Not quite quackery

The Medical Innovation Bill, drafted and promoted by the former advertising magnate and Conservative peer, Maurice Saatchi, has passed the House of Lords legislation committee stage, and may be on the statute books as early as May 2015. If it becomes law, the Bill has the potential
to transform the medico-legal landscape in ways that are difficult to foresee.

The progress of the Bill has itself proved controversial. True to his skill-set, Lord Saatchi has marketed his proposal with artistry. There is a well-presented website with a rolling petition box. The @SaatchiBill Twitter account is a polished, well-managed outlet; its antagonist, @StopSaatchiBill, has only a tenth of the following. The news coverage has been comprehensive.

Inspired by the death of his wife, Josephine Hart, from ovarian cancer in 2011, Saatchi's Bill is loaded with emotive force. It proposes to allow clinicians to trial novel treatments on patients, bypassing many of the usual safeguards of clinical testing and the keystone clinical negligence test set out in the case of Bolam, whereby a treatment must be supported by a "responsible body of medical opinion". For many of those suffering from chronic or terminal illness, the Bill is seen as a pioneer's charter.

To many lawyers and medical professionals, including the British Medical Association, the Bill holds the potential to be a volatile challenge to patient safety. There are fears that, if clinicians are shielded from negligence claims, innovation may spill over into irresponsible risk taking and, in the words of some doctors and journalists, quackery. There are also fears that pharmaceutical companies, perhaps motivated as much by profit as patient safety, may place less emphasis on clinical trials in their haste to provide desperate patients with novel drugs.

Nigel Poole QC has called the bill "well-intentioned but fundamentally flawed", and added that the existing legal framework already allows for medical innovation. The Bolam test will only prohibit a treatment if no responsible body of medical opinion will support it - the opinion does not have to be universally or even widely accepted, and case law has drawn sophisticated boundaries around what the courts will accept as the minimum standard of care.

The contention that a Medical Innovation Act will generate work for lawyers remains to be seen; the idea behind the legislation is, of course, to reduce litigation. If the law does bring clarity and gives doctors enhanced protection, given the post-Jackson landscape, fewer lawyers would be willing to take on a case against a doctor. If the Saatchi Bill throws open the gates to a world of new medical possibilities, this may also stoke the debate over assisted dying and other areas where doctors need certainty as to their legal position.

Similarly, contentious issues arise in so-called 'medical tourism', particularly in what experts term 'circumvention tourism' - desperate patients travelling abroad, seeking treatments that may be illegal or unregulated in their home country. Doctors criticising the Saatchi Bill have cited circumvention tourism as a model that endangers patients. In addition, the failure of untested or poorly regulated treatment, whether abroad or domestically, inevitably leads to a greater burden on the NHS in terms of revision treatment.

In the end, the greatest anxiety relates to the absolute basis of clinical negligence law, which is, and must always be, patient safety. Litigation
may be a blunt instrument to use as
a check on the medical profession,
but the reality is that the threat of legal claims does promote better practice, whether prospectively or in reaction to failures exposed during the claims process. Diluting the negligence test would, at least until the body of case law inevitably builds up around the new Act, remove the certainty that patients harmed by negligent treatment will be able to recover damages in compensation for their injuries. From the perspective of clinicians, the definition of safe practice, as expressed in the Bolam test, may also change dramatically.

Confusion seems a likely outcome on both sides of the medico-legal fence but, whatever happens, safe treatment remains key. While medical innovation has to be promoted, we hope that any new legislation does not do away with the safeguards that patients have come to rely on. Clearly, in the interests of both the patient and the doctor anxious to do the best for his patient, there is a great deal more that needs to be done before this Bill can become law.

Laurence is a partner at Michelmores