After 19 years and more than 20 changes to the existing law, a new Law for Barnat is being prepared, which will bring full harmonisation with European legislation, Health Minister Sasho Klekovski announced, following national consultation on the issue.
Representatives of patients’ associations, pharmaceuticals, pharmaceutical industry, experts and government institutions participated in the advisory meeting.
According to Minister Klekovski, with the new legal framework the current 2007 law will be replaced by a new law, while drugs and medical means will be regulated by separate laws. In the next phase, there is also the adoption of a special law on pharmaceutical activity.
For the patient, a well-organised drug system means taking therapy in time, trusting in its quality and security and obtaining accurate information on its use, Klekovski stressed.
As the next steps have been warned of reviewing all the submitted remarks, establishing the most powerful mechanisms against drug shortages, simplifying the procedure for reporting unwanted reactions, and drafting a plan for law enforcement along with the Agency for Barna and Medical Equipment ( MALMED).
The law will be worth it. Therefore, for any new obligation, we need to know who does, what you know, what tools, and what deadlines, the minister stressed.
The process is being implemented with support from the World Health Organisation ( O BSH) in Macedonia.