Masterarbeit

Legal Basis of the Parallel Participation of the Principality of Lichtenstein in the European Economic Area and the Customs Union with Switzerland ***

Dr. Joachim Heinze (2001)

The Principality of Liechtenstein has joined the European Economic Area by signing the EEA Agreement but has so far not become a member of the European Union.

Therefore the EU's relations with Liechtenstein are based on the EEA Agreement. However; this relationship becomes somewhat complicated due to the fact that Liechtenstein is integrated in the Swiss economy and legally connected with Switzerland in different areas, amongst others some regulatory functions, especially in the field of medicinal products (and here mainly as regards the validity of marketing authorisation in Liechtenstein granted by Swiss authorities).

In this context an important issue is whether the clock start of the document protection period of dossiers used in approval procedures is triggered in the EEA by an approval in Switzerland and how the Supplementary Protection Certificate (SPC) is affected.

Answers to these questions are given in the presented work on the basis of the description and analysis of the legal basis in the form of written legal texts and interpretations of these texts. Furthermore a clarification of the legal situation between Liechtenstein, Switzerland and the EU is given.

It was found that the customs union on the one side and the EEA on the other side are strictly separated legal entities and decisions valid for one area are not effective in the other area.

Concerning medicinal products this was made possible by a special legal construction, namely the existence of two medicinal product laws on the territory of Liechtenstein.

This legal construction is in conformity with the European Economic Area Agreement, which explicitly states that the regional union of Liechtenstein and Switzerland does not impair the good functioning of the agreement.

All in all, marketing authorisation valid in the customs area cannot trigger the clock start of the documentation protection period and the SPC validity period of a medicinal product in the EEA.

As a result, participation of Liechtenstein in the approval procedures (centralised and decentralised) of the EU/EEA has no negative consequences with respect to documentation protection and SPC.

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