The Off-patent Drugs Bill


The George Pantziarka TP53 Trust has been a supporter of the Off-patent Drugs Bill for some time – writing in support of the Bill and adding our name and logo to a number of public interventions in favour of the Bill. The Bill is important in that it tackles one of the main obstacles to the adoption of old drugs for new diseases – the lack of licensing. We have already seen cases where old drugs have shown evidence of positive effects in cancer treatments, but the data from these clinical trials has not lead to changes in clinical practice. Why?

One of the reasons is that doctors are often unwilling to prescribe drugs unless the drug is ‘licensed’ for that disease. Each drug in clinical use is issued a licence by a regulator (the FDA in the US, the MHRA in the UK) for use in a specific disease setting – this is technically called the ‘marketing authorisation’. But if a new use is found for a drug – and my research as part of the Repurposing Drugs in Oncology (ReDO) project is all about finding new uses in cancer for old non-cancer drugs – then a new licence has to be granted. This process is long, complex and therefore expensive. So, in the case of old drugs, which are no longer covered by patent protection and can be manufactured as generics, who is going to invest the time and money to seek a new licence? No company will make the investment – anyone can come along and manufacture the drug and therefore there is no guarantee for a return on that investment.

Therefore, the Off-patent Drugs Bill seeks a way round this issue by suggesting that the government takes the lead and seeks the relicensing when there is evidence that these old drugs are effective in a new disease situation.

The important point is that once a drug gets relicensed then medical practice can start to change – prescribing information is updated, clinical guidelines updated and so on. More importantly any doctor who wants to use the drug can do so without the risks associated with ‘off-label’ prescribing.

In terms of LFS this has important implications. Should we get the evidence that metformin or aspirin can reduce the risk of cancer in people with LFS – and we sincerely hope that we can make progress on this in the future – then we will need to convince clinicians to prescribe this to patients. With a licence in place this job becomes much more straightforward.



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