The new Spanish regulation of the medicinal industry

Abstract

The Spanish legislator has finally decided to approve Royal Decree 824/2010 concerning pharmaceutical laboratories, manufacturers of pharmaceutical active ingredients and foreign trade in medicines. We say ‘finally’ because this is an area of regulation that is obviously primordial in the pharmaceutical sector and which, nevertheless, has been waiting for regulatory development to give operators minimal security and to clarify numerous underlying conflicts. Therefore, since the approval of Act 29/2006 of July 26th on Guarantees and the Rational Use of Medicine and Health Products – LGURM, in Spanish –, the current framework law in Spain, four long years have passed in which many of the mandates set out in article 63 and following were in need of greater specification. Some questions were even in direct conflict with Royal Decree 1564/1992 of December 18th, regulating the authorisation system of Pharmaceutical Laboratories and Medicine Importers and the guarantee of quality in their industrial manufacture, which was developed by the previous Law of Medicines of 1990, and which remained in force in the absence of legal replacement. To give but one example, in this time there have been numerous headers of the former authorisations such as “Commercialising laboratory”, whose administrative recognition was revoked without their being legalised with any alternative formula, leaving them in an unacceptable legal limbo. With such lacunae, it was difficult to encourage domestic, and above all foreign, operators to invest in Spain without a sufficiently predictable entrepreneurial ecosystem.