EU red tape delays new cancer treatments for 18 months

THE development of cancer drugs has slowed by 18 months because of EU red tape, a damning report has warned.

The Institute of Cancer Research found that excessive inspections and needless safety reporting when testing already licensed drugs on different cancers has increased admin and made it more expensive to run clinical trials.

It means that whereas in 2008 NHS patients waited 12.7 years for drugs to be available, now they must wait 14.1 years – even though Nice, the UK drugs watchdog, has speeded up approval by seven months.

The average time taken between the start of phase I clinical trials and authorisation by the European Medical Agency has increased by more than a year from 7.8 years in 2000-08 to 9.1 years in 2009-16 – suggesting most delays occur during trials and licensing.

The regulation of trials is governed by the EU clinical trials directive, which many healthcare experts said had made them far more expensive and bureaucratic.

Prof Paul Workman, the chief executive of the Institute of Cancer Research, London, said: “We are concerned about the length of time it’s taking for new drugs to reach cancer patients. It’s actually getting slower.

“The delays are in the stage of taking drugs through clinical trials, and the licensing process, through bureaucracy. We need to address the regulatory barriers in setting up and running clinical trials, and in getting drugs licensed at as early a stage as possible.”

The report also found that some cancers – including brain, womb, bladder, oesophageal and testicular – had received no new drugs at all since 2000 even though they are among the most deadly and with the fewest treatments.

Only eight of the 97 drugs authorised by the European Medical Agency were licensed for use in children’s cancer.

Dr Olivia Rossanese, the institute’s head of therapeutics biology, said: “We have seen far less progress against many other tumour types, and much less progress in children than in adults. Drugs are taking longer to reach patients when we would expect the process to be getting quicker.”

The report’s authors warned that Nice was failing to appreciate the importance of innovative drugs that fight cancer in new ways. Cancer evolves, and without new mechanisms for battling disease, individuals could discover there are no treatments left if all the drugs work in the same way.