European rules on medical research have decimated academic studies due to spiralling insurance costs and bureaucracy, according to a leading academic.
Professor Dietger Niederwieser from the University of Leipzig said the EU’s Clinical Trials Directive was designed to cater primarily for the pharmaceutical industry and that academia had been “forgotten” by lawmakers.
Speaking after the first of five workshops which seek to examine the impact of the directive, Niederwieser says the rules are geared towards trials by companies hoping to approve new drugs while ignoring research on quality standards or which compares the effectiveness of surgical procedures.
“Academic trials are down dramatically. There were ten times as many research trials taking place in academia before the directive came into force,” he said.
Niederwieser said the cost of conducting trials in Germany had risen by a factor of ten, without any major increase in quality.
“This directive is putting the brakes on science in Europe,” he added.
Variations in how the law is interpreted across Europe is making it difficult to conduct research in several countries as part of a single project, says Niederwieser, who is the president of the European Group for Blood Marrow Transplantation (EBMT).
However, he accepted that there had been some improvement in streamlining the process for securing ethical approval for trials. Asked whether the current directive could be tweaked to fix the flaws he has identified, Niederwieser said he was not optimistic.
“Either we modify the directive or make a new one. But this will not happen because politically, nobody wants to admit they make a mistake,” he said.