Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Generic medicines –Quo vadis essential similarity? ***

Dr. Miriam Gensler (Abschlußjahr: 2005)

Language:English
 
The term “essential similarity” was introduced in the European legislation as a basic principal for applications under the abridged procedure and defined the conditions under which a second applicant can refer to the preclinical and clinical data of the reference product. Due to the initial lack of a detailed definition of the conditions under which a second product can be considered essentially similar to its reference product, a long history of legal proceedings between innovator companies seeking for protection of their data and their position in the market and generic companies aiming at quick market entry combined with low investment for research and development commenced.

In the present thesis, an overview of the development of the pharmaceutical market with its almost unlimited possibilities for copycats of original products to be marketed before the introduction of a common European legal basis is given. With the implementation of Directive 65/65/EEC, not only the obligatory submission of results of physico-chemical, biological or microbiological tests, preclinical tests and clinical trials with the application for marketing authorisation was introduced, but also exemptions for second applicants which were further defined by the introduction of the principal of “essential similarity” with Directive 87/21/EEC. With the description and discussion of four important law cases of the European Court of Justice, the resulting definition of “essential similarity” and the extension of the applicability of the abridged procedure to products that are not essentially similar to their reference product are presented. It could be shown that although the term “essential similarity” will disappear with the implementation of the new pharmaceutical legislation in autumn 2005, it remains the prerequisit for the classical and undisputable case in which an abridged application can be made without submission of bridging data, but lost its status as a dogma for generic applications. Together with additional pro-generic provisions, the new legislation represents a boost for the generic industry and is likely to lead to an increased market penetration by generic products while seeking for compensation and incentives for innovative companies.

Finally, it is shown that the pro-generic course of the European Commission can be understood as a means to enhance competitiveness and innovation in the pharmaceutical sector and is part of the European strategy to strengthen the position of the European pharmaceutical market in comparison to the US market.

Pages:57