SPROUTING UP: THE DIRECTIVE THAT WON'T LIE DOWN

If proponents of the European Union’s (EU) "Life Patents Directive" had thought that the adoption of the directive in 1998 was the final step in its infamous 10-year saga, they are in for a rude awakening. The directive is back on Europe’s political agenda. The deadline for transposition of the directive into national law was July 30th. But many EU governments have become very reluctant to transform the very directive which most of them adopted so enthusiastically at the EU-level only 2 years ago. The stumbling block is the question of patenting human genes.

The deadline for the transposition coincided with the announcement that the whole human genome has now been decoded. In Europe this opened up a public debate on the questions of patentability of these genes. Only weeks prior to the announcement US President Bill Clinton and UK Prime Minister Tony Blair had called for all human genes to remain in the public domain. The disclosure of a patent on human embryos, which had been granted by the European Patent Office (EPO) in 1999, also caused an unprecedented pubic outcry and political stir. Reaction was so extreme that the German government filed a legal opposition to the patent. If the (official) main aim of the directive was to harmonise patent law in Europe, it has failed miserably. The EPO may have incorporated the directive into its own rule-book in anticipation of new national patent laws, but EU governments will only adopt the directive with various amendments, or not at all. The situation has become legally more confusing and incoherent than ever

There seems only one way out of the mess: renegotiate the whole directive at European level – for a third time! Already there are increasingly loud voices calling for such a renegotiation. Several powerful lobby-groups, who kept silent in 1998, have since come out against the directive: most notably perhaps the German Farmer’s Association, who recently called for a moratorium on patents on plants and renegotiation of the directive. The government of Germany is reported to have contacted France and the UK to discuss this possibility as well. In addition, on June 30th the Council of Europe in Strasbourg unanimously passed a (non-binding) resolution calling on EU-Member States not to transpose the directive, and instead to pass a moratorium on the patenting of human genes and start renegotiating the directive.

To start the process, the EU-Ministers would need to call on the EU Commission to prepare a new proposal. The Commission, however, has always been a strong supporter of the directive as it stands. But things seem to change there as well: in a recent speech, the European Commissioner responsible for Research, Mr. Busquin, implied a need to act: "The rule that the product of a discovery should remain within the public domain but that the fruit of invention work can be protected is clear in terms of principle. However, the conditions under which it is applied in the case of ‘genomics’ need to be clarified in order to avoid any ambiguity or abuse."

Source: Thomas Schweiger, who can be contacted at [email protected]