Bureaucracy gone bananas
Most people have enjoyed a wry grin at the expense of the EU when yet another piece of daft legislation has been held up to public ridicule. Ban bendy bananas, curtail curvy cucumbers, chuck out chunky carrots - all victims of bureaucratic zeal in recent years.
But there can be few in the pharmaceutical industry who are smiling about the imminent implementation of the new Clinical Trials Directive, which will be applied in the UK from May. The Directive was conceived to improve safety by harmonising the clinical trials regulatory environment in Europe, safeguarding patient rights and ensuring compliance with GMP, and as such its introduction is to be applauded.
However, in practice, it is likely to burden clinical researchers with onerous reporting standards and legal obligations, which could increase costs significantly and consequently jeopardise research in a number of key therapeutic areas - notably cancer.
Until now, clinical trials in the UK have been regulated by the Medicines Act 1968, which is being replaced by the new regulations. Under the Act, though, most clinical trials were conducted under one of the many exemption schemes - a provision that the Directive does not allow.
Nor does it make any distinction between commercial and non-commercial researchers. Although the effects of the legislation will be serious for big pharma, they are likely to be catastrophic for small research organisations and medical charities as the Directive requires the sponsor of a clinical trial to assume total legal and financial responsibility for every aspect of its investigation. These organisations operate on a shoestring and will find themselves drowning in a sea of paperwork. The bureaucratic burden will outstrip any potential protection for patients, they say, and could effectively end all non-commercial clinical research.
The European Commission claims to have considered these concerns during the consultation period last year. EU Research Commissioner Philippe Busquin has acknowledged that the new rules may be 'problematic' for public sector researchers, but insists that the measures are necessary. His suggestion is that academic institutions and research agencies should establish a European platform to better finance co-operative trials.
Busquin has expressed concern over the decline in research by pharma companies in Europe during the last decade, but it doesn't seem likely that the Directive, however well-intentioned, will correct the situation. In fact, it may well make it even worse - particularly with countries like India ready, willing and able to take centre stage as a venue for clinical trials.
A bent banana never hurt anyone, but putting obstacles in the way of clinical research is almost certain to cost lives.