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April 11, 2021

Romania and Bulgaria, agreement on the patients’ access to medicines

Romanian Government announced that it approved, on Wednesday, November 9, by Memorandum, the negotiation and the conclusion of a cooperation agreement with Bulgaria, whose framework will ensure the patients’ access to medicines.

According to officials, this way, patients from both of the countries will be able to quickly benefit from the medicines missing from various reasons, from one of the countries, being available in the other country.

“The opportunity of signing such an agreement raised within a joint meeting of October 6, this year, between representatives of the Romanian Government, Bulgarian Government and institutions in charge from the two countries”, shows a release issued by the Government.

Thus, Romania and Bulgaria can agree on joint solutions to overcome the lack of some medicines, when such a situation occurs.

In their capacity of signatories of the Cooperation Agreement that ensures the access to medicines, Romania and Bulgaria will also be able to conclude joint agreements with the producers, in order to obtain discounts, they will agree the list of medicines to which the procedure will apply, as well as a joint position related to the confidential price or, where applicable, to the discounts requested for these medicines.

The procedure related to the joint agreements concluded with the medicine producers should be applied for these treatments who are not reimbursed from public funds in none of the signatory countries of the cooperation agreement, for the medicines with common international names and for the so-called orphan medicines, used in the treatment of very rare diseases. This way, patients will benefit more quickly from the newest and most efficient medicines for their diagnosis, and on the other hand, savings will be ensured for the budgets of the two countries.

“The decisions regarding the implementation of the Agreement will be taken by consensus by the Coordination Committee for Joint Actions which will be created to this end, and the first meeting of the Committee will take place in Romania, which is the Depositary of the Agreement, within one month since its entry into force. Subsequently, other Governments from the European space can join this project of volunteer cooperation initiated by Romania and Bulgaria, which aims to have a joint approach that provides the access to efficient treatments in Central and Eastern Europe”, shows the release issued by the Government.

Romania and Bulgaria have presented this project at the Work Meeting of the Health Ministers from Central and Eastern Europe on the growing challenges in the field of the medicine policy, held on June 2 and 3 in Sofia, where Romania was represented by the Health Minister Vlad Voiculescu and by the President of the National Agency of Medicines, Nicolae Fotin.

At the end of the meeting, the participating countries – Romania, Bulgaria, Croatia, Estonia, Latvia, Macedonia, Serbia, Slovenia and Hungary – have signed a joint statement of intent. Poland was the observer of the meeting.

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