by Richard Staines
LONDON, Jan 15 (APM) - Europe's clinical trial regulation was “hijacked” by campaigners for greater clinical trial transparency, such as UK doctor and journalist, Ben Goldacre, the head of its pharma trade body has said.
In an interview with APM looking forward to 2015, Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said he looked forward to a year without significant developments in regulation and welcomed moves by European Commission president, Jean-Claude Juncker, to reduce bureaucracy.
But Bergstrom said he was disappointed by the debate during the drafting of the clinical trial regulation, which he noted was originally intended to encourage more clinical trials to take place in Europe.
Instead the process became dominated by campaigners for clinical trial data transparency, he argued.
He told APM: “It was well intended but during the process people begain to add in things. It became about data transparency and the whole process was hijacked by Ben Goldacre. The amount of time discussing issues related to this was immense.”
He said: “People are going to be much more careful when they are asking for things because of recent experiences. You have to be careful what you ask for as you can't control the process.”
Other EU legislation has also become unduly complex, he added.
“Pharmacovigilance legislation we did not ask for. It was fall out from the Mediator scandal that became too complicated, emphasising adverse events reporting when it should be about using data sampling and registries to look for safety problems."
He also said measures in the falsified medicines directive cracking down on active pharmaceutical ingredient suppliers in India and China were unnecessarily bureaucractic and could lead to shortages.
“Whatever you ask for has to be simple, otherwise it becomes much more complex than you expect. This is not the time for more regulation,” said Bergstrom.
He said the only major outstanding issue is the data protection regulation (APMMA 37794) and any ramifications of trade talks between the U.S. and EU.
But Bergstrom said many of the regulations that affected the pharma industry have become overly burdensome or signficantly changed during the course of the legislative process.
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