BRUSSELS, Belgium ¿ The European Federation of Pharmaceutical Industries and Associations (EFPIA) came out strongly against any undue extension of European Union rules on product liability.

In response to a consultation paper from the European Commission, which suggests offering additional protection to European consumers, EFPIA said: ¿Europe must avoid moving towards the madness of the U.S. situation.¿ Claiming that the drug industry already does everything possible to make its new products safe, it said: ¿Contemporary product liability is essentially not about safety but about money: accordingly, it can attract those who take advantage of the available systems for personal gain.¿

EFPIA is particularly opposed to the idea of requiring drug developers to take out insurance against product liability. ¿We are aware of no case to date where a lack of insurance cover has led to a consumer not being compensated,¿ it said, dismissing the suggestion as ¿an example of a theoretical question with no basis in fact.¿ And it goes on to argue that ¿small companies, such as innovative biotechnology companies, on which reliance is now largely placed to produce the innovative products of the future, may not have adequate resources to cover their risk.¿ Compulsory insurance would be disastrous for such firms, EFPIA said, and added it would also be unnecessary: ¿Their products are usually marketed by multi-nationals,¿ which can arrange insurance.