Pharmaceutical Executive Europe - March 2008 - (Page 8)
8 News & Analysis March 2008 Pharmaceutical Executive Europe BRUSSELS REPORT Animal traps Reflector asks whether the EU’s long threatened revision review of the use of animals in drug research will play fair with pharma. t’s now almost certain that European Union rules on the use of experimental animals are going to get much tougher. European Environment Commissioner Stavros Dimas confirmed in mid-February that the proposed new regulation will appear in early April —and he hinted at some draconian new powers to force drug firms into data sharing on animal data. Until now, the long-threatened revision of the EU’s 20-year old legislation on animal testing looked as if it might never happen. An extensive consultation exercise over a year ago led to widely contradictory recommendations on whether and how to modify the rules, and the subject virtually fell off the EU agenda. Now Commissioner Dimas has changed all that. A new set of controls is now being examined by senior EU officials prior to finalising a draft, and I the signs are that it will make life more difficult for drug firms conducting research in Europe. The European drug industry is bracing itself for a fight, conscious that squeezing animal experimentation unduly will tend to squeeze drug research and development out of Europe — with a loss of jobs, investment and profits. It would also, it will argue, hurt patients too, by slowing the flow of new medicines. The worst-case scenario is that the EU will surrender science to the increasingly vocal opponents of any use of animals. The European Parliament has been ringing with denunciations of wanton cruelty and heartless exploitation, and a resolution aiming to ban the use of primates recently won strong backing in the parliament. Dimas defused some of the worst fears by indicating that he recognises the continuing need for some animal experimentation (and he is no great friend of science-based industries — he has been distinctly unhelpful to the biotech sector over GM crops). He even recognised that some research with primates will still be necessary for the foreseeable future. But impromptu remarks he made at an antiexperiment meeting in the parliament in midFebruary have generated new anxieties. Embracing the widely-accepted idea that sharing of data would reduce unnecessary testing on animals, he appeared to go further than anyone else had so far dared to go, by speaking of obliging companies to share this data. He said the new regulation could impose a legal obligation on firms to share such data, with fines for noncompliance. That will send a shiver through many a research department — and more than a shiver through intellectual property departments too!
Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - March 2008
Pharmaceutical Executive Europe - March 2008
Contents
From the Editor
News and Analysis
Brussels Report
Calendar
The Next Wave of Pharma Talent
The New World Order
Share of Voice to Share of Care
Notes on a Meeting
The Malta Story
Motivation Across Borders
The Mix
No GUTs, No Global
Green is Good
Last Word
Pharmaceutical Executive Europe - March 2008
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