The Medical Innovation Bill (the "Bill") is making its way through the UK Parliament's legislative process. The intention of the Bill is to encourage the use by doctors of innovative treatments without fear of litigation. The Bill has provoked much controversy and divided opinion in the medical community, although it has recently received tentative backing from the General Medical Council. Its scope does not, however, extend to those companies who produce or supply medical devices and should the Bill be adopted in its current form this could lead to an imbalance in future litigation and medical development.
Lord Saatchi proposed the Bill following the death of his wife from ovarian cancer. The Bill is principally aimed at protecting innovative treatment of relatively rare terminal cancers/other terminal conditions. However, the scope of the Bill has not been so restricted (other than to exclude cosmetic surgery). It can be reasonably expected that those treating patients in less extreme circumstances will seek this proposed statutory protection, but whether and to what extent the Courts will be willing to entertain such arguments is impossible to predict.
The Bill aims to allow doctors to use innovative treatments on patients without fear of being the subject of a negligence claim. In order to benefit from this statutory protection, which will sit alongside the common law Bolam test, doctors will need to obtain the further views of one or more appropriately qualified doctors in relation to the proposed treatment, consider those views in the context of the risks and benefits associated with the proposed treatment and also obtain the patient's informed consent.
Why this Bill is relevant
Many product liability claims in the context of the medical devices industry also involve claims of medical negligence against doctors/NHS hospital trusts. Additional protection provided to doctors by virtue of the Bill, especially in more complex areas of specialism where treatment options attract controversy, may have the effect of diverting claimants' attention towards pharmaceutical and medical device manufacturers and suppliers who will not benefit from the statutory protection offered by the Bill.
In addition, given the complexity of the cases potentially falling within the scope of the Bill, any analysis of whether a doctor's decision was responsible will inevitably involve highly technical and specialist medical issues in circumstances where the disease itself may not be sufficiently understood. There may also be a risk that the treatment in question may not be within the product's indication(s).
Continued spotlight on informed consent
The question of informed consent is typically a contentious one in litigation involving medical care and the proposed Bill does little to deflect this focus. However, one recent amendment to the Bill requires that the details of the doctor's discussions in relation to the proposed treatment must be recorded in the patient's notes. It is hoped that this requirement is more than merely administrative and will encourage doctors to give more detailed information to patients when discussing the risk/benefit profile of proposed treatment options. Notwithstanding this, consent is likely to remain a focal point of litigation involving any aspect of medical negligence. For the reasons outlined above, it is also questionable whether pharmaceutical and medical device manufacturers should be consulted too in specific cases.
Under the current proposal, a doctor could benefit from the statutory protection in respect of a medical negligence claim by a patient, whereas in the same case the pharmaceutical or medical device manufacturer or supplier will not have such a defence to, for example, a claim under the Consumer Protection Act 1987. Whilst the encouragement of innovative treatment in a sensible and responsible way is something to be applauded, the potential exposure of product manufacturers or suppliers does not appear to have been sufficiently considered as part of the current debate. Without the investment of such companies into their research and development programmes, doctors may not have access to the necessary innovative treatments that this Bill would seek to protect.
We will continue to follow the development of the Bill with interest.
A copy of the draft Bill can be found here.