My Lords, I remind the House of my interests as declared in the register as chief executive of a medical research charity and chair of the NCRI, as I mentioned earlier.
This is a probing amendment. I apologise that I was unable to attend Second Reading, when I would have flagged up this issue. I took a tumble over the handlebars of my bicycle, so I was not able to be here. I am recovering, although I now have a little lisp.
My amendment probes whether UK Research and Innovation could have a role in ensuring that a particular avenue of research in which I am concerned—research
into new indications for off-patent drugs—is fully exploited for public benefit, for patients and the NHS where appropriate.
Research into new indications for off-patent drugs can be funded by medical research charities, research councils or the National Institute for Health Research. It is often driven forward by clinical academics. There is rarely a commercial incentive for pharmaceutical companies to support such investment once a patent has expired on a drug. There is then little commercial incentive for a pharmaceutical company to fund the regulatory activities needed to promote the availability of off-patent drugs in new indications, such as licensing them to be sold and advertised for such a new purpose. Therefore, the new indication, if identified, can remain off-label—or even unlicensed.
Where a treatment is off-label or unlicensed, a number of barriers prevent it being used routinely, and prevent the public investment in that research being exploited. Clinicians can prescribe for this new indication without a licence, but, if they do, they will take on more personal responsibility and, potentially, a greater administrative burden. This can create disincentives to prescribing, even where there is evidence to support the new indication.
There is no timely system in any of the UK nations for these repurposed drugs to find their way, if appropriate, into baseline commissioning. This results in confusion and patchy access across the UK. There are a number of examples, but I will pick up only two. The first example is bisphosphonates. They were originally licensed for the prevention of bone fractures in adults with advanced breast cancer, and subsequently licensed for osteoporosis. This class of drug is now off patent. However, bisphosphonates have been shown to be effective in reducing the risk in postmenopausal women with primary breast cancer of developing metastatic breast cancer, which is incurable.
Because bisphosphonates are off patent, they have not been licensed for this use and there is no clear national commissioning policy. We are all worrying about the really expensive drugs out there but, when used to prevent metastatic breast cancer, these cost about 43p a day. The treatment could save around 1,100 lives if given to the entire eligible population of about 35,000 women a year. If this treatment was commissioned routinely, as has been suggested, it could save the NHS about £5 million per annual cohort of patients.
Another good example of this would be simvastatin, a drug which may represent a real breakthrough for patients with secondary progressive multiple sclerosis. It is a type of statin which was originally licensed for treating high cholesterol and preventing cardiovascular disease, and the patent ran out in 2004. In a recent phase 2 clinical trial it was shown to be effective in slowing brain atrophy in secondary progressive multiple sclerosis by over 40%. More evidence is needed, but phase 3 clinical trials of this drug could show that this is the first treatment able to slow or stop the deterioration seen in that condition. There are estimated to be about 65,000 people living with this form of MS in the UK. The first patented disease-modifying therapies for
progressive forms of MS are likely to carry significant price tags, but this off-patent drug would cost the NHS pennies.
So there is clearly a gap—one could say a market failure—here. There could be a role for UKRI to fill this and promote the public interest by the exploitation of publicly funded research into new indications for old drugs. Studying repurposed drugs with public funding is an area of great interest. If we do not get it right it is a double waste of taxpayers’ money: once because of the public expenditure on research and twice because the benefits of that research do not reach the patients, resulting in an opportunity cost for the NHS. I am interested in probing whether there is an opportunity for the new institution to take forward this publicly funded research which would not otherwise be exploited commercially. I beg to move.