8 September 2026
Belgium, which has long been considered one of the most attractive European countries for clinical trials, sees its lead under threat. Competition from the United States and China, aggressive strategies by other European countries, and bureaucratic red tape: researchers, hospitals, and the industry are warning of the risk that studies will be moved to other markets. At stake is much more than just economic appeal: namely, Belgian patients’ access to innovative treatments.
The message from the speakers gathered at the Saint-Luc University Clinics goes beyond mere scientific or economic appeal. For Prof. Jean-Philippe Machiels, medical director of the Saint-Luc University Clinics and a medical oncologist, the primary concern is patients’ access to innovation.
“When I suggest to a patient that they participate in a clinical trial, I don’t do it for the sake of science, for the hospital, or for a pharmaceutical company. I do it because I believe this trial can offer a valuable opportunity specifically for this patient,” he explained.
While it does not guarantee individual benefits, a clinical trial can indeed provide access to a treatment option that is not yet available in everyday practice. Participation remains voluntary and requires clear information about both the expected benefits and the potential risks.
An ecosystem that has traditionally been in favor of clinical research
Belgium has long had a particularly well-developed clinical research ecosystem. Universities, university hospitals, research institutes, biotechnology companies, the pharmaceutical industry, and government agencies are geographically close to one another and collaborate closely.
This ecosystem has contributed to the country’s international reputation. In particular, Belgian centers were able to launch studies quickly and were among the first locations where patients gained access to new treatments.
However, this advantage is no longer taken for granted. Administrative burdens, the complexity of European regulations, and increasing international competition are making it more difficult to launch new research projects in Belgium and, more generally, in Europe. As a result, there is a risk that companies will prefer other regions to launch their trials.
A leading position that can no longer be taken for granted
Caroline Ven, CEO of pharma.be, therefore believes that Belgium can no longer rest on its past successes. “International competition is intensifying. The United States is trying to attract investment to its territory, while China and other countries are investing heavily in the life sciences and innovation. Several European countries, including Ireland, Sweden, Denmark, and Switzerland, are developing explicit strategies to strengthen their position in the life sciences.”
To maintain its appeal, she advocates for an integrated national strategy involving governments, industry, hospitals, researchers, universities, and patient organizations. Such a strategy should not be limited to economic benefits but must also encompass scientific excellence, the sustainability of the healthcare system, and health outcomes for patients.
Prévot: “Now is the time to take action”
Deputy Prime Minister and Minister of Foreign Affairs Maxime Prévot also called for maintaining Belgium’s position in clinical research. Compared to countries that are actively trying to attract investment, he believes that the complexity of procedures and administrative requirements currently pose an obstacle for Europe.
“We must take action now,” he emphasized.
This is not just about economic interests. If companies or researchers prefer regions where studies can get off the ground more quickly and easily, Belgian patients might also have delayed access to certain therapeutic innovations.
Simplifying Without Lowering Standards
One of the identified priorities is therefore to reduce the administrative burden without compromising the protection of trial participants.
“Safety and ethical standards must remain central,” emphasized Maxime Prévot, who advocates for more proportionate and risk-based regulation. The goal is to prevent the accumulation of procedures from unnecessarily delaying research without providing any additional benefit to the patient.
The minister also aims to strengthen the mechanisms that enable faster access to innovative medicines, particularly the Early and Fast Access programs.
At the European level, Wouter Beke, a Belgian Member of the European Parliament and rapporteur for the “Biotech Act,” also advocates for simpler, faster, and more predictable procedures. The goal of the future European framework is, in particular, to shorten the time between innovation and access to treatments—while maintaining safety requirements—and to make Europe more attractive compared to, among others, the United States and China.
Access to Medicines and Clinical Trials: A Cycle That Must Be Sustained
However, Belgium’s appeal does not depend solely on how quickly a trial can be launched. The issue of access to innovative treatments after their development was also raised.
Despite the quality of the hospitals, the expertise of the researchers, and the experience gained with clinical trials, some innovative medicines remain difficult for Belgian patients to access due to a lack of reimbursement, a physician noted during the discussions.
This situation, in turn, could undermine the country’s appeal for international trials. Combined with lengthy and complex procedures, this could prompt more sponsors to favor other markets.
The risk is that a negative spiral could develop: reduced attractiveness leads to fewer trials, while the decline in the number of studies reduces patients’ chances of gaining early access to certain therapeutic innovations.
Contracts, Ethics Committees: Areas Where Belgium Can Still Take Action
Several levers have been identified to maintain Belgium’s position: accelerating procedures, simplifying contract negotiations between hospitals and contracting authorities, and further harmonizing the operations of ethics committees.
However, when it comes to rare diseases and advanced therapies—particularly cell and gene therapies—the national level quickly reaches its limits. Enhanced European cooperation appears necessary, particularly to develop patient registries and facilitate cross-border access to clinical trials.
Finally, a broader question arises: that of the financial accessibility of precision treatments and personalized therapies. Maintaining clinical research in Belgium will therefore not depend solely on faster procedures. The country will also need to join a European discussion on the financing of innovation and access to new therapies.
Because behind the international competition to attract clinical trials lies a very concrete question for doctors and their patients: where and how soon will tomorrow’s therapeutic innovations be accessible?
Source: MEDIQUALITY