In his damning report on the Medical Innovation Bill, Sir Robert Francis QC, with the support of Professor Sir Ian Kennedy QC, concludes:
This Bill is, like its two or three predecessors, based on the fundamental misapprehension that the law of negligence inhibits genuine and responsible innovative treatment.
Not only that, but for all its good intentions, it is actually dangerous for patients because it proposes “safeguards” which are illusory and which may give free rein to mavericks peddling dangerous remedies to vulnerable and desperate people.
His full report can be read here and we reproduce it with his permission.
- The law of negligence does not prevent responsible innovation and never has.
- The Bill is not successfully limited in its effect to the sort of treatment Lord Saatchi has in mind and it abolishes the well established and understood principles of negligence in the clinical field across a very wide range of cases
- The safeguards which are proposed in substitution for this are in reality no safeguards at all, but bureaucratic hoops to be jumped through. Further some have no relevance in individual cases. Patients’ safety and their rights to redress for injury caused by unacceptable and irresponsible practice should not be compromised so comprehensively to address a problem which is at worst a misunderstanding which could be cured by clear guidance.
- The Bill does nothing to address what may well be the real obstacles to some forms of innovation such as overzealous bureaucracy, scarcity of resources, ethical reservations and decision-‐making processes. The issues Lord Saatchi has so understandably raised need to be subjected to an evidence based review to identify the obstacles, and solutions to them, in order to produce guidance which could in itself answer any supposed difficulties arising out of the law of negligence.
- This is now the fourth attempt to present acceptable legislation, once previously by Lord Saatchi, one in the Commons and a draft Bill on which the Department of Health has issued a consultation paper and the outcome of which has not yet been made public. The evidence relied on by Lord Saatchi, in so far as it is quoted in his published briefing note, does not provide the convincing support claimed. The difficulties that have caused so many drafts to be produced suggest that if there is to be legislation a more considered and less rushed approach is called for if we are to be satisfied that the patients who are intended to be benefit from this Bill, and patients generally, are not exposed to increased danger and risk.