The government has told conservative peer Lord Saatchi that his medical innovation bill will need amendments before it can proceed to the statute book.
The bill had its second reading in the House of Lords on Friday and was sent to committee stage for further debate.
Health minister Earl Howe gave broad support for the bill, which seeks to lift liability restrictions for doctors who want to innovate in treating cancer patients.
But Howe said the bill in its current form, which gives a role to multidisciplinary teams to oversee the innovation, is not appropriate. The government is likely to insist on amendments to stipulate doctors with relevant experience and expertise will provide checks on what their colleagues are doing.
This change, Howe noted, should be in line with the existing ‘Bolam test’ – the standard duty of care between a doctor and his patient.
‘Doctors should have the confidence to innovate, particularly where existing approaches have been exhausted and where there is no plausible alternative,’ said Howe. ‘It is therefore important that the bill does not create new bureaucratic burdens that could actually decrease innovation, acting against its expressed purpose.’
He said the bill as presented gives a role to multidisciplinary teams in overseeing innovation. ‘This is a solution that Sir Bruce Keogh, national medical director for NHS England, and I do not consider appropriate. Multidisciplinary team meetings involve busy clinical discussions that would struggle to focus on the evidence base for innovative treatments.’
Saatchi (pictured) told peers he plans to make the requested amendments before the bill goes to the House of Commons.
He said the proposed legislation appeared to have support from peers and stressed the bill achieves its aim of ‘safe and responsible innovation in a simple way’.
‘It moves the Bolam “responsible persons” test from after the event to before the event,’ said the advertising guru. ‘The result is that doctors are not obliged to speculate in advance about what might happen in a subsequent trial, and they can move forward with confidence, safe in the support of a responsible body of medical persons.’
Former lord chief justice Lord Woolf told the debate that it was ‘nonsense to suggest that the culture of litigation that now exists does not have a dampening effect on doctors’.
He said the threat of litigation ‘hangs over’ doctors and that while the Bolam test may protect them in court, that is ‘little comfort’ to doctors who face the threat of litigation in the meantime.
But medical and legal groups still insist the bill is not necessary and potentially dangerous to patients.
The Medical Defence Union, which indemnifies around half of UK doctors, said it had not seen any negligence claims relating to innovative treatments.
Dr Michael Devlin, head of professional standards, said: ‘We encourage doctors to innovate. They can do so without an increased threat of litigation, so long as they can show they acted in accordance with current legal and ethical principles governing clinical practice.
‘This includes making sure the patient understands what they want to do and why, and agrees.
‘We see no need for new legislation as the procedure for innovating is long established and straightforward. The danger with the bill is it could lead to confusion and delay which wouldn’t be in patients’ interest.’