The medicines licensing system exists for a reason. Patients have a right to know that the medicines they take have been deemed to be safe following a stringent process. Doctors need to be assured that the benefits of the treatments they prescribe outweigh any risks. A key principle of medicine is to, first, do no harm. The licensing system is an important part of making this principle a reality.
It is therefore always preferable that patients should be prescribed a medicine which is licensed for their condition. However, this is not always possible. A patient's circumstances may differ from those of the population or which a medicine is licensed. Or a patient's condition may be so rare that it has not been possible to license a treatment. In these circumstances, doctors may wish to use their clinical judgement to prescribe a medicine which is not licensed for their particular condition, but which the science suggests may be effective.
These situations are never easy and it is important that doctors are supported by high quality guidance in making them. The key principle should always be that the patient's interests must come first.
Consultation on this document, which began in 2011, has been extensive. The final version contains significant improvements on the draft and retains the GMC’s previous position on prescribing unlicensed medicines.
The result is a victory for common sense and patient safety. The regulator has listened to what stakeholders had to say and should be congratulated for the way it approached the issue.
The ABPI led the pharmaceutical industry response to the consultation. We worked closely with the GMC, government, charities, policy makers and of course our members. The outcome means that patients' interests will be at the heart of clinical decisions on the use of unlicensed medicines. It shows what can be achieved when we work together in a collaborative, open and constructive manner in the interests of patients.
ABPI Chief Executive