Bringing a Drug to Market in the European Union

For businesses in any industry, the European Union (EU) is a market force to be reckoned with. Currently made up of 25 Member States, the EU is the world’s largest economy by gross domestic product, and it is the third largest by population.

Its reach and market strength is soon to be increased by the addition of five new Member States: Bulgaria, Croatia, Macedonia, Romania, and Turkey.

Although each Member State of the EU retains some sovereignty over affairs conducted within its own borders, a considerable body of law is now promulgated by the European Commission (EC) and implemented into national legislation in each Member State. This harmonization of laws across the Member States is designed to bolster the principle of free movement of goods, which, in brief, means that once goods have passed the borders of one Member State having met its entry requirements, they are free to be circulated and imported to all other Member States and sold throughout the EU.

However, in light of the health benefits and associated risks that accompany medicinal products, the situation in the EU is much more complicated. Medicinal products are highly regulated in the EU and are subject to a separate, complicated system of approvals that governs how, when, where, and in what form such products will be allowed to be sold in there. Additionally, a number of important, strategic commercial and corporate considerations accompany this complex regulatory environment. Specifically, the White Paper outlines the following topics:

• Regulatory Framework
• Taxation Issues
• Raising Future Funds

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