19 May 2004
EU expansion hinders development of a single European market for pharmaceuticals
A SINGLE EUROPEAN market for pharmaceuticals will be hindered by the recent expansion of the European Union, says a report by Urch Publishing.
According to European Pharmaceutical Regulation - Implications for Competitiveness, Innovation and a Single Market by Patrick Brennan, full integration of a single European market for pharmaceuticals is currently unlikely for three main reasons:
- The entrenched national sovereignty over health care policies, the complications of which are compounded by differing income levels and willingness and ability to pay (i.e. divergent pricing and reimbursement regulation);
- The joint, sunk nature of pharmaceutical R&D, estimated at over 30% of product cost on a net present value product lifecycle basis, which creates a situation that does not allow for efficient revenue generation under a uniform pricing system, as a certain amount of cross-subsidisation across products and national boundaries will inevitably occur; and,
- The enlargement of the European Union on 1st May, which expanded the free trade area to a potential 455 million* customers. This has only exacerbated the difficulties of achieving a single drug market, due primarily to the wide difference in economic indicators between the established 15 Member States and the ten accession countries.
Integrating the pharmaceutical markets of CEE and the EU raises several issues that have given rise to concern from industry and regulators including: a lack of transparency in national pricing and reimbursement regulation, inconsistent and/or incomplete intellectual property protection for innovative medicines and parallel trade flows, that capitalise on price discrepancies in national drug markets across the EU.
"The inclusion of the Central and Eastern Europe countries in the EU presents the formidable challenge of aligning disparate standards and financial means of health care systems across an enlarged Union. This process requires solutions that go beyond the simple extension of EU law through the acquis communautaire, to those that address the key issue of provision of high quality care under the social welfare system in a dynamic market-based economy" commented Edwin Bailey, managing director of Urch Publishing.
"Although the European Commission wishes to proceed gradually towards convergence through sustained cooperation between Member States and the industry, the question everyone is asking is: will there ever be a single market for pharmaceuticals?" said Mr Bailey.
Urch Publishing Ltd is an independent business information publisher dedicated to delivering quality information products to the global pharmaceuticals industry. For more information contact Urch Publishing on +44 (0) 20 7060 1099 or email press@urchpublishing.com.
