Bosnia’s international administrator called on Wednesday the initiative to create an agency for medicinal products and medical devices for Bosnia’s semi-autonomous Republika Srpska (RS) entity, which would operate separately from the state agency, a “dangerous and unnecessary risk to lives and wellbeing of all BiH citizens.”
Despite his warning and appeal not to do it that came shortly before the vote, the National Assembly of Republika Srpska adopted the bill with 43 votes in favor and two abstentions.
The move is seen as the first step towards the transfer of competencies from the state to the Republika Srpska entity with the goal of achieving more autonomy from Bosnia and Herzegovina.
High Representative Christian Schmidt, who is tasked with overseeing the civilian implementation of the 1995 Dayton peace Agreement, said that a “Law on Pharmaceuticals and Medical Devices of RS” constitutes a severe challenge to the competencies and the unimpeded functioning of the existing state-level agency and a violation of the Constitution.
“The BiH Agency is the only institution in BiH authorized, capable and equipped to ensure that pharmaceuticals and medical devices in use in BiH are safe, of high quality and efficient,” a statement from Schmidt’s office said.
“It is also the only such agency established and operating in accordance with EU Acquis as a requirement for BiH in the EU accession process. Any rollback on this reform is a direct act against public health safeguards, and with that a dangerous and unnecessary risk to the lives and the wellbeing of all BiH citizens,” it said.