The Access to Medical Treatments (Innovation) Act 2016 has reached the statute books, albeit with little fanfare. The Act is based on the private member’s bill famously brought before parliament by Lord Saatchi, the Medical Innovation Bill.
Following the tragic death of Lord Saatchi’s wife from ovarian cancer in 2011 and a two-year campaign, it was only after a surprise veto by the Liberal Democrats that the Bill was defeated.
Lord Saatchi's Bill, in its original form, sought to promote medical innovation by relaxing the law on clinical negligence. It would have afforded doctors protection from being sued for negligence in circumstances where an innovative treatment is given outside the existing rules, so long as the doctor felt on consideration of relevant factors that there were
“plausible reasons why the proposed treatment might be effective”.
Although clearly well-intentioned, the Bill was widely criticised by those in the medical profession and elsewhere for introducing an unacceptable level of risk.
Critics pointed out that the existing legal framework for establishing whether a doctor has been negligent already allows for innovative treatment but with appropriate safeguards. The 1957 Bolam decision established that a medical professional is not negligent if they act in accordance with a practice accepted by a responsible body of medical opinion. And in 1997 Bolitho narrowed this by requiring that a course of action, even if supported by a responsible body of medical opinion, must be capable of withstanding logical analysis.
But proponents of the Bill continued to push for its adoption, leading eventually to the pared-down version that has now passed into law.
The Act shares little with the original Bill and does not change the law on clinical negligence. What it does instead is pave the way for the establishment of a database to encourage information sharing in relation to innovative treatments in England. The database would be maintained by the Health and Social Care Information Centre. It would be searchable by doctors and could include unlicensed medicines and those used off-label. The scheme is expressly not intended to affect the regulation of medical research.
The details are to follow under regulations, and so it is not yet clear what the planned database would look like or how access would be controlled. But it is clear that the far-reaching measures originally proposed are now consigned to history.