pharma.be Forum: Clinical trials, an clear asset for Belgium

9 May 2017

19/05/2017

On May 9th, 2017, pharma.be organized a conference (called Forum) to discuss the importance of clinical trials for Belgium, the changing legal framework and the importance of collaboration between all healthcare actors. Over 180 people attended the conference, including representatives from the government and authorities, from the pharma industry, healthcare professionals, academics, hospitals, sickness funds, and, patients associations.

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They were welcomed by Catherine Rutten, CEO of pharma.be, who referred to the remarkable top-position of the country: “Belgium is clearly a European leader in clinical trials. Last year an estimated 4,000 trials were initiated in the EU, of which 507 in Belgium. That figure means that 1 out of 8 trials that were initiated in the EU, took place in Belgium. And 82 % of the trials in Belgium are industry-sponsored trials.”

Dr. Stefaan Vancayzeele, Chief Scientific Officer at Novartis Belgium and Chairman of the Taskforce Clinical Trials within the pharma.be association, shared the results of a survey among 45 companies that do clinical studies in Belgium: “Our country is well-positioned in Europe thanks to its high-quality research centers and dense medical infrastructure, the real-life experience of investigators and the rapid start-up timelines. The new Belgian law on clinical trials, voted on 20 April 2017, will reinforce these assets.”

Dr. Priya Ratnam, General Manager at Roche Belgium, agreed : “There is a positive environment for clinical trials in Belgium. An environment that fosters close interactions between biopharmaceutical companies, competent authorities, Ethics Committees, universities, investigational sites and CROs.”

The representatives of the authorities focused on the new law and the new initiatives to stimulate the setup of clinical trials. Dr. Diane Kleinermans, Advisor to the Minister of Public Health and Social Affairs: “A national College will coordinate and harmonize the activities and procedures of the Ethics Committees. Belgium’s ultra-fast approval procedures for clinical trials, particularly for phase 1 trials, are also guaranteed with the new law. ” Dr. Greet Musch, Director General at famhp, referred to the National Innovation Office: “With a launch in late 2017, the National Innovation office within the famhp in Belgium will provide a simple, central access point to companies and academics for scientific and technical/regulatory questions. It will encourage the set-up of early-phase clinical trials and will specifically support SMEs in their R&D activities.”

Jean-Pierre Latere, COO at Celyad, one of these SMEs stressed the competitive advantage of Belgium over other European countries: “The rapid timelines, high expertise and strong patient flow are important why Belgium is an attractive country for clinical trials. A quick set-up is important to bring innovation faster to patients.” The positive spirit of collaboration was echoed by Prof. Sylvie Rottey, Vice-president of Bapu (Belgian Association of Phase 1 Units) and Head of the Drug Research Unit Ghent (phase I Oncology trials): “Despite its relatively small size, Belgium is home to several high-quality phase 1 oncology units. We have found a good way to work closely together, also in patient recruitment.”

The third part of the conference was devoted to the perspective of the clinical healthcare professionals. Prof. François Duhoux, Oncologist at Cliniques universitaires Saint-Luc, stressed the need for education of patients: “An important next step in the future is the education of the broad public into participation to clinical trials”. Mrs. Liesbeth Moortgat, IBD nurse at AZ Delta and Member of ECCO Nurses Network, made a plea to better align with healthcare professionals when designing a study: “It is crucial to discuss with healthcare professionals before developing clinical trials on the practicalities and real-life implications. As a clinical nurse, my role is to go into the trial itinerary with the patients and to build trust.”

The final word was for Mr. Julien Compère, CEO at University Hospital of Liège and Chairman of the RUZB-CHAB (Raad van de Universitaire Ziekenhuizen van België - La Conférence des Hôpitaux Académiques de Belgique). He underlined the enriching effect of clinical trials on caregivers: “Clinical trials give access to cutting-edge latest therapies and expand the knowledge of physicians.”