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Department of Health

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


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?

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6 comments

  1. S Hart says:

    This bill is legally unnecessary. There is clear contravention of the European Clinical Trial Directive and misconception of distinctions between treatment and research. There is ample case law on this alongside statements from, eg, World Medical Association. This is dressing up research as treatment of the individual, and is highly inappropriate.

  2. Simon Hughes says:

    Unfortunately, “all relevant matters” again puts the onus on the doctor, and only on the doctor, to decide what is and what is not relevant. There is absolutely NO provision for ensuring that what’s ‘relevant’ has any basis on established science or known efficacies. If a doctor decides that prayer is a substitute for treatment, they considering it is ‘relevant’ to do so based on their own beliefs would satisfy this requirement, an absolutely ludicrous situation.

  3. Richard Borrett says:

    See comments on previous question.

  4. Dr Darren Conway says:

    1(6)refers to ‘accountable and transparent’. What does this mean? to whom is it aimed?
    My main concern is that the currently drafted Bill seeks to provide considerable protection to the doctor with NO counter-balancing protection to the patient (vulnerable or otherwise).
    I suggest that there ought to be an additional claus within which is a mandatory requirement for the doctor to complete an approved consent form which sets out their proposed rationale. It must also be signed by the doctor, their Resposible Officer and the patient (their carer). The approved consent form ought to be typed to avoid interpretaion errors.
    1(7)(a) the explanation must be viewed objectively and not the doctors own subjective view of the explanation.

  5. Professor Ahmed Ashour Ahmed says:

    It is unquestionable, that responsible clinical research is absolutely required for the implementation of novel treatment strategies. The Bill addresses this explicitly and makes it clear that it does not support experimentation or unethical implementation of new treatments. Instead, it seeks to support doctors who endeavor to achieve the best interest of their patients. By providing an explicit legislation, The Bill encourages existing best practice of doctors who undertake appropriate management discussions with peers at multidisciplinary meetings and with patients and their advocates. As a cancer specialist a busy cancer multidisciplinary team in Oxford, I can see how this Bill could support other practicing cancer specialists in their day-to-day patient management. At a personal level having been the relative of several cancer victims, I completely understand how this bill could support a much-needed attitude change to cancer patients.

  6. Nigel Poole says:

    I would repeat my comments in response to the previous question.