In 2007, the European Union adopted a lex specialis, Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regime across the European Union but have to respect national laws. This article describes the recent EU laws, and contrasts two national regimes, asking how France and the United Kingdom regulate ATMPs which do and do not fall under the scope of Regulation (EC) No. 1394/2007. What are the different legal categories and their enforceable regimes, and how does the evolution of these highly complex regimes interact with the material world of regenerative medicine and the regulatory bodies and socioeconomic actors participating in it?
E-Government ist gut für Staat und Bürger - aber nur dann, wenn die Behörden die von ihnen gesammelten Daten auch wieder herausrücken. In den USA bemühen sich zahlreiche Initiativen auch seitens der Regierung um mehr Offenheit. In Europa arbeitet auch WWW-Erfinder Tim Berners-Lee daran mit, die Datenschätze der Behörden zugänglich zu machen.