will become even more harmonized after the entry into force of the MD Regulation. However, analysing the reimbursement systems in our CEE countries, a fascinating bouquet of colours can be arranged.

Starting our bouquet with Belarus as a non-EU country, where the state unitary entity “Belmedtechnika” selects MDs qualifying for reimbursement during a public procurement procedure,

we can let our eyes sweep over systems where the decision on reimbursement lies mostly in the hands of insurance companies and only fundamental issues are commonly regulated (Czechia),

then moving along to systems where reimbursement of MD mainly corresponds to that of medicinal products (Latvia, Lithuania and Poland),

and further still to systems where the distributor has to be added first to a list of approved distributors of the relevant authorities (Hungary) or the MD has to be added first to a list of approved MDs of the relevant authority / health insurance fund (Bulgaria, Poland, Slovakia, Latvia and Lithuania)

and finally ending up with systems where the manufacturer of a MD has to conclude a price agreement with the national health insurance fund to be eligible for reimbursement (Estonia).

No unified practice exists on regular reviews of decisions to reimburse. In some countries, such as. Czechia, lists are usually not updated, whereas in others, such as Hungary, decisions on reimbursement of concrete MDs are under constant review.

Most countries do not use international reference pricing to decide on reimbursement. Belarus, Estonia, Hungary, Poland and Czechia do not apply any international reference pricing, whereas in Bulgaria no real reference pricing is applied but MDs should be reimbursed in at least one Member State of the EU for the same indications and diseases as specified by the Bulgarian Health Insurance Fund. In Latvia, Lithuania and Slovakia, international reference pricing rules analogous to those for medicinal products apply. Some countries that do not apply an international reference pricing system, such as Czechia, or that do apply the international reference system, such as Latvia, establish the amount of reimbursement according to the economically most advantageous MD in the national market.

Some countries determine maximum and minimum prices for MDs (e.g. Lithuania), whereas in others (e.g. Hungary) no price limitation exists.

And even where it seems at first glance that different systems possess a quite similar colour, digging into the details of procedure, the necessary documents, fees, conditions to be included in different lists, as well as the percentages reimbursed for different patient groups, each system opens up a further spectrum of shades for each colour.

Thus, despite the fact that reimbursement is one of the important factors of successful sale of MDs, national laws will never lose their importance here. Thus, each national regulation will also in future provide each manufacturer, distributor and retailer with its own bouquet of colours.