Outstanding regulatory aspects in the European pharmaceutical market.

This paper identifies and analyses a number of outstanding regulatory aspects in the completion of the European pharmaceutical single market. It discusses pricing and competition in pharmaceuticals in the aftermath of the 3 Frankfurt Roundtables and their results. It analyses the environment for generic competition in the European Union (EU) and the extent to which this environment 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 situation in the functioning of the single market, particularly the sovereignty of the member states in determining pricing and reimbursement levels. It argues that the above problems need to be tackled in conjunction with pricing and reimbursement. The paper further points at new developments, in particular biotechnology patenting and orphan drug regulation, where the EU has introduced or is about to introduce new legislation that has been needed for a long time and examines how this legislation can be beneficial. Finally, the paper analyses the implications for healthcare provision in the member states of 2 legal cases heard before the European Court of Justice in relation to the free movement of goods and healthcare provided across borders. The paper concludes that there is still a long list of regulatory aspects that remain unresolved despite the fact that significant progress has been made to date, and observes that economic analysis in pharmaceutical regulation is very much intertwined with political expediency. In addition, the definition 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.