Re: Why have UK doctors been deterred from prescribing Avastin?
It is quite wrong to suggest the GMC's position is unclear or that it is we who are putting doctors in a difficult position. It is also wrong to imply our guidance has recently been altered. Our prescribing guidance, which remains unchanged, was issued in January 2013.
The critical factor here is that our guidance must be lawful, and the law on this matter is unequivocal. Doctors cannot prescribe an unlicensed medicine on grounds of cost where a licensed product is available. This was confirmed by a ruling in the case of European Commission v Republic of Poland (C-185/10) in 2012.
At the same time we do support the efficient use of NHS resources and we are sympathetic to the argument that a better solution needs to be found for the use of Avastin in the treatment of wet age-related macular degeneration (AMD). We recognise too that doctors are placed in an invidious position as things currently stand.
Nevertheless, our guidance must support doctors to act within the law as it currently stands. We do make it clear that doctors may prescribe unlicensed medicines, including medicines for ‘off-label’/unlicensed use, outside the grounds for which they are licensed, where the doctor judges it to be in the patient’s interests and there is no licensed alternative.
Rapid Response:
Re: Why have UK doctors been deterred from prescribing Avastin?
It is quite wrong to suggest the GMC's position is unclear or that it is we who are putting doctors in a difficult position. It is also wrong to imply our guidance has recently been altered. Our prescribing guidance, which remains unchanged, was issued in January 2013.
The critical factor here is that our guidance must be lawful, and the law on this matter is unequivocal. Doctors cannot prescribe an unlicensed medicine on grounds of cost where a licensed product is available. This was confirmed by a ruling in the case of European Commission v Republic of Poland (C-185/10) in 2012.
At the same time we do support the efficient use of NHS resources and we are sympathetic to the argument that a better solution needs to be found for the use of Avastin in the treatment of wet age-related macular degeneration (AMD). We recognise too that doctors are placed in an invidious position as things currently stand.
Nevertheless, our guidance must support doctors to act within the law as it currently stands. We do make it clear that doctors may prescribe unlicensed medicines, including medicines for ‘off-label’/unlicensed use, outside the grounds for which they are licensed, where the doctor judges it to be in the patient’s interests and there is no licensed alternative.
Competing interests: No competing interests