By Yves Geysels & Michèle Garot, Quintiles Belgium
Developing a new treatment typically goes through multiple stages, from early laboratory discovery to authorization. Commercializing a new medicine routinely takes 12 to 15 years. Throughout this development program, a series of steps called ‘clinical trials phase 1, 2, 3 & 4’ are crucial; they consist of the administration of the product to consented patients and need to respond to the standards of quality, efficacy and safety laid down by legislation.
For many companies and over decades, Belgium has played a pivotal role in the development of new medicines, thanks to its world leadership in clinical trials. Every year, 500 trials are running in Belgium. Every year, more than 170,000 Belgian patients participate in phase 2 and 3 trials. The four most frequent domains of research are cancer (21%), cardiovascular diseases (13%), central nervous system diseases (8.3 %) and respiratory diseases (7.6 %).
Belgium’s excellence is the result of numerous factors: effective administrative steps with very short timelines to obtain approval to conduct clinical trials, a fertile ground with well respected, highly qualified clinical researchers & research centers, and lastly, a positive environment which fosters interactions between biopharmaceutical companies and universities. These are important assets that should be preserved and reinforced.
The importance of clinical research for Belgium is multiple:
- Not only does the conduct of clinical trials deliver a substantial contribution to the economy in the form of investments and jobs, but clinical trials are also a driver for the financing and the retention – in Belgium – of scientific and academic research. Both are important factors in a knowledge economy that contribute to innovation and to the development of better medicines for mankind.
- It also allows patients to take part in the most innovative clinical trials, to benefit from the most advanced therapies and best follow up, and together with their physicians to actively contribute to the progress of medicine. It is very important that Belgian patients can continue to have free and early access to innovative medicines.
However, we are aware that this position is challenged from many sides and is far from self-evident.
A new European regulation on clinical trials will enter into force in 2018 introducing the submission of a single application for a clinical trial via a European portal to the European Medicines Agency (EMA), which will be evaluated in consultation with all EU Member States concerned by the trial. The timelines for evaluation & approval will be harmonized throughout Europe.
There is an urgent need for a strategic vision to build a sustainable clinical trials environment in Belgium on the basis of what has been achieved since the entry into force of the regulatory framework in 2004.