BioWorld International Correspondent
BRUSSELS, Belgium - While the European Union continues to display severe disarray over its rules for releasing biotechnology-based products onto the market, 10 of the 15 European Union member states have been assailed by the European Commission for failing to comply with rules the EU itself agreed to on how biotechnology research should be regulated.
The Commission said Monday that reasoned opinions - a technical term for a second (and final) warning letter in proceedings for infringing EU rules - are being sent to France, Luxembourg, Belgium, Germany, Italy, the United Kingdom, Ireland, Greece, Spain and Austria because they have not informed the Commission of how they are implementing the 1998 EU directive on laboratory use of genetically modified microorganisms. If the Commission still does not get satisfaction in the next two months, it may haul the offending countries before the European Court of Justice for a formal ruling and possible fines.
European Environment Commissioner Margot Wallström said, "I am disappointed that so many member states have still not implemented this high-profile directive more than six months after the deadline."
The 1998 directive amended part of the EU's basic 1990 rules on biotechnology, with the intention of adapting them to advances in the understanding of the technology during the decade. The aim was to bring EU legislation into line with current international practice, particularly by linking administrative procedures and notification requirements more closely to the real level of risk of the activities concerned. Under the old rules, a "one-size-fits-all" approach had meant that many low-risk research procedures were subject to an inflexible regime of heavy-duty regulatory controls.
National legislation was required to have been adopted and communicated to the Commission by June 5, 2000, at the latest. As no implementing legislation had been received from the 10 member states, they were each sent a letter of formal notice (the first warning letter) on Aug. 8, giving them two months to submit their observations.
But the Commission said that when member states responded, they did so inadequately. Germany said that it envisaged a law in July 2001 with supporting regulations foreseen for January 2002; Spain merely said an implementing text was being prepared, but supplied no details; Austria claimed existing legislation already covered part of the requirements and additional legislative instruments to fill the gaps were still under preparation. The United Kingdom has provided details of implementing legislation for England, Wales and Scotland, but nothing for Northern Ireland and Gibraltar. Ireland has supplied only a draft text, which is still to be adopted. And France, Luxembourg, Belgium, Italy and Greece failed to reply at all.