Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Kritische Bewertung von Arzneimittel-Re-/Parallelimporten in Deutschland ***

Dr. Ulrike Greger (Abschlußjahr: 2004)

In Europe, national governments are still regulating the demand and prices of medicinal products. Thus, they cement the heterogeneity and prevent an European market for medicinal products. Therefore, the principle of free trade of goods laid down in the EU-Treaty is faced with 15 (since 01 May 2004 twenty five) national regulated drug markets. The consequence of the national intervention are very different prices for medicinal products in the individual member states, which lead to a strongly flourishing parallel trade with medicinal products within the European Union. The legal basis is art. 28 of the EU-Treaty, which allows the free trade of goods within the EU, whereas exceptions are justified especially regarding the protection of human health and life and the protection of industrial (patent rights) and commercial (trademark rights) property rights according to art. 30 of the EU-Treaty.

The aim of this master thesis is to illuminate the complex topic of parallel imports of medicinal products within the EU under different aspects. In the first part, the legal background based on drug legislation, trademark and patent legislation is presented and its realization in parallel trade with medicinal products will be discussed. The drug-legal prerequisites for parallel imports of drugs will be depicted with reference to the marketing authorization of the original authorized product. Mainly, special features of centrally authorized medicinal products are discussed. In this context, the impact of recent decisions of the European Court of Justice (ECJ) such as the withdrawal of marketing authorization for the reference product or the abandonment of the joint origin will be explained.

Furthermore, it is shown which possibilities the owner of intellectual proprietary rights, such as patents and trademarks, has. This makes clear that as a result of the principle of the community-wide exhaustion, these protection rights are not suitable to restrict the parallel trade of medicinal products in the EU effectively. To make the parallel trade of medicinal products possible within the EU, the parallel importer is allowed to intervene in trade mark rights under certain conditions, which are actually reserved to the trademark holder. However, the patent protection is of importance for the special regulation, which was introduced in 2004, called "specific mechanism", which can restrict the parallel import of patent protected products under defined preconditions from the new EU member states partly for a transition period. The quantitative restrictions of drug supplies by the original manufacturers, according to the calculated demand in the individual EU markets to reduce parallel trade, is also discussed. The quota fixing has recently been confirmed by the ECJ as acceptable whereas for all other decisions of the ECJ it becomes evident that promotion of the free trade of goods also for medicinal products has the highest priority.

Resulting problems such as shortage of  products of certain drugs in some countries of origin as well as compliance problems by patients in the import countries by different looking foreign medicinal product packages are also discussed.  

A further aspect of the master thesis deals with the quality of the parallel imported medicinal products starting with packaging and labeling steps which have to be carried out by the parallel importer, but also in connection with transport and storage. It is pointed out, how important the adherence to international standards, such as GMP, GDP and in the future Annex 19 of the GMP guideline (draft) as well as the supervision by the appropriate authorities is in order to reduce any drawbacks and the associated risks of parallel imported drugs effectively.

Furthermore, the increasing risk of drug counterfeits also for the European consumer will be demonstrated as a result of globalization and liberalization of the distribution channels. The question will be discussed, whether the parallel import of medicinal products favors these developments. The legal measures, recently taken, like the obligation to obtain a permission from the pharmaceutical wholesalers or the EU regulation for the avoidance of illegal re-imports are also outlined.

In the last section of the paper, the governmental promotion of parallel imports in Germany and the associated expectations of health politics will be questioned critically. It will become clear that the expected impacts on prices and saving potentials for the health insurance companies have practically not been achieved yet. In this context, the price level of import drugs in comparison to the original product will be discussed.

It will become evident that parallel imports are not able to relieve the national insurance systems because of the small competition and strong focus on a few companies, the price finding strategy of importers and the restricted offer of imported drugs by type and quantity. The real winners of the governmental promotion are the parallel importers themselves.

On the other hand, the impact on the public economy is demonstrated, which arises from the profit cuts of the pharmaceutical industry, the associated smaller investments in research and development as well as the resulting consequences for jobs and the competitiveness of the pharmaceutical industry on the international level.

Summarizingly, it can be said that the  small savings for the compulsory health insurance companies by parallel imports are faced by significant disadvantages in other areas of the economy.

Pages: 68