Pharmaceutical law is integrating more and more ramifications since the number of categories of medicines in European Union law is only increasing, invoking a new group of special rules. At the same time, these definitions, these classifications, and the corresponding standards are not necessarily enshrined in national or European legislation. The vagueness surrounding the legal status is particularly present at the level of denominations of orphan drug products and preparations and their definitions due to their low profitability potential. As such, it is important to consider the significant choice of the regulation for the governing law still used as an instrument in the Community pharmaceutical legislation by choosing the immediate effect and avoiding any risk of a lack of harmonisation in the interpretation of the rules of the EU's pharmaceutical policy. Today, the pharmaceutical products for treating rare diseases arriving on the market are of a high unit cost and target very small populations of patients due to the rarity of their diseases. Even though most EU member states have national pricing policies for common pharmaceutical medicines, the case for determining a price for Orphan medicines can be more challenging and complex.
In this thesis, I will analyse whether Regulation 141/2000/ EC is sufficient to combat against exploitive practises by pharmaceutical firms. Lastly, possible solutions are offered to prevent exploitive practises from occurring within EU territory.
