Tue Sep 24 03:38:00 UTC 2024: ## Belgium’s Medicines Agency Proposes Improvements to EU Pharma Package

**Brussels, Belgium –** The Belgian Federal Agency for Medicines and Health Products (FAMPH) has voiced its support for the European Commission’s proposal to revise the EU’s pharmaceutical legislation, calling it a step in the right direction. However, the agency also proposes several improvements, particularly focusing on incentivizing innovation, combating drug shortages, and strengthening supply chain security.

Hugues Malonne, CEO of FAMPH, emphasized the importance of the reform, stating that it “was more than necessary.” He highlighted the need for a revised legislative framework that ensures the quality, safety, and efficacy of medicines while addressing key challenges like drug shortages and antibiotic resistance.

FAMPH’s priorities include:

* **Combating drug shortages:** The agency advocates for a system that enhances transparency and strengthens supply chains, ensuring patients have access to sufficient quantities of safe and effective medicines.
* **Addressing antibiotic resistance:** FAMPH calls for strengthened European rules regarding the use and prescription of antibiotics, along with mechanisms to stimulate research and development of new antibiotics.
* **Incentivizing innovation:** The agency supports the principle of conditionality when it comes to regulatory incentives, advocating for a system that ensures patient access, considers the specific needs of small and medium enterprises, and ultimately limits administrative burden.

Malonne also emphasized the need for a “simplified and streamlined” system, acknowledging the need to expedite procedures while ensuring that competent authorities have the time and data necessary to properly evaluate medicines.

During Belgium’s six-month presidency of the EU Council, FAMHP played a key role in guiding delegates during negotiations and facilitating discussions within the “pharmaceutical products and medical devices” working group. The agency considers its contribution to the ongoing reform process a success, stating that they “significantly contributed to improving the text and helping the working group advance on a series of major points.”

The agency’s position on the EU pharma package reflects its broader mission of ensuring the effective availability of medicines and health products while maintaining high standards of public health protection.

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