by Ailis Kane
CAMBRIDGE, Dec 1 (APM) - The chairman of Britain's MHRA, Alasdair Breckenridge, has called for clarification over the approval of genetic tests in Europe which could be crucial to the adoption of personalised medicine.
In Europe, most innovative treatments in Europe are approved centrally by the EMEA, while diagnostics and devices are dealt with on a national basis via the in-vitro diagnostics (IVD) regulations.
By contrast, the FDA reviews both the medicine and diagnostic together as a "drug-device" combination, when faced with approving a drug for use in a certain population who must be identified by a genetic test
. A key example is Roche's targeted breast cancer therapy Herceptin (trastuzumab), which is only for use in HER2-positive women.
"This is a paradox that jolly well must be resolved," said Breckenridge at an MHRA workshop on pharmacogenetics
, in Cambridge on Thursday.
However, answers remain unclear. "I'm not certain what the solution is going to be. There is no will within the Commission to have a European devices agency," he said.
"The regulators at the EMEA are discussing this situation. Clearly, many are uncomfortable about it," Breckenridge added.
Dr Graham Lewis, head of the centre for prospective regulation at the University of York, said there was a perception in the industry that the EMEA was lagging behind the FDA in its attitude to pharmacogenetics. However, Dr Linda Surh, head of UK regulatory affairs at GlaxoSmithKline's neurology and pharmacogenetics centre of excellence for drug discovery, said there was no clear reason to change the status quo.
It was "good to have diversity between regulatory agencies if there is not enough evidence to go either way", she said.
Dr Stephen Little, CEO of the personalised medicines' company, DXS Genotyping
, also backed the current system.
Breckenridge said the separation of drug and diagnostic approval in Europe was historical. By contrast, UK regulators had anticipated the need to work together on devices and drug by its merger of the Medical Devices Agency and Medicines Control Agency in 2003 to form the MHRA.
The speakers at the meeting urged a realistic view of the benefits that pharmacogenetics could bring and said that any concrete changes to clinical practice would be some years in the future.
"How long is anyone's guess. But it's certainly not going to be in the next five years," said Professor Geoff Tucker of the University of Sheffield.
He called for more prospectively designed clinical trials to determine the applicability of genetic tests.
 01/12/2006 11:41 GMT - INDUSTRY