In Belgium, the Federal Agency for Medicines and Health Products (FAMHP) is the competent authority to guarantee the quality, safety and effectiveness of medicines and health products, including medical devices and accessories, raw materials, blood and human body material).
Michèle Paque, Senior Advisor Healthcare & Life Sciences, PwC Belgium, interviewed Hugues Malonne, Chief Executive Officer of the FAMHP, to discuss healthcare issues affecting policy in Belgium, and his vision and plans for the Agency.
Right now, the Agency is highly focused on pushing through the new EU pharmaceutical package proposal, during Belgium’s presidency of the EU from January to June 2024.
The proposal is designed to ensure that all EU patients have timely and equitable access to safe and effective medicines, and to boost the attractiveness of the EU pharmaceutical industry.
Availability of medicines and medical devices, and preventing shortages, is a critical focus. Among the measures to address this priority, the EU Commission is setting up a Critical Medicines Alliance, allowing relevant stakeholders to coordinate action at EU level to address shortages and supply chain vulnerabilities.
Hugues noted that there’s some provision for this already today in the EU pharmaceutical package, and that there are things that can already be implemented. For example, the Commission's Health Emergency Preparedness and Response (HERA) department, set up following the COVID-19 pandemic, aims to prevent, detect and rapidly respond to health emergencies, anticipating threats and health crises.
He further discussed the Agency's activities in this context, outlining the importance of partnerships, innovation, information transparency and collaborations with patients and patient organisations.
"The most significant impact of the revised EU pharma legislation will be broader and quicker EU-wide patient access to innovative medicines.”
Hugues Malonne
Chief Executive Officer, FAMHP
Want to learn more about the FAMHP's priorities and activities?
Read our interview with Hugues Malonne here
Contact us
Michele Paque
External Senior Advisor, Life Sciences and Healthcare, PwC Belgium
Tel: +32 477 60 50 51
