Biotechnology back on the EU’s agenda

Date: 14/12/1995

By Fiona McHugh

EU rules on legal protection for biotechnology inventions, shot down by the European Parliament due to ethical concerns, are making a come-back.

The latest version of the draft directive, adopted by the European Commission yesterday (13 December), addresses MEPs' worries about the patenting of human life, while at the same time allowing biotechnology companies to reap financial rewards from investments.

“We are convinced this proposal achieves the right balance between the two equally essential requirements of promoting research and providing ethical protection,” said Single Market Commissioner Mario Monti.

“Without common legislation compatible with the single market, European research and exploitation of its results, particularly for therapeutic purposes, will be discouraged.”

The revised text contains tightened provisions banning patents for body parts, which have been discovered rather than invented, and says genetically-engineered animals can be patented only if the benefit to the human race outweighs the suffering of the animal.

Gene-line therapy, which allows doctors to replace defective genes with healthy ones, would be banned under the rules, which must be approved by ministers and MEPs before becoming law. The draft gives farmers a derogation from patent law, allowing them to breed patented animals for their own use without paying royalties.

Parliament's rejection of the original proposal was greeted with dismay by Europe's biotechnology industry, which had waited seven years for the rules its said were needed to protect investment. MEPs were heavily criticised and are unlikely to oppose the new directive, say Parliament sources.