[Video] After Mediator scandal, no more loopholes on drugs safety: Euro MP

Wednesday, May 09, 2012

Brussels: Drugs scandals such as Mediator have shown that better coordination between EU national health systems and a stronger role for the European Medicines Agency (EMA) is still needed. Members of the all-party environment and health committee in the European Parliament backed Euro MP Linda McAvan's proposals to upgrade drugs safety in the EU following a report by the European Commission which pointed at potential loopholes. The EU adopted a new directive and regulation on pharmacovilgilance in December 2010. However, the emergence of the Mediator case in France in 2011 uncovered some shortcomings in the new directive and regulation which will come into force in July 2012. Linda McAvan, author of the parliamentary report and S&D spokesperson on health, said:

"What happened with the Mediator drug was that this drug was put in the market in many different countries, but even 12 years ago there was a concern about its safety. In Italy and Spain regulators talked about it but nothing happened. The defence that we made now is that if we have concerns like this it has to be a scientific investigation by the European Medicine Agency, by officials to stop this kind of problem. It is not acceptable that 12 years after the problem had been highlighted the drugs was still widely available in France, many years after been taken of the market in the US."

Notably, Mediator was a drug made by the French company Servier and licensed in other EU countries through national procedures (France, Portugal, Luxembourg, Greece, Italy and Spain) for the treatment of type 2 diabetes. The first adverse reactions were reported in 1998 indicating concerns about possible heart valve disorders. Despite this, Mediator was widely prescribed in Europe and in particular France. In 2009 the drug was finally withdrawn from the market, but estimates of deaths related to Mediator vary from 500 to 2,000.

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9 May 2012 at 17:53 delete

'mediator' was a big loop hole in co-ordination between different bodies...........