The Belgian Federal Agency for Medicines and Health Products (FAMHP) has underscored the urgent need for reforms in the EU pharmaceutical legal framework, highlighting essential improvements to ensure drug availability and public health safety. Hugues Malonne, CEO of FAMHP, articulated these concerns in a recent interview with Euractiv, indicating general support for the European Commission’s proposals but stressing that significant enhancements are necessary.
In his remarks, Malonne stated, “A reform of the pharmaceutical legal framework was more than necessary. Overall, we are satisfied with the Commission’s proposal, which moves in the right direction on many issues.” However, he indicated that FAMHP would advocate for specific improvements during upcoming negotiations to better align the framework with contemporary healthcare demands.
FAMHP plays a critical role in coordinating with various governmental bodies while also collaborating closely with Belgium’s permanent representation to the EU. This collaboration is particularly significant given Belgium’s recent six-month presidency of the EU Council, a period during which FAMHP worked diligently to influence health policy at the European level.
A key focus of the proposed reforms is the inclusion of a chapter dedicated to supply chain security and the urgent issue of drug shortages. Malonne noted, “In our view, it is high time to review the existing legislative framework.” The emphasis on supply chain security is seen as vital to ensuring that essential medicines remain available to patients throughout the EU.
While acknowledging the European Commission’s proposals as a step in the right direction, Malonne pointed out that there are several areas requiring further enhancement. Key topics for improvement include the incentives regime, environmental risk assessments, and procedural enhancements that could streamline the approval processes for new medications.
Malonne also highlighted the importance of recognizing the Heads of Medicines Agencies (HMA) network, which aims to uphold high levels of public health protection while ensuring the quality, safety, and efficacy of medicines available to the public.
FAMHP’s overarching mission is to guarantee the quality, safety, efficacy, and availability of medicines and health products throughout their lifecycle. Malonne emphasized the importance of ensuring that patients have adequate access to safe and effective medications. Addressing drug shortages is thus a priority for the agency, which advocates for a more transparent system that strengthens supply chains.
Combating antibiotic resistance (AMR) is another critical area of focus for FAMHP. This global health challenge significantly impacts public health and healthcare systems, necessitating coordinated efforts at local, European, and international levels. The agency is advocating for stricter European regulations on the use and prescription of antibiotics and for mechanisms that incentivize the research and development of new antibiotics.
FAMHP collaborates closely with the European Medicines Agency (EMA) and the regulatory authorities of other EU member states to tackle these pressing issues. Within the European network, FAMHP has prioritized areas where it can make a significant impact, including vaccines and advanced therapies, to meet emerging therapeutic needs.
During Belgium’s presidency of the EU Council, FAMHP’s approach shifted significantly. Malonne explained, “It was no longer a question of expressing a national position on the revision of the European pharmaceutical legislation but rather an opportunity to set priorities through agenda setting.” The agency chose to focus on articles related to combating drug shortages and fostering innovation.
Throughout this six-month period, FAMHP dedicated significant efforts to achieving consensus among the 26 other EU member states. The agency played a crucial role in guiding delegates during meetings of the pharmaceutical products and medical devices working group, providing essential support during technical discussions and assisting in drafting various compromise proposals.
While Malonne noted that the work on these priorities is ongoing, he expressed confidence that FAMHP has made substantial contributions toward enhancing the legislative text and facilitating progress within the working group.
In terms of regulatory incentives, FAMHP supports the principle of conditionality. Malonne remarked, “We believe that incentives should be applied within a legal framework that is clear and predictable.” This framework should not only ensure patient access but also address the specific needs of small and medium-sized enterprises (SMEs), thereby fostering the competitiveness of the European pharmaceutical sector while minimizing administrative burdens.
Access to medicines is a central concern for FAMHP, prompting the agency to advocate for a streamlined authorization process that rewards companies for accelerating patient access to innovative treatments across EU member states. “To accelerate procedures and make medicines available more quickly, many deadlines have been shortened in the Commission’s proposal,” Malonne explained. He emphasized the necessity of balancing expedited processes with the operational capacities of competent authorities, noting that decisions concerning medicines can have significant implications for public health.
Authorities must have adequate time and access to relevant data to fulfill their responsibilities effectively, ensuring that the safety, efficacy, and quality of medicines remain paramount.
Administrative simplification and streamlining procedures are critical priorities for FAMHP, which sees these measures as essential for the sustainability of the European regulatory network. The agency’s commitment to these goals reflects its broader mission of ensuring the effective availability of medicines and health products while upholding high public health standards.
In conclusion, the Belgian Federal Agency for Medicines and Health Products is advocating for comprehensive reforms in the EU pharmaceutical framework. By focusing on supply chain resilience, addressing drug shortages, combating antibiotic resistance, and enhancing regulatory incentives, FAMHP aims to safeguard public health and improve access to vital medicines. As negotiations proceed, the agency remains dedicated to refining these proposals to better meet the needs of patients and healthcare systems across Europe.
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