Biotechnology companies in the UK “are on the verge of extinction” and one of the main reasons is “the crippling self-inflicted extra costs” of clinical trials, which are driving industry abroad, claim more than 100 academics in a letter to The Times newspaper.
According to the co-signees headed by George Griffin, chair of the Association of Clinical Professors of Medicine, European directives designed to harmonise conditions in the sector “have led, in the UK, to an explosion of agencies that add months or even years to the simplest and safest pieces of clinical research, and millions of pounds to the cost – for those few investigators with the patience to persist”
The pharmaceutical industry now recruits one third the number of patients to clinical trials in the UK that it did before the implementation of the European Union’s Clinical Trials Directive (2001/20/EC), Griffin et al say. Meanwhile, the number of studies seeking ethical approval has fallen by 30 per cent and the Medicines and Healthcare products Regulatory Agency has logged a 50% reduction in the number of non-commercial trial authorisations.
Over the same period, since 2004, other European agencies have registered a stable or higher number of trials, the academics add. For smaller biotechnology companies, they note, transferring studies abroad is less feasible than for the pharmaceutical industry. And for “academic researchers on fixed-term grants, the financial and logistic consequences of delay are often insuperable”.
This “waste of taxpayers’ and charitable money on red tape” has managed to reduce productivity without enhancing safety – “as illustrated by the Northwick Park debacle of 2006”, the co-signees comment. For decades prior to 2004, they assert, the UK “led on an effective, simple process ensuring ethical approval of trials with patients giving written informed consent using intelligible consent documents”.
It is, of course, essential that completely new drugs come under scrutiny, the letter points out. However, “the current system does not distinguish at an early stage between projects on a risk basis, ensuring that even the simplest projects take a huge amount of time to gain approval. A chief investigator can now spend months of full-time work before administering one dose of a drug that he or she prescribes every day in the clinic”.
According to Griffin et al, the majority of the regulatory burden faced by clinical researchers “may have little basis in law and is unique to the UK”. The sector should be regulated “by those who care for patients, who realise that obstacles to research are harmful to patients – and development of new drugs”, they insist. “We do not need multiple bodies to share responsibility for reviewing research but a simplified system, such as the Dutch model, employing a single form to harmonise the process.”
An in-depth assessment of how the Clinical Trials Directive has been applied across the European Union was among the objectives set out by the European Commission in a recent communication accompanying its package of legislative proposals for the pharmaceutical sector.
Another leading co-signee of the letter to The Times was Morris Brown, Professor of Clinical Pharmacology at Birmingham University and Addenbrookes Hospital in Cambridge. Brown was one of the authors of a recent article in the BMJ claiming that the UK “has slipped from one of the most attractive to one of the least attractive places to undertake clinical trials” due to an ever-growing regulatory burden.
