Masterarbeit
The legal status of medicinal products: Potential problems arising in case of a compulsory harmonisation as discussed in the current revision of the EU legislation ***
Dr. Christine Bautz (2003)
Today the EU market for medicinal products is still deeply heterogeneous and partitioned in spite of nearly 40 years of working on common interpretations of the necessary criteria and technical standards within national administrations. The present EU legislation concerning pharmaceuticals started in 1965 with Council Directive (65/65/EEC). Over the years, supplementary regulations and directives tried to bring in line the decisions of the involved competent national authorities. In order to advance the existing procedures, the EU commission decided that a general revision of the three main legal texts was due. One of the current text proposals will modify regulation 2309/93, which established the centralised approvals procedure and the European Medicines Evaluation Agency, while the other two proposals will modify the newly codified directives (2001/83 and 2001/82) for human-use and veterinary medicines.
One of the changes considered in these documents affects the legal status of medicinal products for human-use. Currently it is up to each member state's competent authority to classify products in accordance with national requirements. The EU commission has now proposed that the Summary of Product Characteristics should include the legal status of a product as a supplementary point. This proposition has consequences for OTC products, whenever these products contain active substances on which no agreement exist between the EU member states whether these substances should be available as OTC or as Rx products.
If such products had to undergo the mutual recognition procedure, the legal status would be part of the overall assessment. The involved member states would then have to decide about the acceptance of the legal classification of the first national marketing authorisation. As a favourable reception of OTC products is prevalent in a minority of the current EU member states, any disagreements between the involved authorities would result most certainly in failure to obtain the requested OTC status, consequently followed by re-switch activities for the concerned products in the more liberal countries.
Although the commission's intention might be to accelerate the establishment of a single market for OTC products in all EU member states, the idea of this thesis is to show that a compulsory harmonisation of the legal status of medicinal products could prove to be a double-edged attempt for fixing this problem. Instead different national rules regarding reimbursement and price-fixing of pharmaceuticals should be regarded as the key obstacles for the establishment of a single market for medicinal products.
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