The European Union (EU) is a key pharmaceutical market, representing almost 28 per cent of the total world pharmaceutical market value in 2003 (1). A number of changes over recent years, ranging from EU size and regulatory framework to pricing and reimbursement, suggest that the attractiveness and accessibility of the market may, in theory, have changed. We wanted to assess the practical consequences of these changes by examining all centralised marketing authorisations (MA) granted in the EU over the last five years. Given the factors at play, our hypothesis was that, in theory, a weighted balance towards more streamlined access would be reflected in the numbers of approvals granted. However, results from this analysis were equivocal, arguably reflecting the importance of complexities within the changing dynamics of the EU markets, in particular concerning the post-approval issues faced by companies today.

TOWARDS MORE ACCESSIBLE AND ATTRACTIVE EU MARKETS

One of the biggest changes to accessibility of the EU market was the 1995 introduction of a centralised drug approval procedure, matching the US FDA approval structure more closely. This new system was created to unify the regulatory process and provide EU-wide marketing authorisations for innovative medicinal products and, in so doing, significantly improve market access for developers. Since the implementation of this system, drugs approved by the centralised procedure appear to have approval times comparable to the US (2). Although centralised approval is compulsory for biologicals, AIDS, cancer, diabetes, neurodegenerative disease and orphan products, other drugs may still be approved by the decentralised and mutual recognition procedures.