Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Legal Framework for Parallel Trade in Pharmaceuticals for Human Use in the European Economic Area ***

Dr. Franz-Josef Braun (Abschlußjahr: 2004)

Parallel trade within the European Economic Area is a form of trade whereby a wholesaler buys products in a member state with comparatively low prices, and then imports them into another member state with relatively high prices.

This master thesis gives an overview on the legal framework governing the parallel trade in pharmaceuticals for human use in the European Economic Area.

The harmonization of product related laws is a precondition for free movement of pharmaceutical goods. The free movement of goods has been agreed in the EC Treaty and forms the basis of parallel trade. But parallel trade in pharmaceuticals is also affected by competition law, commercial property law and pharmaceutical law.

In the field of pharmaceutical law all regulations affecting parallel trade have to balance the aim to safeguard public health and the need to obstruct as little as possible the free movement of goods. The competent authorities have elaborated a number of detailed measures designed to ensure this balance both for centrally authorized and for nationally authorized products.

In the field of commercial property law all measures concerning parallel trade have to balance the protection of trademark and patent rights and the need to hinder as little as possible the free movement of goods. In contrast to pharmaceutical law however there is a lack of clear regulations governing the commercial property aspects of parallel trade in pharmaceuticals. The current legal situation is mostly defined by case law, which provides details on the rights and obligations of the parties involved in the commercial property issues of parallel trade.

In the field of competition law all measures with regard to parallel trade have to comply with the competition rules as agreed in the EC Treaty. Also here the details of the current legal situation are mostly defined by case law, which for example provides guidance concerning supply agreements and price regulations.

The principle of free movement of goods is only applicable to those products, which comply with EU-law. Nevertheless specific regulations apply in case parallel trade affects those pharmaceuticals, which are not in compliance with current EU-law. An overview on the legal situation is presented for fictitiously approved products in Germany and for products authorized under previous law in the accession countries.

Finally reference is made to the "specific mechanism". This "specific mechanism" has been agreed in the Accession Treaty and introduces a derogation of the principle of free trade for those products which remain unprotected by a patent in certain accession countries while they are patent protected in the "old " member states of the EC.

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