The Medical Innovation Bill, which would allow doctors to try unapproved treatments for patients where other options have been exhausted, has received backing from the Department of Health with the
The Medical Innovation Bill, which would allow doctors to try unapproved treatments for patients where other options have been exhausted, has received backing from the Department of Health with the addition of further safeguards.
The Bill will prevent negligence claims against doctors who "depart from the existing range of accepted treatments for a condition", provided that this is done as part of a transparent procedure. The procedure would involve consultation with specialists, consideration or the relative risks and benefits of treatments options, the patient's opinions and any other reasonably necessary factors.
While Lord Saatchi originally introduced it as a Private Member's Bill, it will now receive the support of the Department of Health after amendments were made by Committee in the House of Lords on 24 October. The amendments provide that any doctor providing treatment under the Bill will need to "take full account of the views" of at least one other specialist in the field before going ahead (rather than just consulting with them, as was the case in the earlier draft of the Bill). The Bill also makes very clear that it may not be used for research purposes or any other treatment that is not in the best interests of the patient. The amendments will next be considered by the entire House of Lords on a date to be fixed.
Use of unapproved drugs and 'fast-tracking' human testing has hit the headlines recently when experimental Ebola cures, such as Z-Map, were used much earlier in the testing process than normally permitted. While there is some support for innovation and the use of experimental drugs, there are also concerns that it may be unethical to use such treatments for terminally ill people, or that patients may not be able to give informed consent to experimental treatment if the risks are not fully understood.
Professional regulation is not discussed in the current draft of the Bill, and should it become law regulators may wish to provide their own guidance on treatment provided under the Bill. Even without further guidance from regulators, doctors acting under the Bill would still be accountable for any treatment decisions they made and would still need to abide by the principles of relevant guidance including, among others, Good Medical Practice.
The Bill will prevent negligence claims against doctors who "depart from the existing range of accepted treatments for a condition", provided that this is done as part of a transparent procedure. The procedure would involve consultation with specialists, consideration or the relative risks and benefits of treatments options, the patient's opinions and any other reasonably necessary factors.
While Lord Saatchi originally introduced it as a Private Member's Bill, it will now receive the support of the Department of Health after amendments were made by Committee in the House of Lords on 24 October. The amendments provide that any doctor providing treatment under the Bill will need to "take full account of the views" of at least one other specialist in the field before going ahead (rather than just consulting with them, as was the case in the earlier draft of the Bill). The Bill also makes very clear that it may not be used for research purposes or any other treatment that is not in the best interests of the patient. The amendments will next be considered by the entire House of Lords on a date to be fixed.
Use of unapproved drugs and 'fast-tracking' human testing has hit the headlines recently when experimental Ebola cures, such as Z-Map, were used much earlier in the testing process than normally permitted. While there is some support for innovation and the use of experimental drugs, there are also concerns that it may be unethical to use such treatments for terminally ill people, or that patients may not be able to give informed consent to experimental treatment if the risks are not fully understood.
Professional regulation is not discussed in the current draft of the Bill, and should it become law regulators may wish to provide their own guidance on treatment provided under the Bill. Even without further guidance from regulators, doctors acting under the Bill would still be accountable for any treatment decisions they made and would still need to abide by the principles of relevant guidance including, among others, Good Medical Practice.