On October 9, 2024, as part of regular meetings, a session was held between the UIPL Regulatory Working Group and the Agency for Medicines and Medical Devices of Bosnia and Herzegovina (ALMBIH), represented by the Agency’s Director, Nataša Grubiša, and Ana Petrović, Director of the Association of Innovative Pharmaceutical Manufacturers (UIPL).
This meeting was part of ongoing efforts to strengthen cooperation between these institutions, aimed at achieving rational pharmacotherapy and ensuring high-quality healthcare focused on the well-being of patients across Bosnia and Herzegovina.
One of the key topics of discussion was the limited availability of medicines and medical devices for healthcare professionals and patients. Representatives from both sides shared their perspectives and experiences regarding the challenges they face, as well as the need for better cooperation with other relevant institutions.
The primary cause of these difficulties was identified as the misalignment of Bosnia and Herzegovina’s legislation with European Union regulations, along with the legislative framework’s failure to meet the actual needs of the market and the rapid changes occurring within the pharmaceutical industry.
It was unanimously agreed that it is essential to ensure faster and easier access to effective and safe medicines, as well as the most advanced therapeutic models for healthcare professionals and patients. To achieve this, several key steps were highlighted:
- Establishing an appropriate economic, political, and administrative environment.
- Involving all relevant institutions in the regulation of the medicines and medical devices market.
- Amending legislation in line with EU regulations and the real healthcare needs of the population.
As a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), UIPL actively encourages institutions to create a favorable environment for achieving these goals. UIPL shares EFPIA’s belief that the interaction between the pharmaceutical industry and healthcare professionals has a positive impact on patient treatment quality and the future of medical research.
It’s worth noting that the Agency has already taken steps to harmonize legal regulations with EU standards by submitting the following proposals to the Directorate for European Integration (DEI):
- The Rulebook on Medicine Registration,
- The Rulebook on Clinical Trials,
- The Rulebook on Medical Device Registration.
Additionally, proposals for the following are in the final stages of preparation:
- The Rulebook on Pharmacovigilance,
- The Rulebook on the Content and Labeling of External and Internal Packaging and the Instructions for Medicines.
During the meeting, several constructive proposals were made, and concrete steps were agreed upon for improving medicine availability, laying the groundwork for further collaboration between the Agency and UIPL.
In conclusion, the adoption of these by-laws is often delayed due to the complex procedure involving a large number of institutions, which slows down the legal decision-making process.