The Medical Innovation Bill: Is the fear of being sued really ruining modern medicine?
This week, Apple a Day explores how innovative the healthcare profession can really be in such a heavily regulated environment
Medical innovation is something we continually strive for, and advances in research and technology are improving diagnosis and treatments for diseases on a daily basis. But is it possible to be truly ‘innovative’ in such a heavily regulated environment? Are we being hindered by legal and regulatory policies that are impeding medical progress and our ability to be creative with modern medicine?
The Medical Innovation Bill, or ‘Saatchi bill’ as it has become known, believes that patients with advanced cancer and other terminal diseases are not receiving the most innovative treatments because doctors are afraid of the legal consequences. The Bill aims to address this by calling for a change in the law in the UK to allow doctors, with consent, to treat terminally ill patients with new innovative treatments that are not necessarily the approved standard of care. On 25 January 2015 the Bill was passed by the House of Lords and has now moved to the House of Commons where it will be debated for the second time on 27 February.
The Bill was realised by Lord Maurice Saatchi, following the death of his wife Josephine Hart to ovarian cancer. Lord Saatchi, so surprised at the lack of available treatments for his wife’s advanced cancer, has been determined to push the Bill through parliament ever since her death, to allow more experimental treatment of terminal diseases.
From its inception, the Bill has sparked a fierce debate over ‘responsible innovation’ with those against it fearing it will encourage doctors to experiment with unlicensed treatments causing unnecessary harm to patients. There is also concern that vulnerable patients with terminally ill diseases will be given false hope that there may be a treatment out there to cure them. Some critics argue that the Bill is not necessary and medical innovation is happening on a daily basis, with doctors by no means living in fear of being sued.
However, the bill has received an unprecedented amount of support from doctors, lawyers, politicians and patients. Doctors will be required to consult with a multi-disciplinary team of senior medical experts before trying any new treatments on consenting patients, and it will be mandatory for anybody using the Bill to register the treatment and the outcome, both positive and negative.
Patient organisations are also keen to stress the importance of patient consent. Doctors must communicate the risks and benefits of any new treatments to their patients and families in order for them to make informed decisions.
It goes without saying that for diseases where there are clear evidence-based treatment options that will improve patient outcomes these are the best choices for care. However for many diseases such as advanced cancer and life-limiting rare diseases there are little or no treatment options and perhaps the Bill can help provide access to possibilities that these patients would otherwise be without.