The government is being urged to support a bill under which it would become responsible for seeking new licenses for off-patent drugs, if there is evidence to show they are effective in new indications.

Once a drug loses its patent there is no incentive for a pharmaceutical company to seek additional licenses for new uses as they no longer have a monopoly on providing it, which means that patients are only able to access promising new treatment approaches with old medicines if doctors prescribe them “off-label”.

The Off-Patent Drugs Bill is seeking to address this by ensuring that the Secretary of State for Health takes steps to secure licences for off-patent drugs in new indications, followed by a National Institute for Health and Care Excellence technology appraisal to ensure their widespread uptake by the NHS if appropriate.

“The Bill could, over time, revolutionise access to treatments across a whole range of medical conditions,” providing “a unique opportunity to take advantage of existing treatments that could have a positive use in a new way,” said Jonathan Evans MP introducing the Bill to parliament earlier this year.

“We are talking about low-cost treatments that have been around for a long time but that have the potential to transform lives,” he noted, while Mia Rosenblatt, Head of Policy and Campaigns at Breast Cancer Campaign, said it is “incomprehensible that there are low-cost, effective treatments out there which are not routinely available to patients because of red-tape”.

And yet, according to the charity, the government “has not yet come out in support of the Bill nor stated that they will vote in favour of it,” instead “suggesting minor awareness activity aimed at changing clinicians’ prescribing behaviour, which would not achieve the ambitions of the Bill”. 

Law needs reform 

“Only a reform of the law will amend this situation and the support of the government is crucial if this is to be achieved. The government needs to give this issue the priority it deserves,” the charity noted, pointing out that for breast cancer its potential impact could on survival rates and treatment costs “is significant”.

For example, it says the cost of the biphosphonate zoledronic acid - which could be given every six months for three to five years to slash the risk of breast cancer spreading to the bone in post-menopausal women by a third and risk of death from breast cancer by a sixth - is less than £1 per day. In comparison, Roche’s Perjeta (pertuzumab), which is available via the Cancer Drugs Fund to treat HER2-postive secondary breast cancer in combination with other drugs, costs at least £114 per day.

This Bill, which will have its second reading debate in parliament today (Friday), is also being supported by the Alzheimer’s Society, Leukaemia Care, Leukaemia & Lymphoma Research, the Association of Medical Research Charities (AMRC), and other leading clinicians.