Medical innovation does not require a new law.

Abstract

In the last months of the UK coalition government, the Liberal Democrats (www.libdems.org.uk) vetoed Lord Saatchi's proposed law after it had successfully had a third reading in the House of Lords and was set to go to the Commons. The Liberal Democrat Health Minister Norman Lamb said that in preventing the proposed legislation he wanted to avoid the threat that the new law might pose to patient safety. Lord Saatchi's Bill now reappears in this new parliament as the Access to Medical Treatments (Innovation) Bill, and is sponsored by a Conservative Member of Parliament. Supported by No. 10 Downing Street (www.gov.uk/government/organisations/prime-ministers-office-10-downing-street), the Bill may well become law. Many lawyers oppose the Bill in its current form. The Medical Defence Union, Action against Medical Accidents, and Association of Personal Injury Lawyers have come out against the Bill. The most crucial reason for this opposition is the erroneous idea (promulgated in ‘Are rigid management protocols stifling innovation in cancer treatment?’) that fear of litigation is preventing innovation in cancer care, by promoting ‘defensive medicine’. This idea, that scientific progress has, as Lord Saatchi claims, been ‘stopped by the law’ is wrong and illustrates a misunderstanding of the basic elements of clinical negligence law. Doctors are already given protection by the law when they innovate, as long as the treatment proposed is agreed by colleagues, is as safe as possible, and the newness of the treatment (and for example lack of knowledge of complications or follow-up data) is fully understood by the patient. Those who promote the Bill appear to be unaware that the Bolam test is satisfied even if only a very small body of reasonable medical opinion supports the treatment given and the management of the patient stands up to logical scrutiny as being rational and justifiable (the ‘Bolitho test’). The recent UK Supreme Court case of Montgomery (which deals with informed consent) is a good illustration of how the law is able to react flexibly and pragmatically to changes in the doctor–patient relationship that have occurred in recent years. The Bolam test would not prevent doctors from departing from standard practice in appropriate and justifiable circumstances. There are other legitimate concerns about the Bill, for example that it does not give patients the right to new treatment and that it may promote irresponsible innovation on vulnerable patients where their right to redress in the civil courts is expressly removed by the legislation. Experimentation without professional accountability does not empower or give a patient ‘clarity and certainty’. In his condemnation of the Bill, Sir Robert Francis QC stated that the barrier to innovative treatment is not the law of negligence but ‘overzealous bureaucracy, scarcity of resources, ethical reservations and decision making processes’ (Response of Robert Francis QC to Legislation to encourage medical innovation – A consultation). Research charities have become successful in raising money and patient awareness. Advances could easily be made by a better utilisation of knowledge, by freeing clinicians from strict management protocols, or by looking at the option of prescribing novel drug treatments outside clinical trials by different licensing arrangements. None of these depend on the Medical Innovation Bill becoming law. None declared. Completed disclosure of interests form available to view online as supporting information. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.