Masterarbeit
Legal uncertainties in European Community legislation regarding data protection
Monika Jung (2010)
A medicinal product may only placed on the market in Germany, respectively the European Economic Area, when a marketing authorisation has been granted by the competent authority. Which authority is the competent one and which documents must be submitted with an application for a marketing authorisation is set out in the Community pharmaceutical legislation. As mentioned in the Notice to Applicants "the primary purpose of the rules governing medicinal products is to safeguard public health. However, this objective must be achieved by means which do not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community. Thus, the pharmaceutical legislation of the European Community has consistently pursued the twin objectives: the protection of public health and the free movement of medicinal products". The laws and provisions regulate upon other different aspects also the miscellaneous possibilities, respectively application types for the different medicinal products as well as the period of data protection. The operating experience shows unfortunately, that the legislation is not in all aspects clear and sufficient. The consequences are legal uncertainties and infringements. There are many reasons for controversial issues concerning the European legislation, but the main scope of this Master Thesis is to deal with the following questions:
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when does the period of data protection start according to Article 10(1) of Directive 2001/83/EC, respectively which medicinal products can be considered to be a reference medicinal product within the meaning of Article 10(2)(a) of Directive 2001/83/EC? and
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on which documents could be referred to in case of applications according to Article 10(a) of Directive 2001/83/EC relying on well established use, respectively which data are protected?
The aim of this Master Thesis is to demonstrate that there are indeed different interpretations possible in point of the legislation concerning data protection. Furthermore, the necessity to close the loopholes in European legislation shall be demonstrated. The discussed cases document that there are many uncertainties concerning the current legislation with regard to data protection. This is highlighted on the fact, that the discussed questions are heard at the highest courts of justice. To remedy those lacks of clarity is in the interest of all involved parties like the authorities, the pharmaceutical industry and not least of the mutual solidarity. The authorities need legal security in order to have the possibility for a correct processing of the submitted applications, the pharmaceutical industry needs planning reliability to amortize the high costs of development and the mutual solidarity needs the access to cost-effective as well as innovative medicinal products. To combine all this interests is the claim laid to the lawgiver.
Pages: 38