TI BiH: Instead of solving the problem of oxygen supply, the RS Government is trying to legalize irregularities and protect those responsible

Instead of using existing procurement mechanisms in urgent and emergency circumstances to solve the problem of oxygen distribution, the Government is embarking on an adventure by passing a new law tailored to the narrow interests of the governing structure and creating parallel institutions

Banja Luka, 20. October 2021. – Transparency International in Bosnia and Herzegovina (TI BiH) warns that the Government of Republika Srpska has not given justified reasons for the urgent adoption of the Law on Medicines and Medical Devices in RS, and recalls that there is already a law governing this area at BiH level. Agency for Medicines and Medical Devices of BiH as an authorized body (regulator).

Due to the circumstances in which such a law is adopted and the establishment of a parallel Agency for Medicines and Medical Devices at the entity level, there are doubts not only about the validity of the adoption of this law at the RS level, but also that instead of establishing responsibility adapts to the narrow particular interests of the governing structure.

Earlier, TI BiH warned and reported to the authorities that unauthorized distributors supply public health institutions with oxygen, and the inspectors determined that this endangers the health of the population. Therefore, it is unacceptable that instead of eliminating these irregularities and sanctioning those responsible, it is trying to legalize this practice, under the pretext that according to the existing regulations, it is not possible to ensure uninterrupted supply of health institutions.

TI BiH reminds that the current regulations allow public health institutions to directly procure medicines in situations when it is required by reasons of urgency and protection of the health of the population, with the approval of the competent entity ministry. However, instead of using the existing procurement mechanisms in urgent and emergency circumstances to solve the problem of oxygen distribution, the Government is embarking on an adventure with the adoption of a new law in the urgent legislative procedure, for which the conditions are also not met.

In the explanation of the Bill, the Government only states that it is passed in an urgent procedure to provide health care to the population, and that failure to pass the law could cause harmful consequences for human life and health, especially due to lack or inability to procure essential medicines for patients. The NARS Rules of Procedure stipulate that passing a law in an urgent procedure is possible only if the law regulates issues and relations arising from circumstances that could not have been foreseen, and failure to pass a law in an urgent procedure could cause harmful consequences for human life and health. As the epidemic has been going on for more than a year, as well as the problems related to the delivery of rolled oxygen, they can no longer be considered circumstances that could not have been foreseen.

Also, if a new regulator of trade in medicines and medical devices were to be established, it would require additional time for the new agency to start working and for all necessary bylaws to be passed within 90 days of the law’s entry into force. The new law would take effect only six months after its publication, leaving 60 days from the day the law enters into force to elect the new Agency’s management. The time needed to establish a new regulatory framework in the field of trade in medicines and medical devices does not justify the urgency in protecting the health of the population, which the Government cites as the main reason for passing the new law.

Press rls – 20.10.2021