Country Report: Belgium - Pharmaceutical Executive


Country Report: Belgium

Pharmaceutical Executive

Clinical Research

Patrik De Haes, CEO of Thrombogenics
In addition to its positioning as a center for research excellence, Belgium's academic distinction has also contributed towards classifying the country as a hub for clinical trials. Michele Garot, vice president of BeCRO, Belgium's Association of Clinical Research Organizations, explains that one driver for the country's strong competitive position in clinical research is "the time required to gain approvals for clinical research is much shorter compared to elsewhere in Europe and the world (less than 2 weeks for phase I)."

Expenditure on R&D by Pharma Companies in Belgium on medical products for human use (in of EUR)
These rapid approval processes have made Belgium a particularly attractive destination for clinical trials. This is stressed by Patricia Lanssiers, managing director of Eli Lilly Belgium and The Netherlands. "Considering that Belgium boasts one of Europe's most favorable and rapid approval processes for clinical trials, it comes as no surprise that it hosts Europe's highest number of clinical trials per capita. Needless to say, we are taking full advantage of this situation, shaping the Belgian affiliate as one of the most attractive destinations for clinical studies across Europe."

"One of the key drivers of our strong presence in the clinical research sector is the high-quality standard of the universities and research institutions," she says. "Furthermore, Belgium is home to several well-known key opinion leaders in the therapeutic areas that we are focused on. This combination of Belgium's outstanding academics and our dedication to innovation makes the country a highly attractive landscape for investment in clinical trials."

Similarly, Mark Connolly, managing director at Boehringer Ingelheim, highlights that "the main attraction is the number of high quality research centers to work with and the expertise of the investigators. When we work in partnership with these centers we consistently see high standards of management of the studies as well as superior data management. Overall, I would say that it is a mixture of reputation and consistent delivery of results that make the environment so appealing."

"For Belgium, building such a reputation and level of expertise certainly takes a great deal of hard work and dedication. For that reason, we have continued to invest in Belgium for over 50 years now and we have consistently expanded our clinical development activities in the country."

From left: Patricia Lanssiers, Managing Director of Lilly Belgium & The Netherlands; Mark Connolly, Managing Director of Boehringer Ingelheim; Tarja Stenvall, Country President of AstraZeneca, Belux
Numerous other leading multinationals have made significant investments to establish a strong local base for drug development including Novartis, Merck Sharp & Dohme (MSD), Janssen and UCB. "We certainly make the most of the country's widely recognized clinical research capabilities, from initial phase studies – which are very important for us – up until phase III studies. We have a range of clinical centers across the country recruiting as many as 1000 patients last year in more than 300 sites and developing approximately 40 new compounds," says Jean-Christophe Bencteux, general manager of Amgen.

Nevertheless, the European Commission has been making progress towards adopting a new proposal from the European Parliament and the Council on clinical trials that will replace the existing Clinical Trials Directive (2001/20/EC). On a European level, the proposal is expected to arrest the general decline in European clinical activities by offering centralized application procedures and harmonize approval times across member states, thereby increasing cost competitiveness. However, in relation to Belgium's rapid clinical approval processes, Garot warns that "the new regulation will unfortunately make Belgium's fast track differentiating factor obsolete."

Despite the directive's potential impact, many believe Belgium's clinical trials industry is still in a favorable position owing to its expertise and long track record of rapid approvals. Jan De Backer, founder and CEO of FluidDA, a cutting edge clinical research organization (CRO), accentuates this point. "Generally speaking, I think that Belgium has somewhat of a head start in this respect owing to its familiarity with rapid approval procedures for clinical trials. On the other hand, if certain countries are currently accustomed to a three month time frame for instance, then it will be very difficult for them to quickly adapt to the new time frames. Illustratively, we carry out a number of multi-center clinical trials in Europe as a whole and the differences between Belgium and the Netherlands for instance is huge where these procedures require extended time periods. That is, there is an underlying dissimilarity in mentalities towards these activities. Therefore, even with the introduction of the new policies, I do not believe that the respective people's attitudes will change as easily."

Although Mark Connolly, managing director of Boehringer Ingelheim, believes that the new regulation will influence their clinical operations to a certain degree, he maintains an equal level of confidence in Belgium's clinical expertise. "The new European regulation could very well have an impact on our clinical research activities. Nonetheless, whatever the regulations, what really matters is the ability to deliver good quality data, good quality management of studies according to the plan as well as recruitment rates. Of course, together these elements are critical to maintaining a healthy clinical trials environment and I believe that Belgium's reputation in doing that will undoubtedly last."


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