Although the proposed European Regulation provides some stimuli for developing orphan drugs, it cannot by itself solve all the issues associated with this research area, particularly the unharmonized reimbursement and pricing situation in Europe, in the hands of the different Member States. The marketing exclusivity is the cornerstone of the orphan drugs system in every orphan drugs policy. This measure ensures a better return on investment for companies and, as a result, will efficiently stimulate the provision of orphan drugs in Europe. Grants, protocole assistance and fast track registration processes are also needed by pharmaceutical companies to secure their orphan drugs development. The fiscal incentives set up by the Member States, or at an European level, are also important to ensure appropriate orphan drugs delivery.
Some issues still remain, mainly for industrial policy.
The relationship between small and medium and biotechnology companies is essential to discover new drugs. This situation is crucial in the orphan drugs field because a lot of drug discovery will need high-tech biotechnological processes like genetic engineering, Therefore it is worth preserving a strong European Biotechnology presence in order to stimulate orphan drug development. The European scheme proposing a European Orphan Drugs regulation includes an extension to treatments of tropical diseases. These tropical diseases have a low prevalence in Europe and may be considered as rare diseases. Orphan drug status for compounds which treat tropical diseases will encourage pharmaceutical companies to develop such kind of drugs mainly for European people, which is the primary target of this text.