Introducing orphan medicinal products in The Netherlands : how to shorten the process?

There are thousands of rare diseases for which developing medicinal products is hard because of the financial burden and the low number of patients. Since these diseases are life threatening for patients, an incentive programme is launched on European level in 2000, trying to stimulate the development of drugs for rare diseases: the so-called orphan drugs. Products developed since 2000 get a market authorisation on European level, after which the product can be introduced in every member state of the European Union. According to different researches, the introduction period in The Netherlands is remarkably longer than in other member states. As well, the deviation of the process differs a lot; the length can be anywhere between 90 and 1400 days per product. This research tries to (1) describe the Dutch process of introduction, (2) reveal the factors that delay the availability of orphan drugs and (3) come up with recommendations to fasten the availability of them. No research has been carried out on this topic before; the research can be seen as explorational.