On February 23, AmCham Healthcare Committee gathered to discuss the new draft Law on medicines, recently submitted for public consultations by the Ministry of Health. While having the purpose to implement EU directives on the matter, the draft law has to be adjusted to fit the context of national legislation and provide clear procedural regulations.
In particular, Committee members voiced concerns that the implementation of such measures as parallel imports, online sales of medicines, as well as distribution through unlicensed stores, in the absence of necessary safeguards, will significantly increase the risk of counterfeit drugs entering the national market.
The draft law also fails to specify relevant exemptions applicable upon authorizing medicines that have a prior registration in EU countries. These and other issues will be addressed in Committee’s subsequent position paper.