The public consultation on the Medical Innovation Bill (‘Saatchi Bill’) closed on Friday 25th April. The Good Thinking Society submitted the following response:
Question 1: Do you have experience or evidence to suggest that the possibility of litigation sometimes deters doctors from innovation?
Under current laws, it would not be negligent of a doctor to depart from standard treatment.
Commenting on the launch of a consultation, the Medical Defence Union, which helps 50% of UK doctors with complaints and claims, said it sees no need for new legislation.
Cancer Research UK have also commented publicly on the consultation, pointing out that there are many things already in place in the UK to encourage innovation. Early stage clinical trials allow patients to be recruited to test new treatments. There are also flexible mechanisms in place that enable doctors to get access to treatments that aren’t widely available on the NHS.
While more could perhaps be done to get new drugs to patients faster and to remove barriers to innovation, it is not felt that the possibility of litigation is a barrier.
Question 2: Do you have experience or evidence to suggest that there is currently a lack of clarity and certainty about the circumstances in which a doctor can safely innovate without fear of litigation?
No. Current law allows innovative treatment providing a responsible body of fellow practitioners would support it if it came to court (Bolam test) and if the opinion is capable of withstanding logical analysis by the courts (Bolitho).
If there is any lack of clarity then that problem ought to be addressed. The Medical Innovation Bill would not clarify current law but would effectively remove the requirement for a doctor’s decision to be supported by a responsible body of fellow practitioners.
Question 3: Do you agree with the circumstances in which the Bill applies, as outlined in clause 1(3)? If not, please identify any changes you suggest, and give your reasons for them.
The Bill would apply if, in the doctor’s opinion, the treatment would not have the support of a responsible body of medical opinion or if it is unclear whether the treatment would have that support.
The circumstances in which the Bill would apply could be harmful to patients.
In allowing a doctor to use treatments which would fail the Bolam test, the Bill removes a safeguard protecting vulnerable patients against individual doctors providing unproven treatments. It would allow a single doctor to use untested, unproven or disproven treatments, even in the knowledge that they would not have the support of other doctors.
In the UK, there are a number of clinics providing alternative unproven cancer treatments. Despite a lack of evidence and a lack of support of other doctors, patients may be convinced by an individual doctor at such a clinic that an unproven alternative treatment could cure them of their cancer. Patients may even decide to use such an alternative in place of effective treatment.
The Bill could protect doctors who provide such unproven alternatives against the threat of litigation, but it does nothing to protect vulnerable patients.
Question 4: Do you have any comments on the matters listed in clause 1(4)-(5) on which the doctor’s decision must be based for it to be responsible? Are there any that should be removed, or changed, or added, and if so why? For example, should the Bill explicitly indicate that the other treatments mentioned in 1(5) (a)-(c) include treatments offered as part of research studies?
If the doctor were in a position to reach a responsible decision then this decision would have the support of a responsible body of medical opinion and therefore the Bill would not apply.
If the treatment is untested then there is a lack of information available to assess the matters listed in clause 1 (4)-(5). A doctor would not be able to responsibly judge what the relative risks would be or could reasonably be expected to be. The doctor would not be able to judge what the likely success rates of the proposed treatment would be or what the consequences of carrying out the proposed treatment would be.
If the doctor proposing a controversial treatment chooses which opinions to take into account, there is a risk that the doctor could choose to take into account the opinions which support their own decision, and to ignore the ones that do not.
Question 5: Do you have any comments on the process set out in clause 1(6)-(7)? Are there any provisions that should be removed, changed or added – and if so, why?
Patients must understand that the proposed treatment is controversial (ie it would not have the support of other doctors) and that it is unproven.
There is a risk that a patient for whom the prognosis is bleak may be vulnerable to the false hope offered by unproven alternative treatments. If a “lone maverick” doctor was providing a controversial alternative treatment at a private clinic, supported by their own multi-disciplinary team, the Bill could effectively remove the safeguard currently provided by Bolam and Bolitho, leaving patients open to exploitation by those selling unproven treatments.
Question 6: If the draft Bill becomes law, do you have any views on the best way to communicate its existence to doctors?
Question 7: To reinforce the Bill, are there other things that need to happen to encourage responsible innovation?
The Bill would not encourage responsible innovation. In providing an alternative to the clinical trials process, it could even act as a barrier to innovation. Patients could be treated with unproven interventions but as individuals, outside of a clinical trial. This would make it difficult or even impossible to interpret results and to assess whether the intervention had been effective.
Responsible innovation could be encouraged by addressing bureaucratic problems which could have damaged UK researchers’ ability to run clinical trials and by encouraging greater transparency in the clinical trials process.
Adaptive licensing could also offer patients promising treatments at an earlier stage in development, before every phase of the clinical trial is complete.
Question 8: Do you have any comments and suggestions for inclusion in the draft impact assessment and equality analysis?
Question 9: Overall, should the draft Bill become law?
No. Since it is not felt that innovation is being held back by fear of litigation, there is no requirement for such a Bill. Furthermore, the Bill would remove the important safeguards provided by Bolam and Bolitho and could therefore be harmful to patients.