Hugues Malonne: looking back on his first months as Chief Executive Officer

In September 2023, Hugues Malonne took over as head of the Federal Agency for Medicines and Health Products. Having previously held the position of Director General of DG POST authorisation and then DG PRE authorisation, Hugues was well aware of the amount of work that lay ahead.

This annual report is an opportunity to find out a bit more about our new Chief Executive Officer.

Hugues Malonne had an international pharmaceutical career before heading up the FAMHP. In 2017, he returned to Belgium and joined the agency. He then rose through the ranks, starting as Director General and eventually becoming Chief Executive Officer.

“I joined the FAMHP as Director General and successively managed the POST and PRE authorisation entities. The position of Director General enabled me to exercise a range of skills, such as a sense of responsibility, innovative thinking, strategic analysis, negotiation skills, human resources management and the creation of national and international networks as a public service. It was a key position with a major impact on the field.

So I was already familiar with the agency’s remarkable work and, above all, I was motivated and confident regarding this new opportunity. I know the importance and positive influence of our actions on the health of all our citizens, as well as on the organisation of all our institution’s external partners at national and international levels. As soon as I took on the role, I knew that, with all my colleagues, I would be able to move this organisation forward and guide us into the future.”

How would you describe these few months as CEO?

“The start of my mandate at the FAMHP was marked by preparations for the Belgian presidency of the Council of the European Union. I am paying close attention to the FAMHP’s involvement in the presidency and the Critical Medicines Act that the Minister wanted to highlight. Furthermore, as co-chair of the Joint Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), I am involved in discussions concerning the level at which each measure should be implemented (regional, national, European or even international).

As a result, the Belgian presidency of the Council of the European Union in the first half of 2024 offers us a unique platform to address crucial themes for our agency, such as antimicrobial resistance, crisis management, unavailability and unmet medical needs. This is why our agency, through its various departments, has made extensive preparations for this presidency.

This opportunity will enable us to demonstrate Belgium’s importance in the European public health arena, a status we will be seeking to reinforce given its essential role in global public health.

I am convinced that the presidency will help us to optimise our activities, advance our work and move towards ever greater collaboration.

At the start of my mandate, I decided to change the old organisation chart. So I set up a formal department for strategic support and chose the old model of separating general services and the CEO’s services into two different entities. The CEO’s services now include the Strategy Realisation Office, the Legal Affairs Division, the Quality Division and Organisational Management, the International Relations Division and the Communication Division.

The general services, now under the management of Pascal Giloteau, include the Budget and Management Control Division, the Personnel and Organisation Division, the ICT Division and the Logistics Unit – Collaboration 1FM. These organisational changes were also accompanied by changes in responsibilities.

So I am delighted that Erik Everaert joined our team as Director General of DG POST authorisation on 1 November 2023. I am convinced that Erik will make a valuable contribution to our organisation thanks to his experience and expertise. I look forward to working with him in his new role and seeing what he will achieve. We will also be welcoming another person to take my place as DG PRE authorisation.”

What are you most proud of?

“First of all, I am already proud of my career at the agency. Starting out as Director General of two entities has given me a wealth of experience and a better overview for my current role.

Secondly, I am proud that the Minister of Public Health, Frank Vandenbroucke, and the Council of Ministers have placed their trust in me to lead the agency for the next six years.

From the outset of my mandate as CEO, I knew I could count on the agency’s staff to meet the challenges ahead. So I am also proud of all my colleagues. Through our work, we contribute to exemplary service by ensuring the quality, safety and efficacy of medicines from conception to use.

Not forgetting the agency’s crucial role in integrating the Medical Devices Amendment (Medical Device Regulation, MDR and In-Vitro Diagnostics Regulation, IVDR) and finalising the new SoHO legislation (substances of human origin). This amendment has three objectives: to extend the transition period for the IVDR, to allow for a gradual implementation of Eudamed (European database on medical devices), and to require notification in the event of imminent unavailability. The SoHO legislation involves the introduction of new rules to protect citizens who donate or receive substances (blood, cells, tissues, breast milk or microbiota), and children born of medically-assisted procreation. On 14 December 2023, agreement was reached on the European regulation on standards of quality and safety for these substances intended for human application. The SoHO legislation is another example of our contribution to improved public health.

We have a direct and tangible impact on public health protection. The websites we have developed, such as PharmaStatut and PharmaInfo, help to fulfil this crucial role by providing citizens with understandable, reliable and impartial information. Our teams are also committed to sharing knowledge and information with our external partners, as you can see from projects such as the development of a web portal for pharmacists. There are more major projects to come, and I have every confidence in my teams’ dedication and commitment to the agency’s continued future development.”

What difficulties did you encounter in taking up this mandate?

“There is no denying that our areas of expertise are highly complex. Particularly so in an ever-changing world with a considerable impact on public health. To carry out our mission as well as possible, we need to recruit specialised profiles with solid skills in a variety of fields. But this is not always an easy task, as there are often tight deadlines involved, which should not be underestimated.”

What have you discovered in the last few months that you never imagined you would find in this job?

“Although I was already familiar with the way the agency worked, this job introduced me to other facets I had never imagined.

Firstly, the complexity of European systems. Of course, I knew that the FAMHP was very involved at European level. In fact, the FAMHP is one of the few Belgian health authorities that is already well integrated into the European network. We often collaborate with the European Medicines Agency and take part in a number of European projects.

However, I also found that, in addition to this collaboration, more time was needed for feedback and evaluation from the European to the national level. We also need to further develop our European projects, for example, in the field of Advanced Therapy Medicinal Products (ATMPs). These are highly complex products, and above all, it is a fast-moving field. We want to be major players in this field. I want the FAMHP to be a key player on a European and even global scale. We do not want to become a kind of ‘subsidiary’ of the EMA.”

What are your main objectives and challenges during your mandate?

“As I explained earlier, we are in a constantly evolving field. So it is important to prepare for this, so we can adapt and use it to our advantage. The FAMHP will therefore have to evolve to meet future challenges, such as artificial intelligence, raw data, megadata and real-life data. What we do today is not the same as what we will do tomorrow. The need to evolve as an individual and as an organisation is essential. It is a major challenge, but an essential one.

Artificial intelligence is becoming increasingly important in various fields, but it is not a threat to us. . I believe that our work will be enriched by this technology. We all need to play our part, making the right choices and investments to take advantage of these changes, and using them as tools to shape our future.

My aim is to support my colleagues through this change. This will inevitably alter our business, but without compromising it – on the contrary. We must make sure we stay at the cutting edge of our fields of expertise. This evolution will benefit us, as it will save us time that we can then devote to more rewarding tasks.”

What are your strategic priorities for 2024?

We should remember that Belgium will hold the presidency of the Council of the European Union in the first half of 2024. This will require a lot of energy, time and resources.

But I do not want this to delay the new version of the FAMHP strategic plan. Nor can it hinder the implementation and monitoring of this plan by our employees and stakeholders.
In my view, our strategic plan is the foundation of our institution. It is the means for our transformation into a future-ready organisation. It is up to all of us to make it happen!”