The High Representative Christian Schmidt strongly points out that a “Law on Pharmaceuticals and Medical Devices of RS” constitutes a severe challenge to the competences and the unimpeded functioning of the BiH Agency for Pharmaceuticals and Medical Devices. Under the Constitution of BiH, entities are obliged to comply fully with the Constitution and decisions of State institutions such as the Law on Pharmaceuticals and Medical Devices of BiH.
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. 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.
The High Representative calls on every single RS National Assembly representative to uphold their obligations under the Constitution of BiH, demonstrate their responsibility towards public health and wellbeing and not proceed with the adoption of the Proposed RS Law on Pharmaceuticals and Medical Devices.
