Skip to content

Department of Health

Medical Innovation Bill: Will it encourage responsible innovation and help prevent what's irresponsible? Please give us your views


Question 9: Overall, do you agree the draft Bill should become law?

Please answer using one of the following options:

  1. Yes, as it stands
  2. Yes, with the changes I’ve outlined in my response to questions 3 to 5
  3. Yes, with the following changes (please list)
  4. No

Back to ‘Having an impact’

Your comment...

Only your name and your comment will be published, the other information you supply here will not be published. Required fields are marked* but it would be very helpful if you could provide the other information requested.

Please note that comments left here are public - you can also make a private submission.

Your email address will not be published. Name, email address and comment are required fields. Please note our moderation policy.

Are you responding as a

33 comments

  1. S Hart says:

    No; this bill should never have reached the consultation stage. It should not become law. The law in this area is robust and fair. Bolam, Bolitho, Simms and a slew of cases all tell us that an acceptable treatment, a responsible treatment, logical treatment, defensible decisions – are not negligent. This has been brought with a fundamental misunderstanding of the nuances of the law in this area, which I feel is troubling. I am also concerned by the ethical aspects of this process, as true consent is arguably an impossibility in such patient groups. It further would confuse and tie red tape around doctors. It removes RECs and associated robustness and safety/ethical analyses for proposed research. It would lead to considerably less innovative treatment (already permitted and approved by BMA, GMC, the law) and would lead to paradoxically significantly higher numbers of legal challenges

  2. Alex Williams says:

    No

    This appears to be an attempt to weaken the definition of negligence with no justification or evidence provided for doing so.

  3. Helen Heaton says:

    No – the draft bill should not become law for the following reasons:

    -it will place doctors under excess emotive pressure to prescribe things which may not be in the interests of the patient

    -‘innovative’ treatments which are unevidenced bring unacceptable risks of harm to the patient

    -aswell as the potential harm of unevidenced treatments, the doctors prescribing existing treatments will not know whether the two treatments have conflicting interactions

    -terminally ill patients and their families are additionally harmed by false hope and the doctor colluding in useless treatments – and avoiding the palliation which helps

    -the care of terminally ill patients is usually in a team (oncologist, nurses, GP, surgeon, radiologist etc) – if one decides to be ‘innovative’ and endorse unevidenced treatment this puts unreasonable pressure on the others who may rightly oppose it; the focus of care is thus fragmented with no clear aim and conflicting messages for the ill vulnerable patient.

    -the cost of unevidenced potentially harmful treatment, plus the cost of the time for the consultations to monitor and discuss it – will be born by the taxpayer – this is quite simply unreasonable at a time when the NHS is unprecedentedly short of funds.

  4. Ian Michaelwaite says:

    No

    It seems as if this bill is built on the basis of anecdotes, not actual need for change. Innovation already takes place, and Doctors are able to step outside of the normal if they are seen to be making a responsible decision. The bill, as worded, will instantly allow unproven, and probably disproven treatments, to be legitimised, wasting valuable opportunities to actually properly research and develop innovative treatments for hard to treat conditions.

    If I were unfortunate enough to be suffering from a hard to treat cancer and was offered the standard of care, with all the hardships that chemothrapy and radiotherapy create as necessary side effects – or a Dr suggested he could deliver the same or better results with reduced side effects using a therapy that the majority of oncologists have dismissed. How would this bill protect me from making the wrong decision if the Dr had the backing of a handful of like minded believers in the medical/ alternative medicine community. Paracticing GP homeopaths are a good example – the NHS says there is no evidence of effect beyond placebo yet homeopathic prescriptions and consultations still take place where proper medical care and/or counselling would be a better solution.

  5. Simon Hughes says:

    No. The bill gives free reign for rogue GPs to exploit patients who believe they are in a trusting and caring relationship with someone who only has their best interests at heart. It allows a GP to act with impunity, safe in the knowledge that ANY nefarious acts can be self-excused so they are immune from prosecution.

    It is unthinkable that in an age of advanced scientific understanding, we should go back to an era where the experimentation on unwary patients using crackpot ideas concocted by a single individual is promoted, yet alone that it carries legislative protection. Excusing yourself under the auspices of such activities being “medical innovation” is naive, disengenuous and at worse for those being experimented on, fatal.

  6. Andy Buckley says:

    No.

    There is currently no legal obstacle to responsible medical innovation. What this Bill proposes is to remove a very reasonable patient safeguard against treatments which would not be considered ethical by a responsible body of medical opinion (not necessarily a majority opinion).

    By removing this restriction, without instituting any kind of equivalent protection or right of redress against fraudulent practitioners, the rights of patients are greatly reduced, not enhanced. Any unscrupulous person with a nonsense theory of healing will be free to practice it without fear of redress: this is an irresponsible quack’s charter.

    A more responsible approach would require some indication of efficacy and medical plausibility to protect against such abuses. If the aim is to reduce red tape, then _limiting_ liability should be the approach rather than eliminating it in a free-for-all of rogue practice. It is implausible that lone practitioners without credible preliminary evidence will be responsible for breakthroughs in serious illness — and structures already exist for credible but novel approaches to be researched in a controlled and responsible manner.

    Patients with terminal illness (and their families) are in a terrible situation, and it is natural for them to grasp at the smallest straws of hope. But it is the responsibility of the law to ensure that such vulnerable people are not exploited: this Bill would undoubtedly open the floodgates for exploitation. Offering (indeed *selling*) false hope to the vulnerable should not be protected or encouraged in the name of “innovation”.

  7. Ash Choudry says:

    No, this Bill should not become law.

    i) The Medical Defence Union, who one would think would be most supportive of a Bill that purports to protect doctors from litigation commented that it : “sees no need for new legislation”

    ii) Doctors already have freedom to depart from medical guidelines (with the proviso that they are not negligent)

    iii) The Bill allows quacks to prey on the vulnerable without fear of litigation.

  8. Adam Gyulai-Lancaster says:

    No.

    I am not aware of any legal impediment to responsible innovation as the law stands. I have attended countless MDTs where decisions about treatments for relevant conditions, such as mesothelioma, have been made. Never once had this been an issue. All doctors that make such decisions are aware of Bolam as modified by Bolitho, and understand that they are not impeded from using innovative treatments.

    This is a pointless piece of legislation that may have the unintended consequence of putting patients’ lives at risk by encouraging non-evidence-based practice. It also erodes patients’ right of legal redress where negligence has occurred.

    It has garnered public support on the back of a manipulative campaign using techniques reminiscent of Orwellian newspeak. On the facebook page, people are asking “Would innovation have saved my relative’s life?”, as though ‘innovation’ is some kind of silver bullet, and not the potentially harmful, probable failure that such interventions normally are. I cannot see the value of petitioning the public on an issue as complex as this. The majority of those who have signed the petition have done so with the best of intentions, but with no understanding of how this bill will affect clinical decision making.

    The questions in the consultation are also seem to have a strong pro-bill bias.

    I sincerely hope the responses of doctors and lawyers will be considered carefully, as it is they who are the experts.

  9. Jason Perry says:

    No, whilst I think its heart is in the right place as it stands it’s full of loopholes.

    Two glaring omissions “Science based medicine” & “Biological plausibility”. These two phrases alone would get rid of most quacks.

    Also a list of CAM “treatments” should be added to the list as completely unacceptable. We know things like homeopathy don’t work, however there are real medically qualified doctors who administer it to patients. The bill as it stands would allow such a doctor with a panel of “knowledgeable” counter parts to use such a treatment.

  10. Joanne Scott-Fernandes says:

    Yes, I believe it should become law. As a parent of 4 year old boy suffering from Duchenne Muscular Dystrophy I strongly believe we need to fast track medical innovations. Hundreds of young boys with Duchennes are desperately in need of an innovative treatment and if we are not more open to the possibilities of new drugs in fatal genetic diseases we are failing a generation of sufferers. A treatment for Duchenne’s in close but still feels a lifetime away because of excessive bureaucracy. I believe this bill is a step in the right direction and will give doctor’s more freedom to do what they do best – save lives. I am not prepared to stand by while each day my son loses the ability to walk and gradually dies from the inside out, and I don’t believe a doctor should either.

  11. Julie Carlisle says:

    I cannot see how the interests of the public will be served by removing the current safeguards and potentially making it even harder for those affected by poor clinical decisions to be compensated for what are usually devastating results.

    People are not Guinea Pigs and the greater good can never be used to justify even one life ruined.

  12. Marcus Durand says:

    No. It gives a way out for bad practice and does nothing to promote innovation. Doctors are given too much responsibility and power. It may have the reverse effect to the intention.

  13. Emma Rayner says:

    Yes, as it stands. My sister died of a brain tumour leaving three small children. How can there be real progress in improving the life expectancy of people with rare cancers within a stationary or some would say stagnant system of standard procedure? Parliament should listen to, trust and act upon the advice of the highly experienced clinical specialists and supporters of this Bill like the inspirational Professor David Walker of The University of Nottingham’s Children’s Brain Tumour Research Centre.

  14. Rachel Atkinson says:

    Question 9: Overall, do you agree the draft Bill should become law?

    No

    Please, do not do this. This bill has been presented as potentially able to lead to new cancer treatments and such things will always lead to signatures of support. But I can see nothing in the bill that suggests it is anything other than a licence for doctors to experiment on human beings. Patients are not guinea pigs. What this bill proposes is monstrous. All the current law requires is that a doctor have “the support of a responsible body of medical opinion” before subjecting a patient to a new treatment with all its inherent potential risks. This bill proposes the law is changed such that “It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition…if the decision to do so is taken responsibly,”. Experimenting on human beings will be allowable if in “the doctor’s opinion that there are plausible reasons why the proposed treatment might be effective”. As others have commented, this is entirely subjective!

    Yes, if we allowed doctors to freely trial new treatments with only a personal viewpoint that in “the doctor’s opinion that there are plausible reasons why the proposed treatment might be effective” medicine might advance more quickly for the majority, but this would be at the expense of those who suffered ill effects from the experimental treatment. I cannot believe that such a bill is being considering in a Western Country in 2014.

    The bill also makes no distinction between experimentation on patients who are terminally ill and experimentation on patients who are not terminally ill and who may have to live for decades with the negative consequences of experimental treatment. These are surely completely different situations. Surely, if this horror is to be allowed, there should at least be a caveat that these new freer conditions should only apply in cases of terminally ill patients who will have little time left to suffer should things go wrong. I have to live my life in a large degree of discomfort and pain often akin to physical torture as the result of an elective operation for a non fatal condition. I was effectively a guinea pig in the use of this operation in that it had only ever been done by a couple of doctors in a small number of people and the results of the operation had never been published. They still have not been published to this day. I am horrified at a bill that will make it more likely that what happened to me will happen to others. It seems to me as though while drug use is tightly regulated (three phases of clinical trials before coming into use) surgery on the other hand is wildly unregulated already with little control on the introduction or audit of new techniques. Experimental drug use or surgery in patients with late stage cancer or who are otherwise near to death is obviously a different thing than experimentation in patients who are not at imminent risk of death. The bill makes no distinction between the two.

    Furthermore, the articles drawing this bill to public attention have been alarmingly inaccurate. In his Telegraph article on this bill Lord Saatchi said:

    “The pre-eminence in law of the standard procedure is a barrier to progress in curing cancer. Any deviation by a doctor is likely to result in a verdict of guilt for medical negligence”

    Ask medical negligence lawyers how often patients actually sue over experimental cancer treatment.

    Lord Saatchi also said in his Times article on the subject.

    “The screening techniques for such cancers are inadequate; no reliable early detection method is available. The treatment regimes, when belatedly provided, the drugs, the cycles of their administration and the surgical procedures, are 40 years old and also ineffective — cancer quickly develops “resistance”. “The process”, as it is called, involves scenes that would not be permitted in a Hollywood horror movie. Not surprisingly, the survival rate for such cancers is the same as it was 40 years ago, ie, nought; and the mortality rate is the same as it was 40 years ago, ie, 100 per cent”

    It was not specified in the article what “such” cancers were – what cancer has a 0% survival rate? Nor was it made clear in this prominent article on the subject that survival rates of most cancers have improved a lot over 40 years – the article did not specify what cancer had a “mortality rate is the same as it was 40 years ago”.
    No other western country permits the kind of licence to experiment on humans that this bill would allow.

  15. Kenneth Leigh says:

    I would support the Draft subject to confirmation that the following provision (or something very similar) was included:

    It should always be made clear to the patient or his/her ‘representatives’ i.e. those empowered via a Living Will or members of his/her close family, that the doctors/surgeons are proposing to utilise the freedom of action provided for in this Bill to try a ‘different’ form of treatment, giving the patient or his representatives the option to reject such a ‘novel’ form of treatment.

  16. David Rodrick says:

    It’s time something like this was enshrined in law.

  17. Irmgarde Horsley says:

    It is the only way forward and should lead to better medical practice with practicioners not being stuck with formulaicstandardapproaches with all patients, when some simply don’t work. This is opening clinical practice to observation and research and truly appropriate patient participation.

  18. Dr Darren Conway says:

    I note there are no sections that enable provision of comments on matters not directly related to the questions.

    I am particularly concerned about 2(1)(b) where-under ‘interpretation’ – it says “reference to treatment of a condition includes reference to its management”. This clause significantly widens the protection to a maverick doctor. Potentially ‘management’ could cover almost any aspect of a patient’s care. Essentially this would remove a patient’s right to sucessfully recieve compensation for clinical negligence for reasons that have nothing to do with medical innovation.

    As far as I can see there is no verifiable evidence to support the Bill in any form.

    I do not think this Bill should become law. It has not been thought through. I suspect the authors were thinking of an intelligent adult patient(with mental capacity) with a terminal condition, seeking to extend their life. However, the Bill proposes to apply to all doctors (in all specialities) in all situations. It would be a licence to maverick practice without recourse for an injured patient. That would not serve justice.

    The current system (whilst not perfect) has evolved over decades. The Bill seeks to provide an answer to a problem that doesn’t exist. It should not become law.

  19. Aneurin Moloney says:

    No.

    See previous comments.

    This Bill, if enacted would provide “It is not negligent for a doctor to depart from the existing range of accepted medical treatments ……..where the proposed medical treatment does not have the support of a responsible body of medical opinion……..provided the decision is taken responsibly.”

    ‘Responsible’ is assessed entirely subjectively and there will be no civil liability if in the Doctor’s belief there are merely plausible reasons why the treatment may be effective. This is not an adequate safeguard.

    The current law is adequate in that a Doctor will escape civil liability if their actions are endorsed by a responsible body of medical opinion, even if that body is in the minority (as low as 5%).

    The current law also provides that a simple mistake or error will not necessarily be negligent. Negligence is so far beyond an ordinary mistake that no reasonable doctor would have acted in that way.

    Innovation is to be encouraged, but not at the expense of putting additional lives at risk.

  20. Helen Neville says:

    No. this Bill should not become law. The current law is fine as it is & is doctor friendly enough to allow medical advancements. This proposed bill will not have a positive impact on medical innovation. Instead it will go too far and won’t protect patients and will remove redress to patients who are harmed by negligent doctors whose actions no responsible body of medical opinion would support.

  21. Professor Ahmed Ashour Ahmed says:

    Yes, I agree with it as it stands. I fully support it and I strongly believe that it will have a significant positive impact on encouraging responsible innovation.

  22. John O'Sullivan says:

    Please, please help to enact this bill into law. We must trust human ingenuity to release the innovation and improvement that will overcome so many unmet needs. The current treatment options for inoperable brain tumours are limited to traditional chemotherapy and/or radiotherapy and do not offer anything other than a limited extension in the amount of “time before dying”. Our researchers and innovators will do better, if we let them!

  23. Christine Hill says:

    I think we should be able to try out new treatments particularly in cancer care, when traditional treatments are, or will fail.

  24. Colin Aylin says:

    This at least gives hope to patients. They would not want to feel that everyone has given up on them.

  25. Dr. Cook says:

    NO

    You seem to feel the ‘plebs’ can be duped into acting as guinea pigs for pharmaceutical companies.

    As usual, the nebulosity of the phrases you use in legislation is duplicitous Mr. Hunt.

    Patients need to be protected. As things stand, on your own figures, 1 in 6 patients are mis-diagnosed by NHS practitioners, one would thus be seeking to reduce their powers, rather than placing them in an unassailable position when they kill or harm,by raising the threshold for a Negligence case, whilst simultaneously removing Legal Aid funding for claimants.

  26. Mr. D. J. Evans says:

    Yes, as it stands.
    Patients are not the only sufferers. Anything that can bring hope where there is none must be supported and encouraged at all costs.

  27. Sarah Wilson says:

    Anything which helps doctors innovate and find new treatments which could help people suffering from terrible diseases is a good thing, in my book.

  28. Alan Moss says:

    I have met and talked with many patients who have been diagnosed with cancer, for some of whom curative treatment was not possible, or offered. I have also known some people whose gratitude for their survival has been enhanced because of the attitude of a minority of experienced surgeons who have operated on them, and succeeded, against the odds and the general run of decisions made by their surgical colleagues. So there are many patients suffering from cancer and other serious illnesses who would welcome the opportunity to be treated by innovative and responsible methods: they would welcome the chance of survival when the prospects otherwise are terminal. Not all of them would opt for such innovative treatments, but a significant number probably would.

    A good number of patients now survive because of innovative advances made in the past which are denied to future generations.

    When patients are told “There is nothing that the doctors can do for me” it may sometimes be more accurate for them to say “There is nothing that the present system will allow the doctors to do for me”
    The Bill would change that situation.

  29. Nigel Poole says:

    No, this Bill should not become law. It is unnecessary, it will not have a positive impact on medical innovation and it will remove a reasonable right of redress to patients who are harmed by negligent doctors whose actions no responsible body of medical opinion would support.

  30. Michael Lytinas says:

    I agree the draft Bill to become law, as is.

    In addition, to conquer cancer we need a smarter way of dealing with this illness, not the usual blocking, inhibiting and killing drug combination. Innovation should start from the proper definition of cancer and then go to the therapeutics of it. Here is what I suggest: http://www.lytinas.com

    Thank you

  31. Stephen Lodge says:

    I’d be happy for the bill as it stands, and after being in pain for two and a half years hereby volunteer for any future experimental treatments that remove that pain.

    • Lucy Sherry says:

      No, it shouldn’t become law. Radical attempted solutions would be permitted if it is the doctor’s genuine belief that there is at least a minimal chance of the treatment having some positive effect – maverick doctors would be given carte blanche unregulated powers. There is a real danger of the principle of ‘Informed Consent’ being eroded, removing the patient’s wishes over their own treatment from the decision making process altogether. Currently innovation is control tested and approved by the applicable International and National Committees, stopping patients getting used as ‘guinea pigs’ which is not how innovation should be brought about; for better or more worryingly, for worse.