Masterstudiengang "Drug Regulatory Affairs"

In the last years transparency of drug regulating authorities has become a matter of public interest. The different aspects of transparency, which are analysed in the present thesis, can be classified on the one hand as administrative or scientific transparency describing the kind of information, and on the other hand as proactive or reactive transparency, describing the way of disclosure.

Administrative transparency of regulatory authorities deals in particular with the supply of information on the daily business. The aim is mainly to strengthen the public trust in the authorities work and to increase the understanding of the regulatory processes. It is implemented e.g. by the publication of documents like meeting minutes, agendas, information on organisational matters as well as of the composition of committees accompanied by personal details like the qualification and declaration of financial interests. Scientific transparency deals mainly with information on medicinal products and with access to high-quality information for stakeholders and the general public. Scientific transparency within the European medicines regulatory system is implemented according to the community code (Directive 2001/83/EC) and Regulation (EC) No 726/2004 by public access to assessment reports and to product information texts like the summary of product characteristics and the package leaflet. In addition, the establishment of the EudraPharm database which shall become a central register for European medicines, providing general information as well as information on pharmacovigilance issues and clinical trials represents a further major source for scientific transparency. The access to this information which is mainly granted proactively by publication on the competent authorities websites or in databases is ruled in particular by the community code and Regulation (EC) No 726/2004.

In contrast, the reactive transparency deals with the public access to information held by authorities on demand. This comprises documents written by members of the authorities as well as third parties like e.g. the pharmaceutical documentation of a marketing authorisation. Whereas the access to information held by EU institutions is subject to Regulation (EC) 1049/2001 and to several implementing guidelines, no harmonised legislation addresses the disclosure of information held by authorities of the member states. Therefore the access to this information on demand is implemented individually based on national freedom of information legislations. As a consequence of the missing community legislation, no common definition of the term “commercially confidential” exists among the member states. For that reason the EU authorities protect or disclose different parts of information.

Increasing transparency and in particular non-harmonised national freedom of information acts give rise to the question to what extend data disclosed for transparency reasons may be used commercially. In the present thesis the use of disclosed information to obtain a premature generic marketing authorisation via a bibliographic application is analysed. Focus is given in that context on the arising problems with the demonstration of a well-established medicinal use and with data protection rules. In summary, transparency in regulatory processes and decisions is undisputable essential, but appropriate measures must be taken to prevent misuse of disclosed information and violation of existing data protection rules.

Pages: 50, Annex: 1 page