With the law establishing a separate Medicines Agency in Bosnia’s Republika Srpska (RS) entity entering into force on Tuesday, the Serb-majority region within the country has started the process of unilaterally taking over state-level competencies.
The RS Law on Pharmaceuticals and Medical Devices, which the RS Government adopted in February after it passed in the RS National Assembly, is part of a wider initiative by the Bosnian Serb member of BiH’s tripartite Presidency, Milorad Dodik.
Dodik, who is the leader of the ruling party in the RS, has initiated steps towards withdrawing the entity from numerous state institutions that were established through post-war reforms in the country, including the tax authority, Armed Forces and judicial institutions.
He announced the establishment of entity institutions that would operate separately from the state, which many foreign and local officials argue represents a step towards secession.
The RS National Assembly expressed support for his plan on December 10 last year.
With the RS Law on Pharmaceuticals and Medical Devices entering into force, the RS is establishing its own, separate Agency for medicinal products and medical devices.
The RS Government is now expected to appoint the officials to top posts in the new agency within 60 days, and they will then be tasked with defining a set of regulations for the institution within 120 days.
It remains unclear whether BiH’s Medicines Agency will still have authority on the territory of Republika Srpska and how such a new setup could affect the country in terms of the market.
The EU Delegation in BiH, as well as the Office of the High Representative of the international community in the country, noted on Monday that the law “violates the BiH Constitution, the BiH Law on Pharmaceuticals and Medical Devices”.
In a joint statement, the EU Delegation and OHR warned that “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” with the implementation of the law.
“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's single economic space,” the statement said.
This law is also part of the reason why the United States introduced sanctions against the RS Health Minister, Alen Seranic.
According to the US Treasury, Seranic “furthered the secessionist efforts of the RS for leading the implementation of the RS Law on Medicines and Medicinal Products which his Ministry submitted to the RS National Assembly for consideration.”
BiH Presidency Chairman Sefik Dzaferovic sent a request to Bosnia’s Constitutional Court on Tuesday asking it to look into whether the law is in line with the BiH Constitution. He also asked the court to issue an interim measure which would put the law out of force until a final ruling is reached.