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European medicine research 'paralysed' by regulation

21 Mar 2013
European medicine research 'paralysed' by regulation

Europe is ruling itself out of the medical innovation race because of its unsophisticated approach to regulation, a conference sponsored by the Irish presidency of the European Union.

 

"Your EU rules, with their lack of nuance, will prevent you being players in innovation," said Stephen Friend, president of Sage Bionetworks of the U.S., presenting his view of the need for a much more ambitious approach to data collection and use in research.

 

He was particularly dismissive of EU approaches to data protection, currently subject to legislative bids to tighten up controls, and which he depicted as handicapping the circulation of data necessary to effective progress.

 

Citing his own experience in trying to bridge the gaps between academia and biotechnology and the medical community and patients - he was the founder of the Seattle Project gene research cooperative that was eventually sold as Rosetta Inpharmatics to Merck &Co - he insisted on the need for aggregation and data sharing.

 

Current attempts at harnessing the 'omics and information technology were, he said, reminiscent of the way mediaeval alchemists worked. Plenty of information is being generated, but "we are working in silos and we just don't know how all this information fits together".

 

The difficulties are multiplied in Europe by the density and complexity of binding regulation, which, he said, had been put in place without taking account of the fact that advanced research was by its nature unpredictable, and vulnerable to being put in a straitjacket.

 

Irish health minister James Reilly admitted "We are losing a lot research from Europe because of red tape", and claimed the Irish presidency was trying to ease some of the bureaucracy through its work to update the EU rules on clinical trials and medical devices.

 

The same view was echoed by Mark Lawler, professor of oncology at Queens University in Belfast. Because of fragmentation and excessive rules. He said:

 

"We are lagging behind in Europe. In the U.S. they are treating cancer patients, while in Europe we are still doing little more than randomised clinical trials."

 

Françoise Meunier, director general of the European Organisation for Research into Treatments for Cancer, also raised concerns during the meeting over impending risks to clinical trials from new EU legislative initiatives.

 

She was deeply concerned over draft provisions in the EU's update of clinical trial rules - under debate this week in the European Parliament - for destruction of data within five or 10 years of the end of a trial.

 

"This would rob us of any possibility of long-term follow-up of patients," she said.

 

She told APM: "EU rules are killing innovation".

 

On the fringes of the meeting, Friend told APM data aggregation was essential "because no single study can cover all the needs for information".

 

On the contentious question of consent - current plans to update EU data protection rules emphasise a "right to be forgotten".
While accepting the need for initial patient consent to use of data, and even the right to subsequent withdrawal of any consent given, that should not have retroactive effect, he insisted - contrary to EU thinking.

 

He said: "Patients may change their mind, so they should have the right to say 'stop' using my data any more. What cannot happen, however, is disentangling that data from research in which it has already been used."

 

The conference - "Innovation and patient access to personalised medicine" - aimed at reviewing achievements and charting the next steps in Europe, and offered plenty of examples of the challenges and impediments.
Irish minister of state John Perry told the meeting it was important for governments to recognise the possible value for money that personalised medicine represented.

 

"The EU regulatory framework should not discourage progress", he said. "The regulatory approval process must reflect new science, paving the way for innovation while protecting the highest levels of safety".

 

Patricia Reilly, a senior adviser to European Research Commissioner Máire Geoghegan- Quinn, said "Innovation in healthcare is critical for Europe, for economic and social reasons, because current therapies are less than effective".

 

"Personalised medicine should allow better prediction, prevention and treatment - but there are many obstacles", she warned. "Progress will depend on an unprecedented level of cooperation and collaboration. There is a pressing need to break down barriers and speak the same language."

 

John Bowis, a former UK health minister and MEP, and now the vice-chair of the European Alliance for Personalised Medicine (which organised the conference), pleaded for "wide engagement of all stakeholders, from scientist through to patients - and crucially, senior politicians".

 

The message needed to be heard by ministers and EU commissioners - "and not just health ministers but economic affairs ministers too", concluded Bowis.

 

Source: APM