Wholesale trade in named-patient medicines in the EU: "Specials" and exempt imports

Article type: Research Article

Authors: Roberts, Julian

Affiliations: Rössner Rechtsanwälte, Höchlstrasse 2, D-81675 Munich, Germany. Fax: +49 89 99 89 22 33; E-mail: roberts@roessner.de

Abstract: This essay is concerned with wholesalers who import and supply unlicensed medicines within the EU on a "named patient" or "special needs" basis – i.e., on the basis that a physician has specially ordered an unlicensed medicine for the treatment of a particular patient. In particular it looks at the position of a wholesaler who supplies such medicines from a British offshore island (the Isle of Man) to Germany. For most purposes, the law governing pharmaceutical wholesaling is in practice identical in the UK (which is an EU member) and on the Isle of Man (which is not). The essay does however consider the specific regulatory position of wholesalers trading from the Isle of Man by virtue of the Island's right to partake in the EU internal market for goods as a result of the UK Treaty of Accession.

Journal: Pharmaceuticals, Policy and Law, vol. 8, no. 0, pp. 51-68, 2005,2006