ETHICAL ISSUES WHEN DEVELOPING new MEDICINEs

Prod. dr. Jutte Van der Werff Ten Bosch

The last decades there has been an important evolution in safety measures during the development of new medicine. The pharmaceutical industry is obliged to keep up with a multitudes of rules in order to be able to guarantee that the product they will eventually sell is not only effective but first and foremost, that it is safe. In order to show safety and effectiveness several studies are preformed. If a certain medicine is also suitable for children, separate studies need to be preformed on children and this is often  very difficult. Not only because the studies need to be repeated on different age categories (newborn v. teenager is completely different) but because children are mostly healthy and patient are harder to find. Developing new medication for children is paired with a lot of practical and ethical questions which we will discuss during this session.