EU red tape making drugs trials 'impossible'

"As we are dependant on charity to continue our research, it’s a really serious pressure."

International trials - which are becoming increasingly important - had been particularly hard-hit, he said.

"If you make them impossible, there’s the risk that we will never do that research."

The directive was brought in to make drugs trials safer and "harmonise" methods across the EU, but Prof Johnson said it had largely failed on both counts.

He explained that the directive appeared to require many licensed drugs or nutrients - including some that could be bought over-the-counter at chemists - to be classed as "innovative medicinal products" in trials.

If they were classed as such, then every suspected adverse reaction had to be logged with every research centre - even if used in already-approved quantities, and even though the drug's safety profile had been determined years before.

"It’s resulted in a deluge of paperwork," he said.

He said CRUK was planning a trial adding selenium, a widely available nutrient, to treatment for those with aggressive lymphoma, or immune system cancer.

But Prof Johnson said: "The trial didn’t happen in the end simply because we could not cope with the regulatory burden. It proved impossible.

"So we will never know if adding selenium adds to the likelihood of your lymphoma treatment working."

Furthermore, he said "grey areas" in the directive meant countries' drugs authorities often differed as to what should and should not be classed as an IMP - making coordinating trials difficult.

He said the UK's Medicines and Healthcare products Regulatory Agency (MHRA) was "more rigourous than any other authority in Europe, in terms of interpreting the regulations".

While the directive's principles were "sensible", in practice it was causing massive problems.

"We haven’t really seen any benefit in terms of quality or safety, it’s just more expensive," he said.

He warned: "The directive is a real threat to UK and European dominance of the clinical trials world. And where clinical trials go today, pharmaceutical companies go tomorrow."

A year ago Pfizer announced it was closing research and development facility in Kent, he noted, with the loss of up to 2,400 jobs.

Last week AstraZeneca announced it was shedding 7,300 jobs worldwide, threatening up to 350 R&D jobs in Alderley Park, Macclesfield.

While Prof Johnson said other factors were at play - such as the global recession and tightening health budgets - he claimed the directive simply made life for drugs firms in Britain more difficult.

The charity and 15 others, including the British Heart Foundation and the Wellcome Trust, do not want to see the directive repealed, but they do want it revised so it is more "proportionate", in the words of the Trust's director, Sir Mark Walport.

Last week, CRUK launched a report at the European Parliament containing its ideas on reform, in response to a EU-wide consultation.

It warned: "The risk of not improving the Directive would be that important medical research will no longer take place in Europe or possibly at all."

Prof Johnson was hopeful of change.

He said: "I think there’s such a broad consensus of the difficulties that have been generated by the directive - among researchers and patients and politicians – that I think there’s a very good chance that we will see the directive substantially amended."

The drugs industry also wants the directive amended.

A spokesman for the Association of the British Pharmaceutical Industry said: "The introduction of the Clinical Trials Directive has increased the quality of EU clinical research, however, various elements of the Directive were interpreted differently across the EU, and this has increased the complexity and cost of performing multinational clinical trials in the EU."

A spokesman for the MHRA said: "We believe we have struck the right balance in the UK - operating within the framework of the current EU regulation, and the MHRA is always available to offer advice and assistance."

He added: "In order to improve implementation of the current Directive, the MHRA has already undertaken a number of projects with the broad aim of applying a risk proportionate approach in the UK to the approval, monitoring and inspection of clinical trials, within the current legal framework."

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EU red tape making drugs trials 'impossible'