Creating European markets through regulation: the case of the Regulation on advanced therapy medicinal products

Publishers Abstract
This article analyses the EU regulatory efforts to create a European market for advanced therapy medicinal products. It focuses on the pitfalls of European regulatory intervention in a difficult market which is characterised by multiple, often contradictory stakeholder expectations, rapid scientific and technological change, and ethical diversity. It contends that while the Regulation on Advanced Therapy Medicinal Products was, in principle, equipped to address these challenges, its fundamental paradigms and choices, and its treatment of some of the dilemmas of the emerging technology market, undermined its ability to establish the balanced and sustainable market desired by the EU legislator.

• Primary Source

Sweet and Maxwell: European Law Review http://www.sweetandmaxwell.co.uk/catalogue/productdetails.aspx?recordid=427&productid=6968

ESO: Background information:European Medicines Agency recommends first marketing authorisation for an advanced therapy medicinal product http://www.europeansources.info/record/press-release-european-medicines-agency-recommends-first-marketing-authorisation-for-an-advanced-therapy-medicinal-product/

ESO Background information: Report from the Commission to the European Parliament and the Council in accordance with Article 25 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 http://www.europeansources.info/record/report-from-the-commission-to-the-european-parliament-and-the-council-in-accordance-with-article-25-of-regulation-ec-no-1394-2007-of-the-european-parliament-and-of-the-council-on-advanced-therapy-me/

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