EU medical trials law ‘putting brakes on science’


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. 

The prospect of having a single authorisation for clinical trials was endorsed by several parties at a meeting of stakeholders in Brussels on 27 July. 

During this first of five workshops of the Roadmap Initiative for Clinical Research in Europe, Jacques Demotes, from the French National Institute for Health and Medical Research  (INSERM), said the current situation could be streamlined. He said clinical trials for a single medicinal product do not need separate evaluations when a project is being run in several countries. 

This is particularly relevant for academic trials, which are often cross-border partnerships between different universities. 

Alan Tyndall from the University of Basel, Switzerland raised the issue of European research competitiveness and attractiveness if it takes longer for clinical trials to get started. 

Discussing the impact on paitents, Ruth Ladenstein from the St Anna Children's Hospital in Vienna, Austria, pointed out that paediatric trials have suffered from rising costs. She said reviving academic trials is essential for young people with cancer. 

"The success story in paediatric cancer over the past two or three decades is due to academic trials," she said. "It is precisely these trials that are in danger because of the bureaucratic load introduced by the current directive." 

German MEP  and physician Dr. Peter Liese has also criticised the implementation of the Clinical Trials Directive. He said member states must recognise the contribution of academic research to clinical trials in Europe. 

"The clinical trials directive has to be implemented in such a way that research done by academics is not prevented. During the debate about the directive, Parliament introduced several amendments which have not been accepted by Council and Commission," he said. 

In a landmark editorial in the British Medical Journal in 2006, Finnish cancer researchers Akseli Hemminki and Pirkko-Liisa Kellokumpu-Lehtinen warned the directive will ulimately harm patients by hindering their access to new treatments. 

They called on doctors, patients, universities and politicians to joni together to ensure that academic trials are not completely wiped out in the EU. "It is in no one's interest if only commercial companies have the resources to plan and carry out clinical trials," they said. 

The EU's Clinical Trials Directive was implemented in 2004 with a view to improving research standards and protecting patients. 

Enhancing the competitiveness of clinical research was a primary concern amid claims that Europe would become an unattractive place to conduct large-scale trials on lucrative new medicines. 

The directive also revamped how researchers get ethical approval for medical trials and sought to improve standards in how new medicines are tested and manufactured. 

An editorial in the British Medical Journal in 2006, written by leading Finnish cancer researchers Akseli Hemminki and Pirkko-Liisa Kellokumpu-Lehtinen, said the existing rules jeopardise the future of cancer trials in Europe. 


  • 21 Sept. 2009: London workshop entitled 'Innovative Approaches to Clinical Trials Co-Sponsorship in the EU'.

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