Masterarbeit

The "Arzneimittel-TSE-Verordnung" in Germany - Motives for this regulation and its consequences for medicinal products containing gelatine

Dr. Doreen Gerlach (2004)

The German regulation for minimising the risk of transmitting spongiform encephalopathy (TSE) agents via medicinal products (Arzneimittel-TSE-Verordnung) in the current version came into force in May 2001. This master thesis concentrates on the background and motives of this regulation and its effects especially on medicinal products containing gelatine.

In comparison with the former regulation (AMG-TSE-Verordnung), the essential change of the Arzneimittel-TSE-Verordnung is the integration of instructions concerning specified risk materials. The German legislator partially went beyond the European provisions and maintains in this way its leading position in protecting consumers against TSE in Europe.

Due to the fact, that bovine bone-gelatine is affected by § 1 (2) of the Arzneimittel-TSE-Verordnung, the consequences of integrating the entire vertebral column as specified risk material in § 1 (2) could be shown on the basis of medicinal products containing gelatine.

If specified risk material is used in medicinal products this regulation differentiates between the usage as active substances or as excipients. Pharmaceutical companies which use for example bovine bone-gelatine as an active substance have to switch to vertebra-free gelatine. Those pharmaceutical companies using bone-gelatine only as excipients do not have to switch, although the usage of bone-gelatine as excipients is much more common than the use as an active substance. Thus this differentiation leads to a discrimination of single companies.

Due to this differentiation there is a gap  in the consumer protection which is contradictory and also incomprehensible with regard to the intended high level of consumer protection in Germany.

Moreover, there is also a loophole in the  legislation. Due to the distribution of the responsibilities between the Federal Government and the provincial governments, the Federal Government is not able to completely regulate the use of medicinal products in Germany. Since the Federal Government lacks the power to regulate, medicinal products, produced and applied by a physician himself, are not subject of the Arzneimittel-TSE-Verordnung. Until now no further regulations have come into force and no endeavour have been made to fill this legal loophole.

Number of Pages: 44