The hon. Lady makes an important point about the classification of different drugs available to clinicians. Without detaining the House with too long a peroration on that classification, it is worth setting out that there is a clear cascade.
Clinicians can use unlicensed medicines in situations where, in their clinical judgment, and with patient consent, they believe it is the right thing to do. They are subject to all their usual professional undertakings. There are then off-label uses of drugs: drugs that do not have a licence for a particular indication but which the clinician, on the basis of evidence, is able to prescribe when they feel that evidence is compelling. The Bill now goes to the heart of that and will help to provide reassurance. For many clinicians, being able to click on a mouse with their patient and say, “For your condition there are one, two, three or no off-label medicines available for which NICE has looked at the evidence,” would be a powerful catalyst in helping to promote off-label use. There are generic drugs, which have been patented and brought to market, that are available at a heavily discounted open price.
There are then on-patent drugs, which have been brought to market and are still subject to a patent. The manufacturer has an exclusivity, which is the period in which their sunk costs in bringing the medicine to the system, can be reimbursed. That is an important protection to make sure we continue to have a thriving life science sector that can take the risks of investing in new drugs. Typically, new drugs take 15 years and £2 billion to develop. If there were no patenting mechanism, there would simply be no enthusiasm to do that research, which has a very high failure rate. In law, there is a key point of principle, which is that a licensed drug should be used first and that an unlicensed drug cannot be used purely on the basis of cost. That is a really important principle. An unlicensed drug can, however, be used on the basis of evidence. That is why the mechanism will allow NICE to look at the evidence and to signal to clinicians that they have the evidence basis on which to use the drug in an off-label indication.
One of the issues we have dealt with in discussions is the whole question of the European licensing of medicines. If we were to go down that route—I know the hon. Member for Central Ayrshire understands this—I can assure the House we would be here not just for weeks and months, but years. I am leading for the Government on reforming the European landscape of 21st medical
research. The central role of protecting innovators’ sunk costs is really important to our life sciences sector, and the new clauses and amendments create a mechanism by which we can accelerate off-label use without running a coach and horses through that.