The European Member States have decided that they cannot accept that certain individuals be denied the benefits of medical progress because these individuals suffer from a disease that affects only a small fraction of the population. It is, therefore, their role to...

Rare diseases are referred to as “orphan diseases”, and the products intended to treat them as “orphan medicinal products”. In addition to rare diseases, orphan diseases include those for which developing new therapeutic tools is not profitable. Following the...

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