Christoph Stoller, the President of Medicines for Europe, led an important mission to Bulgaria to improve access to medicines in partnership with the Bulgarian Generic Pharmaceutical Association chaired by Nikolay Hadjidontchev. Bulgaria has limited public funding for medicines and patients face the highest drug co-payment costs in all of Europe according to the State of Health in the EU report. To address this challenge, Medicines for Europe met with the Bulgarian minister of Health Kiril Ananiev and with the Chair of the Health Committee of the Bulgarian National Assembly Dr. Daniela Daritkova on 10 December in Sofia. During the exchange, our President underlined how EU pharmaceutical policy under the new Commission should help Bulgarian patients.

Regarding shortages and availability, Medicines for Europe warned that Bulgaria should not apply clawback taxes to generic and biosimilar medicines which are the main driver of access in the system through lower prices for both the national health fund and patient co-payments. He underlined that similar measures in Romania led to 3000 medicine withdrawals and major availability problems as was highlighted by the European Commission (citation DG ECFIN). Recent EU documents such as the Euripid guidance document also advise countries not to apply external reference pricing to generic medicines as this leads to a double price cut (first a reduction of the originator reference price, then a reduction of the legally lower generic medicine price), therefore Bulgaria should prioritise measures such as rational prescribing to ensure greater volume usage of generic medicines to increase access and ensure the stability of the national health fund. Finally, the President made a strong case for a dynamic biosimilar medicines policy. Bulgaria has very low levels of access to biological therapies (3rd lowest in the EU) – including to important cancer and immune therapies. By encouraging uptake of biosimilar medicines through competitive procurement in hospitals and benefit sharing measures for physicians and patients for medicines dispensed in a retail setting, Bulgaria could dramatically increase access to essential biosimilar medicines for Bulgarian patients.

Christoph Stoller said: Medicines for Europe will be a partner for the Bulgarian government to play an active role in EU pharmaceutical policy and to implement strong generic and biosimilar medicines policies as recommended by the European Commission and OECD in the State of Health in the EU report. Together, we can improve access to medicines for all Bulgarians through stepwise improvements to pharmaceutical policy at EU and national level. Our industry is committed to deliver on equity of access to medicines and calls on the Commission to provide technical support to Bulgaria to help it achieve real progress for public health.