Blame game slows growth of personalised medicine

By Kate Kelland

LONDON (Reuters) - Expectation has been building for a decade that an era of personalised medicine will transform the global drugs business, but the reality is a slow start and an angry blame game between scientists, marketers and regulators.

Drug firms accuse regulators of imposing cumbersome and expensive licensing requirements they say hark back to an old model of drug discovery when one-size-fits-all drugs had to be tested on thousands of patients before going on sale.

"I've been talking about personalised medicines since 1989, and I was passionate about it ... but 20 years later we have only made modest progress," said Arthur Higgins, chief executive of Bayer HealthCare BAYG.DE and head of Europe's Federation of Pharmaceutical Industries and Associations.

"And to be honest I'm not so convinced we will make much progress in the future...unless things change," he said, adding that the first requirement was a new regulatory framework to allow more interaction between drug firms and regulators.

Speaking alongside Higgins at a pharmaceutical conference in London last week, Chris Viehbacher, chief executive of Sanofi-Aventis (SASY.PA), joined the attack:

"Regulatory decisions on safety have been more around protecting the interests of the regulators," he said. "Making them more developed and transparent will mean, for patients, the right decisions are being made."

But drug licensing chiefs reject such criticism, saying they are ahead of the game with fast-track options for drugs aimed at new areas, and help for firms wanting to design slick clinical trials to speed the path of a personalised drug to its market.

IS INDUSTRY REALLY KEEN?