Thanks to its world-renowned networks of medical and academic institutions, the long-standing presence of Big Pharma, and a favourable regulatory environment, Belgium has a well-established tradition of excellence in clinical trials. Pharma industry leaders and Belgian government officials weigh in on the factors threatening the country’s position as a clinical trials hub and the recently proposed reforms that may help to reinforce it.
A Tradition of European Leadership
Country managers at Belgian pharma affiliates tend to agree that Belgium is a stronghold for clinical trials. “I believe that the country is attractive for early-stage trials due to the fast approval process of the trials by the authorities and the presence of important universities and clinical centres with proper scientific knowledge and background,” says BeLux GM at Amgen, Gábor Sztaniszláv.
Attesting to Belgium’s competitiveness as a research hub, pharma companies have invested heavily in clinical trials in the country. “[Novartis has] probably the largest R&D footprint in the Belgian industry with more than 100 active clinical trials,” says Federico Mambretti, country president, Novartis Belgium & Luxembourg.
The country is attractive for early-stage trials due to the fast approval process of the trials by the authorities and the presence of important universities and clinical centres with proper scientific knowledge and background
Gábor Sztaniszláv, Amgen
“The value of Belgium to Roche can be seen most clearly in our clinical trial operations here. Roche Belgium – unlike many other European countries – has its own clinical trial operations unit which employs over 30 people and conducts trials from phases I to IV. The company invested EUR 27.7 million in R&D in 2021 through clinical trials in Belgium,” states Roche’s BeLux GM, Marie-José Borst.
Pfizer, established in the country for more than 70 years, has a Phase I research centre there that An Van Gerven, country general manager for Pfizer BeLux boasts is “one of just two at Pfizer, with the other one being in the US.”
Moreover, the country holds a key position within Europe and Eli Lilly has made it the home of the company’s European Clinical Trial Services (ELECTS) division. “From a clinical trial perspective, Belgium is quite important to Lilly. It is important to maintain a strong position in Belgium, both in terms of regulatory compliance from a European level and in terms of access to patients for clinical trials. The ELECTS division coordinates all clinical trials and manages all clinical material across Europe, Africa, and Asia, due to Belgium’s historical track record in managing clinical trials,” claims Frederic Clais, country manager at Eli Lilly Belgium.
Despite its historical prominence as a clinical trials axis, many stakeholders feel that Belgium is losing ground. “Belgium’s attractiveness as a clinical trial destination has declined in recent years, for three reasons. The first is that European legislation is taking away some of the country’s historical advantages and levelling the playing field. The second is cost; Belgian labour costs – especially in times of inflation – are very high. The third is the link to access, and the difficulties of committing to clinical trials for a product where reimbursement is not a guarantee,” Mambretti argues.
The reimbursement link is a crucial one. “This has knock-on effects on clinical trial investment because as pharmaceutical companies we have an ethical obligation to run trials in countries where eventually we are able to provide the product to patients. The harsh reality in Belgium is that only 50 percent of EMA-approved medicines are eventually reimbursed on the market, Mambretti continues.
Although university centres and physicians have access to research and development through the large number of clinical trials conducted in the country, this is not reflected in the final access for patients
Frederic Clais, Eli Lilly
“Although university centres and physicians have access to research and development through the large number of clinical trials conducted in the country, this is not reflected in the final access for patients,” complains Clais.
The uncertainty around reimbursement has led to difficult decisions about continuing to conduct trials in Belgium. “Phase III trials, especially for chronic diseases, present a big ethical dilemma because we have patients who are treated with our Phase III trial, but then after the marketing authorization is granted, we often have to wait too long for reimbursement. In some cases, we are asked to provide the product for free post-approval, and this can be challenging to sustain. Additionally, the unpredictability of whether the product will be reimbursed or not makes it difficult to decide if we should bring certain trials to Belgium at all,” Sztaniszláv laments.
With respect to pharma’s complaints about reimbursement, Diane Kleinermans, president of the Commission for the Reimbursement (CRM) at the Medicines Belgian National Institute for Health and Disability Insurance (INAMI) contends: “The industry’s consideration of reimbursement timelines in selecting trial locations is a known argument amongst regulators. While I understand the importance of the pharmaceutical industry to the economy and employment in Belgium, as the CRM, our evaluation must remain objective. We cannot factor in such arguments during the evaluation process.”
Drug Reimbursement Reforms
The Belgian government has not, however, turned a blind eye to the access challenges in a country with an increasingly elaborate approval procedure that must go through both the Commission for the Reimbursement of Medicines (CRM) and the minister of social affairs and can take 180 days. After months of consultation with stakeholders, the Minister of Health, Frank Vandenbroucke, together with the INAMI presented a roadmap for reform. “We hope that decision-makers understand that there is a government-supported intention to bring more innovation and clinical trials to Belgium,” says Sztaniszláv in reference to the proposed reforms.
“Our new medicines roadmap attempts to help maintain Belgium’s competitiveness and attractiveness. The country still boasts solid fundamentals, including the quality of our clinical centres, hospitals, doctors, and training programmes. That said, from the point of view of the payer, it is true that we need to think long-term about early and fast access. The roadmap is not about clinical trials alone, but we need to contribute to a continuously attractive landscape,” asserts Pedro Facon, deputy CEO of NIHDI.
Our new medicines roadmap attempts to help maintain Belgium’s competitiveness and attractiveness. The country still boasts solid fundamentals, including the quality of our clinical centres, hospitals, doctors, and training programmes
Pedro Facon, NIHDI
Beyond streamlining reimbursement to step up patient access to innovative medicines, the reforms include the creation of a new trial and real-world evidence platform Facon claims will “drive better research design, data collection, and data analysis in collaboration with the Belgian Health Care Knowledge Centre (KCE) and the Federal Agency for Medicines and Health Products (FAMHP), Belgium’s drug regulator.” This proposal has garnered support from the life sciences sector because as Facon puts it: “They will get feedback from the Federal Agency for Medicines & Health Products (FAMHP), NIHDI and KCE experts represented on the platform who are very familiar with data research and techniques.” In addition, a new Health Data Agency is being launched.
Facon is hopeful about the outcomes that will come from the consultative approach of the reforms. “All of this inter-stakeholder effort should hopefully lead to a more value-based discussion on reimbursement, beyond budgetary constraints alone.”
Impact of EU’s CTR
Belgium’s status as a clinical trials powerhouse is also expected to feel the impact of the EU’s Clinical Trial Regulation (CTR) that came into effect in January and includes the creation of an EU clinical trials portal and database. “From a Belgian perspective, a centralised EU clinical trial database potentially levels the playing field in Europe and diminishes our competitiveness somewhat,” says Roche’s Borst. “Belgium has a historical advantage in clinical trials, but the new European regulation will be something of an equaliser,” Facon agrees.
From a Belgian perspective, a centralised EU clinical trial database potentially levels the playing field in Europe and diminishes our competitiveness somewhat
Marie-José Borst, Roche
This new EU uniformity requires Belgium to reinforce its competitive edge and look for new ways to compete Borst maintains. “Belgium – and companies implanted in Belgium like Roche – need to find new angles and ways to be competitive. This new EU move will serve as a wake-up call to the Belgian industry. While Belgium may no longer be able to move faster than other EU countries, for example, it could differentiate itself. This is a moment for reinvention if Belgium wants to maintain its privileged position as a clinical trials hub.”
Xavier de Cuyper, CEO of FAMHP, claims the government agency and the country, with its clearly established processes, were prepared for the new European legislation. “The CTR rollout certainly has an impact on clinical trials in Europe and Belgium. But we have shown in the previous years that we were preparing well due to our extensive pilot project for clinical trials, which paid off in the first year of CTR.”
De Cuyper cites Belgium’s competitive timelines for mono-national phase 1 clinical studies and FAMHP’s involvement in the European project on Simultaneous National Scientific Advice (SNSA) as a way forward within the CTR. “The SNSA pilot has a specific focus on, but is not limited to, multinational scientific and technical/regulatory advice to facilitate and accelerate multinational clinical trials within Europe to the maximum extent possible,” he says.