What makes for bad legislation? Sometimes it is a lack of scrutiny from a weak opposition and bored backbenchers. Sometimes it’s an attempt by ministers to make a political point and to hell with any real life damage. And sometimes it’s wishful thinking: an assumption that because a bill has identified an awful problem, it is automatically also presenting the perfect solution.
Lord Saatchi’s Medical Innovation Bill is heading back to Parliament again, after the Lib Dems managed to block it in the last session. Saatchi was naturally furious that Nick Clegg’s party had refused to sign off on his legislation, and now that the Lib Dems are out of government, he’s trying again.
Saatchi drew up this legislation after the death of his wife, Josephine Hart, from ovarian cancer. His Bill is undoubtedly born from grief and a desire to do something to stop very sick people dying if there is something that can be done to save them. But a bill born from grief is not automatically a good bill. Neither is a bill introduced by someone who has great power and commands great respect from those in government. A grieving person can be wrong, as can a powerful person.
The Medical Innovation Bill proposes to allow doctors to treat patients dying from any illness with ‘innovative’ treatments, and then record their outcomes, both positive and negative, in an open access Medical Innovation Register. It aims to address a fear on the part of doctors that they should not resort to innovative treatments because a patient may sue them. Saatchi argues that because so few cancer patients, for instance, are involved in clinical trials, innovative treatments should be open to all who want to give their consent.
But clinicians and researchers are desperately worried that far from offering hope to cancer patients, the legislation will in fact harm them. They also argue that there is no evidence to back up the central claim that doctors are frightened away from innovative medicine by the threat of litigation. The Lancet produced a stunningly angry editorial which said the legislation would undermine the Hippocratic Oath. The oncologist who treated Hart signed a letter opposing the Bill.
There is a fear that as well as treatments that are marketed as innovative but are in fact downright dangerous harming patients unnecessarily, the legislation will further narrow the recruitment field for clinical trials. If you have relapsed Acute Myeloid Leukaemia and have a very poor chance of still being alive after five years, you may be offered a place on a clinical trial where you could be in the control group, or you could be receiving the new medicine. You may also hear about an innovative treatment that sounds rather jazzier than a clinical trial. If you’re desperate for a chance to live longer than five years, one offer may appear rather more attractive than the other.
Dr Sarah Wollaston, the Tory GP turned MP standing for re-election as chair of the Health Select Committee says:
‘This should be renamed the Medical Anecdote Bill because what it’s going to be doing is allowing a series of unconnected anecdotal treatments alongside the removal of protection for patients. It’s worth remembering that some of the most dangerous treatments we have seen went under the radar because they were not part of clinical trials. I think this needs pre-legislative scrutiny as a starting point. I am in favour of a medical innovation bill but this will not deliver it.’
To be fair to the Lib Dems, this is probably one of the few things they blocked where they were right, and where their absence from government will be to the detriment of policymaking. Labour has previously been sympathetic to the bill, and a party source tells me that ‘we’ll need to consider it when we see it - but it will depend on whether there are sufficient safeguards in place with regard to efficacy and safety, and the Bill must not reduce patients’ opportunities for taking part in established clinical research’.
At the same time, the government has embarked on some work that should negate the perceived need for the Saatchi Bill. It has launched a review to look at ways of making it quicker for patients to get access to innovative treatments, such as changing the structure of clinical trials without damaging patient safety. The Accelerated Access Review will publish an interim report later this summer and will finish at the end of 2015. If the problem is that clinical trials are being gummed up by bureaucracy, rather than that doctors are frightened of litigation, then the AAR could mean that treatments that actually keep people alive for longer and even cure them are developed safely.
Even with these improvements, a key point worth remembering is that above speed, the most important thing is that doctors can answer clear clinical questions about a treatment so that they know what it does and doesn’t do and whether it will improve a patient’s condition, rather than whether it might. Otherwise a bill born from wishful thinking could lead to treatments introduced through wishful thinking, which are no more or less haphazard in their application than wishes themselves.