Xavier De Cuyper looks back on his years at the Federal Agency for Medicines and Health Products (FAMHP)

Xavier De Cuyper led the FAMHP from 1 May 2007. He was the agency’s first chief executive officer, coming on board at its inception. In 2022, he reached the age limit for holding a mandate within the federal government, but his term was extended to ensure the FAMHP kept running smoothly, pending the appointment of his successor. He finally retired on 1 September 2023. His long stint at the head of the agency has left its mark on the history of our organisation. His departure gives us the opportunity to ask him a few questions about this period.

Can you give us a brief rundown of your career before the FAMHP was founded?

“Over the course of my career, I’ve held a number of key positions in the Belgian public sector. I was Secretary General of the Ministry of Middle Classes and Agriculture, Managing Director of the Federal Agency for the Safety of the Food Chain, Director General of the DG Animals, Plants and Food of the FPS Public Health, as well as Chief of Staff to several Ministers with responsibility for Agriculture and two Deputy Prime Ministers. All these experiences have increased my desire to serve in very different fields, with a better understanding of our system of public governance.

In the early 2000s, I moved into public health, and when I joined the FAMHP in 2007, I helped define national policy on medicines and healthcare products.

At a European level, I was a member of the Board of Directors of the European Medicines Agency (EMA) and I continue to sit on the Board of Directors of the Agence nationale de sécurité du médicament et des produits de santé (ANSM – the French national agency for the safety of medications and health products). I also played an active role in the network of European Heads of Medicines Agencies (HMA). I was born at the time when the EU came into being and have always been convinced that being actively present at this level is positive, not only for economic agents, but also for our fellow citizens.”

What have your sixteen years with the agency been like?

“There were so many projects that I hardly noticed the passing years. Our agency was set up by the legislature in 2006, with the support of successive ministers. The aim was to respond to the expectations of a range of stakeholders such as patients, healthcare professionals, academics, manufacturers and all parties involved in the distribution of medicines and healthcare products. By way of example, some of you will recall the early days of the agency, struggling with the demands of marketing authorisation applications for drugs. Our Minister had requested that this issue be resolved within two years. Thanks to the expertise of the departments concerned and our willingness to engage in dialogue, various proposals were drawn up, and a solution was proposed on schedule. Since then, we’ve stopped talking about ‘backlogs’ at the agency altogether.

Dialogue and consultation have been the driving forces, both in terms of internal management and managing the services the agency is required to provide. One of the successes I believe is worth highlighting is the willingness to present, discuss and consult with all our partners within platforms specific to each stakeholder group, starting with patients, who occupy a central place in the organisation.

Of course, we took advantage of the agency being set up to develop all the stages in the life cycle of medicines and products: not just inspection, but also research and development, monitoring, surveillance, etc.

A major strategic focus was to build an organisation recognised as a sectoral authority in the fields of medicines and healthcare products by our various target groups.

In the past, the medical profession had no knowledge of the agency. Thanks to our transparency and continuous exchange of information, especially during the various crises, and our use of informal platforms where everything can be said and discussed, this has changed dramatically.

What’s more, I’m convinced that the COVID-19 health crisis has made the public more aware of the agency’s work. However, you can’t speak to a doctor, pharmacist or manufacturer in the same way as a citizen, so we had to adapt accordingly.”

Which projects are you most proud of?

“A difficult question. Above all, I’m proud to have achieved our objectives thanks to the support of our ministers, stakeholders and, of course, the commitment and expertise of the members of the agency.

Since its inception, the agency has grown from 200 employees to over 500 today. This growth is the result of fully justified needs and has been made possible by a special financing mechanism. The agency’s public/private co-financing mechanism is quite unique in Belgium, at least in its scope, and is highly innovative. This financing system took a lot of energy to design, but where there is a common interest, it enables us to develop new projects. This is much more complex for an administration with a traditional financing model. This financing system is an opportunity that benefits everyone, while taking care to avoid conflicts of interest, of course.

The list of significant improvements would be long to go through here. I would, however, like to highlight the progress made in the provision of information, thanks to our new database, which centralises all information on drugs: instructions and summaries of product characteristics, RMA documents (Risk Minimisation Activities), DHPC (Dear Healthcare Professional Communication), etc. And, thanks to PharmaStatut, everyone can find out whether a drug is available. So there have been great strides forward. I’d be delighted if citizens looking for information on medicines and health products instinctively thought to visit the FAMHP website. These efforts have raised our profile. The agency has gained greater visibility, but this objective has not yet been achieved.

Without going into detail, I would also like to express my satisfaction with my contribution to the agency’s recognition as a key European player. This has helped to build in-house expertise, although many Belgian experts are also sought after for positions with, for example, the European Commission or the EMA.

Indeed, I’m convinced that our agency will also be able to be satisfied with its performance during the 2024 European Presidency, thanks to excellent and ambitious preparations over the past two years or so.”

What were the most complicated briefs?

“I don’t know if some briefs are really more complicated than others. I’d mention complicated situations, even crises, which the FAMHP has managed with great professionalism. In my experience, I’ve always seen crises as challenges to be overcome, and therefore as opportunities for us. Each challenge has its own characteristics, but coordination and communication are essential. I won’t go through all the crises we’ve experienced, but generally speaking, we’ve been very active, available, organised, transparent and open to dialogue with all the partners concerned. The COVID-19 crisis, more than any other, demonstrated our ability to take responsibility.

At the start of the crisis, there were major supply difficulties for certain products. There was a bit of a panic on a global scale. At the start of the pandemic, there was a race for vaccines between different countries. I salute the work of the European Commission, which has put in place a transparent system that saves us an enormous amount of time and energy. The group purchase was a success. The European Commission has anchored this mechanism in a structure that will centralise these procedures. It doesn’t make sense for countries to negotiate individually with suppliers, especially small countries that are at a disadvantage compared to large ones.

During the pandemic, the agency was responsible for supplying and inspecting vaccination centres, as well as distributing vaccines. Our aim was to offer our expertise to those who needed it. As soon as the pandemic broke out, we set up a task force at the agency to respond to the various needs. We never stopped providing support for hospitals when they were facing supply shortages, particularly for neuromuscular blocking agents in intensive care. Our collaboration with university hospitals and hospital pharmacists’ federations has been remarkable. But I would like to add that this has never led us astray from our mission: to guarantee the quality, efficacy and safety of medicines and healthcare products made available on the market. We have issued press releases on the adverse effects of vaccines. A pragmatic and transparent initiative. We were pleased to note that both practitioners in the field and the general public reported a huge number of undesirable effects. This is all the more essential in crisis situations, when evaluation procedures are accelerated to ensure that new products such as vaccines are available as quickly as possible.

The whole agency was undeniably under pressure during the health crisis. Our employees have had their work cut out for them, and I’d like to underline the huge personal investment made by dozens of employees over many months to help manage the pandemic in our country with skill and efficiency. So I can understand why a few people then left the agency – to get away from this pressure.

In the end, I was able to observe and confirm the effectiveness of our staff in managing this crisis, and the need for in-depth cooperation. We must pay tribute to them for rising to the challenge in such an extraordinary way.”

What about your life after FAMHP?

“I didn’t want to give the impression that I was hanging on. My time was full of satisfaction, and I’m glad to be able to devote myself first and foremost to my family and friends, but also to have time for interests such as travel and contributing wherever I can.”

Would you like to say a few words to your successor, Hugues Malonne?

“Hugues Malonne and I worked together at the agency for several years. He knows the place inside out, which is an advantage when it comes to pursuing the current objectives set by the Executive Committee, but also and above all when it comes to meeting the agency’s new challenges. I’m thinking in particular of the major issue of supply shortages, and of finding solutions to the many problems that remain unresolved. I’m convinced that he will remain willing to enter into conversations and collaborate with staff and external partners.

Once again I wish him, and all my former colleagues at the agency ‘Plain sailing and every success in future endeavours!”