Outstanding regulatory aspects in the European pharmaceutical market

This paper identifies and analyses a number of outstanding regulatory aspec ts in the completion of the European pharmaceutical single market. It discu sses pricing and competition in pharmaceuticals in the aftermath of the 3 F rankfurt Roundtables and their results. It analyses the environment for gen eric competition in the European Union (EU) and the extent to which this en vironment needs to be amended in order for such competition to be promoted. It links the issues of parallel trade, standardisation, single trademark, the European databank and the definition of innovation with the current sit uation in the functioning of the single market, particularly the sovereignt y of the member states in determining pricing and reimbursement levels. It argues that the above problems need to be tackled in conjunction with prici ng and reimbursement. The paper further points at new developments, in part icular biotechnology patenting and orphan drug regulation, where the EU has introduced or is about to introduce new legislation that has been needed f or a long time and examines how this legislation can be beneficial. Finally , the paper analyses the implications for healthcare provision in the membe r states of 2 legal cases heard before the European Court of Justice in rel ation to the free movement of goods and healthcare provided across borders. The paper concludes that there is still a long list of regulatory aspects t hat remain unresolved despite the fact that significant progress has been m ade to date, and observes that economic analysis in pharmaceutical regulati on is very much intertwined with political expediency. In addition, the def inition of political expediency varies as one considers developments at the EU or national level, since it does not necessarily follow that individual actors coincide in opinion.