Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Generic Medicinal Products A Comparison of Regulatory Framework between Germany and Finland ***
Heli Hulkkonen (Abschlußjahr: 2008)
Language: English
Several concepts relevant to generic medicinal products were introduced into the European pharmaceutical legislation by the Directive 2004/27/EC like a clear definition for generic medicinal product and reference medicinal product, harmonisation of data protection periods, global marketing authorisation and Bolar provision. Furthermore, the mutual recognition procedure was modified, a decentralised procedure introduced and a new co-ordination group established. Concerning the summary of product characteristics, package leaflet and labelling some new requirements were included. Further changes introduced by the Directive 2004/27/EC are e.g. the modification of the renewal system and introduction of a sunset clause for un-used marketing authorisations.
The Member States had to transpose the Directive 2004/27/EC into their national law by the 30 October 2005 at the latest. However, the fact is that the most Member States have transposed it into their national law later and in some Member States the implementation process is still ongoing.
In Germany the transposition of the Directive 2004/27/EC has taken place with the 14th amendment to the German Drug Law in force on 06.09.2005. Finland transposed the Directive 2004/27/EC into their national legislation with the 853/2005 amendment to the Medicines Act, which came into force on 07 November 2005.
This master thesis analyses how the Directive 2004/27/EC has been transposed into the German and Finnish law. Furthermore, the implementation giving the practical effect to a law and ensuring the actual fulfilment with concrete measures is compared between Germany and Finland. At the same time, the impact of the Review 2004 on the generic industry and concrete results achieved so far are evaluated. Additionally, some current problems in the Europe e.g. lack of resources available to the authorities leading to the delays in the marketing authorisation procedures are discussed.
The most articles of the Directive 2004/27/EC have been transposed with the different wording but similar meaning and few articles have even been literally transposed into the national legislative texts in Germany and Finland. Some minor differences between the legislative texts are observed, however, these are not expected to lead to significant discrepancies in practice. By comparing the practical implementation, additional differences were observed between Germany and Finland. In few cases major differences in the implementation can even be identified although the legislative texts are similar. Consequently, it is generally necessary to consider not only the transposition of a directive into the national law but also the practical implementation.
The disharmonised implementation causing additional administrative hurdles has already been observed by comparing only two Member States. If all 27 Member States would be compared together, the disharmonisation would be still more evident and it is assumed that even the legislative texts would differ significantly. The reason for this disharmonisation is the fact that the Member States are obligated to transpose only a minimum requirement of a directive into their national law. Thus, they are allowed to transpose a directive broader.
The main goals of the "Review 2004" are to complete the internal market for pharmaceutical products in a context that favours the competitiveness of the European pharmaceutical industry and, at the same time, ensure a high level of public health protection. The important attempts are also the rationalisation and simplification of the regulatory process as well as the improvement of the transparency of the procedures.
Now, about three years after the implementation of the "Review 2004" it is surely too early to conclude if these main goals have been reached. However, according to the concrete results achieved so far some positive impacts have already been identified and it is likely that the main goals as well as the harmonisation to the certain level will be reached, however, it will surely still take several years.
The variation system is currently being reviewed in the European Union to make the regulatory framework covering changes to medicinal products simpler, clearer and more flexible, while guaranteeing the same level of public health protection. In addition to the revision of the content of the Variations Regulations, the aim is to extend the legal basis of the Variations Regulations to the "purely" national marketing authorisations.
Finally, this master thesis introduces the current European variation system and its weak points as well as the status of the revision of the variation system and the positions of the pharmaceutical industry and authorities on this review. Furthermore, current German and Finnish variation systems for "purely" national marketing authorisations are compared. In Finland, the national requirements on changes to "purely" national marketing authorisations follow the Variation Regulation (EC) No 1084/2003 with the exception of the timelines while in Germany an independent variation system exists. The classification and approval time for some exemplary changes according to these variation systems are compared. These examples demonstrate that there are major differences in the classification and approval times of changes in Germany and Finland for "purely" national marketing authorisations.
The review of the pharmaceutical legislation is a continuous project, which never ends and achieves its end point. Furthermore, a total harmonisation of the regulatory framework can never been reached within all 27 Member States, only a basic harmonisation to the certain level is possible.
Pages: 102