The Law on Medicines and Medical Devices of the Republika Srpska came into force today, which envisages the establishment of the Agency for Medicines of the RS, which should operate in parallel with the Agency for Medicines of Bosnia and Herzegovina.
The RS National Assembly adopted this act on October 21 last year, and the decree on its promulgation, signed by Republika Srpska President Zeljka Cvijanovic, was published in the Official Gazette on December 28, noting that the law will enter into force six months after that date.
It is one in a series of laws that provide for the transfer of competencies from the state of Bosnia and Herzegovina to that entity.
The Constitutional Court of Bosnia and Herzegovina repealed certain provisions on the transfer of competencies from Bosnia and Herzegovina to the Republika Srpska, as well as the conclusions of the National Assembly of the Republika Srpska on the transfer of competencies, adopted at the end of last year. Today, the Chairman of the Presidency of BiH, Sefik Dzaferovic, sent a request to the Constitutional Court of BiH to assess the constitutionality of this law, as well as amendments to the Law on Republic Administration of the RS.
As a reminder, at the beginning of this month, the Ministry of Finance of the United States put RS Minister of Health Alen Seranic on the list of sanctions due to, as stated, separatist efforts to implement the Law on Medicines of Republika Srpska, which the Ministry of Health, headed by him, submitted to consideration by the RS National Assembly.
The High Representative in Bosnia and Herzegovina, Christian Schmit, met with the Director of the Medicines Agency of Bosnia and Herzegovina last week, stressing that the Agency must continue to work according to law and that all challenges it faces are, in fact, challenges to the well-being of all Bosnian citizens. and Herzegovina. His earlier position was that the RS Law on Medicines was illegal, as was the establishment of the Agency.
“The Law on Pharmaceuticals and Medical Devices of Republika Srpska which entered into force today, 28th of June 2022 violates the BiH Constitution, the BiH Law on Pharmaceuticals and Medical Devices and BiH would backslide in its alignment with the EU acquis on consumer and health protection, as well as contravene BiH’s obligations as part of the Stabilization and Association Agreement. This has been made clear repeatedly. The RS authorities could have repealed or suspended the law but they decided not to act and move forward with the application of this law, EU and the OHR stated today.
The application of the RS Law will have grave implications and will put the health of BiH residents, in both entities and Brcko, at risk. It will seriously undermine public health safeguards that are in place and will jeopardize the work of pharmaceutical and medical device wholesalers in RS thus affecting upon the retail sale of pharmaceuticals and medical devices ultimately undermining BiH single economic space.
The detailed account of the implications of the application of the RS Law on Pharmaceuticals and Medical Devices can be found in the joint OHR – EUD memorandum.
