The ABPI welcomes the opportunity to respond to the General Medical Council (GMC) consultation on 'Good practice in prescribing and managing medicines and devices'. This response has been developed in discussion with our member companies.
ABPI considers that the proposed GMC guidance in covering a broad range of topics will generally be useful to doctors. However, in one particular area, namely the prescribing of off-label or unlicensed medicines, there is a significant departure from previous guidance that we believe will result in the public being provided with a reduced level of protection compared to the current guidance.
ABPI supports the critical role that the GMC plays in protecting the public and believes that it can best fulfil this role by ensuring that all its guidance continues to put the best interests of patients above any other consideration. ABPI believes that the GMC’s current guidance offers a higher degree of patient protection than the proposed guidance now being consulted upon.
Our specific concerns are:
The proposed changes to the guidance on off-label and unlicensed medicines which suggest that prescribing of such medicines is acceptable, even where a licensed medicine is available, if the prescriber is satisfied ‘on the basis of authoritative clinical guidance that it is as safe and effective as an appropriately licensed alternative’ will, we believe, increase the risk to patient safety by undermining the medicines regulatory process that is fundamental to protecting the public.
The suggestion that patients need not be given information relevant to informing their consent to treatment with off-label or unlicensed medicines: this is not aligned to the GMC’s wider ethical guidance on patient participation in decisions about their care; nor is it aligned to the broad direction of clinical policy and practice to increase patient involvement in decision making.
The proposed changes pose a threat to the development of new medicines arising from a compromised regulatory framework and will create a potential disincentive for companies to submit medicines for regulatory and licensing approval which includes commitments to continuing post-authorisation safety reviews.
a. between the statutory role of the GMC in protecting the public from substandard medical practice and the statutory role of the MHRA in protecting the public from medicines that have not been independently assessed as offering adequate safety, efficacy and quality; and
b. between the clinical and NHS budgetary responsibilities of prescribers at a time when doctors are being asked to play an enhanced role in resource management accompanied by financial rewards for ‘success’.
ABPI recommends that the GMC maintains unchanged its existing guidance (2008) on the use of off-label and unlicensed medicines, which emphasises that while doctors should make ‘good use of the resources available’ this does not extend to prescribing a medicine outside the terms of its licence, unless the doctor is satisfied that it would better serve the patient’s needs than a licensed alternative. The existing guidance does not imply that cost can be an acceptable consideration in choosing an unlicensed medicine when there is a licensed alternative that meets the same clinical need.