They reiterate the remarks of many doctors responding, both that innovative practice is inherent in medicine, and that innovation is not impeded by guidance or litigation.
‘Medicine is a risky business. There are many people alive today due to the willingness of doctors to innovate, deal with uncertainty and take reasonable risks which are understood by, shared with, and consented to by, the patient.’
Importantly they state the following: ‘legislation may unintentionally weaken the principles ..fundamental to safe, effective patient care; legislation is both unnecessary and undesirable.’
‘We are however concerned that legislation which aims to clarify and encourage good practice in terms of when medical innovation is responsible could have the opposite effect as well as unintentionally weaken the principles which we regard as fundamental to safe, effective patient care. We take the view, therefore, that legislation is both unnecessary and undesirable.’
They note that legislation as proposed would breach core GMC guidance. Good Medical Practice states that doctors
‘must be satisfied that the drugs or treatment serve the patient’s needs’ and must ‘provide effective treatments based on the best available evidence’.
Noting the particular difficulties of innovative treatments, varying capacity and gaps in evidence the GMC reiterate that their guidance on Consent ‘already recognises and allows for innovation’, with important steps for optimally informing the patient in the difficult setting of additional risk or less evidence the GMC emphasise that ‘our guidance certainly does not discourage innovation.’ ‘Doctors who make decisions based on the principles in our guidance will be able to justify their decisions and actions if we receive a complaint about their practice.’
Noting a number of fundamental examples, the GMC state that ‘a lack of clarity in legislation of this kind can only serve to undermine any safeguards aimed at deterring dangerous practice or reducing the risk of exploitation.’
They also believe that this may hinder responsible innovation, using RO notification as an example as to how it may delay and inhibit doctors from ‘taking some of the responsible risks they are able to make under current arrangements’, and RO ‘assurance’ would involve ‘substantially changing the role and remit of ROs’ which
‘would have resource and other implications for NHS and independent sector services, add unwelcome layers of bureaucracy, and require changes to the Medical Act which would be virtually impossible to draft in a meaningful way.’
Further noting ‘it is difficult to see how (the role of the MDT) would be interpreted in law, which would introduce further uncertainty for doctors and members of any multi-disciplinary team.’
They assert that it ‘does not provide a clear enough definition of medical innovation so as to define where the boundary lies between innovation and medical research. Our understanding is that this bill is aimed at doctors innovating to meet the needs of a particular patient. Whereas our understanding would be that innovation for a whole population of patients constitutes medical research.’
Clear that the Bill would ‘add new areas of uncertainty for doctors and others…adding unhelpful addition to the current practice.. removing an important safeguard for patients by removing a key requirement of responsible practice’ ; the GMC state ‘we do not consider that further developments in medical innovation can be best achieved by legislation drafted in these terms. We believe that much more can be done to promote responsible innovation in a way that may be more effective in achieving the stated aims of the draft Bill.’